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The HIV response is hampered by many obstacles to progression along the HIV care cascade, with men, in particular, experiencing different forms of disruption. One group of men, whose stories remain untold, are those who have succumbed to HIV-related illness. In this paper, we explore how next-of-kin account for the death of a male relative. We conducted 26 qualitative after-death interviews with family members of male PLHIV who had recently died from HIV in health and demographic surveillance sites in Malawi, Tanzania, Kenya, Uganda, Zimbabwe and South Africa. The next-of-kin expressed frustration about the defiance of their male relative to disclose his HIV status and ask for support, and attributed this to shame, fear and a lack of self-acceptance of HIV diagnosis. Next-of-kin painted a picture of their male relative as rebellious. Some claimed that their deceased relative deliberately ignored instructions received by the health worker. Others described their male relatives as unable to maintain caring relationships that would avail day-to-day treatment partners, and give purpose to their lives. Through these accounts, next-of-kin vocalised the perceived rebellious behaviour of these men, and in the process of doing so neutralised their responsibility for the premature death of their relative. [ABSTRACT FROM AUTHOR]

To improve outcomes among HIV-positive adolescents, the Malawi Ministry of Health is supporting scale-up of "Teen Clubs," a facility-based antiretroviral treatment (ART) delivery model. Teen Clubs are monthly ART clinics for adolescents (10–19 years old) that provide clinical services and peer psychosocial support. This paper assesses ART adherence among Teen Club attendees in Malawi. We performed a retrospective analysis of medical records and Teen Club attendance data on 589 HIV-positive adolescents at 16 Partners in Hope (PIH)—Extending Quality Improvement for HIV/AIDS in Malawi (EQUIP) supported facilities across Malawi, from January to June of 2017, who attended at least two Teen Club sessions. Multi-level logistic regression models were used to examine the role of gender and age on optimal ART adherence (≥ 95% based on pill count) among HIV-positive adolescents enrolled in Teen Clubs. The median age of adolescents in this sample was 14 years, and 47% were male. Older adolescent males (15–19 years) were 64% more likely to achieve ≥ 95% ART adherence (aOR 1.64, 95% CI 1.16–2.31, p < 0.01) compared to younger (10–14 years) males. The effect of age on adherence was smaller and not significant among females (aOR 1.36, 95% CI 0.96–1.94, p = 0.08). In the full model including males and females, older adolescence was associated with higher odds of optimal adherence (aOR 1.48, 95% CI 1.16–1.90, p < 0.01). These results reinforce the need for age-specialized programming for adolescents, and future research should evaluate this in achieving optimal ART adherence. [ABSTRACT FROM AUTHOR]

Background: The HIV and AIDS epidemic in Malawi poses multiple challenges from an equity perspective. It is estimated that 12% of Malawians are living with HIV or AIDS among the 15-49 age group. This paper synthesises available information to bring an equity lens on Counselling and Testing (CT) and Antiretroviral Therapy (ART) policy, practice and provision in Malawi. Methods: A synthesis of a wide range of published and unpublished reports and studies using a variety of methodological approaches was undertaken. The analysis and recommendations were developed, through consultation with key stakeholders in Malawi. Findings: At the policy level Malawi is unique in having an equity in access to ART policy, and equity considerations are also included in key CT documents. The number of people accessing CT has increased considerably from 149,540 in 2002 to 482,364 in 2005. There is urban bias in provision of CT and more women than men access CT. ART has been provided free since June 2004 and scale up of ART provision is gathering pace. By end December 2006, there were 85,168 patients who had ever started on ART in both the public and private health sector, 39% of the patients were male while 61% were female. The majority of patients were adults, and 7% were children, aged 14 years or below. Despite free ART services, patients, especially poor rural patients face significant barriers in access and adherence to services. There are missed opportunities in strengthening integration between CT and ART and TB, Sexually Transmitted Infections (STI) and maternal health services. Conclusion: To promote equitable access for CT and ART in Malawi there is need to further invest in human resources for health, and seize opportunities to integrate CT and ART services with tuberculosis, sexually transmitted infections and maternal health services. This should not only promote access to services but also ensure that resources available for CT and ART strengthen rather than undermine the provision of the essential health package in Malawi. Ongoing equity analysis of services is important in analyzing which groups are unrepresented in services and developing initiatives to address these. Creative models of decentralization, whilst maintaining quality of services are needed to further enhance access of poor rural women, men, girls and boys. [ABSTRACT FROM AUTHOR]

Background: Malawi introduced an ambitious public health program known as "Option B+" which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. Methods/design: PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. Results: Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17-51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75-100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22-31) years. All women have ≥20 months of possible follow-up time; 96% ≥ 2 years (24-32 months). Conclusion: The PURE Malawi study showed that 3 implementing partner organizations could successfully recruit a complex cohort of pregnant and lactating women across 3 geographical zones in Malawi within a reasonable timeline. Trial registration: This study is registered at clinicaltrials.gov - ID Number NCT02005835. Registered 4 December, 2013. [ABSTRACT FROM AUTHOR]

BACKGROUND Recent evidence from health and demographic surveillance sites (HDSS) has shown that increasing access to antiretroviral therapy (ART) is reducing mortality rates in sub- Saharan Africa (SSA). However, due to limited vital statistics registration in many of the countries most affected by the HIV/AIDS epidemic, there is limited evidence of the magnitude of ART's effect outside of specific HDSS sites. This paper leverages longitudinal household/family roster data from the Malawi Longitudinal Survey of Families and Health (MLSFH) to estimate the effect of ART availability in public clinics on population-level mortality based on a geographically dispersed sample of individuals in rural Malawi. OBJECTIVE We seek to provide evidence on the population-level magnitude of the ART-associated mortality decline in rural Malawi and confirm that this population is experiencing similar declines in mortality as those seen in HDSS sites. METHODS We analyze longitudinal household/family-roster data from four waves of the MLSFH to estimate mortality change after the introduction of ART to study areas. We analyze life expectancy using the Kaplan-Meier estimator and examine how the mortality hazard changed over time by individual characteristics with Cox regression. RESULTS In the four years following rollout of ART, life expectancy at age 15 increased by 3.1 years (95% CI 1.1, 5.1), and median length of life rose by over ten years. CONTRIBUTION Our observations show that the increased availability of ART resulted in a substantial and sustained reversal of mortality trends in SSA and assuage concerns that the post- ART reversals in mortality are not occurring at the same magnitude outside of specific HDSSs. [ABSTRACT FROM AUTHOR]

Background: Undernutrition and malnutrition in children in low- and middle-income countries contribute to high mortality rates. Stunting, a prevalent form of malnutrition, is associated with educational and productivity losses. Environmental enteric dysfunction (EED) and human immunodeficiency virus (HIV) infection worsen these conditions. This study seeks to investigate the presence of enteropathy using EED fecal biomarkers in HIV-infected children who are stable on antiretroviral therapy (ART) across various nutritional statuses. By understanding the interplay between EED, HIV, and nutritional status, this study aims to provide insights that can inform targeted interventions to optimize nutritional outcomes in HIV infected children. Methods/Principal findings: This study evaluated the levels of alpha-1-antitrypsin, calprotectin and myeloperoxidase in frozen fecal samples from 61 HIV infected (mean age 9.16 ±3.08 years) and 31 HIV uninfected (6.65 ±3.41 years) children in Malawi. Anthropometric measurements and clinical data were collected. The height-for-age z-score (-1.66 vs -1.27, p = 0.040) and BMI-for-age z-score (-0.36 vs 0.01, p = 0.037) were lower in HIV infected children. Enzyme-linked immunosorbent assays were used to measure biomarker concentrations. Statistical tests were applied to compare biomarker levels based on HIV status and anthropometric parameters. Myeloperoxidase, alpha-1-antitrypsin, and calprotectin concentrations did not differ between HIV infected and HIV uninfected children of different age groups. In HIV infected children from 5–15 years, there is no difference in biomarker concentration between the stunted and non-stunted groups. Conclusion/Significance: Our study found a higher prevalence of stunting in HIV infected children compared to uninfected children, but no significant differences in biomarker concentrations. This suggests no causal relationship between enteropathy and stunting in HIV infected children. These results contribute to the understanding of growth impairment in HIV infected children and emphasize the need for further research, particularly a longitudinal, biopsy-controlled study. [ABSTRACT FROM AUTHOR]

