80 results on '"James Ayieko"'
Search Results
2. Client experiences with 'Dynamic Choice Prevention,' a model for flexible patient‐centred HIV prevention delivery in rural Eastern Africa
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Carol S. Camlin, Titus Arunga, Jason Johnson‐Peretz, Cecilia Akatukwasa, Fredrick Atwine, Angeline Onyango, Lawrence Owino, Moses R. Kamya, Maya L. Petersen, Gabriel Chamie, Elijah Kakande, Jane Kabami, Laura B. Balzer, Diane V. Havlir, and James Ayieko
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pre‐exposure prophylaxis ,post‐exposure prophylaxis ,HIV self‐testing ,differentiated care ,HIV stigma ,sub‐Saharan Africa ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Identifying the optimal approaches to offering HIV prevention to meet the needs of those at risk is a high priority, particularly given the expanding toolkit of biomedical HIV prevention options. An ongoing study in rural East African communities evaluated the uptake of choices in product, testing mode and location of care delivery through a structured patient‐centred HIV prevention delivery model. In this qualitative study, we sought to understand clients’ experiences of this “dynamic choice prevention model” (DCP) and highlight pathways of action to inform HIV prevention delivery models. Methods In‐depth semi‐structured interviews were conducted from November 2021 through March 2022 with a purposively selected sample of n = 56 participants in DCP trials (across outpatient departments, antenatal clinics and community settings), and n = 21 healthcare providers (total n = 77). A seven‐person multi‐regional team translated and inductively coded transcript data. We used a framework analysis approach to identify emergent themes. Results Individuals taking up HIV pre‐exposure prophylaxis (PrEP) reported feelings of relief, liberation from fears of acquiring HIV and satisfaction with being able to take action despite partners’ behaviours. Couples used a range of approaches afforded by the study to persuade partners to get tested and opt for PrEP. Post‐exposure prophylaxis (PEP) use was less common, although women welcomed it in the event of sexual coercion or assault. Participants discussed switching from PEP to PrEP after familiarizing themselves with usage and ascertaining ongoing risk. Participants felt respected by providers, trusted them and appreciated being able to contact them directly for telephone support. Prevention uptake was hindered by stigma, limited experience with and knowledge of prevention methods, gendered and generational power dynamics within intimate partnerships and families, and negative perceptions of methods due to the products themselves. Participants anticipated long‐acting injectable PrEP could solve their challenges regarding pill size, daily pill burden and the likelihood of unwanted disclosure. Conclusions Diverse preferences and barriers to uptake of prevention require a choice of HIV prevention options, locations and delivery modalities—but in addition, flexible, competent and friendly care provision is crucial to promote uptake. Helping clients feel valued, and addressing their unique needs and challenges, enables their agency to prioritize their health.
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- 2024
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3. Clinical Implications of HIV Treatment and Prevention for Polygamous Families in Kenya and Uganda: 'My Co-Wife Is the One Who Used to Encourage Me'
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Jason Johnson-Peretz MPhil (Oxon), MAOM, Anjeline Onyango BA, Sarah A. Gutin PhD, MPH, Laura Balzer PhD, Cecilia Akatukwasa MPH, BSc, Lawrence Owino BSc, Titus M. O. Arunga BSc, Fred Atwine BA, Maya Petersen MD, PhD, Moses Kamya MMed, PhD, James Ayieko MBChb, MPH, PhD, Ted Ruel MD, Diane Havlir MD, and Carol S. Camlin PhD, MPH
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Diseases of the genitourinary system. Urology ,RC870-923 - Abstract
Polygamy is the practice of marriage to multiple partners. Approximately 6-11% of households in Uganda and 4-11% of households in Kenya are polygamous. The complex families produced by polygamous marriage customs give rise to additional considerations for healthcare providers and public health messaging around HIV care. Using 27 in-depth, semi-structured qualitative interviews with participants in two studies in rural Kenya and Uganda, we analysed challenges and opportunities that polygamous families presented in the diagnosis, treatment and prevention of HIV, and provider roles in improving HIV outcomes in these families. Overall, prevention methods seemed more justifiable to families where co-wives live far apart than when all members live in the same household. In treatment, diagnosis of one member did not always lead to disclosure to other members, creating an adverse home environment; but sometimes diagnosis of one wife led not only to diagnosis of the other, but also to greater household support.
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- 2024
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4. Exploring HIV risk perception mechanisms among youth in a test-and-treat trial in Kenya and Uganda.
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Lawrence Owino, Jason Johnson-Peretz, Joi Lee, Monica Getahun, Dana Coppock-Pector, Irene Maeri, Anjeline Onyango, Craig R Cohen, Elizabeth A Bukusi, Jane Kabami, James Ayieko, Maya Petersen, Moses R Kamya, Edwin Charlebois, Diane Havlir, and Carol S Camlin
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Public aspects of medicine ,RA1-1270 - Abstract
Understanding risk perception and risk-taking among youth can inform targeted prevention efforts. Using a health beliefs model-informed framework, we analysed 8 semi-structured, gender-specific focus group discussions with 93 youth 15-24 years old (48% male, 52% female), drawn from the SEARCH trial in rural Kenya and Uganda in 2017-2018, coinciding with the widespread introduction of PrEP. Highly connected social networks and widespread uptake of antiretrovirals shaped youth HIV risk perception. Amid conflicting information about HIV prevention methods, youth felt exposed to multiple HIV risk factors like the high prevalence of HIV, belief that people with HIV(PWH) purposefully infect others, dislike of condoms, and doubts about PrEP efficacy. Young women also reported minimal sexual autonomy in the context of economic disadvantages, the ubiquity of intergenerational and transactional sex, and peer pressure from other women to have many boyfriends. Young men likewise reported vulnerability to intergenerational sex, but also adopted a sexual conquest mentality. Comprehensive sexuality education and economic empowerment, through credible and trusted sources, may moderate risk-taking. Messaging should leverage youth's social networks to spread fact-based, gender- and age-appropriate information. PrEP should be offered alongside other reproductive health services to address both pregnancy concerns and reduce HIV risk.
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- 2024
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5. Effect of a brief alcohol counselling intervention on HIV viral suppression and alcohol use among persons with HIV and unhealthy alcohol use in Uganda and Kenya: a randomized controlled trial
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Sarah B. Puryear, Florence Mwangwa, Fred Opel, Gabriel Chamie, Laura B. Balzer, Jane Kabami, James Ayieko, Asiphas Owaraganise, Elijah Kakande, George Agengo, Elizabeth Bukusi, Stella Kabageni, Daniel Omoding, Melanie Bacon, John Schrom, Sarah Woolf‐King, Maya L. Petersen, Diane V. Havlir, Moses Kamya, and Judith A. Hahn
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HIV ,viral suppression ,alcohol use ,brief counselling intervention ,sub‐Saharan Africa ,randomized controlled trial ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Unhealthy alcohol use significantly contributes to viral non‐suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub‐Saharan Africa (SSA). Methods As part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills‐based alcohol intervention among PWH with self‐reported unhealthy alcohol use (Alcohol Use Disorders Identification Test–Consumption [AUDIT‐C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non‐suppression, defined as either recent HIV viral non‐suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3‐month in‐person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (200 ng/ml (RR 0.97, 95% CI: 0.92–1.02). Conclusions In a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non‐suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV‐associated co‐morbidities.
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- 2023
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6. A community‐based dynamic choice model for HIV prevention improves PrEP and PEP coverage in rural Uganda and Kenya: a cluster randomized trial
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Elijah R. Kakande, James Ayieko, Helen Sunday, Edith Biira, Marilyn Nyabuti, George Agengo, Jane Kabami, Colette Aoko, Hellen N. Atuhaire, Norton Sang, Asiphas Owaranganise, Janice Litunya, Erick W. Mugoma, Gabriel Chamie, James Peng, John Schrom, Melanie C. Bacon, Moses R. Kamya, Diane V. Havlir, Maya L. Petersen, Laura B. Balzer, and for the SEARCH Study Team
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client‐centred ,community health worker ,dynamic choice ,pre‐exposure prophylaxis ,post‐exposure prophylaxis ,village health team ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Optimizing HIV prevention may require structured approaches for providing client‐centred choices as well as community‐based entry points and delivery. We evaluated the effect of a dynamic choice model for HIV prevention, delivered by community health workers (CHWs) with clinician support, on the use of biomedical prevention among persons at risk of HIV in rural East Africa. Methods We conducted a cluster randomized trial among persons (≥15 years) with current or anticipated HIV risk in 16 villages in Uganda and Kenya (SEARCH; NCT04810650). The intervention was a client‐centred HIV prevention model, including (1) structured client choice of product (pre‐exposure prophylaxis [PrEP] or post‐exposure prophylaxis [PEP]), service location (clinic or out‐of‐clinic) and HIV testing modality (self‐test or rapid test), with the ability to switch over time; (2) a structured assessment of patient barriers and development of a personalized support plan; and (3) phone access to a clinician 24/7. The intervention was delivered by CHWs and supported by clinicians who oversaw PrEP and PEP initiation and monitoring. Participants in control villages were referred to local health facilities for HIV prevention services, delivered by Ministry of Health staff. The primary outcome was biomedical prevention coverage: a proportion of 48‐week follow‐up with self‐reported PrEP or PEP use. Results From May to July 2021, we enrolled 429 people (212 intervention; 217 control): 57% women and 35% aged 15–24 years. Among intervention participants, 58% chose PrEP and 58% chose PEP at least once over follow‐up; self‐testing increased from 52% (baseline) to 71% (week 48); ≥98% chose out‐of‐facility service delivery. Among 413 (96%) participants with the primary outcome ascertained, average biomedical prevention coverage was 28.0% in the intervention versus 0.5% in the control: a difference of 27.5% (95% CI: 23.0–31.9%, p
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- 2023
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7. Uptake of a patient‐centred dynamic choice model for HIV prevention in rural Kenya and Uganda: SEARCH SAPPHIRE study
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Jane Kabami, Elijah Kakande, Gabriel Chamie, Laura B. Balzer, Maya L. Petersen, Carol S. Camlin, Marilyn Nyabuti, Catherine A. Koss, Elizabeth A. Bukusi, Moses R. Kamya, Diane V. Havlir, and James Ayieko
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antenatal ,HIV prevention ,outpatient and community ,PEP ,PrEP ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Person‐centred HIV prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. However, data are lacking on the actual uptake of choices among persons at risk of HIV in southern Africa. In an ongoing randomized study (SEARCH; NCT04810650) in rural East Africa, we evaluated the uptake of choices made when offered in a person‐centred, dynamic choice model for HIV prevention. Methods Using the PRECEDE framework, we developed a persont‐centred, Dynamic Choice HIV Prevention (DCP) intervention for persons at risk of HIV in three settings in rural Kenya and Uganda: antenatal clinic (ANC), outpatient department (OPD) and in the community. Components include: provider training on product choice (predisposing); flexibility and responsiveness to client desires and choices (pre‐exposure prophylaxis [PrEP]/post‐exposure prophylaxis [PEP], clinic vs. off‐site visits and self‐ or clinician‐based HIV testing) (enabling); and client and staff feedback (reinforcing). All clients received a structured assessment of barriers with personalized plans to address them, mobile phone access to clinicians (24 hours/7 days/week) and integrated reproductive health services. In this interim analysis, we describe the uptake of choices of product, location and testing during the first 24 weeks of follow‐up (April 2021−March 2022). Results A total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person‐centred DCP intervention. We delivered the DCP intervention in all three settings with diverse populations: ANC: 39% pregnant; median age: 24 years; OPD: 39% male, median age 27 years; and community: 42% male, median age: 29 years. Baseline choice of PrEP was highest in ANC (98%) vs. OPD (84%) and community (40%); whereas the proportion of adults selecting PEP was higher in the community (46%) vs. OPD (8%) and ANC (1%). Personal preference for off‐site visits increased over time (65% at week 24 vs. 35% at baseline). Interest in alternative HIV testing modalities grew over time (38% baseline self‐testing vs. 58% at week 24). Conclusions A person‐centred model incorporating structured choice in biomedical prevention and care delivery options in settings with demographically diverse groups, in rural Kenya and Uganda, was responsive to varying personal preferences over time in HIV prevention programmes.
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- 2023
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8. Mobility and HIV care engagement: a research agenda
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Marguerite Thorp, James Ayieko, Risa M. Hoffman, Kelvin Balakasi, Carol S. Camlin, and Kathryn Dovel
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HIV ,mobility ,migration ,sub‐Saharan Africa ,antiretroviral therapy ,outcomes ,Immunologic diseases. Allergy ,RC581-607 - Abstract
Abstract Introduction Mobility is common and an essential livelihood strategy in sub‐Saharan Africa (SSA). Mobile people suffer worse outcomes at every stage of the HIV care cascade compared to non‐mobile populations. Definitions of mobility vary widely, and research on the role of temporary mobility (as opposed to permanent migration) in HIV treatment outcomes is often lacking. In this article, we review the current landscape of mobility and HIV care research to identify what is already known, gaps in the literature, and recommendations for future research. Discussion Mobility in SSA is closely linked to income generation, though caregiving, climate change and violence also contribute to the need to move. Mobility is likely to increase in the coming decades, both due to permanent migration and increased temporary mobility, which is likely much more common. We outline three central questions regarding mobility and HIV treatment outcomes in SSA. First, it is unclear what aspects of mobility matter most for HIV care outcomes and if high‐risk mobility can be identified or predicted, which is necessary to facilitate targeted interventions for mobile populations. Second, it is unclear what groups are most vulnerable to mobility‐associated treatment interruption and other adverse outcomes. And third, it is unclear what interventions can improve HIV treatment outcomes for mobile populations. Conclusions Mobility is essential for people living with HIV in SSA. HIV treatment programmes and broader health systems must understand and adapt to human mobility, both to promote the rights and welfare of mobile people and to end the HIV pandemic.
