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Background: HIV incidence is high during pregnancy and postpartum in many settings. PrEP is safe and effective but requires adherence during potential HIV exposure, yet the facilitators of high maternal adherence are not well understood in high HIV burden settings. Methods: We conducted semi-structured interviews with women who reported high adherence (PrEP use [greater than or equal to]25 days in last 30-days) within a PrEP service for pregnant and postpartum women located in a large primary care facility in a high-HIV burden township. Topics for interviews included: individual and interpersonal risk, disclosure, anticipated PrEP stigma, safety, side-effects, and facility-level factors effecting adherence. A thematic approach guided an iterative process of coding (reviewed to ensure intercoder reliability) and analysis using NVivo 12. Results: We interviewed 25 postpartum women with high PrEP adherence who were on PrEP for a median of nine-months, median age 26-years, and median baseline gestational age 24-weeks. Themes identified as key drivers of optimal PrEP use were HIV risk perception --primarily due to partner's perceived risky sexual behaviors and unknown serosatus and a strong desire to have a baby free of HIV. Reported disclosure of PrEP use to family, partners and friends facilitated PrEP adherence. Women continued PrEP postpartum because they felt empowered by PrEP and did not want to 'go backwards' and increase their HIV risk as before PrEP. Women who reported high adherence all discussed having community support and reminders to take PrEP on time. The primary barriers were anticipated or experienced stigma, which most overcame through education of partners/family about PrEP. Pregnant women experienced transient side effects, but found ways to continue, including taking PrEP at night. Women believed PrEP education and counselling were accessible when integrated into antenatal care which contributed to high PrEP adherence. Conclusions: Facilitators of optimal PrEP use through pregnancy and postpartum included fear of HIV acquisition for self and infant, mostly due to partner sexual behaviors and unknown serostatus, along with PrEP disclosure, and encouragement from partners and family. PrEP programs for pregnant and postpartum women should integrate strategies to assist women with realistic appraisals of risk and teach skills for securing support for significant others., OA21.05LB D. Joseph Davey (1); L. Knight (2); K. Dovel (3); N. Tsawe (4); N. Mashele (4); J. Markt-Maloney (1); Y. Gomba (4); P. Gorbach (1); L.-G. Bekker (5); T. [...]

Introduction: Oral pre-exposure prophylaxis (PrEP) is an effective and safe option to prevent HIV acquisition and vertical HIV transmission in pregnant and breastfeeding women. Understanding health system factors influencing the integration of PrEP into care for pregnant and breastfeeding women is key to increasing access. We explored managers' and health care workers' (HCWs) experiences with integrating PrEP into antenatal care and postnatal care services in primary health care clinics in Cape Town, South Africa., Methods: This exploratory qualitative study used codebook thematic analysis, where HCWs were purposively, heterogeneously sampled from an implementation science study. Semistructured individual interviews were conducted with 9 managerial-level staff, and 3 focus group discussions were conducted with HCWs (nurses, midwives, and HIV counselors) providing PrEP (6-7 HCWs per group) between November 2022 and January 2023 (N=28). Interview guides covered health system facilitators, barriers, and recommendations. The Health Systems Dynamics framework guided data analysis and presentation of results., Results: PrEP integration into antenatal care services was described as acceptable and feasible; however, changes to HIV testing policy and indicators in breastfeeding women are needed to integrate PrEP into postnatal clinics, together with identification of mother and baby as a dyad in visits. Results showed that supportive policies facilitated wider, simplified PrEP provision. The availability and accessibility of prescribing nurses and lay HIV counselors, PrEP (both within facilities and in communities), and information about PrEP for implementers and pregnant and breastfeeding women will be pivotal to facilitating integration., Conclusion: Facilitators for PrEP integration include task-shifting PrEP education and identification of women for PrEP initiation to HIV counselors, changes to national guidelines defining who can prescribe PrEP, revision and integration of PrEP training for HCWs, community-level interventions for PrEP demand creation and stigma reduction, and provision of differentiated PrEP delivery options., (© Court et al.)

Introduction: Treatment interruption (TI), defined as >28 days late for ART appointment, is one of the greatest challenges in controlling southern African HIV epidemics. Negative client-provider interactions remain a major reason for TI and barrier for return to care, especially for men. Motivational interviewing (MI) facilitates client-driven counseling and improves client-provider interactions by facilitating equitable, interactive counseling that helps clients understand and develop solutions for their unique needs. Fidelity of MI counseling in resource-constrained health systems is challenging., Methods: We developed a male-specific MI curriculum for Malawian male TI clients. Four psychosocial counselors (PCs, a high-level Malawian counseling cadre) received a 2.5-day curriculum training and job-aid to guide MI counseling approaches. They participated in monthly phone-based discussions with their manager about MI-based solutions to challenges faced. PCs implemented the MI curriculum with men >15 years who were actively experiencing TI. Clients were found at home (through tracing) or at the facility (for those who returned to care on their own). MI counseling sessions were recorded, transcribed, translated into English, and coded in Atlas.ti v9. MI quality was assessed using a modified version of the validated Motivational Interviewing Treatment Integrity tool. The tool has two measures: 1) counts of key MI behaviors throughout the session (questions, reflections, etc.); and 2) overarching scores (using a five-point scale) that characterize three MI dimensions for an entire counseling session (cultivating change talk, partnership, and empathy)., Results: 44 MI sessions were recorded and analyzed between 4/1/22-8/1/22. 64% of counseling sessions focused on work and travel as the main reason for TI. 86% of sessions yielded client-driven, tailored solutions for overcoming TI. PCs implemented multiple MI behaviors very well: asking questions, giving information, simple reflections, and client affirmation. Few PCs used complex reflection, emphasized autonomy, or sought collaboration with clients. Among overarching MI dimensions, HCWs scored high in partnership (promoting client-driven discussions) and cultivating change talk (encouraging client-driven language and behavior change confidence) but scored sub-optimal in empathy. Only 5 sessions had confrontational/negative PC attitudes., Conclusions: PCs implemented MI with fidelity and quality resulting in tailored, actionable plans for male re-engagement in HIV treatment in Malawi. Clinical Trial Number: NCT05137210 and NCT04858243., Competing Interests: Competing Interests The authors declare that they have no competing interests.

Across sub-Saharan Africa, men are less likely to know their HIV status than women, leading to later treatment initiation. Little is known about how experiences with general health services affect men's use of HIV testing. We used data from a 2019 community-representative survey of men in Malawi to understand frequency and cause of men's negative health service experiences (defined as men reporting they "would not recommend" a facility) and their association with future HIV testing. We conducted univariable and multivariable logistic regressions to determine which aspects of health facility visits were associated with would-not-recommend experiences and to determine if would-not-recommend experiences 12-24 months prior to the survey were associated with HIV testing in the 12 months prior to the survey. Among 1,098 men eligible for HIV testing in the 12 months prior to the survey, median age was 34 years; 9% of men reported at least one would-not-recommend experience, which did not differ by sociodemographics, gender norm beliefs, or HIV stigma beliefs. The factors most strongly associated with would-not-recommend experiences were cost (aOR 5.8, 95%CI 2.9-11.4), cleanliness (aOR 4.2, 95%CI 1.8-9.9), medicine availability (aOR 3.3, 95%CI 1.7-6.4), and wait times (aOR 2.7, 95%CI 1.5-5.0). Reporting a would-not-recommend experience 12-24 months ago was associated with a 59% decrease in likelihood of testing for HIV in the last 12 months (aOR 0.41; 95% CI:0.17-0.96). Dissatisfaction with general health services was strongly associated with reduced HIV testing. Coverage of high-priority screening services like HIV testing may benefit from improving overall health system quality., (© 2024. The Author(s).)

