Background: Adolescent and young adult (AYA; 14-24 years old) engagement in HIV programs is often transient, and socioeconomically marginalized AYA are less engaged. Few studies have examined whether engagement can be sustained over time in HIV prevention programs. This study examines correlates of sustained AYA engagement over 24 months in an HIV prevention program in Nigeria. Methods: We conducted a secondary data analysis of longitudinal data from an HIV prevention program among AYA in 32 local communities in Nigeria from 2021 to 2023. In the study, participants were invited to join crowdsourcing open calls, peer-led support meetings, and other activities. Engagement was assessed using a modified 12-item Tiffany-Eckenrode Program Participation Scale (0-4 per item) at months 3, 6, 12, 18, and 24. Sustained AYA engagement was defined as a mean score >/= 3.0/4.0 in at least three consecutive contacts (approximately 12 months). Longitudinal analysis was conducted using generalized estimating equations, and state-level contextual analysis was done using a linear mixed model. Results: A total of 1,259 AYA were included. The mean age was 19.8 years; most were students (n=954,75.8%) and unemployed (n=810,64.3%). The mean participation score remained consistently high throughout the 24 months (3.245 +/-0.535 to 3.319 +/-0.556), with 73.0% demonstrating sustained engagement. Students were less likely to sustain engagement compared to non-students (aRR = 0.91; 95% CI: 0.84-0.97). Unemployed AYA were more likely to sustain engagement than employed AYA (aRR= 1.09; 95% CI:1.03-1.14). States with higher poverty had significantly greater sustained AYA engagement. All the main findings were robust in sensitivity analyses. Conclusion: AYA engagement in the HIV self-testing implementation was high and sustained over 24 months, especially among socio-economically disadvantaged populations. This study supports the use of a participatory, AYA-led approach in sustaining AYA engagement in HIV prevention programs and has implications for the equity of HIV programs.

BACKGROUND:Index case testing (ICT) is an effective strategy for HIV case finding, but implementation in low- and middle-income countries (LMICs) is often limited by cost and logistical challenges. Traditional ICT training-centralized and in-person-is costly, disrupts service delivery, and varies in quality. OBJECTIVE:This study evaluates the cost-effectiveness of a blended learning (BL) implementation package designed to build health care worker capacity for ICT, combining tablet-guided teaching and practice sessions, phone-based feedback, and tablet-guided continuous quality improvement, compared with standard of care (SOC) training. METHODS:The Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness (PRACTICE) cluster-randomized controlled trial included 33 clusters in southern Malawi from May 2022 to September 2023, randomized 2:1 to SOC (n=22) or SOC + BL implementation package (n=11). Our cost-effectiveness analysis, from the health system perspective, used microcosting, time-and-motion assessments, and observed trial outcomes. The decision tree model estimated total program costs, contact testing outcomes, and incremental cost-effectiveness ratios (ICERs) per contact tested and per person diagnosed with HIV across 1 year of implementation. Sensitivity analyses assessed parameter uncertainty, and a scenario analysis modeled a nationwide scale-up under a decentralized, Ministry of Health-led approach. RESULTS:Our model simulated 100,000 index clients eligible for contact elicitation over 1 year across 2 districts (50,000 per arm). The BL implementation package arm yielded 891 additional contacts tested and 54 more HIV diagnoses. The ICERs were US $125 per contact tested and US $2045 per person diagnosed with HIV; excluding training development costs reduced these to US $69 and US $1136, respectively. Nationwide scale-up under a Ministry of Health-led model further reduced ICERs to US $43 per contact tested and US $698 per person diagnosed with HIV. Probabilistic sensitivity analyses showed the BL implementation package was cost-effective in most simulations. CONCLUSIONS:The BL implementation package improved ICT delivery and HIV case finding. Scenario analyses suggested that a decentralized, government-led scale-up could substantially reduce costs and may represent an efficient case-finding strategy, particularly in Malawi's mature epidemic. BL implementation packages provide a scalable, system-integrated, cost-effective approach that could strengthen health care worker capacity across other service delivery areas in low-resource settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1136/bmjopen-2023-077706.