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- 2023
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9. Geographic Mobility and HIV Care Engagement among People Living with HIV in Rural Kenya and Uganda
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James Ayieko, Marguerite Thorp, Monica Getahun, Monica Gandhi, Irene Maeri, Sarah A. Gutin, Jaffer Okiring, Moses R. Kamya, Elizabeth A. Bukusi, Edwin D. Charlebois, Maya Petersen, Diane V. Havlir, Carol S. Camlin, and Pamela M. Murnane
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HIV ,human mobility ,retention in care ,treatment adherence ,sex differences ,Medicine - Abstract
Introduction: Human mobility is a critical aspect of existence and survival, but may compromise care engagement among people living with HIV (PLHIV). We examined the association between various forms of human mobility with retention in HIV care and antiretroviral treatment (ART) interruptions. Methods: In a cohort of adult PLHIV in Kenya and Uganda, we collected surveys in 2016 about past 6-month travel and lifetime migration histories, including reasons and locations, and engagement in HIV care defined as (1) discontinuation of care, and (2) history of a treatment interruption among those who remained in care. We estimated associations between mobility and these care engagement outcomes via logistic regression, adjusted for sex, prior mobility, age, region, marital status, household wealth, and education. Results: Among 1081 participants, 56 (5%) reported having discontinued care; among those in care, 104 (10%) reported treatment interruption. Past-year migration was associated with a higher risk of discontinuation of care (adjusted odds ratio [aOR] 1.98, 95% CI 1.08–3.63). In sex-stratified models, the association was somewhat attenuated in women, but remained robust among men. Past-year migration was associated with reduced odds of having a treatment interruption among men (aOR 0.51, 95% CI 0.34–0.77) but not among women (aOR 2.67, 95% CI 0.78, 9.16). Travel in the past 6 months was not associated with discontinuation of care or treatment interruptions. Conclusions: We observed both negative and protective effects of recent migration on care engagement and ART use that were most pronounced among men in this cohort. Migration can break ties to ongoing care, but for men, who have more agency in the decision to migrate, may foster new care and treatment strategies. Strategies that enable health facilities to support individuals throughout the process of transferring care could alleviate the risk of care disengagement.
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- 2023
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10. Improving care engagement for mobile people living with HIV in rural western Kenya.
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James Ayieko, Edwin D Charlebois, Irene Maeri, Lawrence Owino, Marguerite Thorp, Elizabeth A Bukusi, Maya L Petersen, Moses R Kamya, Diane V Havlir, and Carol S Camlin
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Medicine ,Science - Abstract
BackgroundAntiretroviral therapy (ART) assures major gains in health outcomes among people living with HIV, however, this benefit may not be realized by all due to care interruptions. Mobile populations comprise a subgroup that is likely to have sub-optimal care engagement, resulting in discontinuation of ART. We sought to evaluate the barriers to care engagement among highly mobile individuals living with HIV and explore options aimed at improving engagement in care for this group.MethodsQualitative in-depth interviews were conducted in 2020 among a purposive sample of twelve persons living with HIV and eight health care providers in western Kenya, within a mixed methods study of mobility in communities participating in the SEARCH trial (NCT01864603). We explored the barriers to care engagement among mobile individuals living with HIV and explored different options aimed at enhancing care engagement. These included options such as a coded card containing treatment details, alternative drug packaging to conceal drug identity, longer refills to cover travel period, wrist bands with data storage capability to enable data transfer and "warm handoff" by providers to new clinics upon transfer. Data were inductively analyzed to understand the barriers and acceptability of potential interventions to address them.ResultsStigma and lack of disclosure, rigid work schedules, and unpredictability of travel were major barriers to care engagement for highly mobile individuals living with HIV. Additionally, lack of flexibility in clinic schedules and poor provider attitude were identified as health-system-associated barriers to care engagement. Options that enhance flexibility, convenience and access to care were viewed as the most effective means of addressing the barriers to care by both patients and providers. The most preferred option was a coded card with treatment details followed by alternative drug packaging to conceal drug identity due to stigma and longer refills to cover travel periods.ConclusionHighly mobile individuals living with HIV desire responsive, flexible, convenient and patient-centered care delivery models to enhance care engagement. They embraced simple health delivery improvements such as coded cards, alternative drug packaging and longer refills to address challenges of mobility.
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- 2023
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11. Navigating antiretroviral adherence in boarding secondary schools in Nairobi, Kenya: A qualitative study of adolescents living with HIV, their caregivers and school nurses.
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Nicholas Kipkurui, Emmah Owidi, James Ayieko, Gerald Owuor, Irene Mugenya, Kawango Agot, and Alison C Roxby
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Public aspects of medicine ,RA1-1270 - Abstract
In Kenya, adolescents spend much of their formative years in boarding secondary schools, which presents a challenging environment for antiretroviral (ART) adherence support among adolescents living with HIV (ALHIV). We examined the experiences of ALHIV, caregivers of adolescents, and school nurses regarding navigating ART adherence in boarding secondary schools. Between July and November 2022, we conducted focus group discussions (FGDs) among ALHIV attending boarding schools in Nairobi, Kenya, and caregivers of ALHIV, and in-depth interviews (IDIs) with school nurses. Clinic records were used to identify ALHIV and caregivers, who were invited to participate based on their availability. We categorized boarding schools into national, county, and sub-county levels and selected two schools from each category. We obtained permission from head teachers and invited school nurses to take part in virtual IDIs. The interviews were audio-recorded, transcribed verbatim, and analyzed thematically. We conducted two FGDs with 11 caregivers, two FGDs with 18 adolescents, and 7 IDIs with school nurses. Most of the ALHIV reported having disclosed their HIV status to a school nurse or teacher during admission. School nurse friendliness, being understanding, fair, and confidential were qualities associated with ALHIV willingness to confide in them. Strategies ALHIV used to adhere to medication included: waiting until students were engaged in other activities, waking up early, stepping away from others, and stating their drugs were for different ailments. Caregivers were nervous about school-based adherence counseling, fearing it could lead to inadvertent disclosure of adolescents' HIV status and stigmatization by fellow students. All school nurses reported lacking appropriate training in HIV adherence counseling for adolescents. ALHIV have devised innovative strategies to navigate pill-taking and enlist quiet support while operating in stigmatized school environments. Establishment of a strong school nurse-adolescent rapport and building nurses' skills are key to improving school-based support for ALHIV.
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- 2023
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12. Effect of a one-time financial incentive on linkage to chronic hypertension care in Kenya and Uganda: A randomized controlled trial.
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Matthew D Hickey, Asiphas Owaraganise, Norton Sang, Fredrick J Opel, Erick Wafula Mugoma, James Ayieko, Jane Kabami, Gabriel Chamie, Elijah Kakande, Maya L Petersen, Laura B Balzer, Moses R Kamya, and Diane V Havlir
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Medicine ,Science - Abstract
BackgroundFewer than 10% of people with hypertension in sub-Saharan Africa are diagnosed, linked to care, and achieve hypertension control. We hypothesized that a one-time financial incentive and phone call reminder for missed appointments would increase linkage to hypertension care following community-based screening in rural Uganda and Kenya.MethodsIn a randomized controlled trial, we conducted community-based hypertension screening and enrolled adults ≥25 years with blood pressure ≥140/90 mmHg on three measures; we excluded participants with known hypertension or hypertensive emergency. The intervention was transportation reimbursement upon linkage (~$5 USD) and up to three reminder phone calls for those not linking within seven days. Control participants received a clinic referral only. Outcomes were linkage to hypertension care within 30 days (primary) and hypertension control ResultsWe screened 1,998 participants, identifying 370 (18.5%) with uncontrolled hypertension and enrolling 199 (100 control, 99 intervention). Reasons for non-enrollment included prior hypertension diagnosis (n = 108) and hypertensive emergency (n = 32). Participants were 60% female, median age 56 (range 27-99); 10% were HIV-positive and 42% had baseline blood pressure ≥160/100 mmHg. Linkage to care within 30 days was 96% in intervention and 66% in control (aRR 1.45, 95%CI 1.25-1.68). Hypertension control at 90 days was 51% intervention and 41% control (aRR 1.22, 95%CI 0.92-1.66).ConclusionA one-time financial incentive and reminder call for missed visits resulted in a 30% absolute increase in linkage to hypertension care following community-based screening. Financial incentives can improve the critical step of linkage to care for people newly diagnosed with hypertension in the community.
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- 2022
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13. Effect of universal HIV testing and treatment on socioeconomic wellbeing in rural Kenya and Uganda: a cluster-randomised controlled trial
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Aleksandra Jakubowski, PhD, Jane Kabami, MPH, Laura B Balzer, PhD, James Ayieko, MBChB, Edwin D Charlebois, ProfPhD, Asiphas Owaraganise, MBChB, Carina Marquez, PhD, Tamara D Clark, MPH, Douglas Black, BA, Starley B Shade, ProfPhD, Gabriel Chamie, MD, Craig R Cohen, ProfMD, Elizabeth A Bukusi, ProfPhD, Moses R Kamya, ProfPhD, Maya Petersen, PhD, Diane V Havlir, ProfMD, and Harsha Thirumurthy, PhD
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Public aspects of medicine ,RA1-1270 - Abstract
Summary: Background: Universal testing and treatment for HIV has shown promise as an approach to reduce mortality and lower HIV incidence. Evidence on the economic effects of this approach on individuals and households in low-resource settings is scarce. We aimed to examine the effect of universal HIV testing and treatment on a range of economic outcomes. Methods: We collected data in household surveys done over a 3-year period in a sample of HIV-positive and HIV-negative adults participating in a cluster-randomised trial of universal HIV testing and treatment in 32 rural communities in Kenya and Uganda. Communities of approximately 10 000 people were pair-matched on the basis of geographical and population characteristics, with the best-matching 16 pairs randomly assigned (1:1) to intervention or control groups. Participants in intervention communities received annual HIV and multidisease testing, universal antiretroviral therapy (ART) eligibility, and patient-centred care. Participants in control communities received baseline testing and medical care according to national guidelines. We analysed employment and health-care utilisation outcomes for working-age adults (age 18–65 years) and education outcomes for school-age children (6–17 years) using data from 3 years after the intervention. This trial is now complete, and is registered with ClinicalTrials.gov, NCT01864603. Findings: Between July 9, 2013, and June 15, 2017, we collected survey data on 8198 working-age adults and 6755 school-age children. Compared with adults living with HIV in control communities, adults living with HIV in intervention communities were more likely to be employed (difference 9·7% [95% CI 2·1 to 18·3]), less likely to seek health care (–10·3% [–22·0 to 0·1]), and less likely to spend money on health care (–12·7% [–22·4 to 0·6]) 3 years after the intervention. We found no significant differences in outcomes between HIV-negative adults in intervention and control communities. Among children in households with HIV-positive adults, the intervention led to a 7·3% (95% CI 1·0 to 15·1) increase in primary school completion after 3 years in intervention communities compared with control communities. Interpretation: Universal HIV testing and treatment improved employment outcomes and other indicators of socioeconomic wellbeing for HIV-positive adults and children in their households, but had no effect on HIV-negative adults. Our findings suggest that the considerable investments needed to expand ART access might have substantial short-term and long-term economic returns. Funding: National Institutes of Health.
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- 2022
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14. Provider and Patient Perspectives of Rapid ART Initiation and Streamlined HIV Care: Qualitative Insights From Eastern African Communities
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Florence Mwangwa, Monica Getahun, Harriet Itiakorit, Vivek Jain, James Ayieko, Lawrence Owino, Cecilia Akatukwasa, Irene Maeri, Catherine A. Koss, Gabriel Chamie, Tamara D. Clark, Jane Kabami, Mucunguzi Atukunda, Dalsone Kwarisiima, Norton Sang, Elizabeth A. Bukusi, Moses R. Kamya, Maya L. Petersen, Craig R. Cohen, Edwin D. Charlebois, Diane V. Havlir, and Carol S. Camlin
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Diseases of the genitourinary system. Urology ,RC870-923 - Abstract
The Sustainable East Africa Research in Community Health (SEARCH), a universal test and treat (UTT) trial, implemented ‘Streamlined Care’—a multicomponent strategy including rapid linkage to care and antiretroviral therapy (ART) start, 3-monthly refills, viral load counseling, and accessible, patient-centered care provision. To understand patient and provider experiences of Streamlined Care to inform future care innovations, we conducted in-depth interviews with patients ( n = 18) and providers ( n = 28) at baseline (2014) and follow-up (2015) ( n = 17 patients; n = 21 providers). Audio recordings were transcribed, translated, and deductively and inductively coded. Streamlined Care helped to decongest clinic spaces and de-stigmatize human immunodeficiency virus (HIV) care. Patients credited the individualized counselling, provider-assisted HIV status disclosure, and providers’ knowledge of patient's drug schedules, availability, and phone call reminders for their care engagement. However, for some, denial (repeated testing to disprove HIV+ results), feeling healthy, limited understanding of the benefits of early ART, and anticipated side-effects, and mistrust of researchers hindered rapid ART initiation. Patients’ short and long-term mobility proved challenging for both patients and providers. Providers viewed viral load counselling as a powerful tool to convince otherwise healthy and high-CD4 patients to initiate ART. Patient-centered HIV care models should build on the successes of Streamlined Care, while addressing persistent barriers. #NCT01864683— https://clinicaltrials.gov/ct2/show/NCT01864603
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- 2021
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15. Effect of a patient-centered hypertension delivery strategy on all-cause mortality: Secondary analysis of SEARCH, a community-randomized trial in rural Kenya and Uganda.
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Matthew D Hickey, James Ayieko, Asiphas Owaraganise, Nicholas Sim, Laura B Balzer, Jane Kabami, Mucunguzi Atukunda, Fredrick J Opel, Erick Wafula, Marilyn Nyabuti, Lillian Brown, Gabriel Chamie, Vivek Jain, James Peng, Dalsone Kwarisiima, Carol S Camlin, Edwin D Charlebois, Craig R Cohen, Elizabeth A Bukusi, Moses R Kamya, Maya L Petersen, and Diane V Havlir
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Medicine - Abstract
BackgroundHypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda.Methods and findingsThis is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure ConclusionsIn this cluster randomized comparison where both arms received population-level hypertension screening, implementation of a patient-centered hypertension care model was associated with a 21% reduction in all-cause mortality and a 22% improvement in hypertension control compared to standard care among adults with baseline uncontrolled hypertension. Patient-centered chronic care programs for HIV can be leveraged to reduce the overall burden of cardiovascular mortality in SSA.Trial registrationClinicalTrials.gov NCT01864603.
