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Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents (≥15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults (≥40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI -36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome. In this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope. Clinicaltrials.gov NCT03541382.

To date, no randomized controlled trials have specifically addressed behavior changes after HIV self-testing (HIVST) among transgender women. This study aims to evaluate the effects of HIVST on changes in HIV testing behavior, frequency of condomless sex, and partner numbers among transgender women in China. Participants were recruited from 2 Chinese cities using both online and offline methods. Transgender women were randomly assigned to receive an HIVST intervention. Data from the previous 3 months were collected at baseline, 3 months, and 6 months. The primary outcome was the mean change in the number of HIV tests among transgender women during the 6-month follow-up. An intention-to-treat analysis was conducted. The statistical analysis used analysis of covariance and linear mixed-effects models. From February to June 2021, and 255 transgender women were recruited, of which only 36.5% (93/255) had a steady job, and 27.1% (69/255) earned less than US $414.9 of income per month. They were randomly assigned to the intervention (n=127) and control (n=128) groups. At 6 months, the mean number of HIV tests was 2.14 (95% CI 1.80-2.48) in the intervention group and 1.19 (95% CI 0.99-1.40) in the control group (P<.001), with increases of 0.84 (95% CI 0.54-1.14) and 0.11 (95% CI -0.19-0.41) over 6 months, respectively. The net increase was 0.73 (95% CI 0.31-1.15; P<.001), with a similar adjusted result. No significant differences in the frequency of condomless sex or partner numbers were observed between the 2 groups. HIVST is an effective strategy for enhancing regular HIV testing behavior among transgender women in China. This strategy should be combined with measures to address the financial vulnerability of the transgender women community to reduce subsequent risk behaviors, including condomless sex. Chinese Clinical Trial Registry ChiCTR2000039766; https://www.chictr.org.cn/showproj.html?proj=61402.

Introduction Past research shows that HIV self‐testing (HIVST) can increase testing and facilitate more HIV diagnoses relative to clinic testing. However, in the United States, the use of HIVSTs is limited due to concerns that those who use HIVST could be less likely to be linked to care. Methods From January 2019 to April 2022, we recruited 811 men who have sex with men (MSM) in the United States who tested infrequently using an online marketing campaign and randomized them 1:1:1 to receive one of the following every 3 months for a year: (1) text message reminders to get tested at a local clinic (control); (2) mailed HIVST kits with access to a free helpline (standard HIVST); and (3) mailed HIVST kits with counselling provided within 24 hours of opening a kit (eTest). Quarterly follow‐up surveys assessed HIV testing, sexually transmitted infection (STI) testing, pre‐exposure prophylaxis (PrEP) use and sexual risk behaviour. Findings Eight participants were diagnosed with HIV, and all but one were through HIVST. Participants in either HIVST condition, standard or eTest, had significantly higher odds of any testing (OR = 7.9, 95% CI = 4.9−12.9 and OR = 6.6, 95% CI = 4.2−10.5) and repeat testing (>1 test; OR = 8.5, 95% CI = 5.7−12.6; OR = 8.9, 95% CI = 6.1−13.4) over 12 months relative to the control group. Rates of STI testing and PrEP uptake did not differ across study condition, but those in the eTest condition reported 27% fewer sexual risk events across the study period relative to other groups. Conclusions HIVST vastly increased testing, encouraged more regular testing among MSM, and identified nearly all new cases, suggesting that HIVST could diagnose HIV acquisition earlier. Providing timely follow‐up counselling after HIVST did not increase rates of STI testing or PrEP use, but some evidence suggested that counselling may have reduced sexual risk behaviour. To encourage more optimal testing, programmes should incorporate HIVST and ship kits directly to recipients at regular intervals.