Understanding depression, alcohol use, and sexual behaviors according to HIV infection stage and diagnosis timing is important for HIV prevention efforts. We enrolled persons with recent infection and diagnosis (i.e., acute HIV infection (AHI) (n = 92) persons newly diagnosed seropositive (n = 360)) and persons previously diagnosed with HIV (n = 190) into a randomized controlled trial in Lilongwe, Malawi (N = 641) and estimated the prevalence of probable depression (Patient Health Questionnaire-9 ≥ 5), hazardous alcohol use (Alcohol Use Disorder Identification Test-C: men ≥ 4; women ≥ 3), and sexual behaviors (transactional sex, condomless sex). Compared with previously diagnosed participants, participants newly seropositive and those with AHI reported a higher proportion of probable depression (7%, 27%, 38%; AHI/Previous: Table Probability: 0.02, p < 0.01; AHI/New: Table Probability: <0.01, p < 0.01), hazardous alcohol use (8%, 18%, 29%; AHI/Previous and AHI/New: Table Probability: <0.01, p < 0.01), and transactional sex (5%, 14%, 20%; AHI/Previous: Table Probability: <0.01, p < 0.01; AHI/New: Table Probability: 0.06, p = 0.24), respectively. HIV prevention services addressing mental health and alcohol misuse may be particularly beneficial for persons with recent HIV infection and or diagnosis. [ABSTRACT FROM AUTHOR]

Malawi is a southeastern Africa country that has been heavily affected by the AIDS pandemic. It is estimated that about 170,000 people were in need of highly active antiretroviral therapy (HAART) for the treatment of AIDS in 2006. At the end of 2006, at least 55,000 people in Malawi were on HAART treatment, mostly through the free public sector program. At the time the program was being initiated, an ethical question needed to be answered in respect to who would be targeted for free treatment in an environment where medications, human and other resources were not enough to cater for all who were clinically eligible to be on treatment. In this paper we report on a qualitative study that was carried out to obtain public perceptions and input as to which criteria ought to have been applied to identify persons or groups of persons to be targeted in the free HAART program. In general, there was no agreement as to who should be prioritised for HAART, whether treatment should be free to user or whether cost-sharing should be introduced. While it may have been relatively straightforward in obtaining consensus and agreement among medical practitioners on the clinical criteria for HART in Malawi, deciding on the social criteria was complex. The decision to start the nationwide HAART program was started with the understanding that virtually every social group could be justified as worth of free HAART. [ABSTRACT FROM AUTHOR]

Background: HIV testing among the sexual partners of HIV–positive clients is critical for case identification and reduced transmission in southern and eastern Africa. HIV self-testing (HIVST) may improve uptake of HIV services among sexual partners of antiretroviral therapy (ART) clients, but the impact of HIVST on partner testing and subsequent ART initiation remains unclear. Methods and findings: We conducted an individually randomized, unblinded trial to assess if an index HIVST intervention targeting the partners of ART clients improves uptake of testing and treatment services in Malawi. The trial was conducted at 3 high-burden facilities in central and southern Malawi. ART clients attending HIV treatment clinics were randomized using simple randomization 1:2·5 to: (1) standard partner referral slip (PRS) whereby ART clients were given facility referral slips to distribute to their primary sexual partners; or (2) index HIVST whereby ART clients were given HIVST kits + HIVST instructions and facility referral slips to distribute to their primary sexual partners. Inclusion criteria for ART clients were: ≥15 years of age, primary partner with unknown HIV status, no history of interpersonal violence (IPV) with partner, and partner lives in facility catchment area. The primary outcome was partner testing 4-weeks after enrollment, reported by ART clients using endline surveys. Medical chart reviews and tracing activities with partners with a reactive HIV test measured ART initiation at 12 months. Analyses were conducted based on modified intention-to-treat principles, whereby we excluded individuals who did not have complete endline data (i.e., were loss to follow up from the study). Adjusted models controlled for the effects of age and marital status. A total of 4,237 ART clients were screened and 484 were eligible and enrolled (77% female) between March 28, 2018 and January 5, 2020. A total of 365 participants completed an endline survey (257/34 index HIVST arm; 107/13 PRS arm) and were included in the final analysis (78% female). Testing coverage among sexual partners was 71% (183/257) in the index HIVST arm and 25% (27/107) in the PRS arm (aRR: 2·77, 95% CI [2·56 to 3·00], p ≤ 0.001). Reported HIV positivity rates did not significantly differ by arm (16% (30/183) in HIVST versus 15% (4/27) in PRS; p = 0.99). ART initiation at 12 months was 47% (14/30) in HIVST versus 75% (3/4) in PRS arms; however, index HIVST still resulted in a 94% increase in the proportion of all partners initiating ART due to higher HIV testing rates in the HIVST arm (5% partners initiated ART in HVIST versus 3% in PRS). Adverse events including IPV and termination of the relationship did not vary by arm (IPV: 3/257 index HIVST versus 4/10 PRS; p = 0.57). Limitations include reliance on secondary report by ART clients, potential social desirability bias, and not powered for sex disaggregated analyses. Conclusions: Index HIVST significantly increased HIV testing and the absolute number of partners initiating ART in Malawi, without increased risk of adverse events. Additional research is needed to improve linkage to HIV treatment services after HIVST use. Trial registration: ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316. Author summary: Why was this study done?: Undiagnosed and untreated HIV remains a barrier to sustained epidemic control, particularly among men. HIV self-testing (HIVST) improves HIV testing coverage and can be distributed through sexual networks of antiretroviral therapy (ART) clients (i.e., index HIVST) who are at increased risk of HIV infection. A key innovation for this study is to understand the acceptability and impact of index HIVST among sexual partners of index ART clients and ART initiation rates among partners with reactive HIVST results. What did the researchers do and find?: We conducted an individually randomized, unblinded trial with 365 participants in Malawi (n = 257 index HIVST arm; n = 107 partner referral slip (PRS) arm) to assess the impact of index HIVST on HIV testing and uptake of ART among partners of ART clients. Index HIVST increased HIV testing among partners (71% with index HIVST versus 25% with standard of care), was cost-efficient, and was acceptable and feasible to both ART clients and their partners. ART initiation among those with a reactive HIV test was lower in the index HIVST arm compared to standard of care (47% versus 75%), but the proportion of all partners who initiated ART was higher because testing uptake was substantially higher in the index HIVST arm (5% versus 3% of all partners). What do these findings mean?: Index HIVST is a useful tool to increase HIV testing among sexual partners of ART clients in Malawi, where the majority ART clients were married and already disclosed their HIV status to their partners. Index HIVST may be most successful for treatment uptake when implemented alongside other strategies to increase access and demand for treatment services. Our sample size was not powered on secondary outcomes and did not allow for disagregatted findings by key variables such as relationship status or status disclosure. Additional research is needed to assess if index HIVST is acceptable and impactful in settings with less stable relationships and lower rates of status disclosure. In a randomized controlled trial from Malawi, Kathryn Dovel and colleagues, investigate the impact of HIV self-testing in partners of people taking antiretroviral therapy. [ABSTRACT FROM AUTHOR]

We conducted a programmatic, observational cohort study with mother-infant pairs (MIPs) enrolled in prevention-of-mother-to-child-transmission (PMTCT) programs in Malawi to assess the feasibility and potential HIV-related benefits of integrating Early Childhood Development (ECD) services into PMTCT programs. Six health facilities were included in the intervention. We offered ECD counseling from the WHO/UNICEF Care for Child Development package in PMTCT waiting spaces while MIPs waited for PMTCT and broader treatment consultations. Primary outcomes were mothers' retention in HIV care at 12 months and infant HIV testing at 6 weeks and 12 months after birth. Routine facility-level data from six comparison health facilities were collected as an adhoc standard of care comparison and used to calculate the cost of delivering the intervention. A total of 607 MIPs were enrolled in the integrated ECD-PMTCT intervention between June 2018 and December 2019. The average age of MIPs was 30 years and 7 weeks respectively. We found that 86% of mothers attended ≥ 5 of the 8 ECD sessions over the course of 12 months; 88% of intervention mothers were retained in PMTCT versus 59% of mothers in comparison health facilities, and 96% of intervention infants were tested for HIV by six weeks compared to 66% of infants in comparison health facilities. Costing data demonstrated the financial feasibility of integrating ECD and PMTCT programs in government health facilities in Malawi. Integrating ECD into PMTCT programs was feasible, acceptable, resulted in better programmatic outcomes for both mothers and infants. Further investigation is required to determine optimal delivery design for scale-up. [ABSTRACT FROM AUTHOR]