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- 2021
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16. Detection of HIV-1 Transmission Clusters from Dried Blood Spots within a Universal Test-and-Treat Trial in East Africa
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Emma Pujol-Hodge, Jesus F. Salazar-Gonzalez, Deogratius Ssemwanga, Edwin D. Charlebois, James Ayieko, Heather E. Grant, Teri Liegler, Katherine E. Atkins, Pontiano Kaleebu, Moses R. Kamya, Maya Petersen, Diane V. Havlir, and Andrew J. Leigh Brown
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HIV ,phylogenetics ,phylodynamics ,cluster ,transmission network ,molecular epidemiology ,Microbiology ,QR1-502 - Abstract
The Sustainable East Africa Research in Community Health (SEARCH) trial was a universal test-and-treat (UTT) trial in rural Uganda and Kenya, aiming to lower regional HIV-1 incidence. Here, we quantify breakthrough HIV-1 transmissions occurring during the trial from population-based, dried blood spot samples. Between 2013 and 2017, we obtained 549 gag and 488 pol HIV-1 consensus sequences from 745 participants: 469 participants infected prior to trial commencement and 276 SEARCH-incident infections. Putative transmission clusters, with a 1.5% pairwise genetic distance threshold, were inferred from maximum likelihood phylogenies; clusters arising after the start of SEARCH were identified with Bayesian time-calibrated phylogenies. Our phylodynamic approach identified nine clusters arising after the SEARCH start date: eight pairs and one triplet, representing mostly opposite-gender linked (6/9), within-community transmissions (7/9). Two clusters contained individuals with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance, both linked to intervention communities. The identification of SEARCH-incident, within-community transmissions reveals the role of unsuppressed individuals in sustaining the epidemic in both arms of a UTT trial setting. The presence of transmitted NNRTI resistance, implying treatment failure to the efavirenz-based antiretroviral therapy (ART) used during SEARCH, highlights the need to improve delivery and adherence to up-to-date ART recommendations, to halt HIV-1 transmission.
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- 2022
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17. HIV incidence after pre-exposure prophylaxis initiation among women and men at elevated HIV risk: A population-based study in rural Kenya and Uganda.
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Catherine A Koss, Diane V Havlir, James Ayieko, Dalsone Kwarisiima, Jane Kabami, Gabriel Chamie, Mucunguzi Atukunda, Yusuf Mwinike, Florence Mwangwa, Asiphas Owaraganise, James Peng, Winter Olilo, Katherine Snyman, Benard Awuonda, Tamara D Clark, Douglas Black, Joshua Nugent, Lillian B Brown, Carina Marquez, Hideaki Okochi, Kevin Zhang, Carol S Camlin, Vivek Jain, Monica Gandhi, Craig R Cohen, Elizabeth A Bukusi, Edwin D Charlebois, Maya L Petersen, Moses R Kamya, and Laura B Balzer
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Medicine - Abstract
BackgroundOral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but data are limited on HIV incidence among PrEP users in generalized epidemic settings, particularly outside of selected risk groups. We performed a population-based PrEP study in rural Kenya and Uganda and sought to evaluate both changes in HIV incidence and clinical and virologic outcomes following seroconversion on PrEP.Methods and findingsDuring population-level HIV testing of individuals ≥15 years in 16 communities in the Sustainable East Africa Research in Community Health (SEARCH) study (NCT01864603), we offered universal access to PrEP with enhanced counseling for persons at elevated HIV risk (based on serodifferent partnership, machine learning-based risk score, or self-identified HIV risk). We offered rapid or same-day PrEP initiation and flexible service delivery with follow-up visits at facilities or community-based sites at 4, 12, and every 12 weeks up to week 144. Among participants with incident HIV infection after PrEP initiation, we offered same-day antiretroviral therapy (ART) initiation and analyzed HIV RNA, tenofovir hair concentrations, drug resistance, and viral suppression (ConclusionsPopulation-level offer of PrEP with rapid start and flexible service delivery was associated with 74% lower HIV incidence among PrEP initiators compared to matched recent controls prior to PrEP availability. HIV infections were significantly lower among women who started PrEP. Universal HIV testing with linkage to treatment and prevention, including PrEP, is a promising approach to accelerate reductions in new infections in generalized epidemic settings.Trial registrationClinicalTrials.gov NCT01864603.
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- 2021
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18. Characteristics of HIV seroconverters in the setting of universal test and treat: Results from the SEARCH trial in rural Uganda and Kenya.
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Marilyn N Nyabuti, Maya L Petersen, Elizabeth A Bukusi, Moses R Kamya, Florence Mwangwa, Jane Kabami, Norton Sang, Edwin D Charlebois, Laura B Balzer, Joshua D Schwab, Carol S Camlin, Douglas Black, Tamara D Clark, Gabriel Chamie, Diane V Havlir, and James Ayieko
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Medicine ,Science - Abstract
BackgroundAdditional progress towards HIV epidemic control requires understanding who remains at risk of HIV infection in the context of high uptake of universal testing and treatment (UTT). We sought to characterize seroconverters and risk factors in the SEARCH UTT trial (NCT01864603), which achieved high uptake of universal HIV testing and ART coverage in 32 communities of adults (≥15 years) in rural Uganda and Kenya.MethodsIn a pooled cohort of 117,114 individuals with baseline HIV negative test results, we described those who seroconverted within 3 years, calculated gender-specific HIV incidence rates, evaluated adjusted risk ratios (aRR) for seroconversion using multivariable targeted maximum likelihood estimation, and assessed potential infection sources based on self-report.ResultsOf 704 seroconverters, 63% were women. Young (15-24 years) men comprised a larger proportion of seroconverters in Western Uganda (18%) than Eastern Uganda (6%) or Kenya (10%). After adjustment for other risk factors, men who were mobile [≥1 month of prior year living outside community] (aRR:1.68; 95%CI:1.09,2.60) or who HIV tested at home vs. health fair (aRR:2.44; 95%CI:1.89,3.23) were more likely to seroconvert. Women who were aged ≤24 years (aRR:1.91; 95%CI:1.27,2.90), mobile (aRR:1.49; 95%CI:1.04,2.11), or reported a prior HIV test (aRR:1.34; 95%CI:1.06,1.70), or alcohol use (aRR:2.07; 95%CI:1.34,3.22) were more likely to seroconvert. Among survey responders (N = 607, 86%), suspected infection source was more likely for women than men to be ≥10 years older (28% versus 8%) or a spouse (51% vs. 31%) and less likely to be transactional sex (10% versus 16%).ConclusionIn the context of universal testing and treatment, additional strategies tailored to regional variability are needed to address HIV infection risks of young women, alcohol users, mobile populations, and those engaged in transactional sex to further reduce HIV incidence rates.
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- 2021
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19. Hypertension testing and treatment in Uganda and Kenya through the SEARCH study: An implementation fidelity and outcome evaluation.
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David J Heller, Laura B Balzer, Dhruv Kazi, Edwin D Charlebois, Dalsone Kwarisiima, Florence Mwangwa, Vivek Jain, Prashant Kotwani, Gabriel Chamie, Craig R Cohen, Tamara D Clark, James Ayieko, Dathan M Byonanabye, Maya Petersen, Moses R Kamya, Diane Havlir, and James G Kahn
- Subjects
Medicine ,Science - Abstract
BackgroundHypertension (HTN) is the single leading risk factor for human mortality worldwide, and more prevalent in sub-Saharan Africa than any other region [1]-although resources for HTN screening, treatment, and control are few. Most regional pilot studies to leverage HIV programs for HTN control have achieved blood pressure control in half of participants or fewer [2,3,4]. But this control gap may be due to inconsistent delivery of services, rather than ineffective underlying interventions.MethodsWe sought to evaluate the consistency of HTN program delivery within the SEARCH study (NCT01864603) among 95,000 adults in 32 rural communities in Uganda and Kenya from 2013-2016. To achieve this objective, we designed and performed a fidelity evaluation of the step-by-step process (cascade) of HTN care within SEARCH, calculating rates of HTN screening, linkage to care, and follow-up care. We evaluated SEARCH's assessment of each participant's HTN status against measured blood pressure and HTN history.FindingsSEARCH completed blood pressure screens on 91% of participants. SEARCH HTN screening was 91% sensitive and over 99% specific for HTN relative to measured blood pressure and patient history. 92% of participants screened HTN+ received clinic appointments, and 42% of persons with HTN linked to subsequent care. At follow-up, 82% of SEARCH clinic participants received blood pressure checks; 75% received medication appropriate for their blood pressure; 66% remained in care; and 46% had normal blood pressure at their most recent visit.ConclusionThe SEARCH study's consistency in delivering screening and treatment services for HTN was generally high, but SEARCH could improve effectiveness in linking patients to care and achieving HTN control. Its model for implementing population-scale HTN testing and care through an existing HIV test-and-treat program-and protocol for evaluating the intervention's stepwise fidelity and care outcomes-may be adapted, strengthened, and scaled up for use across multiple resource-limited settings.
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- 2020
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20. Gaps in the child tuberculosis care cascade in 32 rural communities in Uganda and Kenya
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Florence Mwangwa, Gabriel Chamie, Dalsone Kwarisiima, James Ayieko, Asiphas Owaraganise, Theodore D. Ruel, Albert Plenty, Khai Hoan Tram, Tamara D. Clark, Craig R. Cohen, Elizabeth A. Bukusi, Maya Petersen, Moses R. Kamya, Edwin D. Charlebois, Diane V. Havlir, and Carina Marquez
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Diseases of the respiratory system ,RC705-779 ,Infectious and parasitic diseases ,RC109-216 - Abstract
Background: Reducing tuberculosis (TB) deaths among children requires a better understanding of the gaps in the care cascade from TB diagnosis to treatment completion. We sought to assess the child TB care cascade in 32 rural communities in Uganda and Kenya using programmatic data. Methods: This is a retrospective cohort study of 160,851 children (agesâ¯
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- 2017
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21. HIV status and treatment influence on fertility desires among women newly becoming eligible for antiretroviral therapy in western Kenya: insights from a qualitative study
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James Ayieko, Angeline Ti, Jill Hagey, Eliud Akama, Elizabeth A Bukusi, Craig R Cohen, and Rena C Patel
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HIV-infected women ,ART-naïve ,Fertility desires ,Kenya ,Gynecology and obstetrics ,RG1-991 - Abstract
Abstract Background Factors influencing fertility desires among HIV-infected individuals remain poorly understood. With new recommendations for universal HIV treatment and increasing antiretroviral therapy (ART) access, we sought to evaluate how access to early ART influences fertility desires among HIV-infected ART-naïve women. Methods Semi-structured in-depth interviews were conducted with a select subgroup of 20 HIV-infected ART-naïve women attending one of 13 HIV facilities in western Kenya between July and August 2014 who would soon newly become eligible to initiate ART based on the latest national policy recommendations. The interviews covered four major themes: 1) definitions of family and children’s role in community; 2) personal, interpersonal, institutional, and societal factors influencing fertility desires; 3) influence of HIV-positive status on fertility desires; and 4) influence of future ART initiation on fertility desires. An iterative process of reading transcripts, applying inductive codes, and comparing and contrasting codes was used to identify convergent and divergent themes. Results The women indicated their HIV-positive status did influence—largely negatively—their fertility desires. Furthermore, initiating ART and anticipating improved health status did not necessarily translate to increased fertility desires. Instead, individual factors, such as age, parity, current health status, financial resources and number of surviving or HIV-infected children, played a crucial role in decisions about future fertility. In addition, societal influences, such as community norms and health providers’ expectations of their fertility desires, played an equally important role in determining fertility desires. Conclusions Initiating ART may not be the leading factor influencing fertility desires among previously ART-naïve HIV-infected women. Instead, individual and societal factors appear to be the major determinants of fertility desires among these women.
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- 2017
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22. Factors predictive of successful retention in care among HIV-infected men in a universal test-and-treat setting in Uganda and Kenya: A mixed methods analysis.
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Lillian B Brown, Monica Getahun, James Ayieko, Dalsone Kwarisiima, Asiphas Owaraganise, Mucunguzi Atukunda, Winter Olilo, Tamara Clark, Elizabeth A Bukusi, Craig R Cohen, Moses R Kamya, Maya L Petersen, Edwin D Charlebois, Diane V Havlir, and Carol S Camlin
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Medicine ,Science - Abstract
BackgroundPrevious research indicates clinical outcomes among HIV-infected men in sub-Saharan Africa are sub-optimal. The SEARCH test and treat trial (NCT01864603) intervention included antiretroviral care delivery designed to address known barriers to HIV-care among men by decreasing clinic visit frequency and providing flexible, patient-centered care with retention support. We sought to understand facilitators and barriers to retention in care in this universal treatment setting through quantitative and qualitative data analysis.MethodsWe used a convergent mixed methods study design to evaluate retention in HIV care among adults (age > = 15) during the first year of the SEARCH (NCT01864603) test and treat trial. Cox proportional hazards regression was used to evaluate predictors of retention in care. Longitudinal qualitative data from n = 190 in-depth interviews with HIV-positive individuals and health care providers were analyzed to identify facilitators and barriers to HIV care engagement.ResultsThere were 1,863 men and 3,820 women who linked to care following baseline testing. Retention in care was 89.7% (95% CI 87.0-91.8%) among men and 89.0% (86.8-90.9%) among women at one year. In both men and women older age was associated with higher rates of retention in care at one year. Additionally, among men higher CD4+ at ART initiation and decreased time between testing and ART initiation was associated with higher rates of retention. Maintaining physical health, a patient-centered treatment environment, supportive partnerships, few negative consequences to disclosure, and the ability to seek care in facilities outside of their community of residence were found to promote retention in care.ConclusionsFeatures of the ART delivery system in the SEARCH intervention and social and structural advantages emerged as facilitators to retention in HIV care among men. Messaging around the health benefits of early ART start, decreasing logistical barriers to HIV care, support of flexible treatment environments, and accelerated linkage to care, are important to men's success in ART treatment programs. Men already benefit from increased social support following disclosure of their HIV-status. Future efforts to shift gender norms towards greater equity are a potential strategy to support high levels of engagement in care for both men and women.
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- 2019
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23. 'Hurdles on the path to 90-90-90 and beyond': Qualitative analysis of barriers to engagement in HIV care among individuals in rural East Africa in the context of test-and-treat.
