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ObjectiveWe examine the efficacy of short message service (SMS) and SMS with peer navigation (SMS + PN) in improving linkage to HIV care and initiation of antiretroviral therapy (ART).DesignI-Care was a cluster randomized trial conducted in primary care facilities in North West Province, South Africa. The primary study outcome was retention in HIV care; this analysis includes secondary outcomes: linkage to care and ART initiation.MethodsEighteen primary care clinics were randomized to automated SMS ( n  = 7), automated and tailored SMS + PN ( n  = 7), or standard of care (SOC; n  = 4). Recently HIV diagnosed adults ( n  = 752) were recruited from October 2014 to April 2015. Those not previously linked to care ( n  = 352) contributed data to this analysis. Data extracted from clinical records were used to assess the days that elapsed between diagnosis and linkage to care and ART initiation. Cox proportional hazards models and generalized estimating equations were employed to compare outcomes between trial arms, overall and stratified by sex and pregnancy status.ResultsOverall, SMS ( n  = 132) and SMS + PN ( n  = 133) participants linked at 1.28 [95% confidence interval (CI): 1.01-1.61] and 1.60 (95% CI: 1.29-1.99) times the rate of SOC participants ( n  = 87), respectively. SMS + PN significantly improved time to ART initiation among non-pregnant women (hazards ratio: 1.68; 95% CI: 1.25-2.25) and men (hazards ratio: 1.83; 95% CI: 1.03-3.26) as compared with SOC.ConclusionResults suggest SMS and peer navigation services significantly reduce time to linkage to HIV care in sub-Saharan Africa and that SMS + PN reduced time to ART initiation among men and non-pregnant women. Both should be considered candidates for integration into national programs.Trial registrationNCT02417233, registered 12 December 2014; closed to accrual 17 April 2015.

BackgroundIn 2020, the Health Resources and Services Administration's HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites.MethodThe ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients.DiscussionThis approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care.

Voluntary male medical circumcision (VMMC) reduces HIV acquisition by up to 60%. Kenya has successfully scaled up VMMC to an estimated 91% of eligible men and boys in certain regions in combination due to VMMC and cultural circumcisions. VMMC as a program is implemented regionally in traditionally non-circumcising counties where the prevalence is still below 91%, ranging from 56.4% to 66.7%. Given that funding toward VMMC is expected to decline in the coming years, it is important to identify what models of service delivery are most appropriate and efficient to sustainably meet the VMMC needs of new cohorts' eligible men. To this end, we compared the costs of facility-based VMMC and one within a rapid results initiative (RRI), a public health service scheduled during school holidays to perform many procedures over a short period. We employed activity-based micro-costing to estimate the costs, from the implementer perspective, of facility-based VMMC and RRI-based VMMC conducted between October 2017 and September 2018 at 41 sites in Kisumu County, Kenya supported by the Family AIDS care & Education Services (FACES). We conducted site visits and reviewed financial ledger and programmatic data to identify and quantify resources consumed and the number of VMMC procedures performed during routine care and RRIs. Ledger data were used to estimate fixed costs, recurring costs, and cost per circumcision (CPC) in United States dollar (USD). A sensitivity analysis was done to estimate CPC where we allocated 6 months of the ledger to facility-based and 6 months to RRI. Overall, FACES spent $3,092,891 toward VMMC services and performed 42,139 procedures during the funding year. This included $2,644,910 in stable programmatic costs, $139,786 procedure costs, and $308,195 for RRI-specific activities. Over the year, 49% (n = 20,625) of procedures were performed as part of routine care and 51% (n = 21,514) were performed during the RRIs. Procedures conducted during facility-based cost $99.35 per circumcision, those conducted during the RRIs cost $48.51 per circumcision, and according to our sensitivity analysis, CPC for facility-based ranges from $99.35 to $287.24 and for RRI costs ranged from $29.81 to $48.51. The cost of VMMC during the RRI was substantially lower than unit costs reported in previous costing studies. We conclude that circumcision campaigns, such as the RRI, offer an efficient and sustainable approach to VMMC.

IntroductionThere is a high burden of hypertension (HTN) among HIV-infected people in Uganda. However, capacity to prevent, diagnose and treat HTN is suboptimal. This study seeks to leverage the existing HIV-related infrastructure in primary care health facilities (HFs) using the integrated HIV/HTN care model to improve health outcomes of patients with HIV and HTN.Methods and analysisIntegrated HIV/HTN study a type-1 effectiveness/implementation cluster randomised trial, will evaluate the effectiveness of a multicomponent model intervention in 13 districts randomised to the intervention arm compared with 13 districts randomised to control. Two randomly selected HFs per district and their patients will be eligible to participate. The intervention will comprise training of primary healthcare (PHC) providers followed by regular supervision, integration of HTN care into HIV clinics, improvement of the health management information system, IT-based messaging to improve communication among frontline PHCs and district-level managers. HTN care guidelines, sphygmomanometers, patient registers and a buffer stock of essential drugs will be provided to HFs in both study arms. We will perform cross-sectional surveys at baseline, 12 and 24 months, on a random sample of patients attending HFs to measure effectiveness of the integrated care model between 2021 and 2024. We will perform in-depth interviews of providers, patients and healthcare managers to assess barriers and facilitators of integrated care. We will measure the cost of the intervention through microcosting and time-and-motion studies. The outcomes will be analysed taking the clustered structure of the data set into account.Ethics and disseminationEthics approval has been obtained from the Research Ethics Committees at London School of Hygiene and Tropical Medicine, and Makerere University School of Medicine. All participants will provide informed consent prior to study inclusion. Strict confidentiality will be applied throughout. Findings will be disseminated to public through meetings, and publications.Trial registration numberNCT04624061.

BackgroundDespite longstanding guidelines endorsing isoniazid preventive therapy (IPT) for people with HIV, uptake is low across sub-Saharan Africa. Mid-level health managers oversee IPT programmes nationally; interventions aimed at this group have not been tested. We aimed to establish whether providing structured leadership and management training and facilitating subregional collaboration and routine data feedback to mid-level managers could increase IPT initiation among people with HIV compared with standard practice.MethodsWe conducted a cluster randomised trial in Uganda among district-level health managers. We randomly assigned clusters of between four and seven managers in a 1:1 ratio to intervention or control groups. Our intervention convened managers into mini-collaboratives facilitated by Ugandan experts in tuberculosis and HIV, and provided business leadership and management training, SMS platform access, and data feedback. The control was standard practice. Participants were not masked to trial group, but study statisticians were masked until trial completion. The primary outcome was IPT initiation rates among adults with HIV in facilities overseen by participants over a period of 2 years (2019-21). We conducted prespecified analyses that excluded the third quarter of 2019 (Q3-2019) to understand intervention effects independent of a national 100-day IPT push tied to a financial contingency during Q3-2019. This trial is registered with ClinicalTrials.gov (NCT03315962), and is ongoing.FindingsBetween Nov 15, 2017, and March 14, 2018, managers from 82 of 82 eligible districts (61% of Uganda's 135 districts) were enrolled and randomised: 43 districts to intervention, 39 to control. Intervention delivery took place between Dec 6, 2017, and Feb 2, 2022. Over 2 years, IPT initiation rates were 0·74 versus 0·65 starts per person-year in intervention versus control groups (incidence rate ratio [IRR] 1·14, 95% CI 0·88-1·46; p=0·16). Excluding Q3-2019, IPT initiation was higher in the intervention group versus the control group: 0·32 versus 0·25 starts per person-year (IRR 1·27, 95% CI 1·00-1·61; p=0·026).InterpretationFollowing an intervention targeting managers in more than 60% of Uganda's districts, IPT initiation rates were not significantly higher in intervention than control groups. After accounting for large increases in IPT from a 100-day push in both groups, the intervention led to significantly increased IPT rates, sustained after the push and during the COVID-19 pandemic. Our findings suggest that interventions centred on mid-level health managers can improve IPT implementation on a large, subnational scale, and merit further exploration to address key public health challenges for which strong evidence exists but implementation remains suboptimal.FundingNational Institute of Allergy and Infectious Diseases.