Background: Early retention of people living with HIV (PLHIV) in antiretroviral therapy (ART) programs is critical to improve individual clinical outcomes and viral load suppression. Although many mobile health (mHealth) interventions aim to improve retention in care, there is still lack of evidence on mHealth success or failure, including from patient's perspectives. We describe the human-centered design (HCD) process and assess patient usability and acceptability of a two-way texting (2wT) intervention to improve early retention among new ART initiates at Lighthouse Trust clinic in Lilongwe, Malawi. Methods: An iterative HCD approach focused on patient and provider users' needs, incorporating feedback from multidisciplinary teams to adapt 2wT for the local, public clinic context. We present mixed-methods usability and acceptability results from 100 participants, 50 at 3-months and 50 at 6-months, post 2wT enrollment, and observations of these same patients completing core tasks of the 2wT system. Results: Among the 100 usability respondents, 95% were satisfied with visit reminders, and 88% would recommend reminders and motivational messages to friends; however, 17% were worried about confidentiality. In observation of participant task completion, 94% were able to successfully confirm visit attendance and 73% could request appointment date change. More participants in 4–6 months group completed tasks correctly compared to 1–3 months group, although not significantly different (78% vs. 66%, p = 0.181). Qualitative results were overwhelmingly positive, but patients did note confusion with transfer reporting and concern that 2wT would not reach patients without mobile phones or with lower literacy. Conclusion: The 2wT app for early ART retention appears highly usable and acceptable, hopefully creating a solid foundation for lifelong engagement in care. The HCD approach put the local team central in this process, ensuring that both patients' and Lighthouse's priorities, policies, and practices were forefront in 2wT optimization, raising the likelihood of 2wT success in other routine program contexts. [ABSTRACT FROM AUTHOR]

Research on the social impact of ART pivots on questions of individual adherence and community acceptability of treatment programmes. In this paper we examine unexpected and unintended consequences of the scale-up of treatment in rural Malawi, using a unique dataset of more than 150 observational journals from three sites, spanning 2010 to 2013, focusing on men's everyday conversations. Through thematic content analysis, we explore the emerging perception that the widespread availability of ART constitutes a form of social danger, as treatment makes it difficult to tell who does or does not have AIDS. This ambiguity introduced through ART is interpreted as putting individuals at risk, because it is no longer possible to tell who might be infected - indeed, the sick now look healthier and “plumper” than the well. This ambivalence over the social impact of ART co-exists with individual demand for and appreciation of the benefits of treatment. [ABSTRACT FROM AUTHOR]

Introduction: We aimed to explore the medium-long term impacts of anti-retroviral treatment of hypertension in a sample of HIV-positive in Malawi. This was a retrospective study carried out at Disease Relief with Excellent and Advanced Means (DREAM) health Centre in Blantyre/Malawi on enrolled and followed up patients from 2005 to 2019. Methodology: Information about age, gender, blood pressure, ART regimen, BMI, CD4 count, viral load, biochemistry, hemoglobin, marital status, education, survival and period on anti-retroviral drugs were retrieved from data base from 01/01/2006 to 31/12/2015. In total, we enrolled (alive and on HAART) 1350 patients >18 years (Mean age: 43.4 and the SD was ± 10.7 with 1031 (65.9%) females and 534 (34.1%) males who were taking (or have taken) ARVs for more than 6 months at the date of enrolment. Patients were not affected by hypertension or potentially related diseases like renal failure at the beginning of ART. The mean observation time from the HAART initiation was 77 months per person (SD ± 40). Results: The sample was made up by two groups of patients, 675 who developed hypertension and 675 who did not, with similar age and gender composition. Among patients with hypertension, 30/675 (4.4%) developed severe hypertension, 154 developed moderate hypertension (22.8%) and 491 developed mild hypertension (72.8%). Hypertension stages were not associated to statistic significant differences of age and/or gender (p=0.422, p=0.281 respectively). At baseline, patients who developed hypertension showed higher hemoglobin, higher CD4 count and lower VL (p<0.001). Patients on AZT-based regimen and TDF-based regimen were at high risk to develop hypertension while PI-based regimen was protective to hypertension (p<0.001). In a multivariate analysis, factors independently associated to hypertension were higher CD4 count and body mass index at the visit date, while baseline viral load and PI-Including regimes were protective factors. Education level was inversely associated with risk of hypertension, while being married was associated of risk of hypertension (p<0.001). Mortality rate among hypertensive patients was 1.6% for those treated for hypertension against the 3.6% for those not treated. Conclusion: This study shows a protective action of PI-including regimens compared with AZT based regimen that is associated to an increased risk of hypertension. Factors related to a better general health status are associated to a higher risk of hypertension as well as lower education, older age and male gender. Treatment should be started as soon as hypertension stages 2-3 are reached and controlled by behavioral factors is no longer effective. [ABSTRACT FROM AUTHOR]

Background: When people with human immunodeficiency virus (HIV) infection (PWH) develop malaria, they are at risk of poor anti-malarial treatment efficacy resulting from impairment in the immune response and/or drug-drug interactions that alter anti-malarial metabolism. The therapeutic efficacy of artemether-lumefantrine was evaluated in a cohort of PWH on antiretroviral therapy (ART) and included measurement of day 7 lumefantrine levels in a subset to evaluate for associations between lumefantrine exposure and treatment response. Methods: Adults living with HIV (≥ 18 years), on ART for ≥ 6 months with undetectable HIV RNA viral load and CD4 count ≥ 250/mm3 were randomized to daily trimethoprim-sulfamethoxazole (TS), weekly chloroquine (CQ) or no prophylaxis. After diagnosis of uncomplicated Plasmodium falciparum malaria, a therapeutic efficacy monitoring was conducted with PCR-correction according to WHO guidelines. The plasma lumefantrine levels on day 7 in 100 episodes of uncomplicated malaria was measured. A frailty proportional hazards model with random effects models to account for clustering examined the relationship between participant characteristics and malaria treatment failure within 28 days. Pearson's Chi—squared test was used to compare lumefantrine concentrations among patients with treatment failure and adequate clinical and parasitological response (ACPR). Results: 411 malaria episodes were observed among 186 participants over 5 years. The unadjusted ACPR rate was 81% (95% CI 77–86). However, after PCR correction to exclude new infections, ACPR rate was 94% (95% CI 92–97). Increasing age and living in Ndirande were associated with decreased hazard of treatment failure. In this population of adults with HIV on ART, 54% (51/94) had levels below a previously defined optimal day 7 lumefantrine level of 200 ng/ml. This occurred more commonly among participants who were receiving an efavirenz-based ART compared to other ART regimens (OR 5.09 [95% CI 1.52–7.9]). Participants who experienced treatment failure had lower day 7 median lumefantrine levels (91 ng/ml [95% CI 48–231]) than participants who experienced ACPR (190 ng/ml [95% CI 101–378], p-value < 0.008). Conclusion: Recurrent malaria infections are frequent in this population of PWH on ART. The PCR-adjusted efficacy of AL meets the WHO criteria for acceptable treatment efficacy. Nevertheless, lumefantrine levels tend to be low in this population, particularly in those on efavirenz-based regimens, with lower concentrations associated with more frequent malaria infections following treatment. These results highlight the importance of understanding drug-drug interactions when diseases commonly co-occur. [ABSTRACT FROM AUTHOR]

Background: Malawi is a low-income country with a high maternal mortality rate, unmet need for family planning and high reports (41%) of unintended pregnancies. Women on Antiretroviral Therapy (ART) continued to experience unintended pregnancies after using hormonal contraceptives provided by nurses in the family planning clinics. However, the unintended pregnancies could affect the sexual and reproductive health of women and decisions of nurses on contraceptive provision to women on ART. Objective: The purpose of the study was to explore challenges faced by nurses in the provision of hormonal contraceptives to women on ART in selected clinics in Lilongwe, Malawi. Methods: A qualitative approach using an explorative design was used in this study. Eight (8) participants were selected purposefully from five public family planning clinics in Lilongwe. They were interviewed individually using a semi-structured interview guide. Data were analyzed using a content analysis guide. Results: Three themes emerged from the data and these were as follows: limited knowledge of nurses; inadequate resources and inadequate support. Results revealed that nurses had limited knowledge of contraceptives to provide to women on ART due to lack of ART content in the contraceptive training which they had. They also lacked clinical and human resources and adequate time to teach clients which affected provision of the right hormonal contraceptives to women on ART. Furthermore, they needed support in the form of supervision, reference materials and integration of ART and contraceptive provision services. Conclusion: The challenges that nurses faced had an influence on the provision of contraceptives to women on ART. The study recommends that nurses should be trained on the provision of contraceptives to women on ART and be provided with the required resources and support for proper care to be achieved. Furthermore, there is a need for clear guidelines on hormonal contraceptives that women on ART could get and the integration of ART and family planning services. [ABSTRACT FROM AUTHOR]

Dolutegravir HIV drug resistance (HIVDR) data from Africa remain sparse. We reviewed HIVDR results of Malawians on dolutegravir-based antiretroviral therapy (November 2020–September 2021). Of 6462 eligible clients, 33 samples were submitted to South Africa, 27 were sequenced successfully, and 8 (30%) had dolutegravir HIVDR. Malawi urgently requires adequate HIVDR testing capacity. [ABSTRACT FROM AUTHOR]