Introduction: There is little HIV counselling that directly meets the needs of men in Eastern and Southern Africa, limiting men's knowledge about the benefits of HIV treatment and how to overcome barriers to engagement, contributing to poorer HIV-related outcomes than women. Male-specific approaches are needed to improve men's outcomes but may be difficult for healthcare workers (HCWs) to implement with fidelity and quality in low-resource settings. We developed a male-specific counselling curriculum which was implemented by male HCWs and then conducted a mixed-methods quality assessment., Methods: We audio-recorded counselling sessions to assess the quality of implementation (n = 50) by male HCWs from two cadres (nurse, n = 10 and lay cadre, n = 10) and conducted focus group discussions (FGDs) with HCWs at 6 and 9 months after rollout to understand barriers and facilitators to implementation. Counselling sessions and FGDs were translated, transcribed and analysed using thematic analysis adapted from WHO Quality Counselling Guidelines. We assessed if sessions were respectful, informative, interactive, motivating and included tailored action plans for overcoming barriers to care. All data were collected September 2021-June 2022., Results: All sessions used respectful, non-judgemental language. Sessions were highly interactive with most HCWs frequently asking open-ended questions (n = 46, 92%) and often incorporating motivational explanations of how antiretroviral therapy contributes to life goals (n = 42, 84%). Few sessions included individually tailored action plans for clients to overcome barriers to care (n = 9, 18%). New counselling themes were well covered; however, occasionally themes of self-compassion and safe sex were not covered during sessions (n = 16 and n = 11). HCWs believed that having male HCWs conduct counselling, ongoing professional development and keeping detailed counselling notes facilitated quality implementation. Perceived barriers included curriculum length and client hesitancy to participate in action plan development. Findings were similar across cadres., Conclusions: Implementing high-quality male-specific counselling using male nurses and/or lay cadre is feasible. Efforts to utilize lay cadres should be prioritized, particularly in low-resource settings. Programmes should provide comprehensive job aids to support HCWs. Ongoing training and professional development are needed to (1) improve HCWs' skills in tailored action plans, and (2) sensitize HCWs to the need for self-compassion within male clients to promote holistic sexual health., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Facility HIV self-testing (HIVST) in outpatient departments can dramatically increase testing among adult outpatients. However, it is still unclear why populations opt out of facility HIVST and reasons for opt outing. Using data from a parent facility HIVST trial, we sought to understand individual characteristics associated with opting out of facility HIVST and reported reasons for not testing., Methods: Exit surveys were conducted with outpatients aged ≥15 years at 5 facilities in Central and Southern Malawi randomized to the facility HIVST arm of the parent trial. Outpatients were eligible for our substudy if they were offered HIVST and eligible for HIV testing (ie, never previously tested HIV positive and tested ≥12 months ago or never tested). Summary statistics and multivariate regression models were used., Results: Seven hundred seventy-one outpatients were included in the substudy. Two hundred sixty-three (34%) opted out of HIVST. Urban residency (adjusted risk ratios [aRR] 3.48; 95% CI: 1.56 to 7.76) and self-reported poor health (aRR 1.86; 95% CI: 1.27 to 2.72) were associated with an increased risk of opting out. Male participants had a 69% higher risk of opting out (aRR 1.69; 95% CI: 1.14 to 2.51), with risk being 38% lower among working male participants. Primary reasons for not testing were feeling unprepared to test (49·4%) and perceived low risk of HIV infection (30·4%)-only 2.6% believed that HIVST instructions were unclear, and 1.7% were concerned about privacy., Conclusion: Working, risky sexual behavior, rural residence, and good self-rated health were positively associated with opting out of HIVST among outpatients. Strategies to address internalized barriers, such as preparedness to test and perceived need to test, should be incorporated into facility HIVST interventions., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Men are underrepresented in HIV services throughout sub-Saharan Africa. Little is known about health care worker (HCW) perceptions of men as clients, which may directly affect the quality of care provided, and HCWs' buy-in for male-specific interventions. Focus group discussions (FGDs) were conducted in 2016 with HCWs from 15 facilities across Malawi and Mozambique and were originally conducted to evaluate barriers to universal treatment (not HCW bias). FGDs were conducted in local languages, recorded, translated to English, and transcribed. For this study, we focused on HCW perceptions of men as HIV clients and any explicit bias against men, using inductive and deductive coding in Atlas.ti v.8, and analyzed using constant comparison methods. 20 FGDs with 154 HCWs working in HIV treatment clinics were included. Median age was 30 years, 59% were female, and 43% were providers versus support staff. HCWs held strong explicit bias against men as clients. Most HCWs believed men could easily navigate HIV services due to their elevated position within society, regardless of facility-level barriers faced. Men were described in pejorative terms as ill-informed and difficult clients who were absent from health systems. Men were largely seen as "bad clients" due to assumptions about men's 'selfish' and 'prideful' nature, resulting in little HCW sympathy for men's poor use of care. Our study highlights a strong explicit bias against men as HIV clients, even when gender and bias were not the focus of data collection. As a result, HCWs may have little motivation to implement male-specific interventions or improve provider-patient interactions with men. Framing men as problematic places undue responsibility on individual men while minimizing institutional barriers that uniquely affect them. Bias in local, national, and global discourses about men must be immediately addressed., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Dovel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Outcomes of community antiretroviral therapy (ART) distribution (CAD), in which provider-led ART teams deliver integrated HIV services at health posts in communities, have been mixed in sub-Saharan African countries. CAD outcomes and costs relative to facility-based care have not been reported from Malawi., Methods: We performed a retrospective cohort study in two Malawian districts (Lilongwe and Chikwawa districts), comparing CAD with facility-based ART care. We selected an equal number of clients in CAD and facility-based care who were aged >13 years, had an undetectable viral load (VL) result in the last year and were stable on first-line ART for ≥1 year. We compared retention in care (alive and no period of ≥60 days without ART) using Kaplan-Meier survival analysis and Cox regression and maintenance of VL suppression (<1,000 copies/mL) during follow-up using logistic regression. We also compared costs (in US$) from the health system and client perspectives for the two models of care. Data were collected in October and November 2020., Results: 700 ART clients (350 CAD, 350 facility-based) were included. The median age was 43 years (IQR 36-51), median duration on ART was 7 years (IQR 4-9), and 75% were female. Retention in care did not differ significantly between clients in CAD (89.4% retained) and facility-based care (89.3%), p = 0.95. No significant difference in maintenance of VL suppression were observed between CAD and facility-based care (aOR: 1.24, 95% CI: 0.47-3.20, p = 0.70). CAD resulted in slightly higher health system costs than facility-based care: $118/year vs. $108/year per person accessing care; and $133/year vs. $122/year per person retained in care. CAD decreased individual client costs compared to facility-based care: $3.20/year vs. $11.40/year per person accessing care; and $3.60/year vs. $12.90/year per person retained in care., Conclusion: Clients in provider-led CAD care in Malawi had very good retention in care and VL suppression outcomes, similar to clients receiving facility-based care. While health system costs were somewhat higher with CAD, costs for clients were reduced substantially. More research is needed to understand the impact of other differentiated service delivery models on costs for the health system and clients., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Songo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Health care workers (HCWs) in eastern Africa experience high levels of burnout and depression, and this may be exacerbated during the COVID-19 pandemic due to anxiety and increased work pressure. We assessed the prevalence of burnout, depression and associated factors among Malawian HCWs who provided HIV care during the COVID-19 pandemic. From April-May 2021, between the second and third COVID-19 waves in Malawi, we randomly selected HCWs from 32 purposively selected PEPFAR/USAID-supported health facilities for a cross-sectional survey. We screened for depression using the World Health Organization Self Report Questionnaire (positive screen: score≥8) and for burnout using the Maslach Burnout Inventory tool, (positive screen: moderate-high Emotional Exhaustion and/or moderate-high Depersonalization, and/or low-moderate Personal Accomplishment scores). Logistic regression models were used to evaluate factors associated with depression and burnout. We enrolled 435 HCWs, median age 32 years (IQR 28-38), 54% male, 34% were clinical cadres and 66% lay cadres. Of those surveyed, 28% screened positive for depression, 29% for burnout and 13% for both. In analyses that controlled for age, district, and residence (rural/urban), we found that screening positive for depression was associated with expecting to be infected with COVID-19 in the next 12 months (aOR 2.7, 95%CI 1.3-5.5), and previously having a COVID-19 infection (aOR 2.58, 95CI 1.4-5.0). Screening positive for burnout was associated with being in the clinical cadre (aOR 1.86; 95% CI: 1.2-3.0) and having a positive depression screen (aOR 3.2; 95% CI: 1.9-5.4). Reports of symptoms consistent with burnout and depression were common among Malawian HCWs providing HIV care but prevalence was not higher than in surveys before the COVID-19 pandemic. Regular screening for burnout and depression should be encouraged, given the potential for adverse HCW health outcomes and reduced work performance. Feasible interventions for burnout and depression among HCWs in our setting need to be introduced urgently., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Phiri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