IntroductionContinuity of care is an attribute of high-quality health systems and a necessary component of chronic disease management. Assessment of health information systems for HIV care in South Africa has identified substantial rates of clinic transfer, much of it undocumented. Understanding the reasons for changing sources of care and the implications for patient outcomes is important in informing policy responses.MethodsIn this secondary analysis of the 2014 - 2016 I-Care trial, we examined self-reported changes in source of HIV care among a cohort of individuals living with HIV and in care in North West Province, South Africa. Individuals were enrolled in the study within 1 year of diagnosis; participants completed surveys at 6 and 12 months including items on sources of care. Clinical data were extracted from records at participants' original clinic for 12 months following enrollment. We assessed frequency and reason for changing clinics and compared the demographics and care outcomes of those changing and not changing source of care.ResultsSix hundred seventy-five (89.8%) of 752 study participants completed follow-up surveys with information on sources of HIV care; 101 (15%) reported receiving care at a different facility by month 12 of follow-up. The primary reason for changing was mobility (N=78, 77%). Those who changed clinics were more likely to be young adults, non-citizens, and pregnant at time of diagnosis. Self-reported clinic attendance and ART adherence did not differ based on changing clinics. Those on ART not changing clinics reported 0.66 visits more on average than were documented in clinic records.ConclusionAt least 1 in 6 participants in HIV care changed clinics within 2 years of diagnosis, mainly driven by mobility; while most appeared lost to follow-up based on records from the original clinic, self-reported visits and adherence were equivalent to those not changing clinics. Routine clinic visits could incorporate questions about care at other locations as well as potential relocation, particularly for younger, pregnant, and non-citizen patients, to support existing efforts to make HIV care records portable and facilitate continuity of care across clinics.Trial registrationThe original trial was registered with ClinicalTrials.gov , NCT02417233, on 12 December 2014.

IntroductionFew interventions have demonstrated improved retention in care for people living with HIV (PLHIV) in sub-Saharan Africa. We tested the efficacy of two personal support interventions - one using text messaging (SMS-only) and the second pairing SMS with peer navigation (SMS+PN) - to improve HIV care retention over one year.MethodsIn a cluster randomized control trial (NCT# 02417233) in North West Province, South Africa, we randomized 17 government clinics to three conditions: SMS-only (6), SMS+PN (7) or standard of care (SOC; 4). Participants at SMS-only clinics received appointment reminders, biweekly healthy living messages and twice monthly SMS check-ins. Participants at SMS+PN clinics received SMS appointment reminders and healthy living messages and spoke at least twice monthly with peer navigators (PLHIV receiving care) to address barriers to care. Outcomes were collected through biweekly clinical record extraction and surveys at baseline, six and 12 months. Retention in HIV care over one year was defined as clinic visits every three months for participants on antiretroviral therapy (ART) and CD4 screening every six months for pre-ART participants. We used generalized estimating equations, adjusting for clustering by clinic, to test for differences across conditions.ResultsBetween October 2014 and April 2015, we enrolled 752 adult clients recently diagnosed with HIV (SOC: 167; SMS-only: 289; SMS+PN: 296). Individuals in the SMS+PN arm had approximately two more clinic visits over a year than those in other arms (p

Transgender women of color are disproportionately impacted by HIV, poor health outcomes, and transgender-related discrimination (TD). We tested the Model of Gender Affirmation (GA) to identify intervention-amenable targets to enhance viral suppression (VS) using data from 858 transgender women of color living with HIV (49% Latina, 42% Black; 36% virally suppressed) in a serial mediation model. Global fit statistics demonstrated good model fit; statistically significant (p ≤ 0.05) direct pathways were between TD and GA, GA and healthcare empowerment (HCE), and HCE and VS. Significant indirect pathways were from TD to VS via GA and HCE (p = 0.036) and GA to VS via HCE (p = 0.028). Gender affirmation and healthcare empowerment significantly and fully mediated the total effect of transgender-related discrimination on viral suppression. These data provide empirical evidence for the Model of Gender Affirmation. Interventions that boost gender affirmation and healthcare empowerment may improve viral suppression among transgender women of color living with HIV.

BackgroundIn the United States, patients with HIV face significant barriers to linkage to and retention in care which impede the necessary steps toward achieving the desired clinical outcome of viral suppression. Individual-level interventions, such as patient navigation, are evidence based, effective strategies for improving care engagement. In addition, use of surveillance and clinical data to identify patients who are not fully engaged in care may improve the effectiveness and cost-effectiveness of these programs.Methods and findingsWe employed a pre-post design to estimate the outcomes and costs, from the program perspective, of 5 state-level demonstration programs funded under the Health Resources and Services Administration's Special Projects of National Significance Program (HRSA/SPNS) Systems Linkages Initiative that employed existing surveillance and/or clinical data to identify individuals who had never entered HIV care, had fallen out of care, or were at risk of falling out of care and navigation strategies to engage patients in HIV care. Outcomes and costs were measured relative to standard of care during the first year of implementation of the interventions (2013 to 2014). We followed patients to estimate the number and proportion of additional patients linked, reengaged, retained, and virally suppressed by 12 months after enrollment in the interventions. We employed inverse probability weighting to adjust for differences in patient characteristics across programs, missing data, and loss to follow-up. We estimated the additional costs expended during the first year of each intervention and the cost per outcome of each intervention as the additional cost per HIV additional care continuum target achieved (cost per patient linked, reengaged, retained, and virally suppressed) 12 months after enrollment in each intervention. In this study, 3,443 patients were enrolled in Louisiana (LA), Massachusetts (MA), North Carolina (NC), Virginia (VA), and Wisconsin (WI) (147, 151, 2,491, 321, and 333, respectively). Patients were a mean of 40 years old, 75% male, and African American (69%) or Caucasian (22%). At baseline, 24% were newly diagnosed, 2% had never been in HIV care, 45% had fallen out of care, and 29% were at risk of falling out of care. All 5 interventions were associated with increases in the number and proportion of patients with viral suppression [percent increase: LA = 90.9%, 95% confidence interval (CI) = 88.4 to 93.4; MA = 78.1%, 95% CI = 72.4 to 83.8; NC = 47.5%, 95% CI = 45.2 to 49.8; VA = 54.6, 95% CI = 49.4 to 59.9; WI = 58.4, 95% CI = 53.4 to 63.4]. Overall, interventions cost an additional $4,415 (range = $3,746 to $5,619), $2,009 (range = $1,516 to $2,274), $920 (range = $627 to $941), $2,212 (range = $1,789 to $2,683), and $3,700 ($2,734 to $4,101), respectively per additional patient virally suppressed. The results of this study are limited in that we did not have contemporaneous controls for each intervention; thus, we are only able to assess patients against themselves at baseline and not against standard of care during the same time period.ConclusionsPatient navigation programs were associated with improvements in engagement of patients in HIV care and viral suppression. Cost per outcome was minimized in states that utilized surveillance data to identify individuals who were out of care and/or those that were able to identify a larger number of patients in need of improvement at baseline. These results have the potential to inform the targeting and design of future navigation-type interventions.