Introduction The uptake of HIV testing and linkage to care remains low among men, contributing to high HIV incidence in women in South Africa. We conducted the “Home‐Based Intervention to Test and Start” (HITS) in a 2x2 factorial cluster randomized controlled trial in one of the World’s largest ongoing HIV cohorts in rural South Africa aimed at enhancing both intrinsic and extrinsic motivations for HIV testing. Methods Between February and December 2018, in the uMkhanyakude district of KwaZulu‐Natal, we randomly assigned 45 communities (clusters) (n = 13,838 residents) to one of the four arms: (i) financial incentives for home‐based HIV testing and linkage to care (R50 [$3] food voucher each); (ii) male‐targeted HIV‐specific decision support application, called EPIC‐HIV; (iii) both financial incentives and male‐targeted HIV‐specific decision support application and (iv) standard of care (SoC). EPIC‐HIV was developed to encourage and serve as an intrinsic motivator for HIV testing and linkage to care, and individually offered to men via a tablet device. Financial incentives were offered to both men and women. Here we report the effect of the interventions on uptake of home‐based HIV testing among men. Intention‐to‐treat (ITT) analysis was performed using modified Poisson regression with adjustment for clustering of standard errors at the cluster levels. Results Among all 13,838 men ≥ 15 years living in the 45 communities, the overall population coverage during a single round of home‐based HIV testing was 20.7%. The uptake of HIV testing was 27.5% (683/2481) in the financial incentives arm, 17.1% (433/2534) in the EPIC‐HIV arm, 26.8% (568/2120) in the arm receiving both interventions and 17.8% in the SoC arm. The probability of HIV testing increased substantially by 55% in the financial incentives arm (risk ratio (RR)=1.55, 95% CI: 1.31 to 1.82, p < 0.001) and 51% in the arm receiving both interventions (RR = 1.51, 95% CI: 1.21 to 1.87 p < 0.001), compared to men in the SoC arm. The probability of HIV testing did not significantly differ in the EPIC‐HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70). Conclusions The provision of a small financial incentive acted as a powerful extrinsic motivator substantially increasing the uptake of home‐based HIV testing among men in rural South Africa. In contrast, the counselling and testing application which was designed to encourage and serve as an intrinsic motivator to test for HIV did not increase the uptake of home‐based testing.

Introduction Forty years into the epidemic, HIV remains a significant cause of death among migratory populations such as fisherfolk. Fishermen, in particular, face heightened HIV acquisition risk associated with their high alcohol consumption and engagement in transactional sex. Additionally, the increased risk of other life-threatening conditions among fishermen is often under-recognized. We sought to document incidents and possible causes of death among fishermen on Lake Victoria beaches in Siaya County, Kenya. Methods This study reports on deaths among fishermen enrolled in a randomized controlled trial testing whether using a social network-based approach to distribute HIV self-kits with financial incentives compared to counselor-led testing can increase fishermen’s HIV testing, uptake of antiretroviral therapy or pre-exposure prophylaxis following testing, and virologic suppression. Eligible men were aged ≥ 18 years and primarily engaged in the fishing industry. Participants were recruited between July 2020 and February 2022 and followed up for six months post-enrolment to assess the clinical outcomes. We gathered incidents of death from beach leaders, friends, workmates, and family and summed them to compute a crude mortality rate. All cases were reported to the ethics committees of participating institutions and the study’s Data and Safety Monitoring Board. Results We screened 1,509 registered fishermen, of whom 934 were mapped to close social networks (the intent to treat sample), and 733 were enrolled. At baseline, participants’ median age was 36 years, 78% were married/cohabiting, 68% attained primary education or below, the majority (57%) earned ≤ USD 83 a month, and all were engaged in fishing/fish-related trade. During the study period, 12 deaths occurred, resulting in a mortality rate of 1,284 per 100,000, 3.1 times higher than that of the general Kenyan male population (419 per 100,000). Primary causes of death included cancers ( n  = 3, 25%), cardiovascular disease ( n  = 3, 25%), HIV-related complications ( n  = 2, 17%), alcohol-related incidents ( n  = 2, 17%), and other causes ( n  = 2, 17%). Conclusions The causes of death were varied, underscoring the need for a multi-disease approach to address the health risks in high-risk occupations like fishing. Since HIV is one of several significant health threats to fishermen, efforts to end HIV must also address other life-threatening conditions.