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., (© 2023. The Author(s).)

Introduction: Men in sub-Saharan Africa are less likely than women to initiate antiretroviral therapy (ART) and more likely to have longer cycles of disengagement from ART programmes. Treatment interventions that meet the unique needs of men are needed, but they must be scalable. We will test the impact of various interventions on 6-month retention in ART programmes among men living with HIV who are not currently engaged in care (never initiated ART and ART clients with treatment interruption)., Methods and Analysis: We will conduct a programmatic, individually randomised, non-blinded, controlled trial. 'Non-engaged' men will be randomised 1:1:1 to either a low-intensity, high-intensity or stepped arm. The low-intensity intervention includes one-time male-specific counseling+facility navigation only. The high-intensity intervention offers immediate outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. In the stepped arm, intervention activities build in intensity over time for those who do not re-engage in care with the following steps: (1) one-time male-specific counselling+facility navigation→(2) ongoing male mentorship+facility navigation→(3) outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. Our primary outcome is 6-month retention in care. Secondary outcomes include cost-effectiveness and rates of adverse events. The primary analysis will be intention to treat with all eligible men in the denominator and all men retained in care at 6 months in the numerator. The proportions achieving the primary outcome will be compared with a risk ratio, corresponding 95% CI and p value computed using binomial regression accounting for clustering at facility level., Ethics and Dissemination: The Institutional Review Board of the University of California, Los Angeles and the National Health Sciences Research Council in Malawi have approved the trial protocol. Findings will be disseminated rapidly in national and international forums and in peer-reviewed journals and are expected to provide urgently needed information to other countries and donors., Trial Registration Number: NCT05137210., Date and Version: 5 May 2023; version 3., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Men in sub-Saharan Africa are underrepresented in antiretroviral therapy (ART) programs. Our secondary analysis of 40 in-depth interviews with Malawian men living with HIV examined barriers and facilitators for ART initiation versus retention. Interviewees included men who never initiated or initiated ART late (initiation respondents, n = 19); and men who initiated ART but were late for an appointment (retention respondents, n = 21). Transcribed interviews were coded using deductive and inductive coding techniques and analyzed using constant comparison methods. Long wait times, frequent facility visits, and insufficient in-clinic privacy were barriers for initiation and retention. Poor knowledge of ART was primarily a barrier for initiation; unexpected travel was a barrier for retention. Key facilitators for initiation and retention included previous positive experiences with health facilities. Having examples of successful men using ART primarily facilitated initiation; support from spouses and male peers facilitated retention. Results may inform interventions to increase men's engagement in ART services., (© 2022. The Author(s).)