ObjectiveSub-Saharan Africa faces twin epidemics of HIV and noncommunicable diseases including hypertension. Integrating hypertension care into chronic HIV care is a global priority, but cost estimates are lacking. In the SEARCH Study, we performed population-level HIV/hypertension testing, and offered integrated streamlined chronic care. Here, we estimate costs for integrated hypertension/HIV care for HIV-positive individuals, and costs for hypertension care for HIV-negative individuals in the same clinics.DesignMicrocosting analysis of healthcare expenditures within Ugandan HIV clinics.MethodsSEARCH (NCT: 01864603) conducted community health campaigns for diagnosis and linkage to care for both HIV and hypertension. HIV-positive patients received hypertension/HIV care jointly including blood pressure monitoring and medications; HIV-negative patients received hypertension care at the same clinics. Within 10 Ugandan study communities during 2015-2016, we estimated incremental annual per-patient hypertension care costs using micro-costing techniques, time-and-motion personnel studies, and administrative/clinical records review.ResultsOverall, 70 HIV-positive and 2355 HIV-negative participants received hypertension care. For HIV-positive participants, average incremental cost of hypertension care was $6.29 per person per year, a 2.1% marginal increase over prior estimates for HIV care alone. For HIV-negative participants, hypertension care cost $11.39 per person per year, a 3.8% marginal increase over HIV care costs. Key costs for HIV-positive patients included hypertension medications ($6.19 per patient per year; 98% of total) and laboratory testing ($0.10 per patient per year; 2%). Key costs for HIV-negative patients included medications ($5.09 per patient per year; 45%) and clinic staff salaries ($3.66 per patient per year; 32%).ConclusionFor only 2-4% estimated additional costs, hypertension care was added to HIV care, and also expanded to all HIV-negative patients in prototypic Ugandan clinics, demonstrating substantial synergy. Our results should encourage accelerated scale-up of hypertension care into existing clinics.

BackgroundThe US National HIV/AIDS Strategy (NHAS) emphasizes the use of technology to facilitate coordination of comprehensive care for people with HIV. We examined cost-effectiveness from the health system perspective of 6 health information technology (HIT) interventions implemented during 2008 to 2012 in a Ryan White HIV/AIDS Program (RWHAP) Special Projects of National Significance (SPNS) Program demonstration project.Methods/findingsHIT interventions were implemented at 6 sites: Bronx, New York; Durham, North Carolina; Long Beach, California; New Orleans, Louisiana; New York, New York (2 sites); and Paterson, New Jersey. These interventions included: (1) use of HIV surveillance data to identify out-of-care individuals; (2) extension of access to electronic health records (EHRs) to support service providers; (3) use of electronic laboratory ordering and prescribing; and (4) development of a patient portal. We employed standard microcosting techniques to estimate costs (in 2018 US dollars) associated with intervention implementation. Data from a sample of electronic patient records from each demonstration site were analyzed to compare prescription of antiretroviral therapy (ART), CD4 cell counts, and suppression of viral load, before and after implementation of interventions. Markov models were used to estimate additional healthcare costs and quality-adjusted life-years saved as a result of each intervention. Overall, demonstration site interventions cost $3,913,313 (range = $287,682 to $998,201) among 3,110 individuals (range = 258 to 1,181) over 3 years. Changes in the proportion of patients prescribed ART ranged from a decrease from 87.0% to 72.7% at Site 4 to an increase from 74.6% to 94.2% at Site 6; changes in the proportion of patients with 0 to 200 CD4 cells/mm3 ranged from a decrease from 20.2% to 11.0% in Site 6 to an increase from 16.7% to 30.2% in Site 2; and changes in the proportion of patients with undetectable viral load ranged from a decrease from 84.6% to 46.0% in Site 1 to an increase from 67.0% to 69.9% in Site 5. Four of the 6 interventions-including use of HIV surveillance data to identify out-of-care individuals, use of electronic laboratory ordering and prescribing, and development of a patient portal-were not only cost-effective but also cost saving ($6.87 to $14.91 saved per dollar invested). In contrast, the 2 interventions that extended access to EHRs to support service providers were not effective and, therefore, not cost-effective. Most interventions remained either cost-saving or not cost-effective under all sensitivity analysis scenarios. The intervention that used HIV surveillance data to identify out-of-care individuals was no longer cost-saving when the effect of HIV on an individual's health status was reduced and when the natural progression of HIV was increased. The results of this study are limited in that we did not have contemporaneous controls for each intervention; thus, we are only able to assess sites against themselves at baseline and not against standard of care during the same time period.ConclusionsThese results provide additional support for the use of HIT as a tool to enhance rapid and effective treatment of HIV to achieve sustained viral suppression. HIT has the potential to increase utilization of services, improve health outcomes, and reduce subsequent transmission of HIV.

BackgroundA significant proportion (20-59%) of people living with HIV in sub-Saharan Africa desire childbearing, are of reproductive age, and are in sero-different relationships (~50%). Thus it is plausible that some portion of new HIV transmissions are due to attempts to become pregnant. Safer conception (SC) methods that effectively reduce the risk of HIV transmission exist and can be made available in resource-constrained settings. Few studies in the region, and none in Botswana, have quantitatively examined the correlates of information, motivation, and behavioral skills for SC uptake.MethodsWe surveyed 356 women living with HIV from 6/2018 to 12/2018 at six public-sector health clinics in Gaborone, Botswana. Participants were 18-40 years old, not pregnant, and desired future children or were unsure about their childbearing plans. We examined correlates of SC information, motivation, and behavioral skills using nested linear regression models, adjusting for socio-demographic, interpersonal, and structural variables.ResultsKnowledge of SC methods varied widely. While some SC methods were well known (medical male circumcision by 83%, antiretroviral therapy for viral suppression by 64%), most other methods were known by less than 40% of participants. Our final models reveal that stigma as well as relationship and partner factors affect SC information, motivation, and behavioral skills. Both internalized childbearing stigma (ß=-0.50, 95%CI:-0.17, -0.02) and perceived community childbearing stigma were negatively associated with SC information (ß=-0.09, 95%CI:-0.80, -0.21). Anticipated (ß=-0.06, 95%CI:-0.12, -0.003) and internalized stigma (ß=-0.27, 95%CI:-0.44; -0.10) were associated with decreased SC motivation, while perceived community childbearing stigma was associated with increased SC motivation (ß=0.07, 95%CI:0.02, 0.11). Finally, internalized childbearing stigma was associated with decreased SC behavioral skills (ß=-0.80, 95%CI: -1.12, -0.47) while SC information (ß=0.24, 95%CI:0.12, 0.36), motivation (ß=0.36, 95%CI:0.15, 0.58), and perceived partner willingness to use SC (ß=0.47, 95%CI:0.36, 0.57) were positively associated with behavioral skills CONCLUSIONS: Low SC method-specific information levels are concerning since almost half (47%) of the study participants reported they were in sero-different relationships and desired more children. Findings highlight the importance of addressing HIV stigma and partner dynamics in interventions to improve SC information, motivation, and behavioral skills.

