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AbstractIntroductionMobility 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.MethodsFrom 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.ResultsSurvey 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.ConclusionsMen 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.

IntroductionAvoiding unintended pregnancies is important for the health of adolescents living with HIV and has the additional benefit of preventing potential vertical HIV transmission. Health facility providers represent an untapped resource in understanding the barriers and facilitators adolescents living with HIV face when accessing contraception. By understanding these barriers and facilitators to contraceptive use among adolescent females living with HIV, this study aimed to understand how best to promote contraception within this marginalized population.MethodsWe conducted structured in‐depth interviews with 40 providers at 21 Family AIDS Care & Education Services ‐ supported clinics in Homabay, Kisumu and Migori counties in western Kenya from July to August 2014. Our interview guide explored the providers' perspectives on contraceptive service provision to adolescent females living with HIV with the following specific domains: contraception screening and counselling, service provision, commodity security and clinic structure. Transcripts from the interviews were analyzed using inductive content analysis.ResultsAccording to providers, interpersonal factors dominated the barriers adolescent females living with HIV face in accessing contraception. Providers felt that adolescent females fear disclosing their sexual activity to parents, peers and providers, because of repercussions of perceived promiscuity. Furthermore, providers mentioned that adolescents find seeking contraceptive services without a male partner challenging, because some providers and community members view adolescents unaccompanied by their partners as not being serious about their relationships or having multiple concurrent relationships. On the other hand, providers noted that institutional factors best facilitated contraception for these adolescents. Integration of contraception and HIV care allows easier access to contraceptives by removing the stigma of coming to a clinic solely for contraceptive services. Youth‐friendly services, including serving youth on days separate from adults, also create a more comfortable setting for adolescents seeking contraceptive services.ConclusionsProviders at these facilities identified attitudes of equating seeking contraceptive services with promiscuity by parents, peers and providers as barriers preventing adolescent females living with HIV from accessing contraceptive services. Health facilities should provide services for adolescent females in a youth‐friendly manner and integrate HIV and contraceptive services.

AbstractIntroductionPerson‐centred HIV prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. However, data are lacking on the actual uptake of choices among persons at risk of HIV in southern Africa. In an ongoing randomized study (SEARCH; NCT04810650) in rural East Africa, we evaluated the uptake of choices made when offered in a person‐centred, dynamic choice model for HIV prevention.MethodsUsing the PRECEDE framework, we developed a persont‐centred, Dynamic Choice HIV Prevention (DCP) intervention for persons at risk of HIV in three settings in rural Kenya and Uganda: antenatal clinic (ANC), outpatient department (OPD) and in the community. Components include: provider training on product choice (predisposing); flexibility and responsiveness to client desires and choices (pre‐exposure prophylaxis [PrEP]/post‐exposure prophylaxis [PEP], clinic vs. off‐site visits and self‐ or clinician‐based HIV testing) (enabling); and client and staff feedback (reinforcing). All clients received a structured assessment of barriers with personalized plans to address them, mobile phone access to clinicians (24 hours/7 days/week) and integrated reproductive health services. In this interim analysis, we describe the uptake of choices of product, location and testing during the first 24 weeks of follow‐up (April 2021−March 2022).ResultsA total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person‐centred DCP intervention. We delivered the DCP intervention in all three settings with diverse populations: ANC: 39% pregnant; median age: 24 years; OPD: 39% male, median age 27 years; and community: 42% male, median age: 29 years. Baseline choice of PrEP was highest in ANC (98%) vs. OPD (84%) and community (40%); whereas the proportion of adults selecting PEP was higher in the community (46%) vs. OPD (8%) and ANC (1%). Personal preference for off‐site visits increased over time (65% at week 24 vs. 35% at baseline). Interest in alternative HIV testing modalities grew over time (38% baseline self‐testing vs. 58% at week 24).ConclusionsA person‐centred model incorporating structured choice in biomedical prevention and care delivery options in settings with demographically diverse groups, in rural Kenya and Uganda, was responsive to varying personal preferences over time in HIV prevention programmes.