Introduction: Mobility is common and an essential livelihood strategy in sub-Saharan Africa (SSA). Mobile people suffer worse outcomes at every stage of the HIV care cascade compared to non-mobile populations. Definitions of mobility vary widely, and research on the role of temporary mobility (as opposed to permanent migration) in HIV treatment outcomes is often lacking. In this article, we review the current landscape of mobility and HIV care research to identify what is already known, gaps in the literature, and recommendations for future research., Discussion: Mobility in SSA is closely linked to income generation, though caregiving, climate change and violence also contribute to the need to move. Mobility is likely to increase in the coming decades, both due to permanent migration and increased temporary mobility, which is likely much more common. We outline three central questions regarding mobility and HIV treatment outcomes in SSA. First, it is unclear what aspects of mobility matter most for HIV care outcomes and if high-risk mobility can be identified or predicted, which is necessary to facilitate targeted interventions for mobile populations. Second, it is unclear what groups are most vulnerable to mobility-associated treatment interruption and other adverse outcomes. And third, it is unclear what interventions can improve HIV treatment outcomes for mobile populations., Conclusions: Mobility is essential for people living with HIV in SSA. HIV treatment programmes and broader health systems must understand and adapt to human mobility, both to promote the rights and welfare of mobile people and to end the HIV pandemic., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Mobility is associated with worse outcomes across the HIV treatment cascade, especially among men. However, little is known about the mechanisms that link mobility and poor HIV outcomes and what types of mobility most increase the risk of treatment interruption among men in southern Africa., Methods: From August 2021 to January 2022, we conducted a mixed-methods study with men living with HIV (MLHIV) but not currently receiving antiretroviral therapy (ART) in Malawi. Data collection was embedded within two larger trials (ENGAGE and IDEaL trials). We analysed baseline survey data of 223 men enrolled in the trials who reported being mobile (defined as spending ≥14 nights away from home in the past 12 months) using descriptive statistics and negative binomial regressions. We then recruited 32 men for in-depth interviews regarding their travel experiences and ART utilization. We analysed qualitative data using constant comparative methods., Results: Survey data showed that 34% of men with treatment interruptions were mobile, with a median of 60 nights away from home in the past 12 months; 69% of trips were for income generation. More nights away from home in the past 12 months and having fewer household assets were associated with longer periods out of care. In interviews, men reported that travel was often unplanned, and men were highly vulnerable to exploitive employer demands, which led to missed appointments and ART interruption. Men made major efforts to stay in care but were often unable to access care on short notice, were denied ART refills at non-home facilities and/or were treated poorly by providers, creating substantial barriers to remaining in and returning to care. Men desired additional multi-month dispensing (MMD), the ability to refill treatment at any facility in Malawi, and streamlined pre-travel refills at home facilities., Conclusions: Men prioritize ART and struggle with the trade-offs between their own health and providing for their families. Mobility is an essential livelihood strategy for MLHIV in Malawi, but it creates conflict with ART retention, largely due to inflexible health systems. Targeted counselling and peer support, access to ART services anywhere in the country, and MMD may improve outcomes for mobile men., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Men experience twice the mortality of women while on ART in sub-Saharan Africa (SSA) largely due to late HIV diagnosis and poor retention. Here we propose to conduct an individually randomized control trial (RCT) to investigate the impact of three-month home-based ART (hbART) on viral suppression among men who were not engaged in care., Methods and Design: A programmatic, individually randomized non-blinded, non-inferiority-controlled trial design (ClinicalTrials.org NCT04858243). Through medical chart reviews we will identify "non-engaged" men living with HIV, ≥15years of age who are not currently engaged in ART care, including (1) men who have tested HIV-positive and have not initiated ART within 7 days; (2) men who have initiated ART but are at risk of immediate default; and (3) men who have defaulted from ART. With 1:1 computer block randomization to either hbART or facility-based ART (fbART) arms, we will recruit men from 10-15 high-burden health facilities in central and southern Malawi. The hbART intervention will consist of 3 home-visits in a 3-month period by a certified male study nurse ART provider. In the fbART arm, male participants will be offered counselling at male participant's home, or a nearby location that is preferred by participants, followed with an escort to the local health facility and facility navigation. The primary outcome is the proportion of men who are virally suppressed at 6-months after ART initiation. Assuming primary outcome achievement of 24.0% and 33.6% in the two arms, 350 men per arm will provide 80% power to detect the stated difference., Discussion: Identifying effective ART strategies that are convenient and accessible for men in SSA is a priority in the HIV world. Men may not (re-)engage in facility-based care due to a myriad of barriers. Two previous trials investigated the impact of hbART on viral suppression in the general population whereas this trial focuses on men. Additionally, this trial involves a longer duration of hbART i.e., three months compared to two weeks allowing men more time to overcome the initial psychological denial of taking ART., Competing Interests: The authors declare that they have no competing interests., (Copyright: © 2023 Choko et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Few studies have examined gender differences in reported quality of life among persons living with HIV (PLWH) in low-income countries. We conducted a cross-sectional survey of adults on antiretroviral therapy in Malawi, including questions focused on wellbeing, and collected clinical data on these respondents. We compared men's and women's self-reported health and wellbeing using Poisson models that included socio-demographic covariates. Approximately 20% of respondents reported at least one physical functioning problem. In multiple variable models, men were significantly more likely to have a high viral load (≥200 copies/mL; aIRR 2.57), consume alcohol (aIRR 12.58), receive no help from family or friends (aIRR 2.18), and to feel worthless due to their HIV status (aIRR 2.40). Men were significantly less likely to be overweight or obese (aIRR 0.31), or report poor health (health today is not "very good;" aIRR 0.41). Taken together, despite higher prevalence of poor self-rated health, women were healthier across a range of objective dimensions, with better viral suppression, less alcohol use, and less social isolation (although they were more likely to have an unhealthy BMI). Research that includes multi-dimensional and gender-specific measurement of physical, mental and social health is important for improving our understanding of well-being of PLWH.

Introduction: Men have higher rates of morbidity and mortality across nearly all top ten causes of mortality worldwide. Much of this disparity is attributed to men's lower utilization of routine health services; however, little is known about men's general healthcare utilization in sub-Saharan Africa., Methods: We analyze the responses of 1,116 men in a community-representative survey of men drawn from a multi-staged sample of residents of 36 villages in Malawi to identify factors associated with men's facility attendance in the last 12 months, either for men's own health (client visit) or to support the health care of someone else (caregiver visit). We conducted single-variable tests of association and multivariable logistic regression with random effects to account for clustering at the village level., Results: Median age of participants was 34, 74% were married, and 82% attended a health facility in the last year (63% as client, 47% as caregiver). Neither gender norm beliefs nor socioeconomic factors were independently associated with attending a client visit. Only problems with quality of health services (adjusted odds ratio [aOR] 0.294, 95% confidence interval [CI] 0.10-0.823) and good health (aOR 0.668, 95% CI 0.462-0.967) were independently associated with client visit attendance. Stronger beliefs in gender norms were associated with caregiver visits (beliefs about acceptability of violence [aOR = 0.661, 95% CI 0.488-0.896], male sexual dominance [aOR = 0.703, 95% CI 0.505-0.978], and traditional women's roles [aOR = 0.718, 95% CI 0.533-0.966]). Older age (aOR 0.542, 95% CI 0.401-0.731) and being married (aOR 2.380, 95% CI 1.196-4.737) were also independently associated with caregiver visits., Conclusion: Quality of services offered at local health facilities and men's health status were the only variables associated with client facility visits among men, while harmful gender norms, not being married, and being younger were negatively associated with caregiver visits., (© 2022. The Author(s).)

Introduction: Malawi is rapidly closing the gap in achieving the UNAIDS 95-95-95 targets, with 90% of people living with HIV in Malawi aware of their status. As we approach epidemic control, interventions to improve coverage will become more costly. There is, therefore, an urgent need to identify innovative and low-cost strategies to maintain and increase testing coverage without diverting resources from other HIV services. The objective of this study is to model different combinations of facility-based HIV testing modalities and determine the most cost-effective strategy to increase the proportion of men and youth testing for HIV., Methods: A data-driven individual-based model was parameterized with data from a community-representative survey (socio-demographic, health service utilization and HIV testing history) of men and youth in Malawi (data collected August 2019). In total, 79 different strategies for the implementation of HIV self-testing (HIVST) and provider-initiated-testing-and-counselling at the outpatient department (OPD) were evaluated. Outcomes included percent of men/youth tested for HIV in a 12-month period, cost-effectiveness and human resource requirements. The testing yield was assumed to be constant across the scenarios., Results: Facility-based HIVST offered year-round resulted in the greatest increase in the proportion of men and youth tested in the OPD (from 45% to 72%-83%), was considered cost-saving for HIVST kit priced at $1.00, and generally reduced required personnel as compared to the status quo. At higher HIVST kit prices, and more relaxed eligibility criteria, all scenarios that considered year-round HIVST in the OPD remained on the cost-effectiveness frontier., Conclusions: Facility-based HIVST is a cost-effective strategy to increase the proportion of men/youth tested for HIV in Malawi and decreases the human resource requirements for HIV testing in the OPD-providing additional healthcare worker time for other priority healthcare activities., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Cisgender women, particularly pregnant and postpartum women in Eastern and Southern Africa, face an unacceptably high risk of HIV acquisition. Oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention that can reduce HIV acquisition and vertical transmission. In this qualitative study, we interviewed 21 postpartum women from Cape Town, South Africa who initiated PrEP during pregnancy and who self-reported low PrEP adherence or missed > 1 PrEP follow-up collection. We identified multiple overlapping barriers to PrEP continuation and/or adherence. Individual factors included forgetting to take PrEP daily, being away from home when PrEP should be taken, anticipated stigma and limited disclosure of PrEP use. Women also reported pill-related factors such as side effects and having to take PrEP in addition to other tablets during pregnancy and the postpartum period. Facility-related barriers included logistics around PrEP collection especially when not in antenatal care, as well as transport and financial barriers., (© 2022. The Author(s).)