BACKGROUND:Globally, approximately half of new HIV acquisitions occur among African adults. This analysis examines which cisgender men are at highest risk of acquiring HIV-1 and in greatest need of HIV pre-exposure prophylaxis (PrEP). SETTING:National population-based surveys from Eswatini, Ivory Coast, Kenya, Lesotho, Malawi, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. METHODS:The 13 surveys were pooled and sampling weights were applied to represent all susceptible men aged 15-59 years old. HIV-1 incidence was calculated based on a recent HIV-1 testing algorithm. A least absolute shrinkage and selection operator (Lasso) regression model was fit with 28 variables to predict recent HIV-1. Models were trained and internally cross-validated to estimate area under the receiver-operating characteristic curve (AUC). Along the receiver-operating characteristic curve, at sensitivity levels from 10% to 90%, performance tradeoffs were evaluated. RESULTS:Of 167,121 participants, 112 had recent HIV-1, representing 256,000 new annual infections among 122 million men. Only 2 variables were retained-reporting a male sexual partner and living in a subnational area where a high proportion of adults have detectable HIV-1 viremia. Overall AUC was 0.80 (95% Confidence Interval: 0.71 to 0.89); cross-validated AUC was 0.76 (95% CI: 0.64 to 0.87). At 10% sensitivity, 25,000 cases could be averted if 357,000 men adhered to PrEP (Number Needed to Treat = 14). At 90% sensitivity, 229,000 cases could be averted if 50 million men adhered to PrEP (Number Needed to Treat = 219). CONCLUSIONS:This predictive, parsimonious, generalizable risk assessment tool could help policymakers weigh tradeoffs between PrEP reach and efficiency.

Adolescents and young adults (AYA) in Nigeria with increased HIV risk, such as those who engage in multiple sexual partnerships (i.e., more than one sexual partner within a specified period), transactional sex (i.e., exchange of money or gifts for sex), or needle-sharing (i.e., needles or other injection equipment are shared by multiple people), are eligible for pre-exposure prophylaxis (PrEP). One strategy that has the potential to reach PrEP-eligible AYA is HIV self-testing, which can expand existing HIV testing services and support differentiated PrEP programs. However, little is known about HIV self-testing in these AYA populations. We examined associations between these three high-risk behaviors and HIV self-testing. We analyzed data from Innovative Tools to Expand Youth-friendly HIV Self-Testing (I-TEST), a stepped-wedge trial examining the impact of a combination intervention package on HIV self-testing among AYA aged 14-24 years in Nigeria. We fit generalized linear models, with an identity link and a binomial error distribution, using generalized estimating equations. We generalized trial estimates to all AYA in Nigeria using a two-stage weighted approach. Of 1,429 participants, the median age was 20 years (IQR: 18-22), 50.3% were female, and 69.4% reported secondary school as their highest education level completed. AYA who engaged in transactional sex had higher HIV self-testing uptake (8.1% [4.8, 11.5]) than AYA with no history of transactional sex. There were no statistically significant differences in recent HIV self-testing uptake among AYA by sexual partnerships or needle-sharing history. The trial estimates were similar in the adjusted models. The estimates for the trial and generalized samples were in the same direction, except for AYA with two recent sexual partners. There was a high level of HIV self-testing uptake across all categories of sexual partnerships, transactional sex, and needle-sharing, with significantly higher uptake among those who engaged in transactional sex, indicating that HIV self-testing strategies are reaching these various AYA populations and the need to sustain access for these groups.