Background Through universal “test and treat approach” (UTT) it is believed that HIV new infection and AIDS related death will be reduced at community level and through time HIV can be eliminated. With this assumption the UTT program was implemented since 2016. However, the effect of this program in terms of individual patient survival and treatment outcome was not assessed in relation to the pre-existing defer treatment approach. Objective To assess the effects of UTT program on HIV treatment outcomes and patient survival among a cohort of adult HIV infected patients taking antiretroviral treatment in Gurage zone health facilities. Methods Institution based retrospective cohort study was conducted in facilities providing HIV care and treatment. Eight years (2012–2019) HIV/AIDS treatment records were included in the study. Five hundred HIV/AIDS treatment records were randomly selected and reviewed. Data were abstracted using standardized checklist by trained health professionals; then it was cleaned, edited and entered by Epi info version 7 and analyzed by STATA. Cox model was built to estimate survival differences across different study variables. Results A total of 500 patients were followed for 1632.6 person-year (PY) of observation. The overall incidence density rate (IDR) of death in the cohort was 3 per-100-PY. It was significantly higher for differed treatment program, which is 3.8 per-100-PY compared to 2.4 per-100-PY in UTT program with a p value of 0.001. The relative risk of death among differed cases was 1.58 times higher than the UTT cases. The cumulative probability of survival at the end of 1st, 2nd, 3rd, and 4th years was 98%, 90.2%, 89.2% and 88% respectively with difference between groups. The log rank test and Kaplan–Meier survival curve indicated patients enrolled in the UTT program survived longer than patients enrolled in the differed treatment program (log rank X 2 test = 4.1, p value = 0.04). Age, residence, base line CD4 count, program of enrolment, development of new OIS and treatment failure were predicted mortality from HIV infection. Conclusion Mortality was significantly reduced after UTT. Therefore, intervention to further reduce deaths has to focus on early initiation of treatment and strengthening UTT programs.

Introduction Assisted partner services (APS) is an effective strategy for increasing HIV testing, new diagnosis, and linkage to care among sexual partners of people living with HIV (PLWH). APS can be resource intensive as it requires community tracing to locate each partner named and offer them testing. There is limited evidence for the effectiveness of offering HIV self‐testing (HIVST) as an option for partner testing within APS. Methods We conducted a cluster randomized controlled trial comparing provider‐delivered HIV testing (Standard APS) versus offering partners the option of provider‐delivered testing or HIVST (APS+HIVST) at 24 health facilities in Western Kenya. Facilities were randomized 1:1 and we conducted intent‐to‐treat analyses using Poisson generalized linear mixed models to estimate intervention impact on HIV testing, new HIV diagnoses, and linkage to care. All models accounted for clustering at the clinic level and new diagnoses and linkage models were adjusted for individual‐level age, sex, and income a priori. Results From March to December 2021, 755 index clients received APS and named 5054 unique partners. Among these, 1408 partners reporting a prior HIV diagnosis were not eligible for HIV testing and were excluded from analyses. Of the remaining 3646 partners, 96.9% were successfully contacted for APS and tested for HIV: 2111 (97.9%) of 2157 in the APS+HIVST arm and 1422 (95.5%) of 1489 in the Standard APS arm. In the APS+HIVST arm, 84.6% (1785/2111) tested via HIVST and 15.4% (326/2111) received provider‐delivered testing. Overall, 16.7% of the 3533 who tested were newly diagnosed with HIV (APS+HIVST = 357/2111 [16.9%]; Standard APS = 232/1422 [16.3%]). Of the 589 partners who were newly diagnosed, 90.7% were linked to care (APS+HIVST = 309/357 [86.6%]; Standard APS = 225/232 [97.0%]). There were no significant differences between the two arms in HIV testing (relative risk [RR]: 1.02, 95% CI: 0.96–1.10), new HIV diagnoses (adjusted RR [aRR]: 1.03, 95% CI: 0.76–1.39) or linkage to care (aRR: 0.88, 95% CI: 0.74–1.06). Conclusions There were no differences between APS+HIVST and Standard APS, demonstrating that integrating HIVST into APS continues to be an effective strategy for identifying PLWH by successfully reaching and HIV testing >95% of elicited partners, newly diagnosing with HIV one in six of those tested, >90% of whom were linked to care. Clinical Trial Number NCT04774835