Objectives: Integrated early childhood development (ECD) and prevention of mother-to-child transmission (PMTCT) interventions rarely target fathers, a missed opportunity given existing research demonstrating that father involvement improves maternal and child outcomes. We aimed to explore mother's perceptions of fathers' buy-in to an integrated PMTCT-ECD programme, any impact the programme had on couple dynamics, and perceived barriers to fathers' involvement in ECD activities., Design: Qualitative study using individual in-depth interviews with mothers participating in a PMTCT-ECD programme. Interviews assessed mothers' perceptions of father buy-in and engagement in the programme and ECD activities. Data were coded using inductive and deductive strategies and analysed using constant comparison methods in Atlas.ti V.1.6., Setting: Four health facilities in Malawi where PMTCT services were provided., Participants: Study participants were mothers infected with HIV who were enrolled in the PMTCT-ECD programme for >6 months., Interventions: The PMTCT-ECD intervention provided ECD education and counselling sessions during routine PMTCT visits for mothers infected with HIV and their infants (infant age 1.5-24 months). The intervention did not target fathers, but mothers were encouraged to share information with them., Results: Interviews were conducted with 29 mothers. Almost all mothers discussed the PMTCT-ECD intervention with male partners. Most mothers reported that fathers viewed ECD as valuable and practised ECD activities at home. Several reported improved partner relationships and increased communication due to the intervention. However, most mothers believed fathers would not attend the PMTCT-ECD intervention due to concerns regarding HIV-related stigma at PMTCT clinics, time required to attend and perceptions that the intervention was intended for women., Conclusions: Fathers were interested in an integrated PMTCT-ECD programme and actively practised ECD activities at home, but felt uncomfortable visiting PMTCT clinics. Interventions should consider direct community outreach or implementing ECD programmes at facility entry points where men frequent, such as outpatient departments., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women's engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use., Methods: Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation., Discussion: This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting., Trial Registration: NCT05322629 : Date of registration: April 12, 2022., (© 2022. The Author(s).)

Introduction: HIV self-testing (HIVST) increases HIV testing uptake among men; however, the linkage to antiretroviral therapy (ART) among HIVST users is low. Innovative strategies for ART initiation are needed, yet little is known about the unique barriers to care experienced by male HIVST users, and what ART-related interventions men desire., Methods: We conducted semi-structured in-depth interviews with cisgender men (≥15 years) in Malawi who tested HIV positive using HIVST between 2018 and 2020, as well as interviews with their female partners (≥15 years) who distributed the HIVST kits. Medical records from seven facilities were used to identify respondents. We included men who received HIVST from a health facility (primary distribution) and from sexual partners (secondary distribution). Interview guides focused on unique barriers to ART initiation following HIVST and desired interventions to improve linkage and initiation. Interviews were audio recorded, translated and transcribed to English, and analysed using constant comparison methods in Atlas.ti v.8.4. Themes were compared by HIVST distribution strategy. Data were collected between 2019 and 2020., Results: Twenty-seven respondents were interviewed: eight male/female dyads (16 respondents), eight men without a female partner and three women who represented men who did not participate in the study. Among the 19 men represented (16 men interviewed in person, three represented by secondary report from female partners), seven received HIVST through primary distribution, 12 through secondary distribution. Six men never initiated ART (all secondary HIVST distribution). Barriers to ART initiation centred on the absence of healthcare workers at the time of diagnosis and included lack of external motivation for linkage to care (men had to motivate themselves) and lack of counselling before and after testing (leaving ART-related fears and misconceptions unaddressed)--the latter was especially true for secondary HIVST distribution. Desired interventions were similar across distribution strategies and included ongoing peer mentorship for normalizing treatment adherence, counselling messages tailored to men, outside-facility services for convenience and privacy, and facility navigation to help men understand how to navigate ART clinics., Conclusions: Male HIVST users face unique challenges to ART initiation, especially those receiving HIVST through secondary distribution. Male-tailored interventions are desired by men and may help overcome barriers to care., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: South African men are underrepresented in HIV testing and treatment services. Secondary distribution of oral HIV self-test (HIVST) kits by women living with HIV (WLHIV) to their male partners (i.e. index partner HIVST) may increase men's testing and treatment but has been understudied., Methods: Between March and July 2021, we evaluated the effectiveness of index partner HIVST versus the standard of care (SOC) (invitations for men's facility-based testing) on men's testing in a 1:1 randomized control trial. Eligibility criteria included: WLHIV; ≥18 years of age; attending one of four high-density rural clinics; have a working cell phone; and self-reported having a primary male partner of unknown serostatus. The primary outcome was the proportion of WLHIV reporting that her partner tested for HIV within 3 months after enrolment., Results: We enrolled 180 WLHIV and 176 completed an endline survey (mean age = 35 years, 15% pregnant, 47% unmarried or non-cohabiting). In the HIVST arm, 78% of male partners were reported to have tested for HIV versus 55% in SOC (RR = 1.41; 95% CI = 1.14-1.76). In the HIVST arm, nine men were reactive with HIVST (14% positivity), six were confirmed HIV positive with standard testing (67%) and all of those started antiretroviral therapy (ART), and four HIV-negative men started pre-exposure prophylaxis (PrEP) (5%). In SOC, six men were diagnosed with HIV (12% positivity), 100% started ART and seven HIV-negative men started PrEP (16%). One case of verbal intimate partner violence was reported in the HIVST arm., Conclusions: Secondary distribution of HIVST to partners of WLHIV was acceptable and effective for improving HIV testing among men in rural South Africa in our pilot study. Interventions are needed to link reactive HIVST users to confirmatory testing and ART., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

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., (© 2021. The Author(s).)

Little is known about screening tools for adults in high HIV burden contexts. We use exit survey data collected at outpatient departments in Malawi (n = 1038) to estimate the sensitivity, specificity, negative and positive predictive values of screening tools that include questions about sexual behavior and use of health services. We compare a full tool (seven relevant questions) to a reduced tool (five questions, excluding sexual behavior measures) and to standard of care (two questions, never tested for HIV or tested > 12 months ago, or seeking care for suspected STI). Suspect STI and ≥ 3 sexual partners were associated with HIV positivity, but had weak sensitivity and specificity. The full tool (using the optimal cutoff score of ≥ 3) would achieve 55.6% sensitivity and 84.9% specificity for HIV positivity; the reduced tool (optimal cutoff score ≥ 2) would achieve 59.3% sensitivity and 68.5% specificity; and standard of care 77.8% sensitivity and 47.8% specificity. Screening tools for HIV testing in outpatient departments do not offer clear advantages over standard of care., (© 2021. The Author(s).)