Background: In Malawi, early retention in HIV care remains challenging. Depression is strongly associated with reduced anti-retroviral therapy (ART) adherence and viral suppression. Appropriate depression care for people initiating ART is likely to be supportive of early and continued engagement in the HIV care continuum. This paper aims to provide an overview of a task-shifting program that integrates depression screening and treatment into HIV care and the strategy used to evaluate this program, describes the implementation process, and discusses key challenges and lessons learned in the first phase of program implementation.Methods: We are implementing a program integrating depression screening and treatment into HIV care initiation at two clinics in Lilongwe District, Malawi. The program's effect on patients' depression and HIV outcomes will be evaluated using a multiple baseline pre-post study. In this manuscript, we draw from our experiences as program implementers and some of the quantitative data to describe the process of implementation and key lessons learned.Results: We successfully implemented the screening phase of this program at both clinics; 88.3 and 93.2% of newly diagnosed patients have been screened for depression at each clinic respectively. 25% of enrolled patients reported symptoms of mild-to-severe depression and only 6% reported symptoms of moderate-to-severe depression. Key lessons learned from the process show the importance of utilizing existing processes and infrastructure and focusing on iterative and collaborative learning. We continued to face challenges around establishing a sense of program ownership among providers, developing capacity to diagnose and manage depression, and ensuring the availability of appropriate medication. Our efforts to address these challenges provide insight into the technical and managerial support needed to prepare for, roll out, and sustain integrated models of mental health and HIV care.Conclusions: This activity demonstrates how a depression screening program can successfully be integrated into HIV care within the public health system in Malawi. While this program focuses on integrating depression management into HIV care, most of the lessons learned could apply to integration of mental health into any non-psychiatric specialist setting.Trial Registration: ClinicalTrials.gov ID [ NCT03555669 ]. Retrospectively registered on 13 June 2018. [ABSTRACT FROM AUTHOR]

Retention in antiretroviral therapy (ART) services is critical to achieving positive health outcomes for individuals living with HIV, but accumulating evidence indicates that individuals are likely to miss ART appointments over time. Thus, it is important to understand why individuals miss appointments and how they re-engage in HIV care. We used in-depth interviews with 44 ART clients in Malawi who recently missed an ART appointment (> 14 days) but eventually re-engaged in care (within 60 days) to explore reasons for missed appointments and barriers and facilitators to re-engagement. We found that most individuals missed ART appointments due to unexpected life events such as funerals, work, and illness for both clients and their treatment guardians who were also unable to attend facilities. Several reasons differed by gender—work-related travel was common for men, while caring for sick family members was common for women. Barriers to re-engagement included continued travel, illness, and restricted clinic schedules and/or staff shortages that led to repeat facility visits before being able to re-engage in care. Strong internal motivation combined with social support and reminders from community health workers facilitated re-engagement in HIV care. [ABSTRACT FROM AUTHOR]

With wider access to antiretroviral therapy, people living with HIV are reconsidering their reproductive decisions: remarrying and having children. The purpose of the paper is to explore sources of information for reproductive decision used by couples living with HIV in patrilineal and matrilineal districts of Malawi. Data were collected from forty couples from July to December 2010. Our results illuminate five specific issues: some of the informants (1) remarry after divorce/death of a spouse, (2) establish new marriage relationship with spouses living with HIV, and (3) have children hence the need for information to base their decisions. There are (4) shared and interactive couple decisions, and (5) informal networks of people living with HIV are the main sources of information. In addition, in matrilineal community, cultural practices about remarriage set up structures that constrained information availability unlike in patrilineal community where information on sexual and reproductive health, HIV, and AIDS was disseminated during remarriage counselling. However, both sources are not able to provide comprehensive information due to complexity and lack of up to date information. Therefore, health workers should, offer people living with HIV comprehensive information that takes into consideration the cultural specificity of groups, and empower already existing and accepted local structures with sexual and reproductive health, HIV, and AIDS knowledge. [ABSTRACT FROM AUTHOR]

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Transitions between services for continued antiretroviral treatment (ART) during and after pregnancy are a commonly overlooked aspect of the HIV care cascade, but ineffective transitions can lead to poor health outcomes for women and their children. In this qualitative study, we conducted interviews with 15 key stakeholders from Ministries of Health along with PEPFAR-supported and other in-country non-governmental organizations actively engaged in national programming for adult HIV care and prevention of mother-to-child-transmission of HIV (PMTCT) services in Côte d'Ivoire, Lesotho and Malawi. We aimed to understand perspectives regarding transitions into and out of PMTCT services for continued ART. Thematic analysis revealed that, although transitions of care are necessary and a potential point of loss from ART care in all three countries, there is a lack of clear guidance on transition approach and no formal way of monitoring transition between services. Several opportunities were identified to monitor and strengthen transitions of care for continued ART along the PMTCT cascade. [ABSTRACT FROM AUTHOR]

Introduction: HIV planning requires granular estimates for the number of people living with HIV (PLHIV), antiretroviral treatment (ART) coverage and unmet need, and new HIV infections by district, or equivalent subnational administrative level. We developed a Bayesian small‐area estimation model, called Naomi, to estimate these quantities stratified by subnational administrative units, sex, and five‐year age groups. Methods: Small‐area regressions for HIV prevalence, ART coverage and HIV incidence were jointly calibrated using subnational household survey data on all three indicators, routine antenatal service delivery data on HIV prevalence and ART coverage among pregnant women, and service delivery data on the number of PLHIV receiving ART. Incidence was modelled by district‐level HIV prevalence and ART coverage. Model outputs of counts and rates for each indicator were aggregated to multiple geographic and demographic stratifications of interest. The model was estimated in an empirical Bayes framework, furnishing probabilistic uncertainty ranges for all output indicators. Example results were presented using data from Malawi during 2016–2018. Results: Adult HIV prevalence in September 2018 ranged from 3.2% to 17.1% across Malawi's districts and was higher in southern districts and in metropolitan areas. ART coverage was more homogenous, ranging from 75% to 82%. The largest number of PLHIV was among ages 35 to 39 for both women and men, while the most untreated PLHIV were among ages 25 to 29 for women and 30 to 34 for men. Relative uncertainty was larger for the untreated PLHIV than the number on ART or total PLHIV. Among clients receiving ART at facilities in Lilongwe city, an estimated 71% (95% CI, 61% to 79%) resided in Lilongwe city, 20% (14% to 27%) in Lilongwe district outside the metropolis, and 9% (6% to 12%) in neighbouring Dowa district. Thirty‐eight percent (26% to 50%) of Lilongwe rural residents and 39% (27% to 50%) of Dowa residents received treatment at facilities in Lilongwe city. Conclusions: The Naomi model synthesizes multiple subnational data sources to furnish estimates of key indicators for HIV programme planning, resource allocation, and target setting. Further model development to meet evolving HIV policy priorities and programme need should be accompanied by continued strengthening and understanding of routine health system data. [ABSTRACT FROM AUTHOR]

Countries in sub-Saharan Africa have been seriously affected by HIV and now face a new pandemic – COVID-19. How have prior experiences with managing HIV prepared countries for COVID-19? To what extent has the structure of the global health field enabled or constrained countries' ability to respond? Drawing on qualitative methods, this article examines the impact of HIV interventions on the healthcare system in Malawi and its implications for addressing COVID-19. I argue that the historical and continued influence of neoliberalism in global health manifests in the structures and routines of clinical practice. In Malawi's health centres, a parallel NGO system of care has become grafted onto state healthcare, with NGOs managing HIV commodities and providing care to HIV patients. While HIV NGOs do support the work of government providers, it is limited to tasks that align with their programmatic goals. Outside of donor priorities, the conditions of public healthcare are left behind, and government providers struggle with shortages of staff, medical resources, and basic infrastructure. In the context of COVID-19, risks are compounded as public healthcare facilities not only struggle with resources to treat patients, but also become a site of risk itself for COVID-19 infection. [ABSTRACT FROM AUTHOR]

Background Although community and health system factors are known to be critical to timely antiretroviral therapy (ART) initiation, little is known about how they affect men and women. Methods We examined community- and health system-level factors associated with ART initiation in Malawi and whether associations differ by gender; 312 ART initiates and 108 non-initiates completed a survey; a subset of 30 individuals completed an indepth interview. Quantitative data were analyzed using univariate and multivariate logistic regressions, with separate models by gender. Qualitative data were analyzed through constant comparison methods. Results Among women, no community-level characteristics were associated with ART initiation in multivariable models; among men, receiving social support for HIV services (adjusted OR [AOR]=4.61; p<0.05) was associated with ART initiation. Two health system factors were associated with ART initiation among men and one for women: trust that accessing ART services would not lead to unwanted disclosure (women: AOR=4.51, p<0.01; men: AOR=1.71, p<0.01) and trust that clients were not turned away from ART services (men: 12.36, p=0.001). Conclusions Qualitative data indicate that men were concerned about unwanted disclosure due to engaging in ART services and long waiting times for services. Interventions to remove health system barriers to ART services should be explored to promote social support among men. [ABSTRACT FROM AUTHOR]