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James Ayieko, Lillian Brown, Sibyl Anthierens, Annelies Van Rie, Monica Getahun, Edwin D Charlebois, Maya L Petersen, Tamara D Clark, Moses R Kamya, Craig R Cohen, Elizabeth A Bukusi, Diane V Havlir, and Carol S Camlin
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Medicine ,Science - Abstract
BACKGROUND:Despite substantial progress, gaps in the HIV care cascade remain large: globally, while about 36.7 million people were living with HIV in 2015, 11.9 million of these individuals did not know their HIV status, 12.7 million were in need of antiretroviral therapy (ART) and 13.0 million were not virally suppressed. We sought to deepen understanding of the barriers to care engagement at three critical steps of the care cascade proposed to make greatest impact for attaining the UNAIDS 90-90-90 targets aimed at shutting down the HIV epidemic. METHODS:Analyses were conducted among HIV-infected adults in rural East Africa. Qualitative data were collected using in-depth interviews among 63 individuals participating in an ongoing test-and treat trial (NCT01864683) in its baseline year (July 2013-June 2014). Audio recordings were transcribed, translated into English, and coded using Atlas.ti software. Data were analyzed using a thematic framework for explaining barriers to care engagement that drew upon both theory and prior empirical research in similar settings. RESULTS:Multiple barriers to engagement in care were observed. HIV-related stigma across dimensions of anticipated, internalized and enacted stigma manifested in denial and fears of disclosure, and influenced lapses in care engagement across multiple steps in the cascade. Poverty (lack of food and transport), lack of social support, work interference, prior negative experiences with health services, drug side effects, and treatment fatigue also negatively affected ART adherence and viral suppression. Gender differences were observed, with work interference and denial disproportionately affecting men compared to women. CONCLUSION:Multiple barriers to HIV care engagement still pervade rural sub-Saharan settings threatening the realization of the UNAIDS 90-90-90 targets. To control the epidemic, efforts need to be accelerated to combat stigma. Patient economic empowerment, innovative drug formulations, as well as more patient-responsive health systems, may help overcome barriers to engagement in care.
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- 2018
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24. Population-Based Assessment of Hypertension Epidemiology and Risk Factors among HIV-Positive and General Populations in Rural Uganda.
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Dalsone Kwarisiima, Laura Balzer, David Heller, Prashant Kotwani, Gabriel Chamie, Tamara Clark, James Ayieko, Florence Mwangwa, Vivek Jain, Dathan Byonanebye, Maya Petersen, Diane Havlir, and Moses R Kamya
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Medicine ,Science - Abstract
BACKGROUND:Antiretroviral therapy scale-up in Sub-Saharan Africa has created a growing, aging HIV-positive population at risk for non-communicable diseases such as hypertension. However, the prevalence and risk factors for hypertension in this population remain incompletely understood. METHODS:We measured blood pressure and collected demographic data on over 65,000 adults attending multi-disease community health campaigns in 20 rural Ugandan communities (SEARCH Study: NCT01864603). Our objectives were to determine (i) whether HIV is an independent risk factor for hypertension, and (ii) awareness and control of hypertension in HIV-positive adults and the overall population. RESULTS:Hypertension prevalence was 14% overall, and 11% among HIV-positive individuals. 79% of patients were previously undiagnosed, 85% were not taking medication, and 50% of patients on medication had uncontrolled blood pressure. Multivariate predictors of hypertension included older age, male gender, higher BMI, lack of education, alcohol use, and residence in Eastern Uganda. HIV-negative status was independently associated with higher odds of hypertension (OR 1.2, 95% CI: 1.1-1.4). Viral suppression of HIV did not significantly predict hypertension among HIV-positives. SIGNIFICANCE:The burden of hypertension is substantial and inadequately controlled, both in HIV-positive persons and overall. Universal HIV screening programs could provide counseling, testing, and treatment for hypertension in Sub-Saharan Africa.
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- 2016
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25. Weight Change Following Switch to Dolutegravir for HIV Treatment in Rural Kenya During Country Roll-Out
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Matthew D. Hickey, Erick Wafula, Sabina M. Ogachi, Hellen Ojwando, Gordon Orori, Richard O. Adede, Lucas Godoy Garraza, Maya L. Petersen, Diane V. Havlir, Laura B. Balzer, and James Ayieko
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Infectious Diseases ,Pharmacology (medical) - Published
- 2023
26. Two or more significant life-events in 6-months are associated with lower rates of HIV treatment and virologic suppression among youth with HIV in Uganda and Kenya
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Florence Mwangwa, Edwin D. Charlebois, James Ayieko, Winter Olio, Douglas Black, James Peng, Dalsone Kwarisiima, Jane Kabami, Laura B. Balzer, Maya L. Petersen, Bill Kapogiannis, Moses R. Kamya, Diane V. Havlir, and Theodore D. Ruel
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Health (social science) ,Social Psychology ,Public Health, Environmental and Occupational Health - Abstract
Youth living with HIV in sub-Saharan Africa have poor HIV care outcomes. We determined the association of recent significant life-events with HIV antiretroviral treatment (ART) initiation and HIV viral suppression in youth aged 15-24 years living with HIV in rural Kenya and Uganda. This was a cross-sectional analysis of 995 youth enrolled in the SEARCH Youth study. At baseline, providers assessed recent (within 6 months) life-events, defined as changes in schooling/employment, residence, partnerships, sickness, incarceration status, family strife or death, and birth/pregnancy, self-reported alcohol use, being a parent, and HIV-status disclosure. We examined the frequencies of events and their association with ART status and HIV viral suppression (400 copies/ul). Recent significant life-events were prevalent (57.7%). Having
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- 2023
27. Providers' Attitudes and Experiences with Pre-Exposure Prophylaxis Implementation in a Population-Based Study in Kenya and Uganda
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Carol S. Camlin, Monica Getahun, Catherine A. Koss, Lawrence Owino, Cecilia Akatukwasa, Harriet Itiakorit, Anjeline Onyango, Robert Bakanoma, Fredrick Atwine, Irene Maeri, James Ayieko, Mucunguzi Atukunda, Asiphas Owaraganise, Florence Mwangwa, Norton Sang, Jane Kabami, Rachel L. Kaplan, Gabriel Chamie, Maya L. Petersen, Craig R. Cohen, Elizabeth A. Bukusi, Moses R. Kamya, Diane V. Havlir, and Edwin D. Charlebois
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Adult ,Infectious Diseases ,Adolescent ,Attitude ,Anti-HIV Agents ,Public Health, Environmental and Occupational Health ,Humans ,Female ,Pre-Exposure Prophylaxis ,Uganda ,HIV Infections ,Kenya - Abstract
Pre-exposure prophylaxis (PrEP) implementation is underway across sub-Saharan Africa. However, little is known about health care providers' experiences with PrEP provision in generalized epidemic settings, particularly outside of selected risk groups. In this study (NCT01864603), universal access to PrEP was offered to adolescents and adults at elevated risk during population-level HIV testing in rural Kenya and Uganda. Providers received training on PrEP prescribing and support from local senior clinicians. We conducted in-depth interviews with providers (
- Published
- 2023
28. Universal HIV Testing and Treatment with Patient-Centered Care Improves ART Uptake and Viral Suppression among Adults Reporting Hazardous Alcohol Use in Uganda and Kenya
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Sarah B. Puryear, James Ayieko, Judith A. Hahn, Atukunda Mucunguzi, Asiphas Owaraganise, Joshua Schwab, Laura B. Balzer, Dalsone Kwarisiima, Edwin D. Charlebois, Craig R. Cohen, Elizabeth A. Bukusi, Maya L. Petersen, Diane V. Havlir, Moses R. Kamya, and Gabriel Chamie
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Infectious Diseases ,Pharmacology (medical) - Published
- 2023
29. Machine Learning Algorithms Using Routinely Collected Data Do Not Adequately Predict Viremia to Inform Targeted Services in Postpartum Women Living With HIV
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Pamela M. Murnane, James Ayieko, Judith S. Currier, Mandisa E Nyati, Eric Vittinghoff, Craig R. Cohen, Chaplain Katumbi, Mary Glenn Fowler, Amy James Loftis, Patricia M. Flynn, Beteniko Milala, Monica Gandhi, Catherine Nakaye, Peter Kanda, and Dhayendre Moodley
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Infectious Disease Transmission ,HIV Infections ,Reproductive health and childbirth ,postpartum period ,Machine Learning ,risk prediction ,Pregnancy ,Vertical ,Pharmacology (medical) ,Pregnancy Complications, Infectious ,education.field_of_study ,Postpartum Period ,Infectious ,Viral Load ,Infectious Diseases ,Anti-Retroviral Agents ,6.1 Pharmaceuticals ,Public Health and Health Services ,HIV/AIDS ,Female ,Infection ,Algorithm ,Psychosocial ,Algorithms ,Routinely Collected Health Data ,Adult ,Randomization ,Anti-HIV Agents ,Clinical Sciences ,Population ,MEDLINE ,Viremia ,Article ,differentiated service delivery ,Clinical Research ,Virology ,Behavioral and Social Science ,medicine ,Humans ,education ,Receiver operating characteristic ,business.industry ,Prevention ,Evaluation of treatments and therapeutic interventions ,HIV ,medicine.disease ,Infectious Disease Transmission, Vertical ,Confidence interval ,Pregnancy Complications ,Good Health and Well Being ,medication adherence ,business - Abstract
BackgroundAdherence to antiretroviral treatment (ART) among postpartum women with HIV is essential for optimal health and prevention of perinatal transmission. However, suboptimal adherence with subsequent viremia is common, and adherence challenges are often underreported. We aimed to predict viremia to facilitate targeted adherence support in sub-Saharan Africa during this critical period.MethodsData are from PROMISE 1077BF/FF, which enrolled perinatal women between 2011 and 2014. This analysis includes postpartum women receiving ART per study randomization or country-specific criteria to continue from pregnancy. We aimed to predict viremia (single and confirmed events) after 3 months on ART at >50, >400, and >1000 copies/mL within 6-month intervals through 24 months. We built models with routine clinical and demographic data using the least absolute shrinkage and selection operator and SuperLearner (which incorporates multiple algorithms).ResultsAmong 1321 women included, the median age was 26 years and 96% were in WHO stage 1. Between 0 and 24 months postpartum, 42%, 31%, and 28% of women experienced viremia >50, >400, and >1000 copies/mL, respectively, at least once. Across models, the cross-validated area under the receiver operating curve ranged from 0.74 [95% confidence interval (CI): 0.72 to 0.76] to 0.78 (95% CI: 0.76 to 0.80). To achieve 90% sensitivity predicting confirmed viremia >50 copies/mL, 64% of women would be classified as high risk.ConclusionsUsing routinely collected data to predict viremia in >1300 postpartum women with HIV, we achieved moderate model discrimination, but insufficient to inform targeted adherence support. Psychosocial characteristics or objective adherence metrics may be required for improved prediction of viremia in this population.
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- 2021
30. Transitioning youth living with HIV to adult HIV care
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James Ayieko and Marguerite Thorp
- Subjects
Adult ,Infectious Diseases ,Adolescent ,Epidemiology ,Virology ,Immunology ,Humans ,HIV Infections - Published
- 2022
31. 'I was still very young': agency, stigma and HIV care strategies at school, baseline results of a qualitative study among youth in rural Kenya and Uganda
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Jason Johnson‐Peretz, Sarah Lebu, Cecilia Akatukwasa, Monica Getahun, Theodore Ruel, Joi Lee, James Ayieko, Florence Mwangwa, Lawrence Owino, Anjeline Onyango, Irene Maeri, Frederick Atwine, Edwin D. Charlebois, Elizabeth A. Bukusi, Moses R. Kamya, Diane V. Havlir, and Carol S. Camlin
- Subjects
Adult ,Pediatric AIDS ,Adolescent ,Social Stigma ,Clinical Sciences ,HIV Infections ,Medication Adherence ,Young Adult ,7.1 Individual care needs ,Clinical Research ,Behavioral and Social Science ,Humans ,Uganda ,Qualitative Research ,eastern Africa ,Pediatric ,Other Medical and Health Sciences ,Prevention ,Public Health, Environmental and Occupational Health ,HIV ,highly active antiretroviral therapy ,Kenya ,Mental Health ,Infectious Diseases ,Good Health and Well Being ,Anti-Retroviral Agents ,Public Health and Health Services ,HIV/AIDS ,Management of diseases and conditions - Abstract
IntroductionAdolescents and young adults living with HIV (AYAH) have the lowest rates of retention in HIV care and antiretroviral therapy (ART) adherence, partly due to the demands of school associated with this life stage, to HIV-related stigma and to fears of serostatus disclosure. We explore the implications of school-based stigma and disclosure on the development of agency during a critical life stage in rural Kenya and Uganda.MethodsWe conducted a qualitative study in the baseline year of the SEARCH Youth study, a combination intervention using a life-stage approach among youth (15-24 years old) living with HIV in western Kenya and southwestern Uganda to improve viral load suppression and health outcomes. We conducted in-depth, semi-structured interviews in 2019 with three cohorts of purposively selected study participants (youth [n = 83], balanced for sex, life stage and HIV care status; recommended family members of youth [n = 33]; and providers [n = 20]). Inductive analysis exploring contextual factors affecting HIV care engagement revealed the high salience of schooling environments.ResultsStigma within school settings, elicited by non-consensual serostatus disclosure, medication schedules and clinic appointments, exerts a constraining factor around which AYAH must navigate to identify and pursue opportunities available to them as young people. HIV status can affect cross-generational support and cohort formation, as AYAH differ from non-AYAH peers because of care-related demands affecting schooling, exams and graduation. However, adolescents demonstrate a capacity to overcome anticipated stigma and protect themselves by selectively disclosing HIV status to trusted peers and caregivers, as they develop a sense of agency concomitant with this life stage. Older adolescents showed greater ability to seek out supportive relationships than younger ones who relied on adult caregivers to facilitate this support.ConclusionsSchool is a potential site of HIV stigma and also a setting for learning how to resist such stigma. School-going adolescents should be supported to identify helpful peers and selectively disclose serostatus as they master decision making about when and where to take medications, and who should know. Stigma isavoidedby fewer visits to the clinic; providers should consider longer refills, discreet packaging and long-acting, injectable ART for students.