AbstractIntroductionAntiretroviral‐based HIV prevention, including pre‐exposure prophylaxis (PrEP), is expanding in generalized epidemic settings, but additional prevention options are needed for individuals with periodic, high‐risk sexual exposures. Non‐occupational post‐exposure prophylaxis (PEP) is recommended in global guidelines. However, in Africa, awareness of and access to PEP for sexual exposures are limited. We assessed feasibility, acceptability, uptake and adherence in a pilot study of a patient‐centred PEP programme with options for facility‐ or community‐based service delivery.MethodsAfter population‐level HIV testing with universal access to PrEP for persons at elevated HIV risk (SEARCH Trial:NCT01864603), we conducted a pilot PEP study in five rural communities in Kenya and Uganda between December 2018 and May 2019. We assessed barriers to PEP in the population and implemented an intervention to address these barriers, building on existing in‐country PEP protocols. We used community leaders for sensitization. Test kits and medications were acquired through the Ministry of Health supply chain and healthcare providers based at the Ministry of Health clinics were trained on PEP delivery. Additional intervention components were (a)PEP availability seven days/week, (b)PEP hotline staffed by providers and (c)option for out‐of‐facility medication delivery. We assessed implementation using the Proctor framework and measured seroconversions via repeat HIV testing. Successful "PEP completion" was defined as self‐reported adherence over four weeks of therapy with post‐PEP HIV testing.ResultsCommunity leaders were able to sensitize and mobilize for PEP. The Ministry of Health supplied test kits and PEP medications; after training, healthcare providers delivered the 28‐day regimen with high completion rates. Among 124 persons who sought PEP, 66% were female, 24% were ≤25 years and 42% were fisherfolk. Of these, 20% reported exposure with a serodifferent partner, 72% with a new or existing relationship and 7% from transactional sex. 12% of all visits were conducted at out‐of‐facility community‐based sites; 35% of participants had ≥1 out‐of‐facility visit. No serious adverse events were reported. Overall, 85% met the definition of PEP completion. There were no HIV seroconversions.ConclusionsAmong individuals with elevated‐risk exposures in rural East African communities, patient‐centred PEP was feasible, acceptable and provides a promising addition to the current prevention toolkit.

AbstractIntroductionAdolescents and young adults living with HIV (AYAH) have the lowest rates of retention in HIV care and antiretroviral therapy (ART) adherence, partly due to the demands of school associated with this life stage, to HIV‐related stigma and to fears of serostatus disclosure. We explore the implications of school‐based stigma and disclosure on the development of agency during a critical life stage in rural Kenya and Uganda.MethodsWe conducted a qualitative study in the baseline year of the SEARCH Youth study, a combination intervention using a life‐stage approach among youth (15–24 years old) living with HIV in western Kenya and southwestern Uganda to improve viral load suppression and health outcomes. We conducted in‐depth, semi‐structured interviews in 2019 with three cohorts of purposively selected study participants (youth [n = 83], balanced for sex, life stage and HIV care status; recommended family members of youth [n = 33]; and providers [n = 20]). Inductive analysis exploring contextual factors affecting HIV care engagement revealed the high salience of schooling environments.ResultsStigma within school settings, elicited by non‐consensual serostatus disclosure, medication schedules and clinic appointments, exerts a constraining factor around which AYAH must navigate to identify and pursue opportunities available to them as young people. HIV status can affect cross‐generational support and cohort formation, as AYAH differ from non‐AYAH peers because of care‐related demands affecting schooling, exams and graduation. However, adolescents demonstrate a capacity to overcome anticipated stigma and protect themselves by selectively disclosing HIV status to trusted peers and caregivers, as they develop a sense of agency concomitant with this life stage. Older adolescents showed greater ability to seek out supportive relationships than younger ones who relied on adult caregivers to facilitate this support.ConclusionsSchool is a potential site of HIV stigma and also a setting for learning how to resist such stigma. School‐going adolescents should be supported to identify helpful peers and selectively disclose serostatus as they master decision making about when and where to take medications, and who should know. Stigma is avoided by fewer visits to the clinic; providers should consider longer refills, discreet packaging and long‐acting, injectable ART for students.

AbstractIntroductionUnhealthy alcohol use significantly contributes to viral non‐suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub‐Saharan Africa (SSA).MethodsAs part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills‐based alcohol intervention among PWH with self‐reported unhealthy alcohol use (Alcohol Use Disorders Identification Test–Consumption [AUDIT‐C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non‐suppression, defined as either recent HIV viral non‐suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3‐month in‐person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (<400 copies/ml) at 24 weeks, and the secondary outcome was unhealthy alcohol use, defined by AUDIT‐C or phosphatidylethanol (PEth), an alcohol biomarker, ≥50 ng/ml at 24 weeks.ResultsBetween April and September 2021, 401 persons (198 intervention, 203 control) were enrolled from HIV clinics in Uganda (58%) and Kenya (27%) and alcohol‐serving venues in Kenya (15%). At baseline, 60% were virally suppressed. Viral suppression did not differ between arms at 24 weeks: suppression was 83% in intervention and 82% in control arms (RR: 1.01, 95% CI: 0.93–1.1). Among PWH with baseline viral non‐suppression, 24‐week suppression was 73% in intervention and 64% in control arms (RR 1.15, 95% CI: 0.93–1.43). Unhealthy alcohol use declined from 98% at baseline to 73% in intervention and 84% in control arms at 24 weeks (RR: 0.86, 95% CI: 0.79–0.94). Effects on unhealthy alcohol use were stronger among women (RR 0.70, 95% CI: 0.56–0.88) than men (RR 0.93, 95% CI: 0.85–1.01) and among participants with a baseline PEth⩽200 ng/ml (RR 0.68, 95% CI: 0.53–0.87) versus >200 ng/ml (RR 0.97, 95% CI: 0.92–1.02).ConclusionsIn a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non‐suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV‐associated co‐morbidities.