BackgroundThe United States HIV care workforce is shrinking, which could complicate service delivery to people living with HIV (PLWH). In this study, we examined the impact of practice transformations, defined as efficiencies in structures and delivery of care, on demonstration project sites within the Workforce Capacity Building Initiative, a Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program Special Projects of National Significance (SPNS).Methods and findingsData were collected at 14 demonstration project sites in 7 states and the District of Columbia. Organizational assessments were completed at sites once before and 4 times after implementation. They captured 3 transformation approaches: maximizing the HIV care workforce (efforts to increase the number of existing healthcare workforce members involved in the care of PLWH), share-the-care (team-based care giving more responsibility to midlevel providers and staff), and enhancing client engagement in primary HIV care to reduce emergency and inpatient care (e.g., care coordination). We also obtained Ryan White HIV/AIDS Program Services Reports (RSRs) from sites for calendar years (CYs) 2014-2016, corresponding to before, during, and after transformation. The RSR include data on client retention in HIV care, prescription of antiretroviral therapy (ART), and viral suppression. We used generalized estimating equation (GEE) models to analyze changes among sites implementing each practice transformation approach. The demonstration projects had a mean of 18.5 prescribing providers (SD = 23.5). They reported data on more than 13,500 clients per year (mean = 969/site, SD = 1,351). Demographic characteristics remained similar over time. In 2014, a majority of clients were male (71% versus 28% female and 0.2% transgender), with a mean age of 47 (interquartile range [IQR] 37-54). Racial/ethnic characteristics (48% African American, 31% Hispanic/Latino, 14% white) and HIV risk varied (31% men who have sex with men; 31% heterosexual men and women; 7% injection drug use). A substantial minority was on Medicaid (41%). Across sites, there was significant uptake in practices consistent with maximizing the HIV care workforce (18% increase, p < 0.001), share-the-care (25% increase, p < 0.001), and facilitating patient engagement in HIV primary care (13% increase, p < 0.001). There were also significant improvements over time in retention in HIV care (adjusted odds ratio [aOR] = 1.03; 95% confidence interval [CI] 1.02-1.04; p < 0.001), ART prescription levels (aOR = 1.01; 95% CI 1.00-1.01; p < 0.001), and viral suppression (aOR = 1.03; 95% CI 1.02-1.04; p < 0.001). All outcomes improved at sites that implemented transformations to maximize the HIV care workforce or improve client engagement. At sites that implemented share-the-care practices, only retention in care and viral suppression outcomes improved. Study limitations included use of demonstration project sites funded by the Ryan White HIV/AIDS Program (RWHAP), which tend to have better HIV outcomes than other US clinics; varying practice transformation designs; lack of a true control condition; and a potential Hawthorne effect because site teams were aware of the evaluation.ConclusionsIn this study, we found that practice transformations are a potential strategy for addressing anticipated workforce challenges among those providing care to PLWH. They hold the promise of optimizing the use of personnel and ensuring the delivery of care to all in need while potentially enhancing HIV care continuum outcomes.

BackgroundUniversal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health.MethodsWe randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only).ResultsA total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39).ConclusionsUniversal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).

IntroductionTo achieve epidemic control of HIV by 2030, countries aim to meet 90-90-90 targets to increase knowledge of HIV-positive status, initiation of antiretroviral therapy (ART) and viral suppression by 2020. We assessed the progress towards these targets from 2014 to 2016 in South Africa as expanded treatment policies were introduced using population-representative surveys.MethodsData were collected in January to March 2014 and August to November 2016 in Dr. Ruth Segomotsi Mompati District, North West Province. Each multi-stage cluster sample included 46 enumeration areas (EA), a target of 36 dwelling units (DU) per EA, and a single resident aged 18 to 49 per DU. Data collection included behavioural surveys, rapid HIV antibody testing and dried blood spot collection. We used weighted general linear regression to evaluate differences in the HIV care continuum over time.ResultsOverall, 1044 and 971 participants enrolled in 2014 and 2016 respectively with approximately 77% undergoing HIV testing. Despite increases in reported testing, known status among people living with HIV (PLHIV) remained similar at 68.7% (95% Confidence Interval (CI) = 60.9-75.6) in 2014 and 72.8% (95% CI = 63.6-80.4) in 2016. Men were consistently less likely than women to know their status. Among those with known status, PLHIV on ART increased significantly from 80.9% (95% CI = 71.9-87.4) to 91.5% (95% CI = 84.4-95.5). Viral suppression (

Background: Cardiovascular disease (CVD) morbidity and mortality is increasing in Africa, largely due to undiagnosed and untreated hypertension. Approaches that leverage existing primary health systems could improve hypertension treatment and reduce CVD, but cost-effectiveness is unknown. We evaluated the cost-effectiveness of population-level hypertension screening and implementation of chronic care clinics across eastern, southern, central, and western Africa. Methods and findings: We conducted a modeling study to simulate hypertension and CVD across 3,000 scenarios representing a range of settings across eastern, southern, central, and western Africa. We evaluated 2 policies compared to current hypertension treatment: (1) expansion of HIV primary care clinics into chronic care clinics that provide hypertension treatment for all persons regardless of HIV status (chronic care clinic or CCC policy); and (2) CCC plus population-level hypertension screening of adults ≥40 years of age by community health workers (CHW policy). For our primary analysis, we used a cost-effectiveness threshold of US $500 per disability-adjusted life-year (DALY) averted, a 3% annual discount rate, and a 50-year time horizon. A strategy was considered cost-effective if it led to the lowest net DALYs, which is a measure of DALY burden that takes account of the DALY implications of the cost for a given cost-effectiveness threshold. Among adults 45 to 64 years, CCC implementation would improve population-level hypertension control (the proportion of people with hypertension whose blood pressure is controlled) from mean 4% (90% range 1% to 7%) to 14% (6% to 26%); additional CHW screening would improve control to 44% (35% to 54%). Among all adults, CCC implementation would reduce ischemic heart disease (IHD) incidence by 10% (3% to 17%), strokes by 13% (5% to 23%), and CVD mortality by 9% (3% to 15%). CCC plus CHW screening would reduce IHD by 28% (19% to 36%), strokes by 36% (25% to 47%), and CVD mortality by 25% (17% to 34%). CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was cost-effective in 7% of scenarios. Pooling across setting-scenarios, incremental cost-effectiveness ratios were $69/DALY averted for CCC and $389/DALY averted adding CHW screening to CCC. Conclusions: Leveraging existing healthcare infrastructure to implement population-level hypertension screening by CHWs and hypertension treatment through integrated chronic care clinics is expected to reduce CVD morbidity and mortality and is likely to be cost-effective in most settings across Africa. Matthew Hickey and colleagues report the results of a modelling study that indicates that leveraging existing healthcare infrastructure to implement population-level hypertension assessment and treatment could be cost effective. Author summary: Why was this study done?: Cardiovascular disease (CVD), such as heart attacks and strokes, are increasingly causing illness and death in Africa, mainly due to undiagnosed and untreated hypertension. Hypertension is currently treated primarily in specialized clinics; existing primary health systems, particularly those developed for HIV care, could potentially be used to treat hypertension more effectively. Prior research also demonstrates that community health workers can successfully conduct hypertension screening in the community, improving both diagnosis and linkage to care. This research aimed to determine whether integration of hypertension care within existing primary health systems with or without community health worker screening of all adults aged 40 or greater in the community for hypertension would be a worthwhile investment in Africa. What did the researchers do and find?: We incorporated hypertension and CVD into an existing individual-level HIV model and simulated hypertension and CVD outcomes across 3,000 scenarios in eastern, southern, central, and western Africa. We evaluated 2 policies compared to current standard hypertension care: expanding primary care clinics to include HIV and hypertension (chronic care clinic or CCC policy) and adding community health worker (CHW) screening for all adults over 40 years of age. For all adults, CCC would reduce heart attacks by 10%, strokes by 13%, and cardiovascular deaths by 9%, while adding CHW screening would reduce these by 28%, 36%, and 25%, respectively. CHW screening was cost-effective in 62% of scenarios, CCC in 31%, and neither policy was considered cost-effective in 7% of scenarios. What do these findings mean?: Using existing primary health care and community health worker infrastructure to screen and treat hypertension can significantly reduce illness and death from CVD in Africa. Implementing chronic care clinics and community health worker screenings for hypertension is likely to be cost-effective in most settings. These findings support policy changes to integrate hypertension management into existing primary health services to improve CVD prevention. Though we considered numerous factors in our model, findings are limited by uncertainty in model parameters, inability to include all potential policy alternatives, and uncertainty around how the current state of hypertension care will evolve in the future. [ABSTRACT FROM AUTHOR]