Introduction: The Malawi Ministry of Health (MoH) has been in collaboration with Médecins sans Frontières (MSF) to increase access to quality HIV care through decentralization of antiretroviral therapy (ART) diagnosis and treatment from hospital to clinics in Nsanje District since 2011. A population-based household survey was implemented to provide information on HIV prevalence and cascade of care to inform and prioritize community-based HIV interventions in the district. Methods: A cross-sectional survey was conducted between September 2016 and January 2017. Using two-stage cluster sampling, eligible adult individuals aged ≥15 years living in the selected households were asked to participate. Participants were interviewed and tested for HIV at home. Those tested HIV-positive had their HIV-RNA viral load (VL) measured, regardless of their ART status. All participants tested HIV-positive at the time of the survey were advised to report their HIV test result to the health facility of their choice that MSF was supported in the district. HIV-RNA VL results were made available in this health facility. Results: Among 5,315 eligible individuals, 91.1% were included in the survey and accepted an HIV test. The overall prevalence was 12.1% (95% Confidence Interval (CI): 11.2–13.0) and was higher in women than in men: 14.0% versus 9.5%, P<0.001. Overall HIV-positive status awareness was 80.0% (95%CI: 76.4–83.1) and was associated with sex (P<0.05). Linkage to care was 78.0% (95%CI: 74.3–81.2) and participants in care 76.2% (95%CI: 72.4–79.5). ART coverage among participants aware of their HIV-positive status was 95.3% (95%CI: 92.9–96.9) and was not associated with sex (P = 0.55). Viral load suppression among participants on ART was 89.9% (95%CI: 86.6–92.4) and was not statistically different by sex (p = 0.40). Conclusions: Despite encouraging results in HIV testing coverage, cascade of care, and UNAIDS targets in Nsanje District, some gap remains in the first 90, specifically among men and young adults. Enhanced community engagement and new strategies of testing, such as index testing, could be implemented to identify those who are still undiagnosed, particularly men and young adults. [ABSTRACT FROM AUTHOR]

Background: Long-term viral load (VL) suppression among HIV-positive, reproductive-aged women on ART is key to eliminating mother-to-child transmission (MTCT) but few data exist from sub-Saharan Africa. We report trends in post-partum VL in Malawian women on ART and factors associated with detectable VL up to 24 months post-partum. Methods: 1–6 months post-partum mothers, screened HIV-positive at outpatient clinics in Malawi, were enrolled (2014–2016) with their infants. At enrollment, 12- and 24-months post-partum socio-demographic and PMTCT indicators were collected. Venous samples were collected for determination of maternal VL (limit of detection 40 copies/ml). Results were returned to clinics for routine management. Results: 596/1281 (46.5%) women were retained in the study to 24 months. Those retained were older (p<0.01), had higher parity (p = 0.03) and more likely to have undetectable VL at enrollment than those lost to follow-up (80.0% vs 70.2%, p<0.01). Of 590 women on ART (median 30.1 months; inter-quartile range 26.8–61.3), 442 (74.9%) with complete VL data at 3 visits were included in further analysis. Prevalence of detectable VL at 12 and 24 months was higher among women with detectable VL at enrollment than among those with undetectable VL (74 detectable VL results/66 women vs. 19/359; p<0.001). In multivariable analysis (adjusted for age, parity, education, partner disclosure, timing of ART start and self-reported adherence), detectable VL at 24 months was 9 times more likely among women with 1 prior detectable VL (aOR 9.0; 95%CI 3.5–23.0, p<0.001) and 226 times more likely for women with 2 prior detectable VLs (aOR 226.4; 95%CI 73.0–701.8, p<0.001). Conclusions: Detectable virus early post-partum strongly increases risk of ongoing post-partum viremia. Due to high loss to follow-up, the true incidence of detectable VL over time is probably underestimated. These findings have implications for MTCT, as well as for the mothers, and call for intensified VL monitoring and targeted adherence support for women during pregnancy and post-partum. [ABSTRACT FROM AUTHOR]

As in other sub-Saharan countries, the burden of depression is high among people living with HIV in Malawi. However, the association between depression at ART initiation and two critical outcomes—retention in HIV care and viral suppression—is not well understood. Prior to the launch of an integrated depression treatment program, adult patients were screened for depression at ART initiation at two clinics in Lilongwe, Malawi. We compared retention in HIV care and viral suppression at 6 months between patients with and without depression at ART initiation using tabular comparison and regression models. The prevalence of depression among this population of adults newly initiating ART was 27%. Those with depression had similar HIV care outcomes at 6 months to those without depression. Retention metrics were generally poor for those with and without depression. However, among those completing viral load testing, nearly all achieved viral suppression. Depression at ART initiation was not associated with either retention or viral suppression. Further investigation of the relationship between depression and HIV is needed to understand the ways depression impacts the different aspects of HIV care engagement. [ABSTRACT FROM AUTHOR]

Effective implementation of policies for expanding antiretroviral therapy (ART) requires a well-trained and adequately staffed workforce. Changes in national HIV workforce policies, health facility practices, and provider experiences were examined in rural Malawi and Tanzania between 2013 and 2017. In both countries, task-shifting and task-sharing policies were explicit by 2013. In facilities, the cadre mix of providers varied by site and changed over time, with a higher and growing proportion of lower cadre staff in the Malawi site. In Malawi, the introduction of lay counsellors was perceived to have eased the workload of other providers, but lay counsellors reported inadequate support. Both countries had guidance on the minimum numbers of personnel required to deliver HIV services. However, patient loads per provider increased in both settings for HIV tests and visits by ART patients and were not met with corresponding increases in provider capacity in either setting. Providers reported this as a challenge. Although increasing patient numbers bodes well for achieving universal antiretroviral therapy coverage, the quality of care may be undermined by increased workloads and insufficient provider training. Task-shifting strategies may help address workload concerns, but require careful monitoring, supervision and mentoring to ensure effective implementation. [ABSTRACT FROM AUTHOR]

Little is known about how CD4 and viral load testing have evolved following implementation of universal test and treat (UTT) in African settings. We reviewed World Health Organization (WHO) guidance from 2013 to 2018, and compared it against national HIV policies in Malawi, Tanzania and South Africa. Three surveys rounds were conducted in 2013, 2016 and 2017–2018 in 33 health facilities across the three settings to assess implementation of national policies on the use of biological markers. Qualitative interviews were conducted with 26 HIV policymakers or programme managers, 21 providers and 66 people living with HIV to explore understandings and experiences of these tests. Various factors influenced adoption and implementation of WHO guidance, including historical policies on CD4 counts, governance issues, supply chain challenges and funding mechanisms. Facility-level practices relating to the use of these tests often diverged from national policies. Patients and providers valued both tests, but did not always understand their roles. In addition to continued support for scaling-up viral load testing, renewed focus should be placed on the ongoing value of point-of-care CD4 tests in the UTT era, including its role in assessing disease progression and informing clinical management of cases to reduce HIV-related mortality. [ABSTRACT FROM AUTHOR]

Background: Reaching the 90-90-90 targets requires efficient resource use to deliver HIV testing and treatment services. We investigated the costs and efficiency of HIV services in relation to HIV testing yield in rural Karonga District, Malawi.Methods: Costs of HIV services were measured over 12 months to September 2017 in five health facilities, drawing on recognised health costing principles. Financial and economic costs were collected in Malawi Kwacha and United States Dollars (US$). Costs were calculated using a provider perspective to estimate average annual costs (2017 US$) per HIV testing episode, per HIV-positive case diagnosed, and per patient-year on antiretroviral therapy (ART), by facility. Costs were assessed in relation to scale of operation and facility-level annual HIV positivity rate. A one-way sensitivity analysis was undertaken to understand how staffing levels and the HIV positivity rate affected HIV testing costs.Results: HIV testing episodes per day and per full-time equivalent HIV health worker averaged 3.3 (range 2.0 to 5.7). The HIV positivity rate averaged 2.4% (range 1.9 to 3.7%). The average cost per testing episode was US$2.85 (range US$1.95 to US$8.55), and the average cost per HIV diagnosis was US$116.35 (range US$77.42 to US$234.11), with the highest costs found in facilities with the lowest daily number of tests and lowest HIV yield respectively. The mean facility-level cost per patient-year on ART was approximately US$100 (range US$90.67 to US$115.42). ART drugs were the largest cost component averaging 71% (range 55 to 76%). The cost per patient-year of viral load tests averaged US$4.50 (range US$0.52 to US$7.00) with cost variation reflecting differences in the tests to ART patient ratio across facilities.Conclusion: Greater efficiencies in HIV service delivery are possible in Karonga through increasing daily testing episodes among existing health workers or allocating health workers to tasks in addition to testing. Costs per diagnosis will increase as yields decline, and therefore, encouraging targeted testing strategies that increase yield will be more efficient. Given the contribution of drug costs to per patient-year treatment costs, it is critical to preserve the life-span of first-line ART regimens, underlining the need for continuing adherence support and regular viral load monitoring. [ABSTRACT FROM AUTHOR]