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- 2022
32. SEARCH Human Immunodeficiency Virus (HIV) Streamlined Treatment Intervention Reduces Mortality at a Population Level in Men With Low CD4 Counts
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Maya L. Petersen, James Peng, Elizabeth A. Bukusi, Yea-Hung Chen, Craig R. Cohen, Diane V. Havlir, Norton Sang, Jane Kabami, Edwin D. Charlebois, Laura B. Balzer, Tamara D. Clark, Moses R. Kamya, Vivek Jain, Gabriel Chamie, Dalsone Kwariisima, James Ayieko, and Joshua Schwab
- Subjects
Male ,0301 basic medicine ,Human immunodeficiency virus (HIV) ,HIV Infections ,medicine.disease_cause ,Medical and Health Sciences ,0302 clinical medicine ,Uganda ,030212 general & internal medicine ,population-based HIV testing ,education.field_of_study ,streamlined care ,Standard treatment ,Biological Sciences ,Infectious Diseases ,6.1 Pharmaceuticals ,Community health ,HIV/AIDS ,Female ,Infection ,Adult ,Microbiology (medical) ,medicine.medical_specialty ,Anti-HIV Agents ,Clinical Trials and Supportive Activities ,Population ,Hiv testing ,Microbiology ,03 medical and health sciences ,Acquired immunodeficiency syndrome (AIDS) ,Clinical Research ,Internal medicine ,advanced HIV-disease ,medicine ,Humans ,Online Only Articles ,education ,business.industry ,Prevention ,HIV ,Evaluation of treatments and therapeutic interventions ,medicine.disease ,mortality ,030112 virology ,Confidence interval ,CD4 Lymphocyte Count ,Good Health and Well Being ,Relative risk ,business - Abstract
Background We tested the hypothesis that patient-centered, streamlined human immunodeficiency virus (HIV) care would achieve lower mortality than the standard treatment model for persons with HIV and CD4 ≤ 350/uL in the setting of population-wide HIV testing. Methods In the SEARCH (Sustainable East Africa Research in Community Health) Study (NCT01864603), 32 communities in rural Uganda and Kenya were randomized to country-guided antiretroviral therapy (ART) versus streamlined ART care that included rapid ART start, visit spacing, flexible clinic hours, and welcoming environment. We assessed persons with HIV and CD4 ≤ 350/uL, ART eligible in both arms, and estimated the effect of streamlined care on ART initiation and mortality at 3 years. Comparisons between study arms used a cluster-level analysis with survival estimates from Kaplan-Meier; estimates of ART start among ART-naive persons treated death as a competing risk. Results Among 13 266 adults with HIV, 2973 (22.4%) had CD4 ≤ 350/uL. Of these, 33% were new diagnoses, and 10% were diagnosed but ART-naive. Men with HIV were almost twice as likely as women with HIV to have CD4 ≤ 350/uL and be untreated (15% vs 8%, respectively). Streamlined care reduced mortality by 28% versus control (risk ratio [RR] = 0.72; 95% confidence interval [CI]: .56, .93; P = .02). Despite eligibility in both arms, persons with CD4 ≤ 350/uL started ART faster under streamlined care versus control (76% vs 43% by 12 months, respectively; P Conclusions After population-based HIV testing, streamlined care reduced population-level mortality among persons with HIV and CD4 ≤ 350/uL, particularly among men. Streamlined HIV care models may play a key role in global efforts to reduce AIDS deaths.
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- 2021
33. PEP for HIV prevention: are we missing opportunities to reduce new infections?
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James Ayieko, Maya L. Petersen, Moses R. Kamya, and Diane V. Havlir
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Male ,Other Medical and Health Sciences ,Infectious Diseases ,Anti-HIV Agents ,Clinical Sciences ,Public Health and Health Services ,Public Health, Environmental and Occupational Health ,Humans ,HIV Infections ,Homosexuality ,Homosexuality, Male - Published
- 2022
34. Associations between alcohol use and HIV care cascade outcomes among adults undergoing population-based HIV testing in East Africa
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Dalsone Kwarisiima, Craig R. Cohen, Moses R. Kamya, Gabriel Chamie, Laura B. Balzer, Diane V. Havlir, Tamara D. Clark, Sarah B Puryear, James Ayieko, Elizabeth A. Bukusi, Judith A. Hahn, Edwin D. Charlebois, and Maya L. Petersen
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Male ,0301 basic medicine ,Human immunodeficiency virus (HIV) ,HIV Infections ,Alcohol ,Underage Drinking ,Eastern ,Cardiovascular ,medicine.disease_cause ,Medical and Health Sciences ,HIV Testing ,Substance Misuse ,Alcohol Use and Health ,chemistry.chemical_compound ,0302 clinical medicine ,Immunology and Allergy ,030212 general & internal medicine ,Pediatric ,education.field_of_study ,care continuum ,Confounding ,Africa, Eastern ,Biological Sciences ,viral load ,Alcoholism ,Infectious Diseases ,HIV/AIDS ,Female ,Infection ,Adult ,medicine.medical_specialty ,Alcohol Drinking ,Clinical Trials and Supportive Activities ,antiretroviral therapy ,Immunology ,Population ,Hiv testing ,Population based ,Article ,03 medical and health sciences ,Clinical Research ,Virology ,Internal medicine ,Behavioral and Social Science ,medicine ,East africa ,Humans ,education ,business.industry ,Prevention ,Psychology and Cognitive Sciences ,Kenya ,substance-related disorders ,Cross-Sectional Studies ,Good Health and Well Being ,030104 developmental biology ,chemistry ,Relative risk ,Africa ,business - Abstract
OBJECTIVE To assess the impact of alcohol use on HIV care cascade outcomes. DESIGN Cross-sectional analyses. METHODS We evaluated HIV care cascade outcomes and alcohol use in adults (≥15 years) during baseline (2013--2014) population-based HIV testing in 28 Kenyan and Ugandan communities. 'Alcohol use' included any current use and was stratified by Alcohol Use Disorders Identification Test-Concise (AUDIT-C) scores: nonhazardous/low (1--3 men/1--2 women), hazardous/medium (4--5 men/3--5 women), hazardous/high (6--7), hazardous/very-high (8--12). We estimated cascade outcomes and relative risks associated with each drinking level using targeted maximum likelihood estimation, adjusting for confounding and missing measures. RESULTS Among 118 923 adults, 10 268 (9%) tested HIV-positive. Of those, 10 067 (98%) completed alcohol screening: 1626 (16%) reported drinking, representing 7% of women (467/6499) and 33% of men (1 159/3568). Drinking levels were: low (48%), medium (34%), high (11%), very high (7%). Drinkers were less likely to be previously HIV diagnosed (58% [95% CI: 55--61%]) than nondrinkers [66% (95% CI: 65-67%); RR: 0.87 (95% CI: 0.83-0.92)]. If previously diagnosed, drinkers were less likely to be on ART [77% (95% CI: 73-80%)] than nondrinkers [83% (95% CI 82-84%); RR: 0.93 (95% CI: 0.89-0.97)]. If on ART, there was no association between alcohol use and viral suppression; however, very-high-level users were less likely to be suppressed [RR: 0.80 (95% CI: 0.68-0.94)] versus nondrinkers. On a population level, viral suppression was 38% (95% CI: 36-41%) among drinkers and 44% (95% CI: 43-45%) among nondrinkers [RR: 0.87 (95% CI 0.82-0.94)], an association seen at all drinking levels. CONCLUSION Alcohol use was associated with lower viral suppression; this may be because of decreased HIV diagnosis and ART use.
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- 2020
35. Accelerating adolescent HIV research in low-income and middle-income countries: evidence from a research consortium
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Joseph D. Tucker, James Ayieko, Erin C. Wilson, Joana Falcao, Grace John-Stewart, Lisa M. Kuhns, David Oladele, Pamela Kohler, Dara R. Blachman-Demner, Sujha Subramanian, Elaine J. Abrams, Juliet Iwelunmor, Titilola Gbajabiamila, Babafemi Taiwo, Geri R. Donenberg, Bill G. Kapogiannis, Chisom Obiezu-Umeh, Lauren Laimon, Emilia M. Jalil, Oliver Ezechi, and Kelechi P. Chima
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Adolescent ,Immunology ,Human immunodeficiency virus (HIV) ,Low income and middle income countries ,HIV Infections ,medicine.disease_cause ,Article ,Young Adult ,Infectious Diseases ,Stakeholder Participation ,medicine ,Income ,Immunology and Allergy ,Humans ,Psychology ,Socioeconomics ,Child ,Developing Countries ,Poverty - Abstract
OBJECTIVE: Many adolescents and young adults (AYA) have unmet HIV prevention needs. We describe the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC(3)H) consortium organization, transition milestones, and youth engagement strategies. The PATC(3)H consortium focuses on reducing HIV incidence and related health disparities among AYA. DESIGN AND METHODS: Organizational data were obtained from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and supplemented with a brief survey completed by study principal investigators. Transition from the initial phase (years 1–2) to the subsequent phase (years 3–5) was contingent on meeting pre-specified milestones. We reviewed the structure and function of the research consortium, identified shared elements of transition milestones, and examined common youth engagement strategies. RESULTS: The PATC(3)H consortium supports eight research studies through a milestone transition mechanism. The consortium includes AYA HIV research studies in seven countries - Brazil, Kenya, Mozambique, Nigeria, South Africa, Uganda, and Zambia. The NIH request for applications required transition milestones that included early consultation with stakeholders. The transition milestones required by NIH for the eight studies included early consultation with health and policy stakeholders, pilot intervention data and commitment from national government stakeholders. All studies provided multiple pathways for AYA engagement, including AYA advisory boards and youth-led research studies. CONCLUSION: Data suggest that requiring milestones to transition to the final phase may have facilitated health and policy stakeholder engagement and enhanced formative assessment of regulatory protocols. These data have implications for designing engaged research studies in low and middle-income countries.
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- 2021
36. Provider and Patient Perspectives of Rapid ART Initiation and Streamlined HIV Care: Qualitative Insights From Eastern African Communities
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Jane Kabami, Mucunguzi Atukunda, Diane V. Havlir, Craig R. Cohen, Catherine A. Koss, Elizabeth A. Bukusi, Norton Sang, Edwin D. Charlebois, Irene Maeri, Tamara D. Clark, James Ayieko, Vivek Jain, Monica Getahun, Florence Mwangwa, Moses R. Kamya, Gabriel Chamie, Harriet Itiakorit, Dalsone Kwarisiima, Carol S. Camlin, Cecilia Akatukwasa, Lawrence Owino, and Maya L. Petersen
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Counseling ,rapid ART ,medicine.medical_specialty ,viral suppression ,Anti-HIV Agents ,media_common.quotation_subject ,Art initiation ,Immunology ,Human immunodeficiency virus (HIV) ,8.1 Organisation and delivery of services ,HIV Infections ,Dermatology ,Disclosure ,patient-centered care ,medicine.disease_cause ,Care provision ,viral load counseling ,differentiated service delivery ,Denial ,Clinical Research ,Behavioral and Social Science ,medicine ,East africa ,Humans ,Original Research Article ,media_common ,business.industry ,care linkage ,Viral Load ,Diseases of the genitourinary system. Urology ,Infectious Diseases ,Good Health and Well Being ,Feeling ,Family medicine ,Community health ,HIV/AIDS ,RC870-923 ,HIV care ,business ,Infection ,Viral load ,Health and social care services research - Abstract
The Sustainable East Africa Research in Community Health (SEARCH), a universal test and treat (UTT) trial, implemented ‘Streamlined Care’—a multicomponent strategy including rapid linkage to care and antiretroviral therapy (ART) start, 3-monthly refills, viral load counseling, and accessible, patient-centered care provision. To understand patient and provider experiences of Streamlined Care to inform future care innovations, we conducted in-depth interviews with patients ( n = 18) and providers ( n = 28) at baseline (2014) and follow-up (2015) ( n = 17 patients; n = 21 providers). Audio recordings were transcribed, translated, and deductively and inductively coded. Streamlined Care helped to decongest clinic spaces and de-stigmatize human immunodeficiency virus (HIV) care. Patients credited the individualized counselling, provider-assisted HIV status disclosure, and providers’ knowledge of patient's drug schedules, availability, and phone call reminders for their care engagement. However, for some, denial (repeated testing to disprove HIV+ results), feeling healthy, limited understanding of the benefits of early ART, and anticipated side-effects, and mistrust of researchers hindered rapid ART initiation. Patients’ short and long-term mobility proved challenging for both patients and providers. Providers viewed viral load counselling as a powerful tool to convince otherwise healthy and high-CD4 patients to initiate ART. Patient-centered HIV care models should build on the successes of Streamlined Care, while addressing persistent barriers. #NCT01864683— https://clinicaltrials.gov/ct2/show/NCT01864603
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- 2021
37. Machine Learning to Identify Persons at High-Risk of Human Immunodeficiency Virus Acquisition in Rural Kenya and Uganda
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Moses R. Kamya, Dalsone Kwarisiima, Jane Kabami, Mucunguzi Atukunda, Gabriel Chamie, Norton Sang, Elizabeth A. Bukusi, Craig R. Cohen, Catherine A. Koss, Edwin D. Charlebois, Maya L. Petersen, Mark J. van der Laan, Diane V. Havlir, James Ayieko, Vivek Jain, Carol S. Camlin, Laura B. Balzer, and Tamara D. Clark
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0301 basic medicine ,Microbiology (medical) ,HIV prevention ,Population ,Human immunodeficiency virus (HIV) ,HIV Infections ,SEARCH Study ,Clinical prediction rule ,HIV risk score ,Logistic regression ,medicine.disease_cause ,Machine learning ,computer.software_genre ,Medical and Health Sciences ,Microbiology ,Machine Learning ,03 medical and health sciences ,0302 clinical medicine ,clinical prediction rule ,Clinical Research ,Humans ,Medicine ,Uganda ,030212 general & internal medicine ,Seroconversion ,education ,education.field_of_study ,Framingham Risk Score ,business.industry ,Prevention ,HIV ,Biological Sciences ,Kenya ,030112 virology ,PrEP ,Clinical trial ,Major Articles and Commentaries ,Good Health and Well Being ,Infectious Diseases ,Spouse ,HIV/AIDS ,Pre-Exposure Prophylaxis ,Artificial intelligence ,Infection ,business ,computer - Abstract
Background In generalized epidemic settings, strategies are needed to prioritize individuals at higher risk of human immunodeficiency virus (HIV) acquisition for prevention services. We used population-level HIV testing data from rural Kenya and Uganda to construct HIV risk scores and assessed their ability to identify seroconversions. Methods During 2013–2017, >75% of residents in 16 communities in the SEARCH study were tested annually for HIV. In this population, we evaluated 3 strategies for using demographic factors to predict the 1-year risk of HIV seroconversion: membership in ≥1 known “risk group” (eg, having a spouse living with HIV), a “model-based” risk score constructed with logistic regression, and a “machine learning” risk score constructed with the Super Learner algorithm. We hypothesized machine learning would identify high-risk individuals more efficiently (fewer persons targeted for a fixed sensitivity) and with higher sensitivity (for a fixed number targeted) than either other approach. Results A total of 75 558 persons contributed 166 723 person-years of follow-up; 519 seroconverted. Machine learning improved efficiency. To achieve a fixed sensitivity of 50%, the risk-group strategy targeted 42% of the population, the model-based strategy targeted 27%, and machine learning targeted 18%. Machine learning also improved sensitivity. With an upper limit of 45% targeted, the risk-group strategy correctly classified 58% of seroconversions, the model-based strategy 68%, and machine learning 78%. Conclusions Machine learning improved classification of individuals at risk of HIV acquisition compared with a model-based approach or reliance on known risk groups and could inform targeting of prevention strategies in generalized epidemic settings. Clinical Trials Registration NCT01864603.