Background: Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. Human immunodeficiency virus self-testing (HIVST) for male partners combined with biofeedback counseling through real-time adherence measures may improve PrEP use among postpartum women., Methods: Between August 2020 and April 2021, we randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counseling after urine tenofovir test) or to standard of care ([SOC] facility-based human immunodeficiency virus [HIV] tests and routine counseling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72 hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomization. Secondary outcomes included the proportion of partners who tested for HIV and the discrepancy between self-reported PrEP adherence and urine tenofovir result., Results: We enrolled 106 women (median age = 26 years). At enrollment, 72% of women reported missing <2 doses in the past 7 days; 36% of women had tenofovir present in her urine. One month after enrollment, 62% (n = 33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n = 18) in SOC (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.19-2.82; P  = .001). Two thirds of women in the intervention arm reported that her partner tested for HIV (66%; n = 35), compared to 17% (n = 9) in SOC (RR = 3.89; 95% CI = 2.08-7.27; P  < .001). Self-reported PrEP adherence (took PrEP >5 of last week) with no tenofovir in urine test was lower in the intervention group (17% vs 46%; RR = 0.33; 95% CI = 0.17-0.67; P  = .03). No social or clinical adverse events were reported in the intervention arm., Conclusions: The HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population., (© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Facility HIV self-testing (HIVST) within outpatient departments can increase HIV testing coverage by facilitating HIVST use in outpatient waiting spaces while clients wait for routine care. Facility HIVST allows for the majority of outpatients to test with minimal health care worker time requirements. However, barriers and facilitators to outpatients' use of facility HIVST are still unknown., Methods: As part of a cluster randomized trial on facility HIVST in Malawi, we conducted in-depth interviews with 57 adult outpatients (> 15 years) who were exposed to the HIVST intervention and collected observational journals that documented study staff observations from facility waiting spaces where HIVST was implemented. Translated and transcribed data were analyzed using constant comparison analysis in Atlas.ti., Results: Facility HIVST was convenient, fast, and provided autonomy to outpatients. The strategy also had novel facilitators for testing, such as increased motivation to test due to seeing others test, immediate support for HIVST use, and easy access to additional HIV services in the health facility. Barriers to facility HIVST included fear of judgment from others and unwanted status disclosure due to lack of privacy. Desired changes to the intervention included private, separate spaces for kit use and interpretation and increased opportunity for disclosure and post-test counseling., Conclusions: Facility HIVST was largely acceptable to outpatients in Malawi with novel facilitators that are unique to facility HIVST in OPD waiting spaces., Trial Registration: The parent trial is registered with ClinicalTrials.gov , NCT03271307 , and Pan African Clinical Trials, PACTR201711002697316., (© 2021. The Author(s).)

PrEP is safe and effective but requires adherence during potential HIV exposure, yet the facilitators of long-term maternal adherence are not well understood. We conducted semi-structured interviews with 25 postpartum women who reported high adherence (PrEP use ≥ 25 days in last 30-days and never missed a PrEP prescription in pregnancy/postpartum period) within a PrEP service for pregnant and postpartum women. A thematic approach guided an iterative process of coding and analysis. Themes identified as drivers of optimal PrEP use were HIV risk perception, mainly because of partner's behaviors and unknown serostatus, and a strong desire to have a baby free of HIV. Reported disclosure of PrEP use facilitated PrEP adherence. Women discussed having partner and family support, which included reminders to take PrEP daily. Primary barriers were anticipated or experienced stigma, overcome through education of partners and family about PrEP. Pregnant women experienced transient side-effects, but found ways to continue, including taking PrEP at night. PrEP programs for pregnant and postpartum women should integrate strategies to assist women with realistic appraisals of risk and teach skills for disclosure and securing support from significant others., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To determine how often men in Malawi attend health facilities and if testing for human immunodeficiency virus (HIV) is offered during facility visits., Methods: We conducted a cross-sectional, community-representative survey of men (15-64 years) from 36 villages in Malawi. We excluded men who ever tested HIV-positive. Primary outcomes were: health facility visits in the past 12 months (for their own health (client visit) or to support the health services of others (guardian visit)); being offered HIV testing during facility visits; and being tested that same day. We disaggregated all results by HIV testing history: tested ≤ 12 months ago, or in need of testing (never tested or tested > 12 months before)., Findings: We included 1116 men in the analysis. Mean age was 34 years (standard deviation: 13.2) and 55% (617/1116) of men needed HIV testing. Regarding facility visits, 82% (920/1116) of all men and 70% (429/617) of men in need of testing made at least one facility visit in the past 12 months. Men made a total of 1973 visits (mean two visits): 39% (765/1973) were as guardians and 84% (1657/1973) were to outpatient departments. Among men needing HIV testing, only 7% (30/429) were offered testing during any visit. The most common reason for not testing was not being offered services (37%; 179/487)., Conclusion: Men in Malawi attend health facilities regularly, but few of those in need of HIV testing are offered testing services. Health screening services should capitalize on men's routine visits to outpatient departments as clients and guardians., ((c) 2021 The authors; licensee World Health Organization.)

(1) Background: Men frequent outpatient departments (OPD) but are underrepresented in HIV testing services throughout sub-Saharan Africa. (2) Methods: We conducted a secondary analysis on data from a community-based survey with men in rural Malawi to assess factors associated with HIV testing, and being offered testing, during men's OPD visits. We include OPD visits made by men in-need of testing as our unit of observation. Multilevel mixed-effects logistic regression models were conducted. (3) Results: 782 men were eligible for these analyses, with 1575 OPD visits included (median two visits per man; IQR 1-3). 17% of OPD visits resulted in HIV testing. Being offered testing (aOR 42.45; 95% CI 15.13-119.10) and satisfaction with services received (aOR 3.27; 95% CI 1.28-8.33) were significantly associated with HIV testing. 14% of OPD visits resulted in being offered HIV testing. Being married/steady relationship (aOR 2.53; 95% CI 1.08-5.91) and having a sexual partner living with HIV (aOR 8.22; 95% CI 1.67-40.49) were significantly associated with being offered testing. (4) Conclusion: Being offered HIV testing was the strongest factor associated with testing uptake, while HIV status of sexual partner had the strongest association with being offered testing. Implementation of provider-initiated-testing should be prioritized for male OPD visits.

Background: Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing., Methods: We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2·5% margin was used to assess non-inferiority. This study is registered with ClinicalTrials.gov, NCT03101592., Findings: Between May 15, 2017, and April 30, 2018, 9118 participants were randomly assigned, of whom 8719 participants (n=3012, standard of care group; n=2726, 3-monthly ART dispensing group; n=2981, 6-monthly ART dispensing group) had primary outcome data available at 12 months and were included in the primary analysis. The median age of participants was 42·7 years (IQR 36·1-49·9) and 5774 (66·2%) of 8719 were women. The primary outcome was met by 2478 (82·3%) of 3012 participants in the standard of care group, 2356 (86·4%) of 2726 participants in the 3-monthly ART dispensing group, and 2729 (91·5%) of 2981 participants in the 6-monthly ART dispensing group. After adjusting for clustering, for retention in care at 12 months, the 6-monthly ART dispensing group was non-inferior to the standard of care group (percentage-point increase 9·1 [95% CI 0·9-17·2]) and to the 3-monthly ART dispensing group (5·0% [1·0-9·1])., Interpretation: Clinical visits with ART dispensing every 6 months was non-inferior to standard of care and 3-monthly ART dispensing. 6-monthly ART dispensing is a promising strategy for the expansion of ART provision and achievement of HIV treatment targets in resource-constrained settings., Funding: US Agency for International Development., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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., (© The Author(s) 2020. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)

Background: HIV-positive mothers who face the dual burden of HIV-positive status and motherhood, may benefit from holistic services that include early childhood development (ECD). We evaluated the acceptability and impact of integrated ECD-PMTCT interventions for mothers and their children., Methods: We implemented an integrated ECD-PMTCT intervention in 4 health facilities in Malawi for HIV-positive mothers and their infants. WHO/UNICEF Care for Child Development (CCD) education and counseling sessions were offered during routine PMTCT visits between infant age 1.5-24 months. From June-July 2019, we conducted in-depth interviews with 29 mothers enrolled in the intervention for ≥6 months across 4 health facilities. The interview guide focused on perceived impact of the intervention on mothers' ECD and PMTCT practices, including barriers and facilitators, and unmet needs related to the program. Data were coded and analyzed using constant comparison methods in Atlas ti.8., Results: The vast majority of mothers believed the ECD-PMTCT intervention improved their overall experience with the PMTCT services, strengthened their relationship with providers, and excited and motivated them to attend PMTCT services during the postpartum period. Unlike prior experience, mothers felt more welcome at the health facility, and looked forward to the next visit in order to interact with other mothers and learn new ECD skills. Mothers formed new social support networks with other mothers engaged in ECD sessions, and they provided emotional and financial support to one another, including encouragement regarding ART adherence. Mothers believed their infants reached developmental milestones faster compared to non-intervention children they observed at the same age, and they experienced improved engagement in caregiving activities among male caregivers. Nearly half of women requested additional support with depression or anxiety, coping mechanisms to deal with the stresses of life, or support in building positive dynamics with their male partner., Conclusion: The integrated ECD-PMTCT intervention improved mother's experiences with PMTCT programs and health care providers, increased ECD practices such as responsive and stimulating parenting, and created social support networks for women with other PMTCT clients.