Many countries have expanded insurance programmes in an effort to achieve universal health coverage (UHC). We assess a complementary path toward financial risk protection: increased access to technologies that improve health and reduce the risk of large health expenditures. Malawi has provided free HIV treatment since 2004 with significant US Government support. We investigate the impact of treatment access on medical spending, capacity to pay and catastrophic health expenditures at the population level, exploiting the phased rollout of HIV treatment in a difference-in-differences design. We find that increased access to HIV treatment generated a 10% decline in medical spending for urban households, a 7% increase in capacity to pay for rural households and a 3-percentage point decrease in the likelihood of catastrophic health expenditure among urban households. These risk protection benefits are comparable to that found from broad-based insurance coverage in other contexts. Our findings show that targeted treatment programmes that provide free care for high burden causes of death can provide substantial financial risk protection against catastrophic health expenditure, while moving developing nations toward UHC. [ABSTRACT FROM AUTHOR]

Community norms shape the childbearing goals and behaviors of persons living with HIV/AIDS (PLWHA) but little is known about how norms around HIV-positive childbearing have changed with expanded access to antiretroviral treatment (ART). We analyze data collected in 2009 and 2015 by the Tsogolo la Thanzi (TLT) project—a longitudinal, population-based study of young adults in southern Malawi. Respondents were asked about the acceptability of childbearing using vignettes that varied a hypothetical couple's HIV status and number of children. We assess mean differences in support for childbearing over time and by respondent gender and serostatus. The acceptability of childbearing for PLWHA increased dramatically over the 6-year period; however, support levels varied based on a couple's current number of children and whether they were seropositive concordant or discordant. Differences in attitudes by gender and HIV status diminished over time, pointing to a population-level convergence in norms about acceptable childbearing. [ABSTRACT FROM AUTHOR]

Alcohol use among HIV-positive individuals in sub-Saharan Africa directly impacts adherence to antiretroviral therapy and HIV outcomes. Few studies have examined approaches to reduce alcohol use among HIV-affected couples, despite evidence that alcohol use is a couple-level concern. We conducted a qualitative study with 23 alcohol-using couples to identify multilevel barriers and facilitators of alcohol use, and potential intervention options with couples. Data were analyzed at individual and dyadic levels using framework analysis. All couples were married and had at least one partner on ART. Men were the primary alcohol drinkers with few women reporting alcohol use. Most women tried to persuade their partners to reduce their alcohol intake and when unsuccessful, enlisted help from relatives and HIV care providers. Effective couple negotiation around men's alcohol use was constrained by negative peer influence and men's desire for friendship to cope with life stressors. Women were primarily concerned about the expense of alcohol and described how alcohol prevented the family from meeting basic needs and investing in the future. Alcohol use was described as a major barrier to ART adherence, but was also viewed as the cause of couple and family violence, extramarital partnerships, food insecurity, and poverty. We conclude that multilevel interventions based on couples' needs and preferences are urgently needed. Couple-based intervention approaches could include provider-led alcohol counseling with couples, alcohol reduction support groups for couples, couples' counseling to bolster couple communication and problem-solving around alcohol, and economic-strengthening interventions for couples. [ABSTRACT FROM AUTHOR]

Background: Depression is highly prevalent among patients newly starting antiretroviral treatment (ART) in Malawi and many other countries. Untreated depression at ART initiation can disrupt the HIV care continuum. Effective approaches for depression screening and treatment exist for low-resource settings, but they are rarely applied. Identifying effective implementation strategies are critical. Methods: A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a screening-only "control" phase and an active "intervention" phase. During the intervention phase, providers prescribed antidepressants or referred patients for Friendship Bench problem-solving therapy. We evaluated the program's impact on retention in HIV care, viral suppression, and depression remission at 6 months using tabular comparisons and log-binomial models to estimate adjusted risk ratios and mean differences among the intervention group relative to the control group. Results: Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms. During the intervention phase, 86% of participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants with moderate to severe depressive symptoms started antidepressants. Few participants in the intervention group received consistent depression treatment over their first 6 months in care. In the adjusted main analysis, program exposure did not demonstrably affect most HIV or mental health outcomes, though the probability of currently being on ART at 6 months was significantly lower among the intervention group than the control group [RR 0.6(95%CI: 0.4–0.9)]. Conclusions: While it is feasible to integrate depression screening and treatment initiation into ART initiation, providing ongoing depression treatment over time is challenging. Similar implementation science studies focused on maintaining depression management will be increasingly important as we strive to understand and test the best ways to implement evidence-based depression treatment within HIV care. [ABSTRACT FROM AUTHOR]

There are concerns that pneumococcal conjugate vaccines (PCVs) in sub-Saharan Africa sub-optimally interrupt Streptococcus pneumoniae vaccine-serotype (VT) carriage and transmission. Here we assess PCV carriage using rolling, prospective nasopharyngeal carriage surveys between 2015 and 2018, 3.6–7.1 years after Malawi's 2011 PCV13 introduction. Carriage decay rate is analysed using non-linear regression. Despite evidence of reduction in VT carriage over the study period, there is high persistent residual carriage. This includes among PCV-vaccinated children 3–5-year-old (16.1% relative reduction from 19.9% to 16.7%); PCV-unvaccinated children 6–8-year-old (40.5% reduction from 26.4% to 15.7%); HIV-infected adults 18-40-years-old on antiretroviral therapy (41.4% reduction from 15.2% to 8.9%). VT carriage prevalence half-life is similar among PCV-vaccinated and PCV-unvaccinated children (3.26 and 3.34 years, respectively). Compared with high-income settings, there is high residual VT carriage 3.6–7.1 years after PCV introduction. Rigorous evaluation of strategies to augment vaccine-induced control of carriage, including alternative schedules and catch-up campaigns, is required. Impact of pneumococcal conjugate vaccines (PCV) in controlling carriage needs to be evaluated to inform vaccine policy. Here, Swarthout et al. show in a prospective rolling cross-sectional study in Malawi a high residual prevalence of vaccine-serotype S. pneumoniae 7 years after PCV introduction. [ABSTRACT FROM AUTHOR]

HIV testing among female sex workers (FSWs) is an established global health priority. HIV self-testing (HIVST) seems to have the potential to address issues of confidentiality, privacy and convenience among this key population. HIVST, however, may result in unintended consequences as its implementation unfolds in a complex sex work context characterised by unequal power relations, stigma and high HIV prevalence. We aimed to explore the experiences of FSWs with HIVST in the context of retesting and antiretroviral usage in Blantyre, Malawi. We used an ethnographic approach to understand meanings and views around HIVST and retesting. We found high levels of retesting, especially among those on antiretroviral, two of which received "false-negative" results. We identified three broad narratives: (1) retesting in response to experiences in the sex work context, (2) retesting driven by the desire to self-monitor HIV-negative status, and (3) retesting in the hope of sero-reversion. The FSWs' experiences indicate that the implementation of HIVST in this context is complex with potential for unintended harms such as coercive testing. HIVST programmes must include clear and appropriate messaging to reduce retesting while on ART and implement strategies to address FSW concerns and anxieties about the accuracy of their HIV-positive test results. [ABSTRACT FROM AUTHOR]

Background: Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART.Methods: This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses.Discussion: This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes.Trial Registration: ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018. [ABSTRACT FROM AUTHOR]

Background As routine viral load testing among HIV-infected individuals on antiretroviral therapy (ART) expands, virologic failure (VF) among children in developing countries remains poorly understood. We assessed the rate of VF, the proportion failing who were subsequently switched to second-line ART and factors associated with VF among children ≤18 y. Methods An observation cohort study among 1312 children at two public clinics in Lilongwe, Malawi who initiated a first-line ART regimen between January 2014 and December 2017 and remained on treatment for ≥6 mo was conducted. Kaplan-Meier methods estimated the probabilities of VF. Univariable and multivariable Poisson regression models were used to explore predictors of VF. Result Overall, 16% (208/1312) of children experienced VF with an incidence rate of 10.1 events per 100 person-years. Of the 208, 184 (88%) were switched to second-line ART: 68 (43%) switched the same day VF was confirmed and 106 (66%) switched within 90 d of confirmed VF. Use of a Nevirapine (NVP)-based regimen and initiating ART in 2016–2017 compared with 2014–2015 were independent predictors of VF. Conclusion VF is common among children receiving ART. The findings suggest that VF can be reduced by phasing out NVP-based regimen and by ensuring optimal adherence to ART. [ABSTRACT FROM AUTHOR]