Background:Task shifting in low-resource settings requires lay health care workers (HCWs) to provide a variety of health services, such as HIV index case testing, whereby sexual partners and family members of people living with HIV are offered HIV testing. For this, lay HCWs require adequate specialized training. Digital technologies hold promise for training lay HCWs in low-resource settings, but their impacts on improving knowledge, attitudes, and skills are not understood. Objective:This study evaluates the impact of digital training on lay HCWs' knowledge, attitudes, and skills to provide HIV index case testing. Methods:We recruited lay HCWs from 34 health facilities in Malawi. We conducted a 2-arm cluster randomized controlled trial from 2022 to 2023, evaluating the impact of a digital training approach. Health facilities (clusters) were randomized 1:2 to the enhanced or standard arms. Lay HCWs in both arms received the standard in-person index case testing training. In addition, lay HCWs in the enhanced arm received tablet-guided training. Knowledge acquisition was measured using multiple-choice questionnaires administered before and after training. Attitudinal gains were assessed through a questionnaire with Likert scale responses before and after training. Between-arm mean differences were evaluated using generalized estimating equations. Skills (fidelity to index and contact testing protocols) were measured using 15-item checklists. Fidelity scores were compared between the enhanced and standard arms by estimating mean differences and 95% CIs using generalized estimating equations. Results:We enrolled 306 lay HCWs, with 125 (40.8%) in the enhanced arm and 181 (59.2%) in the standard arm. In the enhanced arm, there was 100% completion of the digital portion, 98% (123/125) completion of the face-to-face tablet-guided portion, and 81% (101/125) to 93% (116/125) completion of quality improvement sessions. Knowledge improved by 4.4% (95% CI 0.7%-8.2%) more in the enhanced arm than in the standard arm (P=.02). Attitudes toward digital training improved by 4.5% (95% CI 0.3%-7.0%) more in the enhanced arm than in the standard arm (P=.03). Lay HCWs' fidelity to index client counseling protocols was 30.5 (95% CI 26.0%-35.0%; P<.001) percentage points higher in the enhanced arm than in the standard arm. Fidelity to contact client counseling protocols was 24.0 (95% CI 20.6%-27.3%; P<.001) percentage points higher in the enhanced arm than in the standard arm. Conclusions:Digital training improved lay HCWs' knowledge, attitudes, and skills surrounding index case testing counseling. These findings support digital training as a useful strategy for strengthening the capacity of lay HCWs in low-resource contexts.

Background:HIV index case testing involves offering HIV testing services to the sexual partners and children of people living with HIV. In Malawi, index case testing implementation has been suboptimal due to inadequately trained health care workers (HCW). In a cluster-randomized trial, we tested the impact of a digital training approach (Enhanced strategy) to improve HCW capacity to conduct HIV index case testing services. We conducted a qualitative explanatory analysis to understand the impacts of the training on health workers' perceptions of delivering the intervention. Methods:In a cluster randomized trial, 33 clusters (health facilities) were randomized 1:2 to the Enhanced and Standard arms. HCWs in both arms received brief centralized in-person training on index case testing. HCWs in the Enhanced arm also received decentralized digital training through 20 synchronous and asynchronous sessions, which provided knowledge on protocols and principles of index case testing, modelled counseling scenarios, practice counseling, and individual feedback. We conducted 26 in-depth interviews with HCWs from 14 clusters (n = 6 Enhanced, n = 8 Standard) in the weeks after the Enhanced training. Interviews focused on HCW perceptions of their work. Interview transcripts in the weeks after training were analyzed thematically using an inductive approach. We compared responses of HCWs from Enhanced and Standard arms. Results:Overall, HCW in the Enhanced arm perceived greater ease counseling clients after the training. This was attributed to five facilitators:1) HCWs perceived the checklists as helping them operationalize ICT, 2) Video vignettes facilitated new counseling skills, 3) HCWs expressed greater comfort and confidence handling a range of clients, 4) HCWs perceived their counselling skills were more impactful, and 5) HCWs expressed greater confidence identifying and solving facility-level challenges. HCWs from the Standard arm requested additional tools, and referred to more experienced providers, reflecting less confidence in index case testing implementation. Conclusions:Digital training was viewed as a mechanism for enhancing knowledge, counselling skills, and comfort and confidence to address facility-level challenges. Digital training with video vignettes, and checklists to guide practice and feedback sessions are key strategies for HCWs capacity-building in low-resource settings. Trial Registration Number:NCT05343390.