There is relatively little research on aging with HIV and wellbeing in sub-Saharan Africa. A cross-sectional survey was implemented in Malawi; eligible respondents were ≥ 30 years old and on ART for ≥ 2 years. Univariate and multiple regression analyses were stratified by age (younger adults: aged 30-49; older adults: aged ≥ 50) and gender. The median age was 51 years (total sample n = 134). Viral suppression was less common among older respondents (83.7% versus 93.0% among younger respondents) although not significant in adjusted models. Despite exhibiting worse physical and cognitive functioning (any physical functioning challenge: aOR 5.35, p = 0.02; cognitive functioning score difference: - 0.89 points, p = 0.04), older adults reported less interpersonal violence and fewer depressive symptoms (mild depression: aOR 0.23 p = 0.002; major depression: aOR 0.16, p = 0.004); in gender-stratified models, these relationships were significant only for females. More research is needed to disentangle the interplay between aging, gender and HIV in high-burden contexts and develop interventions to support comprehensive wellbeing in this population.

Background: In Malawi, numerous barriers may prevent women from accessing cervical cancer screening services - including social factors such as male partner involvement. We conducted surveys that included open- and closed-ended questions with married Malawian men to evaluate their knowledge and beliefs about cervical cancer., Methods: HIV-positive adult (≥18 years) men (married or in a stable relationship) were recruited from an antiretroviral therapy clinic in Lilongwe, Malawi. Men were asked a series of survey questions to assess their knowledge about cervical cancer, experience with cervical cancer, their female partner's screening history, and their beliefs about gender norms and household decision-making. Following the survey, participants responded to a set of open-ended interview questions about cervical cancer screening, and men's role in prevention., Results: One hundred-twenty men were enrolled with average age 44 years and 55% having completed secondary school or higher education. Despite only moderate knowledge about cervical cancer and screening (average assessment score of 62% correct), all men expressed support of cervical cancer screening, and most (86%) believed they should be involved in their female partner's decision to be screened. Over half (61%) of men said their female partner had previously been screened for cervical cancer, and this was positively correlated with the male respondent having more progressive gender norms around sexual practices. Some men expressed concerns about the screening process, namely the propriety of vaginal exams when performed by male clinicians, and whether the procedure was painful., Conclusions: Male partners in Malawi want to be involved in decisions about cervical cancer screening, but have limited knowledge about screening, and hold rigid beliefs about gender norms that may affect their support for screening. Messaging campaigns addressing men's concerns may be instrumental in improving women's adoption of cervical cancer screening services in Malawi and similar settings.

Pre-exposure prophylaxis (PrEP) in pregnancy can reduce HIV incidence and vertical transmission. Healthcare providers (HCPs) play a critical role in delivering PrEP in antenatal care but little is known about HCP knowledge and attitudes about PrEP in pregnancy. We conducted a qualitative study in two healthcare facilities to assess HCPs' PrEP knowledge and perspectives relating to HIV prevention in pregnant women. Between January-March'19, we administered in-depth interviews among antenatal HCPs. We utilized a constant comparison approach to identify major qualitative findings. We enrolled 35 female HCPs (median age=43yrs. Fewer than half of HCPs had heard of PrEP before. Of those who had heard of PrEP, most felt that it was safe to take during pregnancy. Most HCPs described inaccurate PrEP knowledge regarding effectiveness, and most who knew about PrEP lacked clinical detail. HCPs highlighted important potential barriers to maternal PrEP use including: fear that PrEP may be unsafe, or belief that women must talk to partners/parents before initiating PrEP. Facilitators include good knowledge about serodiscordancy and vulnerability to seroconversion in pregnancy and desire to help women gain control overHIV prevention. We recommend integrating PrEP training into HIV testing and PMTCT nurse training to improve counseling and maternal PrEP delivery.

Introduction: HIV self-testing (HIVST) in outpatient departments (OPD) is a promising strategy for HIV testing in Malawi, given high OPD patient volumes and substantial wait times. To evaluate the relative cost and expected impact of facility-based HIVST (FB-HIVST) at OPDs in Malawi for increasing HIV status awareness, we conducted an economic evaluation of an HIVST cluster-randomized controlled trial., Methods: A cluster-randomized trial was conducted at 15 sites in Malawi from September 2017 to February 2018 with three arms: 1) Standard provider-initiated-testing-and-counselling (PITC); 2) Optimized PITC (additional provider training and job-aids) and 3) FB-HIVST (HIVST demonstration, distribution and kit use in OPD, private kit interpretation and optional HIV counselling). The total production cost per newly identified positive and per person newly initiated on ART were calculated by study arm. These were calculated as the total cost of testing everyone divided by the number of newly identified positives; and the total cost of testing everyone divided by the number of those initiated on ART. Cost-outcomes were calculated under three cost scenarios: (1) full study costs, (2) routine implementation costs and (3) routine implementation + reduced cost for HIVST kits., Results: The average cost per person newly diagnosed in the full study cost scenario was $101, $156 and $189, and cost per person initiated on ART was $121, $156 and $279 for Standard PITC, Optimized PITC and FB-HIVST respectively. In the routine implementation cost scenario, the average cost per person newly diagnosed was reduced to $83, and $93, and cost per person initiated on ART to $83, and $137 for Optimized PITC and FB-HIVST respectively. In the negotiated HIVST cost scenario, the average cost per person newly diagnosed was reduced to $55 and cost per person newly initiated on ART reduced to $81 in the FB-HIVST arm., Conclusions: While the cost per new ART initiation through FB-HIVST was higher than Standard PITC, FB-HIVST could become cost-saving compared to PITC if the cost of kits is reduced or if treatment linkage rate were increased in the FB-HIVST arm. For high volume OPDs, HIVST may increase facility capacity and increase the number of newly diagnosed positives., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Objective: We sought to evaluate whether HIV-positive adults in Malawi were willing to distribute HIV self-testing (HIVST) kits to their sexual partners of unknown HIV status (index HIVST)., Design: A mixed-methods study was nested within a larger HIVST trial conducted at 15 health facilities in Malawi. Exit surveys were conducted with HIV-positive adults during routine outpatient department visits to assess perceived acceptability of index partner HIVST versus standard partner referral slips that request partner(s) to attend the health facility. Individuals were included in the sub-analysis irrespective of date of HIV diagnosis or ART initiation (or non-initiation). In-depth interviews were conducted with a sub-sample of respondents., Results: 404 HIV-positive adults completed a survey (159 male and 245 female); 21 completed in-depth interviews. Respondents reported feeling more comfortable distributing HIVST versus partner referral slips to their partners (90% vs. 81%) and expressed confidence that their partners would test using HIVST compared to referral slips (77% vs. 66%). Acceptability of HIVST did not vary by sex. Qualitative data revealed that index HIVST was perceived to be private, convenient, and may strengthen relationships by assisting in serostatus disclosure. There were minimal fears of adverse events. Reported barriers to index HIVST included lack of trust within the relationship and harmful gender norms., Conclusions: HIV-positive clients were willing to distribute HIVST kits to their sexual partners of unknown serostatus. Additional studies are needed to evaluate use of HIVST by index partners, positivity, linkage to care, and adverse events related to index partner HIVST, such as coercion to test among index partners or interpersonal violence among index clients., Competing Interests: The authors have declared that no competing interests exist.