AbstractIntroduction: The 2015 WHO recommendation of antiretroviral therapy (ART) for all HIV‐positive persons calls for treatment initiation in millions of persons newly eligible with high CD4+ counts. Efficient and effective care models are urgently needed for this population. We evaluated clinical outcomes of asymptomatic HIV‐positive adults and children starting ART with high CD4+ counts using a novel streamlined care model in rural Uganda and Kenya.Methods: In the 16 intervention communities of the HIV test‐and‐treat Sustainable East Africa Research for Community Health Study (NCT01864603), all HIV‐positive individuals irrespective of CD4 were offered ART (efavirenz [EFV]/tenofovir disoproxil fumarate + emtricitabine (FTC) or lamivudine (3TC). We studied adults (≥fifteen years) with CD4 ≥ 350/μL and children (two to fourteen years) with CD4 > 500/μL otherwise ineligible for ART by country guidelines. Clinics implemented a patient‐centred streamlined care model designed to reduce patient‐level barriers and maximize health system efficiency. It included (1) nurse‐conducted visits with physician referral of complex cases, (2) multi‐disease chronic care (including for hypertension/diabetes), (3) patient‐centred, friendly staff, (4) viral load (VL) testing and counselling, (5) three‐month return visits and ART refills, (6) appointment reminders, (7) tiered tracking for missed appointments, (8) flexible clinic hours (outside routine schedule) and (9) telephone access to clinicians. Primary outcomes were 48‐week retention in care, viral suppression (% with measured week 48 VL ≤ 500 copies/mL) and adverse events.Results: Overall, 972 HIV‐positive adults with CD4+ ≥ 350/μL initiated ART with streamlined care. Patients were 66% female and had median age thirty‐four years (IQR, 28–42), CD4+ 608/μL (IQR, 487–788/μL) and VL 6775 copies/mL (IQR, <500–37,003 c/mL). At week 48, retention was 92% (897/972; 2 died/40 moved/8 withdrew/4 transferred care/21/964 [2%] were lost to follow‐up). Viral suppression occurred in 778/838 (93%) and 800/972 (82%) in intention‐to‐treat analysis. Grade III/IV clinical/laboratory adverse events were rare: 95 occurred in 74/972 patients (7.6%). Only 8/972 adults (0.8%) switched ART from EFV to lopinavir (LPV) (n = 2 for dizziness, n = 2 for gynaecomastia, n = 4 for other reasons). Among 83 children, week 48 retention was 89% (74/83), viral suppression was 92% (65/71) and grade III/IV adverse events occurred in 4/83 (4.8%).Conclusions: Using a streamlined care model, viral suppression, retention and ART safety were high among asymptomatic East African adults and children with high CD4+ counts initiating treatment.Clinical Trial Number: NCT01864603

AbstractIntroductionOptimizing HIV prevention may require structured approaches for providing client‐centred choices as well as community‐based entry points and delivery. We evaluated the effect of a dynamic choice model for HIV prevention, delivered by community health workers (CHWs) with clinician support, on the use of biomedical prevention among persons at risk of HIV in rural East Africa.MethodsWe conducted a cluster randomized trial among persons (≥15 years) with current or anticipated HIV risk in 16 villages in Uganda and Kenya (SEARCH; NCT04810650). The intervention was a client‐centred HIV prevention model, including (1) structured client choice of product (pre‐exposure prophylaxis [PrEP] or post‐exposure prophylaxis [PEP]), service location (clinic or out‐of‐clinic) and HIV testing modality (self‐test or rapid test), with the ability to switch over time; (2) a structured assessment of patient barriers and development of a personalized support plan; and (3) phone access to a clinician 24/7. The intervention was delivered by CHWs and supported by clinicians who oversaw PrEP and PEP initiation and monitoring. Participants in control villages were referred to local health facilities for HIV prevention services, delivered by Ministry of Health staff. The primary outcome was biomedical prevention coverage: a proportion of 48‐week follow‐up with self‐reported PrEP or PEP use.ResultsFrom May to July 2021, we enrolled 429 people (212 intervention; 217 control): 57% women and 35% aged 15–24 years. Among intervention participants, 58% chose PrEP and 58% chose PEP at least once over follow‐up; self‐testing increased from 52% (baseline) to 71% (week 48); ≥98% chose out‐of‐facility service delivery. Among 413 (96%) participants with the primary outcome ascertained, average biomedical prevention coverage was 28.0% in the intervention versus 0.5% in the control: a difference of 27.5% (95% CI: 23.0–31.9%, p<0.001). Impact was larger during periods of self‐reported HIV risk: 36.6% coverage in intervention versus 0.9% in control, a difference of 35.7% (95% CI: 27.5–43.9, p<0.001). Intervention effects were seen across subgroups defined by sex, age group and alcohol use.ConclusionsA client‐centred dynamic choice HIV prevention intervention, including the option to switch between products and CHW‐based delivery in the community, increased biomedical prevention coverage by 27.5%. However, substantial person‐time at risk of HIV remained uncovered.

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

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