In sub-Saharan Africa, adolescent girls and young women aged 15-24 (AGYW) experience high risk of early and unintended pregnancy. We assessed the impact of youth-friendly health services (YFHS) on pregnancy risk among AGYW who participated in the Girl Power study. In 2016, Girl Power randomly assigned four government-run health centers in Lilongwe, Malawi, to provide a standard (n=1) or youth-friendly (n=3) model of service delivery. At six and 12 months, study participants (n=250 at each health center) self-reported their current pregnancy status and received a urine pregnancy test. Because of missing pregnancy test results, we used multiple imputation to correct for outcome misclassification in self-reported pregnancy status, and applied the parametric g-formula on the corrected data to estimate the effect of YFHS on the 12-month risk of pregnancy. After correcting for outcome misclassification, the risk of pregnancy under the scenario where all health centers offered YFHS was 15.8% compared to 23.2% under the scenario where all health centers offered standard of care (risk difference: -7.3%, 95% CI: -15.5%, 0.8%). Access to a model of YFHS that integrates provider training with youth-friendly clinic modifications and community outreach activities may decrease risk of pregnancy among AGYW relative to standard of care.

ABSTRACTIntroductionWhile African countries have expanded access to HIV pre‐exposure prophylaxis (PrEP) since 2015, regional targets for PrEP uptake remain unmet. Understanding which populations are prioritized for PrEP at the policy level is an important step in determining the scope of PrEP distribution across Africa and identifying gaps in programme implementation. We reviewed national guidance to characterize populations prioritized for PrEP in Africa.MethodsBetween January and June 2023, we searched for current National HIV Treatment and Prevention Guidelines, National HIV Strategic Plans, and the United States President's Emergency Plan for AIDS Relief (PEPFAR) Country Operational Plans (COPs) for all African countries implementing PrEP programmes supported by PEPFAR in 2022. From each document, we summarize the populations prioritized for PrEP within a country and describe PrEP eligibility.ResultsIn 2022, 19 African countries implemented PrEP programmes supported by PEPFAR. Eighteen of these countries contributed National Guidelines (2016−2022), 18 contributed National Strategic Plans (2017−2023) and 19 contributed COPs (2022) to this review. Twenty‐nine population groups were prioritized for PrEP in these documents. All countries prioritized HIV‐serodifferent couples, female sex workers (FSWs), adolescent girls and young women (AGYW), pregnant and breastfeeding women (PBFW) and people who inject drugs (PWID), and most prioritized men who have sex with men (MSM; n = 18), transgender people (n = 18) and people in prisons (n = 17). The remaining 21 populations were prioritized in fewer than two‐thirds of countries.DiscussionFSWs, MSM, PWID, transgender people and people in prisons were typically prioritized for PrEP with no eligibility restrictions. In contrast, most countries had at least one document indicating that HIV‐serodifferent couples, AGYW and PBFW were only eligible for PrEP if classified as high risk. Few documents specified how risk was determined, and no document included validated HIV risk assessment tools to guide implementation. We observed similarities in priority populations across countries with different HIV epidemics and inconsistencies in who was prioritized for PrEP within a country's own set of policy documents.ConclusionsUnderstanding how PrEP prioritization policies impact HIV incidence in different epidemiologic settings is critical for strengthening PrEP implementation across the continent.

Background Crowdsourcing is a process whereby a large group, including experts and non-experts, collaborate to solve a problem and then share the solution with the public. Crowdsourcing can be used to identify strategies to sustain HIV services in low-and-middle-income countries. This study aims to identify innovative adolescent and young adult (AYA) solutions through a crowdsourcing open call to sustain HIV services. Methods Building on HIV prevention services developed by AYA from an initial open call, we organized a crowdsourcing open call to identify innovative, AYA-led strategies to sustain these services through partnerships with the community. The open call question was, 'How might we sustain the 4 Youth by Youth HIV prevention services while nurturing our existing relationships, practices, procedures and services that will last in our communities?'. All submissions were assessed based on prespecified judging criteria. Qualitative data were analyzed using thematic analysis and categorized into strategies for sustaining AYA-friendly HIV prevention services in Nigeria. Results We received 102 eligible submissions from AYA. Twenty-three submissions met the mean score threshold and were qualitatively analyzed. Through this analysis, we identified four strategies for sustaining AYA-friendly HIV prevention services in Nigeria: AYA engagement and leadership in research, digital health solutions, financing and efficiency, and partnerships. Conclusion This open call highlights how strategies developed by AYA may sustain AYA-friendly HIV prevention services. Our findings offer key insights for maintaining HIV prevention services in Nigeria and other similar settings.