Objectives: We examine long-term retention of adults, adolescents and children on antiretroviral therapy under different HIV treatment guidelines in Malawi. Design: Prospective cohort study. Setting and participants: Adults and children starting ART between 2005 and 2015 in 21 health facilities in southern Malawi. Methods: We used survival analysis to assess retention at clinic level, Cox regression to examine risk factors for loss to follow up, and competing risk analysis to assess long-term outcomes of people on antiretroviral therapy (ART). Results: We included 132,274 individuals in our analysis, totalling 270,256 person years of follow up (PYFU; median per patient 1.3, interquartile range (IQR) 0.26–3.1), 62% were female and the median age was 32 years. Retention on ART was lower in the first year on ART compared to subsequent years for all guideline periods and age groups. Infants (0–3 years), adolescents and young adults (15–24 years) were at highest risk of LTFU. Comparing the different calendar periods of ART initiation we found that retention improved initially, but remained stable thereafter. Conclusion: Even though the number of patients and the burden on health care system increased substantially during the study period of rapid ART expansion, retention on ART improved in the early years of ART provision, but gains in retention were not maintained over 5 years on ART. Reducing high attrition in the first year of ART should remain a priority for ART programs, and so should addressing poor retention among adolescents, young adults and men. [ABSTRACT FROM AUTHOR]

Background: Private health facilities are increasingly being recognized as the neglected partner in the provision of HIV services. The non-adherence rate in the study sites ranged from 19 to 22%. This study explored the factors associated with non-adherence from antiretroviral therapy (ART) among adult patients accessing ART services at two privately owned urban health facilities in Malawi.Methods: We conducted a descriptive qualitative approach employing in-depth interviews among adults who either defaulted or were retained in HIV care in two privately owned facilities in Malawi from March to July 2017. We purposively selected participants and interviewed a total of 6 ART providers and 24 ART clients. Data were analyzed manually using a thematic approach.Results: Overall, participants identified four facilitators for retention in care and four broad categories of barriers namely individual, psychological, drug related and human resource related factors. The factors that facilitated retention in care included follow up visits after missing a visit, adequate information education and counseling, and supportive relationships.Conclusion: The main reason for defaulting from antiretrovirals (ARVs) was fear of disclosing an HIV status to avert potential stigma and discrimination. In implementing ART clinics due consideration and strategies need to be adopted to ensure that privacy and confidentiality is preserved. Although adoption of all the key Malawi Implementing strategies like expert clients and a guardian may optimize retention in care, there is need for prior analysis of how those may lead to unintended disclosure which inadvertently affects adherence. Furthermore, private facilities should orient their clients to the public facilities within the catchment area so that clients have an option for alternative access to HIV care in the event of financial constraints. [ABSTRACT FROM AUTHOR]

In public health research, information that is readily available may be insufficient to address the primary question(s) of interest. One cost-efficient way forward, especially in resource-limited settings, is to conduct a two-phase study in which the population is initially stratified, at phase I, by the outcome and/or some categorical risk factor(s). At phase II detailed covariate data is ascertained on a subsample within each phase I strata. While analysis methods for two-phase designs are well established, they have focused exclusively on settings in which participants are assumed to be independent. As such, when participants are naturally clustered (eg, patients within clinics) these methods may yield invalid inference. To address this, we develop a novel analysis approach based on inverse-probability weighting that permits researchers to specify some working covariance structure and appropriately accounts for the sampling design and ensures valid inference via a robust sandwich estimator for which a closed-form expression is provided. To enhance statistical efficiency, we propose a calibrated inverse-probability weighting estimator that makes use of information available at phase I but not used in the design. In addition to describing the technique, practical guidance is provided for the cluster-correlated data settings that we consider. A comprehensive simulation study is conducted to evaluate small-sample operating characteristics, including the impact of using naïve methods that ignore correlation due to clustering, as well as to investigate design considerations. Finally, the methods are illustrated using data from a one-time survey of the national antiretroviral treatment program in Malawi. [ABSTRACT FROM AUTHOR]

Female sex workers (FSW) are disproportionately at risk for HIV. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method, yet approaches for incorporating PrEP within prevention strategies used by FSW are lacking. Semistructured focus group discussions were conducted with 44 HIV-negative FSW in Lilongwe, Malawi to explore perceptions of PrEP: acceptability, integration within HIV prevention behaviors, and barriers to use. Acceptability of PrEP was high. Motivation to use PrEP was rooted in love for one's life, anticipated negative economic effects associated with HIV acquisition. PrEP was viewed as complementary to existing norms for engaging in healthy sexual behaviors. Many felt PrEP may provide extra protection from HIV, along with condoms and frequent STI testing. Unpredictable daily lives, stigma, and side effects were barriers that could affect PrEP use. Leveraging existing HIV prevention strategies and social norms surrounding HIV prevention behaviors may positively impact PrEP uptake among FSW in Malawi and sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

Increasing numbers of people living with HIV (PLHIV) in sub-Saharan Africa are experiencing failure of first-line antiretroviral therapy and transitioning onto second-line regimens. However, there is a dearth of research on their treatment experiences. We conducted in-depth interviews with 43 PLHIV on second- or third-line antiretroviral therapy and 15 HIV health workers in Kenya, Malawi and Mozambique to explore patients' and health workers' perspectives on these transitions. Interviews were audio-recorded, transcribed and translated into English. Data were coded inductively and analysed thematically. In all settings, experiences of treatment failure and associated episodes of ill-health disrupted daily social and economic activities, and recalled earlier fears of dying from HIV. Transitioning onto more effective regimens often represented a second (or third) chance to (re-)engage with HIV care, with patients prioritising their health over other aspects of their lives. However, many patients struggled to maintain these transformations, particularly when faced with persistent social challenges to pill-taking, alongside the burden of more complex regimens and an inability to mobilise sufficient resources to accommodate change. Efforts to identify treatment failure and support regimen change must account for these patients' unique illness and treatment histories, and interventions should incorporate tailored counselling and social and economic support. [ABSTRACT FROM AUTHOR]

Background: The contribution of immune activation to arterial stiffness and its reversibility in human immunodeficiency virus (HIV)-infected adults in sub-Saharan Africa is unknown.Methods: HIV-uninfected and HIV-infected Malawian adults initiating antiretroviral therapy (ART) with a CD4+ T-cell count of <100 cells/μL were enrolled and followed for 44 weeks; enrollment of infected adults occurred 2 weeks after ART initiation. We evaluated the relationship between carotid femoral pulse wave velocity (cfPWV) and T-cell activation (defined as HLA-DR+CD38+ T cells), exhaustion (define as PD-1+ T cells), and senescence (defined as CD57+ T cells) and monocyte subsets, using normal regression.Results: In 279 HIV-infected and 110 HIV-uninfected adults, 142 (37%) had hypertension. HIV was independently associated with a 12% higher cfPWV (P = .02) at baseline and a 14% higher cfPWV at week 10 (P = .02), but the increases resolved by week 22. CD4+ and CD8+ T-cell exhaustion were independently associated with a higher cfPWV at baseline (P = .02). At 44 weeks, arterial stiffness improved more in those with greater decreases in the percentage of CD8+ T cells and the percentage of PD-1+CD8+ T cells (P = .01 and P = .03, respectively). When considering HIV-infected participants alone, the adjusted arterial stiffness at week 44 tended to be lower in those with higher baseline percentage of PD-1+CD8+ T cells (P = .054).Conclusions: PD-1+CD8+ T-cells are associated with HIV-related arterial stiffness, which remains elevated during the first 3 months of ART. Resources to prevent cardiovascular disease in sub-Saharan Africa should focus on blood pressure reduction and individuals with a low CD4+ T-cell count during early ART. [ABSTRACT FROM AUTHOR]