Men in sub-Saharan Africa continue to experience health disparities that are exacerbated by low employment. This study qualitatively assessed men's perceptions of the economic and health-care-seeking effects of participation in an integrated microfinance and peer health leadership intervention on violence and HIV risk reduction in Tanzania. Three focus group discussions with 27 men, aged 20 to 44 years, examined the perceived effects on income generation, employability, mental health, and uptake of HIV and related health services. All discussions were recorded, transcribed, and analyzed using deductive and inductive coding methods. Men reported that the benefits of the intervention included increased employability and income-earning activities due to greater access to entrepreneurial training, low-interest microfinancing, and male-oriented group supports to start or strengthen their businesses. Increased wages through business or other forms of employment were also attributed to men's lower anxiety and distress as financial providers for their families. However, men indicated that apart from the uptake of free HIV testing services, there was limited change in overall health-care-seeking behavior given the high clinic fees and lost time to earn income when attending routine health visits. Men recommended that future microfinance and health promotion interventions provide larger loan amounts, less frequent repayment intervals, and access to health and social insurance. Microfinance and peer health leadership interventions may help to address economic and health disparities in poor, urban men. Efforts are needed to assist lower income men in accessing financial tools as well as fee-based preventive and health-care services.

Introduction: Men in sub-Saharan Africa are less likely to use HIV testing services than their female counterparts. Norms of masculinity are frequently cited as the main barrier to men's use of HIV testing services, but very little is known about how health institutions are organized to facilitate or impede men's care. We examined the organization of health institutions in Malawi, and implications for men's use of HIV testing services., Methods: A mixed methods ethnography was conducted in Malawi between October 2013 and September 2014. National Ministry of Health guidelines from 2012 to 2014 were analysed, counting the frequency of recommended preventative services by sex. In-depth interviews were conducted with 18 healthcare workers and 11 national key informants (29 total). Five rural health facilities participated in direct observation and 52 observational journals were completed to document the structure and implementation of HIV services within local facilities. All data were analysed using the theory of gendered organization. Findings were grouped into one of the three theoretical levels of organization: (1) organizational policy; (2) organizational practice; and (3) structure of gendered expectations., Results: Health institutions were gendered across three levels. Organizational policy: National guidelines omitted young and adult men's health during reproductive years (176-433 recommended visits for women vs. 32 visits for men). Health education strategies focused on reproductive and child health services, with little education strategies targeting men. Organizational practice: HIV testing was primarily offered during reproductive and child health services and located near female-focused departments within health facilities. As these departments were women's spaces, others could easily tell that men were using HIV services. Structure of gendered expectations: Clients who successfully accessed HIV testing services were perceived as exemplifying characteristics that were traditionally considered feminine: compliance (obeying instructions without explanation); deference (respecting providers regardless of provider behaviour); and patience ("waiting like a woman")., Conclusions: Health institutions in Malawi were organized in ways that created substantial, multilevel barriers to men's HIV testing and reinforced perceptions of absent, difficult men. Future research should prioritize a gendered organization framework to understand and address the complex realities of men's constrained access to HIV services., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Introduction: Multimonth dispensing (MMD) of antiretroviral therapy (ART) is a differentiated model of care that can help overcome health system challenges and reduce the burden of HIV care on clients. Although 3-month dispensing has been the standard of care, interest has increased in extending refill intervals to 6 months. We explored client and provider experiences with MMD in Malawi as part of a cluster randomized trial evaluating 3- versus 6-month ART dispensing., Methods: Semi-structured in-depth interviews were conducted with 17 ART providers and 62 stable, adult clients with HIV on ART. Clients and providers were evenly divided by arm and were eligible for an interview if they had been participating in the study for 1 year (clients) or 6 months (providers). Questions focused on perceived challenges and benefits of the 3- or 6-month amount of ART dispensing. Interviews were transcribed, and data were coded and analyzed using constant comparison., Results: Both clients and providers reported that the larger medication supply had benefits. Clients reported decreased costs due to less frequent travel to the clinic and increased time for income-generating activities. Clients in the 6-month dispensing arm reported a greater sense of personal freedom and normalcy. Providers felt that the 6-month dispensing interval reduced their workload. They also expressed concerned about clients' challenges with ART storage at home, but clients reported no storage problems. Although providers mentioned the potential risk of clients sharing the larger medication supply with family or friends, clients emphasized the value of ART and reported only rare, short-term sharing, mostly with their spouses. Providers mentioned clients' lack of motivation to seek care for illnesses that might occur between refill appointments., Conclusions: The 6-month ART dispensing arm was particularly beneficial to clients for decreased costs, increased time for income generation, and a greater sense of normalcy. Providers' concerns about storage, sharing, and return visits to the facility did not emerge in client interviews. Further data are needed on the feasibility of implementing a large-scale program with 6-month dispensing., (© Hubbard et al.)

Background: Little is known about the proportion of HIV-positive clients on antiretroviral therapy (ART) who meet stability criteria for differentiated service delivery (DSD) models. We report the proportion of ART clients meeting stability criteria as part of screening for a randomized trial of multimonth dispensing in Malawi and Zambia., Methods: For a DSD trial now underway, we screened HIV-positive clients aged at least 18 years presenting for HIV treatment in 30 adult ART clinics in Malawi and Zambia to determine eligibility for DSD. Stability was defined as on first-line ART (efavirenz/tenofovir/lamivudine) for at least 6 months, no ART side effects, no toxicity or infectious complications, no noncommunicable diseases being treated in ART clinic, no lapses in ART adherence in the prior 6 months (>30 days without taking ART), and if female, not pregnant or breastfeeding., Results: In total, 3465 adult ART clients were approached between 10 May 2017 and 30 April 2018 (Malawi: 1680; Zambia: 1785). Of the 2938 who answered screening questions (Malawi: 1527; Zambia: 1411), 2173 (73.5%) met criteria for DSD eligibility (Malawi: 72.8%; Zambia: 74.3%). The most common reasons for ineligibility were being on ART less than 6 months (9.6%) and a regimen other than standard first-line (7.9%)., Conclusion: Approximately three-quarters of all adult clients presenting at ART clinics in Malawi and Zambia were eligible for DSD using a typical definition of stability. High uptake of DSD models by eligible clients would have a major impact on the infrastructure and the allocation of HIV treatment resources.

Background: HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi., Methods: In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316., Findings: Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group., Interpretation: Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing., Funding: United States Agency for International Development., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)