Adolescents and young adults (AYAs) participatory approaches for HIV control have increased across LMICs, but there are few trials to evaluate effectiveness. We assessed a crowdsourced HIV self-testing (HIVST) intervention among a cohort of AYA in Nigeria. METHODS:We conducted a pragmatic stepped-wedge cluster randomized control trial recruiting participants (aged 14-24 years) from 32 local government areas across four geo-political zones in Nigeria. Eligible AYA were HIV negative or unknown HIV status, residing in study sites, spoke English, and consented. Areas were randomly assigned to one of four steps and AYA were followed for 24 months. AYA research facilitators implemented a 4YBY crowdsourced HIV prevention bundle. The primary outcome was self-reported HIVST uptake. We compared the probability of HIVST between the control and intervention periods using a generalized linear mixed model. We examined the fixed cost and per capita cost of the intervention. The protocol was registered with Clinical Trials.gov on January 15, 2021, under registration NCT04710784. RESULTS:2652 AYA were screened, and 1500 were enrolled in the study (March 10, 2021- August 31, 2023). 1333/1500 (89 %) were followed up at 24 months. The mean age of AYA was 20 ± 2.65 years old, most were students (1155/1500, 77 %), and unemployed (915/1500, 61 %). The intervention led to a 9.96-fold increase in HIV self-testing uptake compared to the control period (95 % CI: 8.36-11.85, p < 0.0001). The annual fixed cost of the intervention was estimated at US$42,237, with a per capita testing cost of US$14.8. No significant adverse events were reported. CONCLUSION:A crowdsourced HIV prevention intervention increased HIVST uptake among Nigerian AYA. Greater participation of AYA in the design and implementation of clinical trials is needed to achieve UNAIDS targets.

Adolescent girls and young women (AGYW) in sub-Saharan Africa (SSA) face difficulties accessing sexual and reproductive health (SRH) services. Youth-friendly service delivery models may prove an alternative to increase SRH service uptake. This analysis utilises evidence from the Girl Power-Malawi study, a study designed to compare the impact of different models of service delivery on SRH service uptake for AGYW. Three intervention clinics trained providers in youth-friendly health services (YFHS), engaged young peer educators in patient outreach, expanded hours and integrated various services into youth-dedicated spaces. A standard of care (SOC) clinic was included as a comparator. This paper draws on qualitative data from in-depth interviews with 60 participants (15 per clinic) and 8 focus group discussions (2 per clinic). Thematic analysis identified three key themes regarding SRH service acceptability: having peer educators made AGYW feel more comfortable seeking services; AGYW perceived services at intervention clinics to be more private; and clinic modifications such as free services, longer operating hours and integration of different SRH services made services easier to access. Adolescents expressed that these factors contributed to higher service uptake in intervention clinics. Youth-friendly service provisions are needed to ensure AGYW find care-seeking acceptable.

The global HIV/AIDS response is facing its most serious crisis in decades. Despite expanded access to antiretroviral therapy (ART) and the growing availability of prevention tools such as oral preexposure prophylaxis (PrEP), and long-acting PrEP, progress toward the UNAIDS 2025 targets has stalled. HIV incidence remains unacceptably high across key populations and geographic regions, while treatment coverage gaps and preventable deaths persist. The abrupt 2025 suspension of U.S. foreign aid programs, including the President's Emergency Plan for AIDS Relief (PEPFAR) and the United States Agency for International Development (USAID), has further disrupted service delivery, particularly for prevention programs and marginalized groups. This editorial assesses the underlying structural, political, and programmatic failures that led to missed targets and highlights the compounded risks posed by policy reversals. Drawing on recent epidemiological data and modeling, we estimate the impact of prevention gaps, disparities in access, and policy changes on global HIV trajectories. We argue that a path forward requires reforms, renewed political will, and sustainable financing. In a moment of rising global polarization and shrinking public health budgets, the HIV response must be reimagined around equity, inclusion, and collective action. Without such recalibration, the vision of ending AIDS as a public health threat by 2030 will remain out of reach.