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- 2019
38. Predictors of isoniazid preventive therapy completion among HIV-infected patients receiving differentiated and non-differentiated HIV care in rural Uganda
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Mucunguzi Atukunda, Moses R. Kamya, Khai Hoan Tram, Asiphas Owaraganise, Maya L. Petersen, Diane V. Havlir, Edwin D. Charlebois, Carina Marquez, Gabriel Chamie, James Ayieko, Vivek Jain, Tamara D. Clark, Florence Mwangwa, and Dalsone Kwarisiima
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Rural Population ,Male ,Health (social science) ,Antitubercular Agents ,Human immunodeficiency virus (HIV) ,8.1 Organisation and delivery of services ,HIV Infections ,Negative association ,medicine.disease_cause ,SEARCH collaboration ,0302 clinical medicine ,7.1 Individual care needs ,Isoniazid preventive therapy ,Psychology ,Hiv infected patients ,Uganda ,030212 general & internal medicine ,Hiv treatment ,Isoniazid ,differentiated care ,Middle Aged ,Preventive therapy ,Infectious Diseases ,TB prevention ,Public Health and Health Services ,HIV/AIDS ,Female ,Public Health ,Infection ,0305 other medical science ,Health and social care services research ,medicine.drug ,Adult ,medicine.medical_specialty ,Social Psychology ,Anti-HIV Agents ,Article ,03 medical and health sciences ,Social support ,Clinical Research ,Internal medicine ,parasitic diseases ,medicine ,Humans ,Tuberculosis ,030505 public health ,business.industry ,Prevention ,Public Health, Environmental and Occupational Health ,HIV ,East Africa ,Antiretroviral therapy ,Cross-Sectional Studies ,Good Health and Well Being ,Management of diseases and conditions ,business - Abstract
Rates of IPT completion remain low in programmatic settings in sub-Saharan Africa. Differentiated HIV care, a patient-centered adaptive care model scaling-up throughout sub-Saharan Africa, may improve IPT completion by addressing joint barriers to IPT and HIV treatment. However, the impact of differentiated care on IPT completion remains unknown. In a cross-sectional study of people living with HIV (PLWH) on antiretroviral therapy (ART) in care in 5 communities in rural Uganda we sought to: (1) compare IPT completion between PLWH on ART receiving HIV care via a differentiated care model versus a standard HIV care model delivered in the same health center, (2) assess individual, interpersonal, and structural predictors of IPT completion by survey interviews of patients enrolled in each care model, and (3) investigate the mechanisms underlying potential differences in IPT between care models via multivariable regression modeling. A total of 103/144 (72%) of HIV-positive patients who received differentiated care and 85/161 (53%) who received standard care completed IPT (p
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- 2019
39. Effect of universal HIV testing and treatment on socioeconomic wellbeing in rural Kenya and Uganda: a cluster-randomised controlled trial
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Aleksandra Jakubowski, Jane Kabami, Laura B Balzer, James Ayieko, Edwin D Charlebois, Asiphas Owaraganise, Carina Marquez, Tamara D Clark, Douglas Black, Starley B Shade, Gabriel Chamie, Craig R Cohen, Elizabeth A Bukusi, Moses R Kamya, Maya Petersen, Diane V Havlir, and Harsha Thirumurthy
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Adult ,Male ,Rural Population ,Adolescent ,HIV Infections ,General Medicine ,Health Services ,Middle Aged ,Patient Acceptance of Health Care ,Viral Load ,Kenya ,HIV Testing ,Young Adult ,Anti-Retroviral Agents ,Socioeconomic Factors ,Educational Status ,Humans ,Mass Screening ,Female ,Uganda ,Public aspects of medicine ,RA1-1270 ,Child ,Aged - Abstract
Summary: Background: Universal testing and treatment for HIV has shown promise as an approach to reduce mortality and lower HIV incidence. Evidence on the economic effects of this approach on individuals and households in low-resource settings is scarce. We aimed to examine the effect of universal HIV testing and treatment on a range of economic outcomes. Methods: We collected data in household surveys done over a 3-year period in a sample of HIV-positive and HIV-negative adults participating in a cluster-randomised trial of universal HIV testing and treatment in 32 rural communities in Kenya and Uganda. Communities of approximately 10 000 people were pair-matched on the basis of geographical and population characteristics, with the best-matching 16 pairs randomly assigned (1:1) to intervention or control groups. Participants in intervention communities received annual HIV and multidisease testing, universal antiretroviral therapy (ART) eligibility, and patient-centred care. Participants in control communities received baseline testing and medical care according to national guidelines. We analysed employment and health-care utilisation outcomes for working-age adults (age 18–65 years) and education outcomes for school-age children (6–17 years) using data from 3 years after the intervention. This trial is now complete, and is registered with ClinicalTrials.gov, NCT01864603. Findings: Between July 9, 2013, and June 15, 2017, we collected survey data on 8198 working-age adults and 6755 school-age children. Compared with adults living with HIV in control communities, adults living with HIV in intervention communities were more likely to be employed (difference 9·7% [95% CI 2·1 to 18·3]), less likely to seek health care (–10·3% [–22·0 to 0·1]), and less likely to spend money on health care (–12·7% [–22·4 to 0·6]) 3 years after the intervention. We found no significant differences in outcomes between HIV-negative adults in intervention and control communities. Among children in households with HIV-positive adults, the intervention led to a 7·3% (95% CI 1·0 to 15·1) increase in primary school completion after 3 years in intervention communities compared with control communities. Interpretation: Universal HIV testing and treatment improved employment outcomes and other indicators of socioeconomic wellbeing for HIV-positive adults and children in their households, but had no effect on HIV-negative adults. Our findings suggest that the considerable investments needed to expand ART access might have substantial short-term and long-term economic returns. Funding: National Institutes of Health.
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- 2021
40. HIV incidence after pre-exposure prophylaxis initiation among women and men at elevated HIV risk: A population-based study in rural Kenya and Uganda
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Joshua Nugent, Benard Awuonda, Carol S. Camlin, Kevin Zhang, Craig R. Cohen, Carina Marquez, Florence Mwangwa, Yusuf Mwinike, Edwin D. Charlebois, Catherine A. Koss, James Peng, Monica Gandhi, Gabriel Chamie, James Ayieko, Diane V. Havlir, Laura B. Balzer, Moses R. Kamya, Katherine Snyman, Tamara D. Clark, Winter Olilo, Hideaki Okochi, Maya L. Petersen, Jane Kabami, Mucunguzi Atukunda, Asiphas Owaraganise, Dalsone Kwarisiima, Elizabeth A. Bukusi, Lillian B. Brown, Douglas Black, Vivek Jain, and Newell, Marie-Louise
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0301 basic medicine ,Male ,RNA viruses ,Pediatric AIDS ,Epidemiology ,HIV Infections ,Rate ratio ,Pathology and Laboratory Medicine ,Medical and Health Sciences ,Pre-exposure prophylaxis ,0302 clinical medicine ,Immunodeficiency Viruses ,80 and over ,Medicine and Health Sciences ,Medicine ,Uganda ,Public and Occupational Health ,030212 general & internal medicine ,Young adult ,Virus Testing ,Pediatric ,Aged, 80 and over ,education.field_of_study ,Framingham Risk Score ,Incidence (epidemiology) ,Incidence ,General Medicine ,Homosexuality ,Middle Aged ,Vaccination and Immunization ,Infectious Diseases ,Mental Health ,Medical Microbiology ,HIV epidemiology ,Viral Pathogens ,Viruses ,HIV/AIDS ,Infectious diseases ,Female ,Pathogens ,Infection ,medicine.drug ,Research Article ,Adult ,Risk ,Medical conditions ,Adolescent ,Anti-HIV Agents ,Population ,Clinical Trials and Supportive Activities ,HIV prevention ,Immunology ,Antiretroviral Therapy ,Viral diseases ,Emtricitabine ,Microbiology ,Medication Adherence ,03 medical and health sciences ,Young Adult ,Sex Factors ,Antiviral Therapy ,Clinical Research ,Diagnostic Medicine ,General & Internal Medicine ,Behavioral and Social Science ,Retroviruses ,Humans ,Seroconversion ,Homosexuality, Male ,education ,Tenofovir ,Microbial Pathogens ,Aged ,business.industry ,Prophylaxis ,Prevention ,Lentivirus ,Organisms ,Biology and Life Sciences ,HIV ,030112 virology ,Kenya ,Good Health and Well Being ,Medical Risk Factors ,Pre-Exposure Prophylaxis ,Preventive Medicine ,business ,Demography - Abstract
Background Oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but data are limited on HIV incidence among PrEP users in generalized epidemic settings, particularly outside of selected risk groups. We performed a population-based PrEP study in rural Kenya and Uganda and sought to evaluate both changes in HIV incidence and clinical and virologic outcomes following seroconversion on PrEP. Methods and findings During population-level HIV testing of individuals ≥15 years in 16 communities in the Sustainable East Africa Research in Community Health (SEARCH) study (NCT01864603), we offered universal access to PrEP with enhanced counseling for persons at elevated HIV risk (based on serodifferent partnership, machine learning–based risk score, or self-identified HIV risk). We offered rapid or same-day PrEP initiation and flexible service delivery with follow-up visits at facilities or community-based sites at 4, 12, and every 12 weeks up to week 144. Among participants with incident HIV infection after PrEP initiation, we offered same-day antiretroviral therapy (ART) initiation and analyzed HIV RNA, tenofovir hair concentrations, drug resistance, and viral suppression (, Catherine Koss and co-workers report on HIV incidence in African settings where antiretroviral pre-exposure prophylaxis has been implemented., Author summary Why was this study done? Despite major gains in HIV testing and treatment, there were 1.7 million new HIV infections worldwide in 2019, of which nearly 60% occurred in sub-Saharan Africa. Daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is highly effective for HIV prevention and could substantially reduce new HIV infections if offered alongside access to HIV testing and treatment. Little is known about the incidence of new HIV infections among PrEP users in settings with generalized HIV epidemics, particularly when offered broadly across communities where access to HIV testing and treatment have already been scaled up. What did the researchers do and find? In 16 communities in rural Kenya and Uganda, we conducted community-wide HIV testing and offered universal access to PrEP with an inclusive approach to eligibility (for persons in serodifferent partnerships, those identified by an HIV risk prediction tool, or those who self-identified as being at risk of HIV). We offered rapid PrEP start and a flexible care delivery model with follow-up visits at health facilities or community-based sites for HIV testing and PrEP refills. Of 74,541 persons who tested negative for HIV, 15,632 (21%) were assessed to be at elevated HIV risk, of whom 5,447 (35%) started PrEP. Overall, 79% of persons who initiated PrEP engaged in the program for follow-up visits. Among PrEP initiators in the 16 study communities, there were 25 seroconversions over 7,150 person-years of follow-up. HIV incidence was 0.35 per 100 person-years (95% confidence interval [CI] 0.22–0.49). In 8 communities, we compared HIV incidence among PrEP initiators to persons with similar characteristics (matched controls) from the year before PrEP was available. Compared to matched controls, HIV incidence was 74% lower among PrEP initiators overall; 76% lower among women who initiated PrEP; and 40% lower among men who initiated PrEP, although this result among men did not reach statistical significance. What do these findings mean? Providing universal access to PrEP in the context of community-wide HIV testing in rural Kenya and Uganda was associated with lower HIV incidence among persons who initiated PrEP compared to matched recent controls. We found lower HIV incidence after PrEP initiation among women, for whom rates of new HIV infections are higher than in men, including in recent prevention studies without PrEP. These results suggest that PrEP may help to close the gap in new infections between men and women. Universal access to HIV testing, treatment, and prevention, including rapid provision of PrEP with flexible service delivery, could reduce HIV incidence in generalized epidemic settings.