BackgroundFemale positive/male negative HIV-serodiscordant couples express a desire for children and may engage in condomless sex to become pregnant. Current guidelines recommend antiretroviral treatment in HIV-serodiscordant couples, yet HIV RNA viral suppression may not be routinely assessed or guaranteed and pre-exposure prophylaxis may not be readily available. Therefore, options for becoming pregnant while limiting HIV transmission should be offered and accessible to HIV-affected couples desiring children.MethodsA prospective pilot study of female positive/male negative HIV-serodiscordant couples desiring children was conducted to evaluate the acceptability, feasibility, and effectiveness of timed vaginal insemination. Eligible women were 18-34 years with regular menses. Prior to timed vaginal insemination, couples were observed for two months, and tested and treated for sexually transmitted infections. Timed vaginal insemination was performed for up to six menstrual cycles. A fertility evaluation and HIV RNA viral load assessment was offered to couples who did not become pregnant.FindingsForty female positive/male negative HIV-serodiscordant couples were enrolled; 17 (42.5%) exited prior to timed vaginal insemination. Twenty-three couples (57.5%) were introduced to timed vaginal insemination; eight (34.8%) achieved pregnancy, and six live births resulted without a case of HIV transmission. Seven couples completed a fertility evaluation. Four women had no demonstrable tubal patency bilaterally; one male partner had decreased sperm motility. Five women had unilateral/bilateral tubal patency; and seven women had an HIV RNA viral load (≥ 400 copies/mL).ConclusionTimed vaginal insemination is an acceptable, feasible, and effective method for attempting pregnancy. Given the desire for children and inadequate viral suppression, interventions to support safely becoming pregnant should be integrated into HIV prevention programs.

Objectives/designAs antiretroviral therapy (ART) rapidly expands in sub-Saharan Africa using new efficient care models, data on costs of these approaches are lacking. We examined costs of a streamlined HIV care delivery model within a large HIV test-and-treat study in Uganda and Kenya.MethodsWe calculated observed per-person-per-year (ppy) costs of streamlined care in 17 health facilities in SEARCH Study intervention communities (NCT: 01864603) via micro-costing techniques, time-and-motion studies, staff interviews, and administrative records. Cost categories included salaries, ART, viral load testing, recurring goods/services, and fixed capital/facility costs. We then modeled costs under three increasingly efficient scale-up scenarios: lowest-cost ART, centralized viral load testing, and governmental healthcare worker salaries. We assessed the relationship between community-specific ART delivery costs, retention in care, and viral suppression.ResultsEstimated streamlined HIV care delivery costs were $291/ppy. ART ($117/ppy for TDF/3TC/EFV [40%]) and viral load testing ($110/ppy for 2 tests/year [39%]) dominated costs versus salaries ($51/ppy), recurring costs ($5/ppy), and fixed costs ($7/ppy). Optimized ART scale-up with lowest-cost ART ($100/ppy), annual viral load testing ($24/ppy), and governmental healthcare salaries ($27/ppy), lowered streamlined care cost to $163/ppy. We found clinic-to-clinic heterogeneity in retention and viral suppression levels versus streamlined care delivery costs, but no correlation between cost and either retention or viral suppression.ConclusionsIn the SEARCH Study, streamlined HIV care delivery costs were similar to or lower than prior estimates despite including viral load testing; further optimizations could substantially reduce costs further. These data can inform global strategies for financing ART expansion to achieve UNAIDS 90-90-90 targets.

This mixed-methods study used qualitative interviews to explore discrepancies between self-reported HIV care and treatment-related behaviors and the presence of antiretroviral medications (ARVs) in a population-based survey in South Africa. ARV analytes were identified among 18% of those reporting HIV-negative status and 18% of those reporting not being on ART. Among participants reporting diagnosis over a year prior, 19% reported multiple HIV tests in the past year. Qualitative results indicated that participant misunderstandings about their care and treatment played a substantial role in reporting inaccuracies. Participants conflated the term HIV test with CD4 and viral load testing, and confusion with terminology was compounded by recall difficulties. Data entry errors likely also played a role. Frequent discrepancies between biomarkers and self-reported data were more likely due to poor understanding of care and treatment and biomedical terminology than intentional misreporting. Results indicate a need for improving patient-provider communication, in addition to incorporating objective measures of treatment and care behaviors such as ARV analytes, to reduce inaccuracies.

BackgroundAlcohol use has been shown to accelerate disease progression in experimental studies of simian immunodeficiency virus in macaques, but the results in observational studies of HIV have been conflicting.MethodsWe conducted a prospective cohort study of the impact of unhealthy alcohol use on CD4 cell count among HIV-infected persons in southwestern Uganda not yet eligible for antiretroviral treatment (ART). Unhealthy alcohol consumption was 3-month Alcohol Use Disorders Identification Test-Consumption positive (≥3 for women, ≥4 for men) and/or phosphatidylethanol (PEth-an alcohol biomarker) ≥50 ng/mL, modeled as a time-dependent variable in a linear mixed effects model of CD4 count.ResultsAt baseline, 43% of the 446 participants were drinking at unhealthy levels and the median CD4 cell count was 550 cells/mm (interquartile range 416-685). The estimated CD4 cell count decline per year was -14.5 cells/mm (95% confidence interval: -38.6 to 9.5) for unhealthy drinking vs. -24.0 cells/mm (95% confidence interval: -43.6 to -4.5) for refraining from unhealthy drinking, with no significant difference in decline by unhealthy alcohol use (P value 0.54), adjusting for age, sex, religion, time since HIV diagnosis, and HIV viral load. Additional analyses exploring alternative alcohol measures, participant subgroups, and time-dependent confounding yielded similar findings.ConclusionUnhealthy alcohol use had no apparent impact on the short-term rate of CD4 count decline among HIV-infected ART naive individuals in Uganda, using biological markers to augment self-report and examining disease progression before ART initiation to avoid unmeasured confounding because of misclassification of ART adherence.