BACKGROUND:There has been tremendous progress in reducing vertical transmission of HIV in the past two decades due to the broad availability of antiretroviral therapy (ART) globally. Despite this progress, new paediatric infections are still occurring. METHODS:In a pilot study, we evaluated a combination adherence support package, which included an adapted motivational interviewing-informed counselling approach (Integrated Next Step Counselling, iNSC) and an optional adherence supporter, for pregnant and breastfeeding women living with HIV. Participants were recruited from the antenatal clinic in Lilongwe, Malawi. Eligible participants were randomly allocated 1:1 to receive either the combination adherence package (intervention) or standard care (control) at the health facility. Our clinical outcome, measured at three- and six-month follow-up, was a composite endpoint of study retention with HIV viral suppression (HIV RNA <40 copies per mL). RESULTS:We screened 106 women living with HIV between March and July 2020. Of these, 100 women enrolled and were randomly assigned to intervention (n=51) or control (n=49). The majority of participants (94 of 100; 94%) were newly diagnosed with HIV. Retention in care was 92% at three months and 84% at six months. Three-quarters of women retained in care were virally suppressed at the three- and six-month study visits. At three months, our composite outcome (retention & viral suppression) was achieved by 70.6% (36/51) and 69.4% (34/49) of women in the intervention and control groups, respectively. At six months, this composite outcome was achieved by 68.6% (35/51) of the intervention group and 61.2% (30/49) of the control group (probability difference: 7.4%, 95% CI: -11.3%, 26.1%). CONCLUSION:These encouraging pilot findings suggest that this combination adherence package could be used to support ART adherence among pregnant and breastfeeding women living with HIV. We demonstrate feasibility of using a combined measure of adherence and viral suppression as an outcome measure. TRIAL REGISTRATION:ClinicalTrials.gov (NCT04330989).

The use of antiretroviral drugs has been proven effective in preventing and treating HIV; however, adherence remains a challenge. In two parallel pilot studies, we implemented a combination adherence intervention involving patient-centered counseling and adherence supporter training, tailored for HIV treatment (ART) or prevention (PrEP) during pregnancy and breastfeeding. The intervention included Integrated Next Step Counseling (iNSC), focused on well-being and medication adherence, with an option to involve a social support member. Independent auditors assessed implementation fidelity for 151 participants (51 women living with HIV and 100 PrEP-eligible women) by scoring iNSC sessions using a standard checklist. High fidelity was observed overall in both study populations, with variability between counselors observed. The results demonstrate the ability to assess implementation fidelity in a behavioral intervention aimed at supporting adherence to antiretroviral drugs among pregnant women and offers critical information on the complexities of implementation of iNSC in a real-world setting.

Background: HIV index case testing (ICT) aims to identify people living with HIV and their contacts, engage them in HIV testing services, and link them to care. ICT implementation has faced challenges in Malawi due to limited counseling capacity among lay health care workers (HCWs). Enhancing capacity through centralized face-to-face training is logistically complex and expensive. A decentralized blended learning approach to HCW capacity-building, combining synchronous face-to-face and asynchronous digital modalities, may be an acceptable way to address this challenge. Objective: The objective of this analysis is to describe factors influencing HCW anticipated acceptability of blended learning using the Technology Acceptance Model (TAM). Methods: This formative qualitative study involved conducting 26 in-depth interviews with HCWs involved in the ICT program across 14 facilities in Machinga and Balaka, Malawi (November-December 2021). Results were analyzed thematically using TAM. Themes were grouped into factors affecting the 2 sets of TAM constructs: perceived usefulness and perceived ease of use. Results: A total of 2 factors influenced perceived usefulness. First, HCWs found the idea of self-guided digital learning appealing, as they believed it would allow for reinforcement, which would facilitate competence. They also articulated the need for opportunities to practice and receive feedback through face-to-face interactions in order to apply the digital components. In total, 5 factors influenced perceived ease of use. First, HCWs expressed a need for orientation to the digital technology given limited digital literacy. Second, they requested accessibility of devices provided by their employer, as many lacked personal devices. Third, they wished for adequate communication surrounding their training schedules, especially if they were going to be asynchronous. Fourth, they wished for support for logistical arrangements to avoid work interruptions. Finally, they wanted monetary compensation to motivate learning, a practice comparable with offsite trainings. Conclusions: A decentralized blended learning approach may be an acceptable method of enhancing ICT knowledge and skills among lay HCWs in Malawi, although a broad range of external factors need to be considered. Our next step is to integrate these findings into a blended learning package and examine perceived acceptability of the package in the context of a cluster randomized controlled trial. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2023-077706