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- 2021
41. Two-Stage TMLE to Reduce Bias and Improve Efficiency in Cluster Randomized Trials
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Laura B Balzer, Mark van der Laan, James Ayieko, Moses Kamya, Gabriel Chamie, Joshua Schwab, Diane V Havlir, and Maya L Petersen
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Statistics and Probability ,FOS: Computer and information sciences ,TMLE ,Outcome Assessment ,Missing data ,Statistics & Probability ,Clinical Trials and Supportive Activities ,Multi-level models ,Machine Learning (stat.ML) ,01 natural sciences ,Statistics - Applications ,Methodology (stat.ME) ,010104 statistics & probability ,03 medical and health sciences ,Double robust ,0302 clinical medicine ,Bias ,Clinical Research ,Statistics - Machine Learning ,Cluster randomized trials ,Genetics ,Humans ,Cluster Analysis ,Computer Simulation ,Applications (stat.AP) ,030212 general & internal medicine ,0101 mathematics ,Statistics - Methodology ,Probability ,Randomized Controlled Trials as Topic ,Group randomized trials ,Covariate adjustment ,Statistics ,General Medicine ,8.4 Research design and methodologies (health services) ,Health Care ,Clustered data ,Data-adaptive ,Good Health and Well Being ,Super Learner ,Research Design ,Statistics, Probability and Uncertainty ,Health and social care services research - Abstract
Cluster randomized trials (CRTs) randomly assign an intervention to groups of individuals (e.g., clinics or communities) and measure outcomes on individuals in those groups. While offering many advantages, this experimental design introduces challenges that are only partially addressed by existing analytic approaches. First, outcomes are often missing for some individuals within clusters. Failing to appropriately adjust for differential outcome measurement can result in biased estimates and inference. Second, CRTs often randomize limited numbers of clusters, resulting in chance imbalances on baseline outcome predictors between arms. Failing to adaptively adjust for these imbalances and other predictive covariates can result in efficiency losses. To address these methodological gaps, we propose and evaluate a novel two-stage targeted minimum loss-based estimator (TMLE) to adjust for baseline covariates in a manner that optimizes precision, after controlling for baseline and post-baseline causes of missing outcomes. Finite sample simulations illustrate that our approach can nearly eliminate bias due to differential outcome measurement, while existing CRT estimators yield misleading results and inferences. Application to real data from the SEARCH community randomized trial demonstrates the gains in efficiency afforded through adaptive adjustment for baseline covariates, after controlling for missingness on individual-level outcomes., Comment: 37 pages total; main text is 17 pgs with 2 figures and 3 tables; supp material is 14 pgs with 1 figure and 5 tables
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- 2021
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42. Characteristics of HIV seroconverters in the setting of universal test and treat: Results from the SEARCH trial in rural Uganda and Kenya
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Diane V. Havlir, Carol S. Camlin, Florence Mwangwa, Norton Sang, Joshua Schwab, Edwin D. Charlebois, Elizabeth A. Bukusi, James Ayieko, Gabriel Chamie, Moses R. Kamya, Douglas Black, Laura B. Balzer, Tamara D. Clark, Marilyn Nyabuti, Maya L. Petersen, Jane Kabami, and Price, Matt A
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RNA viruses ,Rural Population ,Male ,Epidemiology ,HIV Infections ,Pathology and Laboratory Medicine ,Geographical Locations ,HIV Testing ,Immunodeficiency Viruses ,Risk Factors ,Medicine and Health Sciences ,Medicine ,Mass Screening ,Uganda ,Young adult ,Virus Testing ,Multidisciplinary ,Organic Compounds ,Incidence (epidemiology) ,Incidence ,Middle Aged ,Chemistry ,Infectious Diseases ,Spouse ,Medical Microbiology ,HIV epidemiology ,Viral Pathogens ,Cohort ,Viruses ,Physical Sciences ,Infectious diseases ,HIV/AIDS ,Female ,Pathogens ,Infection ,Research Article ,Medical conditions ,Adult ,Adolescent ,Anti-HIV Agents ,General Science & Technology ,Science ,Context (language use) ,Transactional sex ,Viral diseases ,Microbiology ,Young Adult ,Sex Factors ,Diagnostic Medicine ,Clinical Research ,Retroviruses ,Behavioral and Social Science ,Humans ,Seroconversion ,Microbial Pathogens ,business.industry ,Prevention ,Lentivirus ,Organic Chemistry ,Organisms ,Chemical Compounds ,Biology and Life Sciences ,HIV ,Kenya ,Good Health and Well Being ,Relative risk ,Medical Risk Factors ,Alcohols ,People and Places ,Africa ,business ,Demography - Abstract
Background Additional progress towards HIV epidemic control requires understanding who remains at risk of HIV infection in the context of high uptake of universal testing and treatment (UTT). We sought to characterize seroconverters and risk factors in the SEARCH UTT trial (NCT01864603), which achieved high uptake of universal HIV testing and ART coverage in 32 communities of adults (≥15 years) in rural Uganda and Kenya. Methods In a pooled cohort of 117,114 individuals with baseline HIV negative test results, we described those who seroconverted within 3 years, calculated gender-specific HIV incidence rates, evaluated adjusted risk ratios (aRR) for seroconversion using multivariable targeted maximum likelihood estimation, and assessed potential infection sources based on self-report. Results Of 704 seroconverters, 63% were women. Young (15–24 years) men comprised a larger proportion of seroconverters in Western Uganda (18%) than Eastern Uganda (6%) or Kenya (10%). After adjustment for other risk factors, men who were mobile [≥1 month of prior year living outside community] (aRR:1.68; 95%CI:1.09,2.60) or who HIV tested at home vs. health fair (aRR:2.44; 95%CI:1.89,3.23) were more likely to seroconvert. Women who were aged ≤24 years (aRR:1.91; 95%CI:1.27,2.90), mobile (aRR:1.49; 95%CI:1.04,2.11), or reported a prior HIV test (aRR:1.34; 95%CI:1.06,1.70), or alcohol use (aRR:2.07; 95%CI:1.34,3.22) were more likely to seroconvert. Among survey responders (N = 607, 86%), suspected infection source was more likely for women than men to be ≥10 years older (28% versus 8%) or a spouse (51% vs. 31%) and less likely to be transactional sex (10% versus 16%). Conclusion In the context of universal testing and treatment, additional strategies tailored to regional variability are needed to address HIV infection risks of young women, alcohol users, mobile populations, and those engaged in transactional sex to further reduce HIV incidence rates.
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- 2021
43. Uptake and outcomes of a novel community-based HIV post-exposure prophylaxis (PEP) programme in rural Kenya and Uganda
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James Ayieko, Moses R. Kamya, Florence Mwangwa, James Peng, Edwin D. Charlebois, Jane Kabami, Catherine A. Koss, Diane V. Havlir, Laura B. Balzer, Gabriel Chamie, Elizabeth A. Bukusi, Maya L. Petersen, Fred Opel, and Marilyn Nyabuti
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Rural Population ,medicine.medical_specialty ,Anti-HIV Agents ,HIV post exposure prophylaxis ,Population ,education ,HIV prevention ,Short Report ,Transactional sex ,HIV Infections ,Pilot Projects ,03 medical and health sciences ,0302 clinical medicine ,Short Reports ,Intervention (counseling) ,Medicine ,Humans ,Uganda ,030212 general & internal medicine ,Adverse effect ,post‐exposure prophylaxis (PEP) ,implementation ,education.field_of_study ,030505 public health ,Hotline ,business.industry ,Public Health, Environmental and Occupational Health ,high‐risk exposure ,Kenya ,Test (assessment) ,Regimen ,Infectious Diseases ,Family medicine ,uptake ,cardiovascular system ,Female ,Pre-Exposure Prophylaxis ,0305 other medical science ,business ,Post-Exposure Prophylaxis ,pre‐exposure prophylaxis (PrEP) ,circulatory and respiratory physiology - Abstract
Author(s): Ayieko, James; Petersen, Maya L; Kabami, Jane; Mwangwa, Florence; Opel, Fred; Nyabuti, Marilyn; Charlebois, Edwin D; Peng, James; Koss, Catherine A; Balzer, Laura B; Chamie, Gabriel; Bukusi, Elizabeth A; Kamya, Moses R; Havlir, Diane V | Abstract: IntroductionAntiretroviral-based HIV prevention, including pre-exposure prophylaxis (PrEP), is expanding in generalized epidemic settings, but additional prevention options are needed for individuals with periodic, high-risk sexual exposures. Non-occupational post-exposure prophylaxis (PEP) is recommended in global guidelines. However, in Africa, awareness of and access to PEP for sexual exposures are limited. We assessed feasibility, acceptability, uptake and adherence in a pilot study of a patient-centred PEP programme with options for facility- or community-based service delivery.MethodsAfter population-level HIV testing with universal access to PrEP for persons at elevated HIV risk (SEARCH Trial:NCT01864603), we conducted a pilot PEP study in five rural communities in Kenya and Uganda between December 2018 and May 2019. We assessed barriers to PEP in the population and implemented an intervention to address these barriers, building on existing in-country PEP protocols. We used community leaders for sensitization. Test kits and medications were acquired through the Ministry of Health supply chain and healthcare providers based at the Ministry of Health clinics were trained on PEP delivery. Additional intervention components were (a)PEP availability seven days/week, (b)PEP hotline staffed by providers and (c)option for out-of-facility medication delivery. We assessed implementation using the Proctor framework and measured seroconversions via repeat HIV testing. Successful "PEP completion" was defined as self-reported adherence over four weeks of therapy with post-PEP HIV testing.ResultsCommunity leaders were able to sensitize and mobilize for PEP. The Ministry of Health supplied test kits and PEP medications; after training, healthcare providers delivered the 28-day regimen with high completion rates. Among 124 persons who sought PEP, 66% were female, 24% were ≤25nyears and 42% were fisherfolk. Of these, 20% reported exposure with a serodifferent partner, 72% with a new or existing relationship and 7% from transactional sex. 12% of all visits were conducted at out-of-facility community-based sites; 35% of participants had ≥1 out-of-facility visit. No serious adverse events were reported. Overall, 85% met the definition of PEP completion. There were no HIV seroconversions.ConclusionsAmong individuals with elevated-risk exposures in rural East African communities, patient-centred PEP was feasible, acceptable and provides a promising addition to the current prevention toolkit.
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- 2020
44. Improved Viral Suppression With Streamlined Care in the SEARCH Study
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Fredrick J. Opel, Elizabeth A. Bukusi, Diane V. Havlir, James Ayieko, Craig R. Cohen, Vivek Jain, Laura B. Balzer, Asiphas Owaraganise, James Peng, Dalsone Kwarisiima, Edwin D. Charlebois, Gabriel Chamie, Moses R. Kamya, Carol S. Camlin, Maya L. Petersen, and Matthew D. Hickey
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Adult ,Male ,medicine.medical_specialty ,viral suppression ,Adolescent ,Anti-HIV Agents ,Clinical Sciences ,Human immunodeficiency virus (HIV) ,Viremia ,HIV Infections ,Hiv testing ,medicine.disease_cause ,Young Adult ,differentiated service delivery ,Clinical Research ,Internal medicine ,Virology ,medicine ,Humans ,universal test and treat ,Pharmacology (medical) ,Uganda ,Viral suppression ,Implementation Science ,business.industry ,HIV ,differentiated care ,Guideline ,Viral Load ,Middle Aged ,medicine.disease ,Antiretroviral therapy ,Kenya ,East Africa ,CD4 Lymphocyte Count ,Clinic visit ,Treatment Outcome ,Infectious Diseases ,Good Health and Well Being ,Test and treat ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Public Health and Health Services ,HIV/AIDS ,Female ,business ,Infection ,Delivery of Health Care - Abstract
Supplemental Digital Content is Available in the Text., Background: HIV differentiated service delivery (DSD) models are scaling up in resource-limited settings for stable patients; less is known about DSD outcomes for patients with viremia. We evaluated the effect on viral suppression (VS) of a streamlined care DSD model implemented in the SEARCH randomized universal test and treat trial in rural Uganda and Kenya (NCT:01864603). Methods: We included HIV-infected adults at baseline (2013) who were country guideline antiretroviral therapy (ART) eligible (prior ART experience or CD4 ≤ 350) with ≥1 HIV clinic visit between 2013 and 2017 in SEARCH communities randomized to intervention (N = 16) or control (N = 16). We assessed the effect of streamlined care in intervention community clinics (patient-centered care, increased appointment spacing, improved clinic access, reminders, and tracking) on VS at 3 years. Analysis was stratified by the baseline care status: ART-experienced with viremia, ART-naïve with CD4 ≤ 350, or ART-experienced with VS. Results: Among 6190 ART-eligible persons in care, year 3 VS was 90% in intervention and 87% in control arms (RR 1.03, 95% CI: 1.01 to 1.06). Among ART-experienced persons with baseline viremia, streamlined care was associated with higher VS (67% vs 47%, RR 1.41, 95% CI: 1.05 to 1.91). Among ART-naïve persons, VS was not significantly higher with streamlined care (83% vs 79%, RR 1.05, 95% CI: 0.95 to 1.16). Among ART-experienced persons with baseline VS, nearly all remained virally suppressed in both arms (97% vs 95%, RR 1.01, 95% CI: 1.00 to 1.03). Conclusions: Streamlined care was associated with higher viral suppression among ART-experienced patients with viremia in this randomized evaluation of ART-eligible patients who were in care after universal HIV testing.
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- 2020
45. Effect of a patient-centered hypertension delivery strategy on all-cause mortality: Secondary analysis of SEARCH, a community-randomized trial in rural Kenya and Uganda
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Laura B. Balzer, Asiphas Owaraganise, James Ayieko, Gabriel Chamie, Craig R. Cohen, Fredrick J. Opel, Matthew D. Hickey, Moses R. Kamya, Erick Wafula, Edwin D. Charlebois, James Peng, Diane V. Havlir, Elizabeth A. Bukusi, Lillian B. Brown, Jane Kabami, Mucunguzi Atukunda, Marilyn Nyabuti, Maya L. Petersen, Dalsone Kwarisiima, Carol S. Camlin, Vivek Jain, Nicholas Sim, and Basu, Sanjay
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Male ,RNA viruses ,Comparative Effectiveness Research ,Pediatrics ,Time Factors ,Physiology ,Blood Pressure ,HIV Infections ,Cardiovascular Medicine ,Cardiovascular ,Pathology and Laboratory Medicine ,Medical and Health Sciences ,Vascular Medicine ,law.invention ,Body Mass Index ,Geographical Locations ,Endocrinology ,Medical Conditions ,Randomized controlled trial ,Immunodeficiency Viruses ,law ,Integrated ,Cause of Death ,Patient-Centered Care ,Medicine and Health Sciences ,Mass Screening ,Uganda ,Community Health Services ,Chronic care ,education.field_of_study ,Delivery of Health Care, Integrated ,Mortality rate ,General Medicine ,Health Services ,Middle Aged ,Treatment Outcome ,Physiological Parameters ,Medical Microbiology ,Cardiovascular Diseases ,Viral Pathogens ,Hypertension ,Viruses ,Medicine ,HIV/AIDS ,Female ,Pathogens ,Research Article ,Adult ,medicine.medical_specialty ,Adolescent ,Anti-HIV Agents ,Death Rates ,Endocrine Disorders ,Clinical Trials and Supportive Activities ,Population ,Cardiology ,Microbiology ,Young Adult ,Population Metrics ,Clinical Research ,General & Internal Medicine ,Retroviruses ,medicine ,Diabetes Mellitus ,Humans ,Hypoglycemic Agents ,education ,Microbial Pathogens ,Antihypertensive Agents ,Aged ,Population Biology ,business.industry ,Prevention ,Lentivirus ,Body Weight ,Organisms ,Repeated measures design ,Biology and Life Sciences ,HIV ,Cardiovascular Disease Risk ,Kenya ,Good Health and Well Being ,Blood pressure ,Cost Effectiveness Research ,Relative risk ,Metabolic Disorders ,People and Places ,Africa ,business ,Delivery of Health Care ,Body mass index - Abstract
Background Hypertension treatment reduces morbidity and mortality yet has not been broadly implemented in many low-resource settings, including sub-Saharan Africa (SSA). We hypothesized that a patient-centered integrated chronic disease model that included hypertension treatment and leveraged the HIV care system would reduce mortality among adults with uncontrolled hypertension in rural Kenya and Uganda. Methods and findings This is a secondary analysis of the SEARCH trial (NCT:01864603), in which 32 communities underwent baseline population-based multidisease testing, including hypertension screening, and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Patient-centered care included on-site introduction to clinic staff at screening, nursing triage to expedite visits, reduced visit frequency, flexible clinic hours, and a welcoming clinic environment. The analytic population included nonpregnant adults (≥18 years) with baseline uncontrolled hypertension (blood pressure ≥140/90 mm Hg). The primary outcome was 3-year all-cause mortality with comprehensive population-level assessment. Secondary outcomes included hypertension control assessed at a population level at year 3 (defined per country guidelines as at least 1 blood pressure measure, Matthew Hickey and co-workers report on outcomes of the SEARCH trial of hypertension screening and care in sub-Saharan Africa., Author summary Why was this study done? There is a growing burden of hypertension and resultant cardiovascular disease (CVD) globally, and particularly in sub-Saharan Africa (SSA). Maintenance of normal blood pressure through treatment with antihypertensive medications clearly reduces CVD morbidity and mortality; yet across SSA, only 28% are aware of their hypertension diagnosis, only 18% are on treatment, and only 7% have controlled blood pressure. The HIV chronic care system offers a platform for integrating noncommunicable disease (NCD) care for both people with HIV and the general population, though there are limited data on the implementation and effectiveness of such care models. What did the researchers do and find? We conducted a secondary analysis of data from the SEARCH cluster randomized controlled trial in 32 communities in Kenya and Uganda where all communities received population-wide hypertension and multidisease screening and were randomized to standard country-guided treatment or to a patient-centered integrated chronic care model including treatment for hypertension, diabetes, and HIV. Among 86,078 nonpregnant adults screened at baseline, we identified 10,928 (13%) with uncontrolled hypertension, all of whom were referred to the nearest government-run health facility for hypertension care. We conducted comprehensive vital status assessment after 3 years, determining vital status for 99% of participants. Among adults with baseline uncontrolled hypertension, all-cause mortality was 21% lower in intervention compared to control communities (3.1% versus 4.2%). What do these findings mean? Providing hypertension care through an integrated, patient-centered chronic care model was associated with a 21% reduction in all-cause mortality over 3 years among patients with uncontrolled hypertension at study baseline. Though the intervention was associated with improved hypertension control, half of participants remained uncontrolled, attenuating the benefits of hypertension treatment. Strategies to improve linkage and engagement in hypertension care are likely to further improve treatment outcomes in the context of integrated patient-centered hypertension care models. Leveraging the HIV care platform is a promising strategy for delivering chronic hypertension and other NCD care to address the growing burden of NCDs in SSA.