IntroductionThe rapid scale-up of HIV care and treatment in resource-limited countries requires concurrent, rapid development of health information systems to support quality service delivery. Mozambique, a country with an 11.5% prevalence of HIV, has developed nation-wide patient monitoring systems (PMS) with standardized reporting tools, utilized by all HIV treatment providers in paper or electronic form. Evaluation of the initial implementation of PMS can inform and strengthen future development as the country moves towards a harmonized, sustainable health information system.ObjectiveThis assessment was conducted in order to 1) characterize data collection and reporting processes and PMS resources available and 2) provide evidence-based recommendations for harmonization and sustainability of PMS.MethodsThis baseline assessment of PMS was conducted with eight non-governmental organizations that supported the Ministry of Health to provide 90% of HIV care and treatment in Mozambique. The study team conducted structured and semi-structured surveys at 18 health facilities located in all 11 provinces. Seventy-nine staff were interviewed. Deductive a priori analytic categories guided analysis.ResultsHealth facilities have implemented paper and electronic monitoring systems with varying success. Where in use, robust electronic PMS facilitate facility-level reporting of required indicators; improve ability to identify patients lost to follow-up; and support facility and patient management. Challenges to implementation of monitoring systems include a lack of national guidelines and norms for patient level HIS, variable system implementation and functionality, and limited human and infrastructure resources to maximize system functionality and information use.ConclusionsThis initial assessment supports the need for national guidelines to harmonize, expand, and strengthen HIV-related health information systems. Recommendations may benefit other countries with similar epidemiologic and resource-constrained environments seeking to improve PMS implementation.

BackgroundAttrition along the HIV care continuum slows gains in mitigating the South African HIV epidemic. Understanding population-level gaps in HIV identification, linkage, retention in care, and viral suppression is critical to target programming.MethodsWe conducted a population-based household survey, HIV rapid testing, point-of-care CD4 testing, and viral load measurement from dried blood spots using multistage cluster sampling in 2 subdistricts of North West Province from January to March, 2014. We used weighting and multiple imputation of missing data to estimate HIV prevalence, undiagnosed infection, linkage and retention in care, medication adherence, and viral suppression.ResultsWe sampled 1044 respondents aged 18-49. HIV prevalence was 20.0% (95% confidence interval: 13.7 to 26.2) for men and 26.7% (95% confidence interval: 22.1 to 31.4) for women. Among those HIV positive, 48.4% of men and 75.7% of women were aware of their serostatus; 44.0% of men and 74.8% of women reported ever linking to HIV care; 33.1% of men and 58.4% of women were retained in care; and 21.6% of men and 50.0% of women had dried blood spots viral loads

BackgroundMany HIV-infected pregnant women identified during antenatal care (ANC) do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants.MethodsWe performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, prevention of mother-to-child transmission, and HIV care delivered in the ANC clinic; n = 6 intervention facilities) or standard ANC services (including prevention of mother-to-child transmission and referral to a separate clinic for HIV care; n = 6 control facilities).ResultsThere were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was 12-month follow-up data for 256 of 611 (41.8%) women and postpartum data for only 325 of 1172 (28%) women. By 9 months of age, 382 of 568 (67.3%) infants at intervention sites and 338 of 594 (57.0%) at control sites had tested for HIV [odds ratio (OR) 1.45, 95% confidence interval (CI): 0.71 to 2.82]; 7.3% of infants tested HIV positive at intervention sites compared with 8.0% of infants at control sites (OR 0.89, 95% CI: 0.56 to 1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1%, OR 0.83, 95% CI: 0.41 to 1.68).ConclusionsDespite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes.

Background: Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods: ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or nonintegrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results: HIV care enrollment was higher in intervention compared with control clinics [69% versus 36%; odds ratio 3.94, 95% confidence interval (CI): 1.14 to 13.63]. Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, hazard ratio 2.20, 95% CI: 1.62 to 3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%; odds ratio 3.22, 95% CI: 1.81 to 5.72). Infant testing was more common in the intervention arm (25% versus 18%), however, not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions: Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions.

BackgroundThe National HIV/AIDS Strategy (NHAS) emphasizes the use of technology to facilitate coordination of comprehensive care for people with HIV. We examined the effect of six health information technology (HIT) interventions in a Ryan White-funded Special Projects of National Significance (SPNS) on care completion services, engagement in HIV care, and viral suppression.MethodsInterventions included use of surveillance data to identify out-of-care individuals, extending access to electronic health records to support service providers, use of electronic laboratory ordering and prescribing, and development of a patient portal. Data from a sample of electronic patient records from each site were analyzed to assess changes in utilization of comprehensive care (prevention screening, support service utilization), engagement in primary HIV medical care (receipt of services and use of antiretroviral therapy), and viral suppression. We used weighted generalized estimating equations to estimate outcomes while accounting for the unequal contribution of data and differences in the distribution of patient characteristics across sites and over time.ResultsWe observed statistically significant changes in the desired direction in comprehensive care utilization and engagement in primary care outcomes targeted by each site. Five of six sites experienced statistically significant increases in viral suppression.DiscussionThese results provide additional support for the use of HIT as a valuable tool for achieving the NHAS goal of providing comprehensive care for all people living with HIV. HIT has the potential to increase utilization of services, improve health outcomes for people with HIV, and reduce community viral load and subsequent transmission of HIV.

INTRODUCTION Transgender women (TW) are highly impacted by HIV worldwide and in the United States. Global HIV prevalence estimates among TW range from 19.9% to 40% [1, 2]. In the [...], : Introduction: Transgender women (TW) worldwide have a high prevalence of HIV, and TW with HIV encounter numerous healthcare barriers. It is critical to develop evidence‐informed interventions to improve their engagement in healthcare to achieve durable viral suppression (VS). We evaluated whether participation in one of nine interventions designed specifically for TW was associated with improved engagement in HIV care among transgender women of colour (TWC). Methods: Between 2013 and 2017, nine US organizations implemented nine distinct and innovative HIV care engagement interventions with diverse strategies, including: individual and group sessions, case management and navigation, outreach, drop‐in spaces, peer support and/or incentives to engage TWC with HIV in care. The organizations enrolled 858 TWC, conducted surveys, captured intervention exposure data and extracted medical record data. Our evaluation of the interventions employed a pre‐post design and examined four outcomes—any HIV care visit, antiretroviral therapy (ART) prescription, retention in HIV care and VS (both overall and among those with a clinic visit and viral load test), at baseline and every 6 months for 24 months. We employed logistic generalized estimating equations to assess the relative odds of each outcome at 12 and 24 months compared to baseline. Results: Overall, 79% of participants were exposed to at least one intervention activity. Over 24 months of follow‐up, participants received services for a median of over 6 hours (range: 3–69 hours/participant). Compared to baseline, significantly (p Conclusions: These evaluation results illustrate promising approaches to improve engagement in HIV care and VS among TWC with HIV. Continued development, adaptation and scale‐up of culturally tailored HIV care interventions for this key population are necessary to meet the UNAIDS 95‐95‐95 goals.