Introduction: Couple-based behavioral interventions (CBIs) have been associated with improved HIV virological outcomes for pregnant women and their male partners living with HIV in observational settings, but have never been tested in a randomized controlled trial (RCT). Setting: Bwaila District Hospital Antenatal Clinic (Lilongwe, Malawi). Methods: An RCT was conducted among 500 pregnant women living with HIV (index clients) randomized 1:1 to the standard of care (SOC) or CBI and followed for 1 year. The CBI offered an initial session for index clients, HIV-assisted partner notification, 2 enhanced couple counseling and testing sessions, illustrated materials, and antiretroviral therapy pickup for either couple member at the antenatal clinic. At 12 months, viral load among index clients and male partners with HIV was measured. Risk differences (RD) and 95% confidence intervals (CIs) compared viral suppression (<1000 copies/mL) between arms. Results: The mean index client age was 26.6 years; most were married or cohabiting (93.3%). Index client viral suppression was 6.5% higher in the CBI arm (88.0%) than in the SOC arm (81.6%). Male partner viral suppression was 16.2% higher in the CBI arm (73.6%) than the SOC arm (57.4%). Overall, couple viral suppression was 7.8% higher (CI: 0.5% to 15.1%, P = 0.04) in the CBI arm (84%) than in the SOC arm (76.0%). Social harms were rare (3.6%) and comparable between arms (P = 0.8). Conclusions: This CBI had a positive impact on couple viral suppression. Scaling this CBI to antenatal clients with HIV and their male partners could improve HIV outcomes among expecting families.

INTRODUCTION:HIV Prevention Trials Network (HPTN) 071 (PopART) was a cluster-randomized trial to evaluate universal testing and treatment (UTT) strategies for HIV prevention. HPTN071 compared three arms: (A) combination prevention with UTT; (B) combination prevention with universal testing and antiretroviral therapy initiation according to local guidelines; and (C) standard of care (SOC). Interventions were implemented in entire randomized communities, with impacts on HIV incidence measured in "population cohorts," that is the HPTN071 sample. Unexpectedly, a significantly lower incidence was not observed in arm A relative to SOC. Importantly, rates of participation in the HPTN071 sample differed among population subgroups, for example men were underrepresented. METHODS:To correct for underrepresented subgroups, PopART intervention effects are estimated in a population of interest, adults aged 18-44 in trial provinces, characterized with two nationally representative HIV-focused surveys. The HPTN071 sample is weighted to match the population of interest by demographics and HIV risk factors. Risk of HIV acquisition is compared across arms, both in the trial population (unweighted) and the population of interest (weighted). Both (1) the risk of HIV acquisition between 1 and 3 years and (2) the risk of HIV acquisition by 3 years are compared. RESULTS:In the trial population, estimated risk in arm A is, counterintuitively, slightly higher than SOC (Year 1-3 Risk Difference [RD]: 0.10%; 95% CI: -1.15%, 1.25%). After weighting, risk in arm A is lower than SOC in the population of interest (RD: -0.34%; 95% CI: -2.04%, 0.96%). Weighting also strengthened the estimated effect in arm B relative to SOC (unweighted RD: -0.66%, 95% CI: -1.88%, 0.46%; weighted RD: -1.18%, 95% CI: -2.85%, 0.15%). Weighted year 3 risk difference estimates indicated even stronger possible intervention effects: A versus SOC -0.83% (95% CI: -2.94%, 0.99%), B versus SOC -1.86% (95% CI: -3.80%, -0.09%). CONCLUSIONS:PopART interventions are estimated to be more protective in the population of interest than observed in the HPTN071 sample. These results partially explain the unexpected finding in arm A, providing further support for UTT strategies for HIV prevention. This analysis also highlights the importance of considering heterogeneous treatment effects among population subgroups when measuring the overall efficacy of HIV interventions.