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- 2020
46. Far from MCAR: Obtaining Population-level Estimates of HIV Viral Suppression
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Mark J. van der Laan, Laura B. Balzer, James Ayieko, Maya L. Petersen, Joshua Schwab, Edwin D. Charlebois, Moses R. Kamya, Diane V. Havlir, Dalsone Kwarisiima, and Gabriel Chamie
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Rural Population ,Male ,TMLE ,Epidemiology ,Missing data ,Human immunodeficiency virus (HIV) ,Prevalence ,HIV Infections ,medicine.disease_cause ,01 natural sciences ,law.invention ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Clinical Research ,Machine learning ,medicine ,Humans ,Uganda ,HIV viral suppression ,030212 general & internal medicine ,Viral suppression ,0101 mathematics ,Baseline (configuration management) ,Disease burden ,Estimation ,business.industry ,Statistics ,Viral Load ,Kenya ,Confidence interval ,3. Good health ,Good Health and Well Being ,Super Learner ,Public Health and Health Services ,HIV/AIDS ,Female ,business ,Infection ,Demography ,Causal inference - Abstract
BackgroundPopulation-level estimates of disease prevalence and control are needed to assess the effectiveness of prevention and treatment strategies. However, available data are often subject to differential missingness. Consider population-level HIV viral suppression: proportion of all HIV-positive persons who are suppressing viral replication. Individuals with measured HIV status, and, among HIV-positive individuals, those with measured viral suppression are likely to differ from those without such measurements.MethodsWe discuss three sets of assumptions sufficient to identify population-level suppression over time in the intervention arm of the SEARCH Study (NCT01864603), a community randomized trial in rural Kenya and Uganda (2013-2017). Using data on nearly 100,000 participants, we compare estimates from an unadjusted approach assuming data are missing-completely-at-random (MCAR); stratification on age group, sex, and community; and, targeted maximum likelihood estimation (TMLE) with Super Learner to adjust for baseline and time-updated predictors of measurement.ResultsDespite high annual coverage of testing, estimates of population-level viral suppression varied by identification assumption. Unadjusted estimates were most optimistic: 50% of HIV-positive persons suppressed at baseline, 80% at Year 1, 85% at Year 2, and 85% at Year 3. Stratification on baseline predictors yielded slightly lower estimates, and full adjustment reduced estimates further: 42% of HIV-positive persons suppressed at baseline, 71% at Year 1, 76% at Year 2, and 79% at Year 3.ConclusionsEstimation of population-level disease burden and treatment coverage require appropriate adjustment for missingness. Even in “Big Data” settings, estimates relying on the MCAR assumption or baseline stratification should be interpreted with caution.
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- 2020
47. Universal HIV Testing and Treatment (UTT) Integrated with Chronic Disease Screening and Treatment: the SEARCH study
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Diane V. Havlir, Moses R. Kamya, Matthew D. Hickey, Gabriel Chamie, James Ayieko, and Dalsone Kwarisiima
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0301 basic medicine ,Male ,HIV Infections ,Disease ,Cardiovascular ,0302 clinical medicine ,Mass Screening ,030212 general & internal medicine ,education.field_of_study ,Health Services ,Non-communicable disease ,HIV testing ,Infectious Diseases ,Medical Microbiology ,Hypertension ,HIV/AIDS ,Female ,Infection ,Adult ,medicine.medical_specialty ,Anti-HIV Agents ,Population ,Clinical Trials and Supportive Activities ,Immunology ,Hiv testing ,Article ,03 medical and health sciences ,Clinical Research ,Intervention (counseling) ,Diabetes mellitus ,Virology ,medicine ,Diabetes Mellitus ,Humans ,HIV treatment ,Intensive care medicine ,education ,Africa South of the Sahara ,business.industry ,Research ,Prevention ,Treatment as prevention ,medicine.disease ,030104 developmental biology ,Chronic disease ,Good Health and Well Being ,Chronic Disease ,business ,Delivery of Health Care - Abstract
PURPOSE OF REVIEW: The growing burden of untreated chronic disease among persons with HIV (PWH) threatens to reverse heath gains from ART expansion. Universal test and treat (UTT)’s population-based approach provides opportunity to jointly identify and treat HIV and other chronic diseases. This review’s purpose is to describe SEARCH UTT study’s integrated disease strategy and related approaches in Sub-Saharan Africa. RECENT FINDINGS: In SEARCH 97% of adults were HIV tested, 85% were screened for hypertension and 79% for diabetes at health fairs after two years, for an additional $1.16/person. After 3 years, population-level hypertension control was 26% higher in intervention versus control communities. Other mobile/home-based multi-disease screening approaches have proven successful, but data on multi-disease care delivery are extremely limited and show little effect on clinical outcomes. SUMMARY: Integration of chronic disease into HIV in the UTT era is feasible and can achieve population level effects; however, optimization and implementation remain a huge unmet need.
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- 2020
48. Population-level viral suppression among pregnant and postpartum women in a universal test and treat trial
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Hachem Saddiki, Elizabeth A. Bukusi, Gabriel Chamie, Theodore Ruel, Maya L. Petersen, Dalsone Kwarisiima, Edwin D. Charlebois, Catherine A. Koss, Craig R. Cohen, Laura B. Balzer, P. Musoke, Tamara D. Clark, Jane Kabami, Diane V. Havlir, Mucunguzi Atukunda, James Ayieko, and Moses R. Kamya
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0301 basic medicine ,HIV Infections ,Reproductive health and childbirth ,Medical and Health Sciences ,0302 clinical medicine ,Pregnancy ,Antiretroviral Therapy, Highly Active ,Prevalence ,Immunology and Allergy ,Medicine ,Uganda ,030212 general & internal medicine ,Cluster randomised controlled trial ,Viral suppression ,postpartum ,Pediatric ,education.field_of_study ,Obstetrics ,Postpartum Period ,Viral Load ,Middle Aged ,Biological Sciences ,Mental Health ,Infectious Diseases ,Anti-Retroviral Agents ,6.1 Pharmaceuticals ,HIV/AIDS ,Female ,Live birth ,Infection ,Viral load ,Adult ,medicine.medical_specialty ,Adolescent ,Anti-HIV Agents ,Immunology ,Population ,Clinical Trials and Supportive Activities ,Antiretroviral Therapy ,Article ,population viral suppression ,03 medical and health sciences ,Young Adult ,Clinical Research ,Virology ,Behavioral and Social Science ,Humans ,universal test and treat ,Highly Active ,Risk factor ,education ,business.industry ,Prevention ,Psychology and Cognitive Sciences ,Evaluation of treatments and therapeutic interventions ,medicine.disease ,Kenya ,030104 developmental biology ,Good Health and Well Being ,Test and treat ,Pregnant Women ,business - Abstract
OBJECTIVE(S) We sought to determine whether universal 'test and treat' (UTT) can achieve gains in viral suppression beyond universal antiretroviral treatment (ART) eligibility during pregnancy and postpartum, among women living with HIV. DESIGN A community cluster randomized trial. METHODS The SEARCH UTT trial compared an intervention of annual population testing and universal ART with a control of baseline population testing with ART by country standard, including ART eligibility for all pregnant/postpartum women, in 32 communities in Kenya and Uganda. When testing, women were asked about current pregnancy and live births over the prior year and, if HIV-infected, had their viral load measured. Between arms, we compared population-level viral suppression (HIV RNA
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- 2020
49. Understanding Demand for PrEP and Early Experiences of PrEP Use Among Young Adults in Rural Kenya and Uganda: A Qualitative Study
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Diane V. Havlir, Cecilia Akatukwasa, Asiphas Owaraganise, Harriet Itiakorit, Irene Maeri, Dalsone Kwarisiima, Lawrence Owino, Catherine A. Koss, Florence Mwangwa, Frederick Atwine, Jane Kabami, Craig R. Cohen, Mucunguzi Atukunda, Carol S. Camlin, Norton Sang, Edwin D. Charlebois, Anjeline Onyango, Moses R. Kamya, Maya L. Petersen, James Ayieko, Monica Getahun, Robert Bakanoma, and Elizabeth A. Bukusi
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Gerontology ,Male ,Pediatric AIDS ,Youth ,HIV Infections ,Peer support ,Adolescents ,law.invention ,0302 clinical medicine ,7.1 Individual care needs ,law ,Uganda ,030212 general & internal medicine ,Qualitative Research ,Pediatric ,education.field_of_study ,Pre-exposure prophylaxis ,Focus Groups ,Sub-Saharan africa ,Health psychology ,Infectious Diseases ,Mental Health ,Public Health and Health Services ,HIV/AIDS ,Female ,Public Health ,0305 other medical science ,Psychology ,Infection ,medicine.medical_specialty ,Social Work ,Social Psychology ,Adolescent ,Anti-HIV Agents ,Population ,HIV prevention ,Clinical Trials and Supportive Activities ,Transactional sex ,Article ,03 medical and health sciences ,Young Adult ,Condom ,Clinical Research ,Behavioral and Social Science ,medicine ,Humans ,education ,030505 public health ,Public health ,Prevention ,Public Health, Environmental and Occupational Health ,Focus group ,Kenya ,Good Health and Well Being ,Pre-Exposure Prophylaxis ,Management of diseases and conditions ,Qualitative research - Abstract
Few studies have sought to understand factors influencing uptake and continuation of pre-exposure prophylaxis (PrEP) among young adults in sub-Saharan Africa in the context of population-based delivery of open-label PrEP. To address this gap, this qualitative study was implemented within the SEARCH study (NCT#01864603) in Kenya and Uganda, which achieved near-universal HIV testing, and offered PrEP in16 intervention communitiesbeginning in 2016-2017. Focus group discussions (8 groups, n = 88 participants) and in-depth interviews (n = 23) with young adults who initiated or declined PrEP were conducted in five communities, to explore PrEP-related beliefs and attitudes, HIV risk perceptions, motivations for uptake and continuation, and experiences. Grounded theoretical methods were used to analyze data. Young people felt personally vulnerable to HIV, but perceived the severity of HIV to be low, due to the success of antiretroviral therapy (ART): daily pill-taking was more threatening than the disease itself. Motivations for PrEP were highly gendered: young men viewed PrEP as a vehicle for safely pursuing multiple partners, while young women saw PrEP as a means to control risks in the context of engagement in transactional sex and limited agency to negotiate condom use and partner testing. Rumors, HIV/ART-related stigma, and desire for "proof" of efficacy militated against uptake, and many women required partners' permission to take PrEP. Uptake was motivated by high perceived HIV risk, and beliefs that PrEP use supported life goals. PrEP was often discontinued due to dissolution of partnerships/changing risk, unsupportive partners/peers, or early side effects/pill burden. Despite high perceived risks and interest, PrEP was received with moral ambivalence because of its associations with HIV/ART and stigmatized behaviors. Delivery models that promote youth access, frame messaging on wellness and goals, and foster partner and peer support, may facilitate uptake among young people.
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- 2020
50. Shifting the narrative: from 'the missing men' to 'we are missing the men'
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Anna Grimsrud, Tanya Shewchuk, James Ayieko, and Wole Ameyan
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Adult ,Male ,medicine.medical_specialty ,Anti-HIV Agents ,Human immunodeficiency virus (HIV) ,MEDLINE ,men ,HIV Infections ,medicine.disease_cause ,differentiated service delivery ,90‐90‐90 ,Social Norms ,medicine ,Humans ,Narrative ,Homosexuality, Male ,Child ,Psychiatry ,Health Services Needs and Demand ,business.industry ,Public Health, Environmental and Occupational Health ,HIV ,testing ,Editorial ,Infectious Diseases ,Female ,Men's Health ,business ,Delivery of Health Care - Published
- 2020
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