BackgroundEffective strategies to identify and screen children at risk for HIV are needed. The objectives of this study were to evaluate the utilization of a family information table (FIT) to identify and test at-risk children in Kenya and identify factors associated with child testing.MethodsA cross-sectional study was conducted among HIV-infected adults with children at five Kenyan clinics. HIV testing status for children aged ≤18 years was gathered from the patients' FITs and compared to reports from in-person clinic visits as the gold standard. Generalized estimating equations were used to assess predictors for HIV testing of children adjusted for confounders and within parent correlation.ResultsOur sample included 384 HIV-infected adults enrolled in care with 933 reported children. Overall, 323 FITs (84%) correctly listed all children in the family and 340 (89%) documented an HIV testing status (including untested) for all children. Seventy-five percent of parents verbally reported all children tested, compared to only 46% of FITs (OR=13.5, 95% CI 6.5-27.8). Verbal reports identified 739 (79%) children tested, with 55 (7.4%) HIV-positive and 17 (2.3%) HIV-exposed infants (HEI). Of 63 adults with HIV-positive children or HEI, 60 (95%) reported enrolling children into care. Likelihood that children had been tested was higher for younger children (≤4y vs. > 4y, aOR=2.0; 95% CI 1.4-2.9) and lower if the partner's serostatus was unknown vs. seropositive (aOR=0.3; 95% CI: 0.1-0.8).ConclusionsAlthough the FIT may be a useful tool to identify children at risk for HIV, this study found underutilization by providers. To maximize impact of this tool, documentation of follow-up for untested and positive children is essential.Global health implicationsThrough early documentation of at-risk children and follow up of untested and infected children, the FIT may serve as an effective resource for improving HIV testing and linkage to care.

BackgroundEffective strategies to identify and screen children at risk for HIV are needed. The objectives of this study were to evaluate the utilization of a family information table (FIT) to identify and test at-risk children in Kenya and identify factors associated with child testing.MethodsA cross-sectional study was conducted among HIV-infected adults with children at five Kenyan clinics. HIV testing status for children aged ≤18 years was gathered from the patients' FITs and compared to reports from in-person clinic visits as the gold standard. Generalized estimating equations were used to assess predictors for HIV testing of children adjusted for confounders and within parent correlation.ResultsOur sample included 384 HIV-infected adults enrolled in care with 933 reported children. Overall, 323 FITs (84%) correctly listed all children in the family and 340 (89%) documented an HIV testing status (including untested) for all children. Seventy-five percent of parents verbally reported all children tested, compared to only 46% of FITs (OR=13.5, 95% CI 6.5-27.8). Verbal reports identified 739 (79%) children tested, with 55 (7.4%) HIV-positive and 17 (2.3%) HIV-exposed infants (HEI). Of 63 adults with HIV-positive children or HEI, 60 (95%) reported enrolling children into care. Likelihood that children had been tested was higher for younger children (≤4y vs. > 4y, aOR=2.0; 95% CI 1.4-2.9) and lower if the partner's serostatus was unknown vs. seropositive (aOR=0.3; 95% CI: 0.1-0.8).ConclusionsAlthough the FIT may be a useful tool to identify children at risk for HIV, this study found underutilization by providers. To maximize impact of this tool, documentation of follow-up for untested and positive children is essential.Global health implicationsThrough early documentation of at-risk children and follow up of untested and infected children, the FIT may serve as an effective resource for improving HIV testing and linkage to care.

The delivery of HIV risk assessment and behavioral counseling by clinicians in HIV clinical settings is one component in a comprehensive "positive prevention" strategy to help patients reduce their transmission risk behavior. Clinicians engage in behavioral prevention inconsistently, however, depending on whether patients are new to a practice or are established in regular care and on their attitudes and characteristics of their practices. We analyzed clinician reports of behavioral prevention delivered before and after participation in a large federal demonstration project of positive prevention interventions. The interventions that were part of this project were successful in increasing behavioral prevention among both new and returning patients. Prior to study interventions, clinicians reported counseling 69% of new patients and 52% of returning patients. In follow-up interviews 12 months after receiving training, clinicians reported delivering prevention messages to 5% more new patients and 9% of returning patients (both p

HIV departments within Kenyan health facilities are usually better staffed and equipped than departments offering non-HIV services. Integration of HIV services into primary care may address this issue of skewed resource allocation. Between 2008 and 2010, we piloted a system of integrating HIV services into primary care in rural Kenya. Before integration, we conducted a survey among returning adults ≥18-year old attending the HIV clinic. We then integrated HIV and primary care services. Three and twelve months after integration, we administered the same questionnaires to a sample of returning adults attending the integrated clinic. Changes in patient responses were assessed using truncated linear regression and logistic regression. At 12 months after integration, respondents were more likely to be satisfied with reception services (adjusted odds ratio, aOR 2.71, 95% CI 1.32-5.56), HIV education (aOR 3.28, 95% CI 1.92-6.83), and wait time (aOR 1.97 95% CI 1.03-3.76). Men's comfort with receiving care at an integrated clinic did not change (aOR = 0.46 95% CI 0.06-3.86). Women were more likely to express discomfort after integration (aOR 3.37 95% CI 1.33-8.52). Integration of HIV services into primary care services was associated with significant increases in patient satisfaction in certain domains, with no negative effect on satisfaction.

PurposeThe purpose of this article is to describe how comprehensive HIV care is delivered within Ryan White Program (RWP)-funded clinics and to characterize proposed health information exchange (HIE) interventions, which employ technology to exchange information among providers, designed to improve the quality and coordination of clinical and support services.MethodsWe use HIV patient care quality and coordination indicators from electronic data systems to describe care delivery in six RWP demonstration sites and describe HIE interventions designed to enhance that care.ResultsAmong patients currently in care, 91% were retained in care in the previous six months (range across sites: 63-99%), 79% were appropriately prescribed antiretroviral therapy (54-91%) and 52% had achieved undetectable HIV viral load (16-85%). To facilitate coordination of care across clinical and support services, sites designed HIE interventions to access a variety of data systems (e.g. surveillance, electronic health records, laboratory and billing) and focused on improving linkage and retention, quality and efficiency of care and increased access to patient information.DiscussionCare quality in RWP settings can be improved with HIE tools facilitating linkage, retention and coordination of care. When fully leveraged, HIE interventions have the potential to improve coordination of care and thereby enhance patient health outcomes.

PurposeThe objective of this paper is to describe how members of HIV patients' care teams perceived the usefulness and ease of use of newly implemented, innovative health information exchange systems (HIEs) in diverse HIV treatment settings. Five settings with existing electronic medical records (EMRs) received special funding to test enhancements to their systems. Participating clinics and community-based organizations added HIEs permitting bi-directional exchange of information across multiple provider sites serving the same HIV patient population.MethodsWe conducted in-depth qualitative interviews and quantitative web-based surveys with case managers, medical providers, and non-clinical staff members to assess the systems' perceived usefulness and ease of use shortly after the HIEs were implemented. Our approach to data analysis was iterative. We first conducted a thematic analysis of the qualitative data and discovered that there were key differences in perceptions and actual use of HIEs across occupational groups. We used these results to guide our analysis of the quantitative survey data, stratifying by occupational group.ResultsWe found differences in reports of how useful and how well-used HIEs were, by occupation. Medical providers were more likely to use HIEs if they provided easier access to clinical information than was present in existing EMRs. Case managers working inside medical clinics found HIEs to be less helpful because they already had access to the clinical data. In contrast, case managers working in community settings appreciated the new access to patient information that the HIEs provided. Non-clinical staff uniformly found the HIEs useful for a broad range of tasks including clinic administration, grant writing and generating reports for funders.ConclusionOur study offers insights into the use and potential benefits of HIE in the context of HIV care across occupational groups.