Task shifting in low-resource settings requires lay health care workers (HCWs) to provide a variety of health services, such as HIV index case testing whereby sexual partners and family of people living with HIV are offered HIV testing. For this, lay HCWs require adequate specialized training. Digital technologies hold promise for training lay HCWs in low-resource settings, but their impacts on improving knowledge, attitudes, and skills are not understood. We evaluated the impact of digital training on lay HCWs’ knowledge, attitude, and skills to provide HIV index case testing. We recruited lay HCWs from 34 health facilities in Malawi. We conducted a two-arm cluster randomized controlled trial from 2022-2023, evaluating the impact of a digital training approach. Health facilities (clusters) were randomized 1:2 to the Enhanced or Standard arms. Lay HCWs in both arms received the standard in-person index case testing training. In addition, lay HCWs in the Enhanced arm received tablet-guided training. Knowledge acquisition was measured using multiple-choice questionnaires administered before and after training. Attitudinal gains were assessed through a questionnaire with Likert scale responses before and after training. Between-arm mean differences were evaluated using t-tests. Skills (fidelity to index and contact testing protocols) were measured using 15-item checklists. Fidelity scores were compared between the Enhanced and Standard arms by estimating mean differences and 95% confidence intervals (CIs) using generalized estimating equations. We enrolled 306 lay HCWs, 125 (40.8%) in Enhanced arm and 181 (59.2%) in Standard arm. Knowledge improved 4.4% more in the Enhanced arm than in the Standard arm (p=0.005). Attitudes toward digital training improved 4.5% more in the Enhanced arm than the Standard arm (p=0.008). Fidelity to index client counseling protocols was 30.5% higher among HCWs in the Enhanced arm than the Standard arm (CI: 26.0%, 35.0%, p<0.001). Fidelity to contact client counseling protocols was 22.7% higher in the Enhanced arm than the Standard arm (CI: 19.5%, 25.9%, p<0.001). The digital training improved lay HCWs’ knowledge, attitudes and skills surrounding index case testing counseling. The findings support digital training as a useful strategy for strengthening the capacity of lay HCWs in low-resource contexts. NCT05343390

Background Assisted index case testing (ICT), in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase status awareness in people living with HIV. While the available evidence from eastern and southern Africa suggests that assisted ICT can be an effective, efficient, cost-effective, acceptable, and low-risk strategy to implement in the region, it reveals that feasibility barriers to implementation exist. This study aims to inform the design of implementation strategies to mitigate these feasibility barriers by examining "assisting" health care workers' experiences of how barriers manifest throughout the assisted ICT process, as well as their perceptions of potential opportunities to facilitate feasibility.Methods In-depth interviews were conducted with 26 lay health care workers delivering assisted ICT in Malawian health facilities. Interviews explored health care workers' experiences counseling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted ICT. Analysis included multiple rounds of coding and iteration with the data collection team.Results Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including sensitivities around discussing ICT with clients, privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, and logistical obstacles to tracing. Participants also reported several health care worker characteristics that facilitate feasibility (knowledge, interpersonal skills, non-stigmatizing attitudes and behaviors, and a sense of purpose), as well as identified process improvements with the potential to mitigate barriers.Conclusions Maximizing assisted ICT's potential to increase status awareness in people living with HIV requires equipping health care workers with effective training and support to address and overcome the many feasibility barriers that they face in implementation. Findings demonstrate the need for, as well as inform the development of, implementation strategies to mitigate barriers and promote facilitators to feasibility of assisted ICT.Trial registration NCT05343390. Date of registration: April 25, 2022.