The majority of international migrants from Malawi to South Africa are undocumented, and some of them are on ART. This study explored how these migrants manage to access ART. Qualitative data were collected using open-ended questions in semi-structured interviews. 23 returned undocumented Malawian migrants from South Africa participated in the study. Also, key informant discussions were held with three health workers. Data collection took place in April and May 2015 at a rural village of Namwera in Mangochi district in southern Malawi. Interviews were audio-recorded, transcribed and translated into English for thematic analysis. The guardians collected ART from health facilities in Malawi on behalf of the migrants. The guardians sent ART through truck and bus drivers to the migrants in South Africa. The migrants shared their ART. Others bought ART from the 'street pharmacies'. Others accessed ART from South African health facilities through the help of their South African friends. There are risks to dispensing ART to the migrants who do not themselves present at health facilities. There is value to more regular contacts between clients and health service system that is compromised by alternative strategies. It is better to deliver ART services in South Africa to the undocumented migrants. [ABSTRACT FROM AUTHOR]

Background: Despite substantial progress in antiretroviral therapy (ART) scale up, some people living with HIV (PLHIV) continue to present with advanced HIV disease, contributing to ongoing HIV-related morbidity and mortality. Objective: We aimed to quantify population-level estimates of advanced HIV from three high HIV prevalence settings in Sub-Saharan Africa. Methods: Three cross-sectional surveys were conducted in (Ndhiwa (Kenya): September–November 2012), (Chiradzulu (Malawi): February–May 2013) and (Eshowe (South Africa): July–October 2013). Eligible individuals 15–59 years old who consented were interviewed at home followed by rapid HIV test and CD4 count test if tested HIV-positive. Advanced HIV was defined as CD4 < 200 cells/µl. We used logistic regression to identify patient characteristics associated with advanced HIV. Results: Among 18,991 (39.2% male) individuals, 4113 (21.7%) tested HIV-positive; 385/3957 (9.7% (95% Confidence Interval [CI]: 8.8–10.7)) had advanced HIV, ranging from 7.8% (95%CI 6.4–9.5) Chiradzulu (Malawi) to 11.8% (95%CI 9.8–14.2) Ndhiwa (Kenya). The proportion of PLHIV with advanced disease was higher among men 15.3% (95% CI 13.2–17.5) than women 7.5% (95%CI 6.6–8.6) p < 0.001. Overall, 62.7% of all individuals with advanced HIV were aware of their HIV status and 40.3% were currently on ART. Overall, 65.6% of individuals not on ART had not previously been diagnosed with HIV, while only 29.6% of those on ART had been on ART for ≥6 months. Individuals with advanced HIV disease were more likely to be men (adjusted Odds Ratio [aOR]; 2.1 (95%CI 1.7–2.6), and more likely not to be on ART (aOR; 1.7 (95%CI 1.3–2.1). Conclusion: In our study, about 1 in 10 PLHIV had advanced HIV with nearly 40% of them unaware of their HIV status. However, a substantial proportion of patients with advanced HIV were established on ART. Our findings suggest the need for a dual focus on alternative testing strategies to identify PLHIV earlier as well as improving ART retention. [ABSTRACT FROM AUTHOR]

Background In Malawi in 2014, <20% of human immunodeficiency virus (HIV)–exposed infants received an early infant diagnosis (EID) test in the first 2 months of life and only 30% of HIV-infected children were on antiretroviral therapy (ART). We sought to understand the potential patient impact of improving timely infant diagnosis and treatment initiation through implementation of point-of-care (POC) EID technologies in Malawi. Methods In this observational study, POC EID technologies were introduced into routine services at 7 health facilities across Malawi in September 2015. The primary outcome was the proportion of HIV-infected infants initiating ART within 60 days of sample collection in the POC arm compared to the baseline arm with conventional laboratory-based EID testing. Results The time from sample collection to result received by the patient decreased significantly from 56 days (interquartile range [IQR], 30–81 days) in the baseline arm to <1 day in the POC arm (P <.001). Of the HIV-infected infants, the time between sample collection and ART initiation was reduced from 38 days (IQR, 30–54 days) in the baseline arm to <1 day (IQR, 0–1 day) in the POC arm (P =.019). Furthermore, the proportion of HIV-infected infants initiated on ART within 60 days of sample collection increased significantly from 41.9% to 91.1% after the introduction of POC (adjusted risk ratio, 2.28; P <.001). Conclusions ART initiation rates were significantly improved with the implementation of same-day POC EID testing compared with referred, longer-turnaround laboratory-based testing. [ABSTRACT FROM AUTHOR]

Background. Human immunodeficiency virus self-testing (HIVST) is effective, with scale-up underway in sub-Saharan Africa. We assessed cost-effectiveness of adding HIVST to existing facility-based HIV testing and counseling (HTC) services. Both 2010 (initiate at CD4 <350 cells/μL) and 2015 (initiate all) World Health Organization (WHO) guidelines for antiretroviral treatment (ART) were considered. Methods. A microsimulation model was developed to evaluate cost-effectiveness, from both health provider and societal perspectives, of an HIVST service implemented in a cluster-randomized trial (CRT; ISRCTN02004005) in Malawi. Costs and health outcomes were evaluated over a 20-year time horizon, using a discount rate of 3%. Probabilistic sensitivity analysis was conducted to account for parameter uncertainty. Results. From the health provider perspective and 20-year time horizon, facility HTC using 2010 WHO ART guidelines was the least costly ($294.71 per person; 95% credible interval [CrI], 270.79--318.45) and least effective (11.64 quality-adjusted life-years [QALYs] per person; 95% CrI, 11.43--11.86) strategy. Compared with this strategy, the incremental cost-effectiveness ratio (ICER) for facility HTC using 2015 WHO ART guidelines was $226.85 (95% CrI, 198.79--284.35) per QALY gained. The strategy of facility HTC plus HIVST, using 2010 WHO ART guidelines, was extendedly dominated. The ICER for facility HTC plus HIVST, using 2015 WHO ART guidelines, was $253.90 (95% CrI, 201.71--342.02) per QALY gained compared with facility HTC and using 2015 WHO ART guidelines. Conclusions. HIVST may be cost-effective in a Malawian population with high HIV prevalence. HIVST is suited to an early HIV diagnosis and treatment strategy. [ABSTRACT FROM AUTHOR]

Abstract: We evaluated effects of antiretroviral (ARV) therapy and lipid‐based nutrient supplements (LNSs) on iron, copper, and zinc in milk of exclusively breastfeeding HIV‐infected Malawian mothers and their correlations with maternal and infant biomarkers. Human milk and blood at 2, 6, and 24 weeks post‐partum and blood during pregnancy (≤30 weeks gestation) were collected from 535 mothers/infant‐pairs in the Breastfeeding, Antiretrovirals, and Nutrition study. The participants received ARV, LNS, ARV and LNS, or no intervention from 0 to 28 weeks post‐partum. ARVs negatively affected copper and zinc milk concentrations, but only at 2 weeks, whereas LNS had no effect. Among all treatment groups, approximately 80–90% of copper and zinc and <50% of iron concentrations met the current adequate intake for infants at 2 weeks and only 1–19% at 24 weeks. Pregnancy haemoglobin was negatively correlated with milk iron at 2 and 6 weeks (r = −.18, p < .02 for both). The associations of the milk minerals with each other were the strongest correlations observed (r = .11–.47, p < .05 for all); none were found with infant biomarkers. At 2 weeks, moderately anaemic women produced milk higher in iron when ferritin was higher or TfR lower. At 6 weeks, higher maternal α‐1‐acid glycoprotein and C‐reactive protein were associated with higher milk minerals in mildly anaemic women. Infant TfR was lower when milk mineral concentrations were higher at 6 weeks and when mothers were moderately anaemic during pregnancy. ARV affects copper and zinc milk concentrations in early lactation, and maternal haemoglobin during pregnancy and lactation could influence the association between milk minerals and maternal and infant iron status and biomarkers of inflammation. [ABSTRACT FROM AUTHOR]

Malawi launched Option B+, a program for all pregnant or breastfeeding HIV-positive women to begin lifelong combination antiretroviral therapy (cART), in July 2011. This study characterises a portion of the continuum of care within an antenatal setting in Lilongwe. Women testing HIV-positive and having a cART initiation record at Bwaila Antenatal Clinic from July 2013 to January 2014 were included. Using logistic regression models, we analysed relationships between maternal characteristics and return for infant testing. Among 490 HIV-positive women with a cART initiation record, 360 (73%) were retained at three months. Of these, 203 (56%) were adherent. Records of infant testing were located for 204 women (42%). Women who were not retained were less likely to have an early infant diagnosis record (aOR = 0.20; 95% CI: 0.10, 0.41). Among the women retained, there was a non-significant association between maternal adherence and infant testing (OR = 1.35; 95% CI: 0.89, 2.06). Women lost at earlier continuum stages, who are at higher risk for mother-to-child-transmission, were less likely to bring infants for testing. Even with a test-and-treat program, many women did not remain in care or bring their infant for testing. Facilitating strategies to improve these measures remains an important unmet need. [ABSTRACT FROM AUTHOR]