Prevention with Positives (PwP) is a component of the US HIV prevention strategy that targets HIV-infected persons who are aware of their seropositive status. This paper examines the use of prevention messages by clinical providers during the PwP intervention period of the US Health Resources and Services Administration's Special Projects of National Significance program. Quantitative approaches were used to learn which prevention topics were most discussed and qualitative interviews were also utilized to better understand the clinician perspective in providing prevention counseling. At 12-month follow-up, there was a significant increase in the percent of patients receiving all PwP counseling messages (p

AbstractBackgroundConcerns about the confidentiality of personal health information have been identified as a potential obstacle to implementation of Health Information Exchanges (HIEs). Considering the stigma and confidentiality issues historically associated with human immunodeficiency virus (HIV) disease, we examine how trust—in technology, processes, and people—influenced the acceptability of data sharing among stakeholders prior to implementation of six HIEs intended to improve HIV care in parts of the United States. Our analyses identify the kinds of concerns expressed by stakeholders about electronic data sharing and focus on the factors that ultimately facilitated acceptability of the new exchanges.MethodsWe conducted 549 surveys with patients and 66 semi-structured interviews with providers and other stakeholders prior to implementation of the HIEs to assess concerns about confidentiality in the electronic sharing of patient data. The patient quantitative data were analyzed using SAS 9.2 to yield sample descriptive statistics. The analysis of the qualitative interviews with providers and other stakeholders followed an open-coding process, and convergent and divergent perspectives emerging from those data were examined within and across the HIEs.ResultsWe found widespread acceptability for electronic sharing of HIV-related patient data through HIEs. This acceptability appeared to be driven by growing comfort with information technologies, confidence in the security protocols utilized to protect data, trust in the providers and institutions who use the technologies, belief in the benefits to the patients, and awareness that electronic exchange represents an enhancement of data sharing already taking place by other means. HIE acceptability depended both on preexisting trust among patients, providers, and institutions and on building consensus and trust in the HIEs as part of preparation for implementation. The process of HIE development also resulted in forging shared vision among institutions.ConclusionsPatients and providers are willing to accept the electronic sharing of HIV patient data to improve care for a disease historically seen as highly stigmatized. Acceptability depends on the effort expended to understand and address potential concerns related to data sharing and confidentiality, and on the trust established among stakeholders in terms of the nature of the systems and how they will be used.

Abstract Background Nyanza Province, Kenya, had the highest HIV prevalence in the country at 14.9% in 2007, more than twice the national HIV prevalence of 7.1%. Only 16% of HIV-infected adults in the country accurately knew their HIV status. Targeted strategies to reach and test individuals are urgently needed to curb the HIV epidemic. The family unit is one important portal. Methods A family model of care was designed to build on the strengths of Kenyan families. Providers use a family information table (FIT) to guide index patients through the steps of identifying family members at HIV risk, address disclosure, facilitate family testing, and work to enrol HIV-positive members and to prevent new infections. Comprehensive family-centred clinical services are built around these steps. To assess the approach, a retrospective study of patients receiving HIV care between September 2007 and September 2009 at Lumumba Health Centre in Kisumu was conducted. A random sample of FITs was examined to assess family reach. Results Through the family model of care, for each index patient, approximately 2.5 family members at risk were identified and 1.6 family members were tested. The approach was instrumental in reaching children; 61% of family members identified and tested were children. The approach also led to identifying and enrolling a high proportion of HIV- positive partners among those tested: 71% and 89%, respectively. Conclusions The family model of care is a feasible approach to broaden HIV case detection and service reach. The approach can be adapted for the local context and should continue to utilize index patient linkages, FIT adaption, and innovative methods to package services for families in a manner that builds on family support and enhances patient care and prevention efforts. Further efforts are needed to increase family member engagement.

BackgroundDespite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma.Methodology/principal findingsA prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines.Conclusions/significanceThis is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health.Trial registrationClinicalTrials.gov NCT00931216 http://clinicaltrials.gov/ct2/show/NCT00931216.

Abstract Background Antiretroviral treatment (ART) regimens in HIV patients commonly cause significant lipid elevations, including increases in both triglycerides and cholesterol. Standard treatments for hypercholesterolemia include the HMG CoA reductase inhibitors, or "statins." Because many ART agents and statins share a common metabolic pathway that uses the cytochrome P450 enzyme system, coadministration of ART with statins could increase statin plasma levels significantly. The oyster mushroom, Pleurotus ostreatus, has been shown in animal models to decrease lipid levels - a finding that has been supported by preliminary data in a small human trial. Methods To assess the safety and efficacy of P. ostreatus in patients with HIV and ART-induced hyperlipidemia, a single-arm, open-label, proof-of-concept study of 8 weeks' duration with a target enrollment of 20 subjects was conducted. Study patients with ART-induced elevated non-HDL cholesterol levels (> 160 mg/dL) were enrolled. Participants received packets of freeze-dried P. ostreatus (15 gm/day) to be administered orally for the 8 week trial period. Lipid levels were drawn every two weeks to assess efficacy. Safety assessments included self-reported incidence of muscle aches and measurement of liver and muscle enzymes. Mean within-person change in lipid levels were estimated using generalized estimating equations to account for repeated observations on individuals. A 30 mg/dL decrease in non-HDL cholesterol was deemed clinically significant. Results 126 patients were screened to enroll 25, of which 20 completed the 8-week study. The mean age was 46.4 years (36-60). Patients had a mean 13.7 yrs of HIV infection. Mean non-HDL cholesterol was 204.5 mg/dL at day 0 and 200.2 mg/dL at day 56 (mean within-person change = -1.70; 95% confidence interval (CI) = -17.4, 14.0). HDL cholesterol levels increased from 37.8 mg/dL at day 0 to 40.4 mg/dL on day 56 (mean within-person change = 2.6; 95% CI = -0.1, 5.2). Triglycerides dropped from 336.4 mg/dL on day 0 to 273.4 mg/dL on day 56 (mean within-person change = -63.0; 95% CI = -120.9, -5.1). Only 3 individuals achieved a sustained clinically significant (30 mg/dL) decline in non-HDL cholesterol after 8 weeks of therapy. There were no adverse experiences reported other than patients' distaste for the preparation. Liver function tests and muscle enzymes were not affected by the 8 weeks of treatment. Conclusions Pleurotus ostreatus as administered in this experiment did not lower non-HDL cholesterol in HIV patients with ART-induced hypercholesterolemia. Small changes in HDL and triglycerides were not of a clinical magnitude to warrant further study. Trial Registration clinicaltrials.gov Identifier: NCT00069524

To support expanded prevention services for people living with HIV, the US Health Resources and Services Administration (HRSA) sponsored a 5-year initiative to test whether interventions delivered in clinical settings were effective in reducing HIV transmission risk among HIV-infected patients. Across 13 demonstration sites, patients were randomized to one of four conditions. All interventions were associated with reduced unprotected vaginal and/or anal intercourse with persons of HIV-uninfected or unknown status among the 3,556 participating patients. Compared to the standard of care, patients assigned to receive interventions from medical care providers reported a significant decrease in risk after 12 months of participation. Patients receiving prevention services from health educators, social workers or paraprofessional HIV-infected peers reported significant reduction in risk at 6 months, but not at 12 months. While clinics have a choice of effective models for implementing prevention programs for their HIV-infected patients, medical provider-delivered methods are comparatively robust.

We assessed risk of transmission among 4,016 HIV-infected patients in primary care, including men who have sex with men (MSM, n = 2,109), women (n = 1,104) and men who had sex with women (MSW, n = 803) in clinics in 15 cities across the U.S. A transmission risk act, assessed by computer assisted interviews, was defined as unprotected vaginal or anal sex with a partner who was HIV-uninfected or of unknown HIV status. MSM were more than twice as likely to report transmission risk acts than MSW (Odds Ratio [OR] = 2.35; 95% Confidence Interval [CI] = 1.84, 3.00; P