Young sexual minority men (YSMM) are disproportionately impacted by HIV in the United States. HIV or sexually transmitted infection (STI) testing rates and pre-exposure prophylaxis (PrEP) uptake are low in this priority population. Novel strategies are needed to increase access to HIV and STI prevention services among YSMM. This study aims to describe the development and assess the feasibility and acceptability of LYNX, a mobile app to increase HIV testing and PrEP uptake among YSMM. Informed by the Information-Motivation-Behavioral Skills model, the LYNX app was refined through 4 iterative focus groups in 2 US cities among YSMM aged 15 to 24 years. The LYNX app includes SexPro, an innovative tool that provides a personalized sexual health protection score, a sex diary to track sexual partners, HIV and STI testing information and reminders, access to home HIV and STI test kits, and geospatial-based testing and PrEP clinic site information. The refined app was then tested for feasibility and acceptability in a 2-month technical pilot. Baseline and 2-month follow-up assessments and exit interviews were completed. Self-reported app acceptability and use based on paradata were reported. In iterative focus groups among 30 participants (age: mean 20, SD 3 years; Black: 12/30, 40%; Hispanic or Latinx: 13/30, 43%), the app's design was well-received. Participants recommended providing information on how the SexPro score was calculated and how they could improve their score, changes to the language in the sex diary tailored for YSMM, providing a chat feature to facilitate communication between staff and app users, and gamification features to increase overall youth engagement with the app. These recommendations were incorporated into the app. In the technical pilot among 17 participants (age: mean 22.4, SD 1.6 years; Black: 4/17, 24%; Hispanic or Latinx: 8/17, 47%), the mean system usability score was 70 out of 100, falling in the \"good\" range. Use of the app was high over the 2-month pilot (app opened an average of 8.5, SD 8.0 times with an average duration of 3.8, SD 3.2 min/session), indicating good feasibility. The most commonly used features included the testing feature (n=15, 100%), activity calendar (n=14, 93%), and diary (n=13, 86%). Overall, 11 (79%) participants were likely to continue using LYNX, and 10 (71%) participants were likely to recommend it to a friend. In exit interviews, there was a high level of acceptability of the content, interface, and features of the LYNX app. Following a user-centered design approach, we tailored the LYNX app to increase HIV and STI testing and PrEP uptake among YSMM in the United States. Our positive findings support further testing of this mobile health tool in an upcoming effectiveness trial in broader youth populations. ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/study/NCT03177512. RR2-10.2196/10659.

Introduction Humanitarian settings are underserved by HIV self-testing (HIV-ST). Methods We conducted a randomized controlled trial to evaluate the effectiveness of HIV-ST (Arm 1), HIV-ST alongside edutainment comics (Arm 2), and edutainment comics (Arm 3), compared with the standard of care (SOC), in increasing HIV testing with refugee youth aged 16–24 in the Bidi Bidi Refugee Settlement, Uganda. Intervention effects on HIV testing at 3-month follow-up (T2) were assessed using generalized estimating equation models alongside open-ended questions. Results Retention was 98% (n = 117/120) at T2. In adjusted analyses compared with the SOC, HIV testing changes from baseline to T2 were highest in Arm 2 (adjusted odds ratio [aOR]: 8.46; 95% confidence interval [CI]: 2.87–24.97), followed by Arm 3 (aOR: 4.14; 95% CI: 1.58–10.87), with no significant differences in Arm 1. Conclusion HIV self-testing is feasible for refugee youth in Uganda and can be supplemented with edutainment comics to advance HIV prevention efforts. Plain Language Summary: Findings from an HIV self-testing and comic intervention with refugee youth in a humanitarian setting in Uganda.

Introduction Male partner HIV testing and engagement in antenatal care (ANC) is associated with improved clinical outcomes for men, pregnant women and infants. However, testing rates remain low among male partners of pregnant women receiving ANC in Africa. We evaluated the impact of male peer outreach to increase HIV testing among partners of pregnant women in Uganda. Methods We conducted a randomized trial in Kampala, Uganda, enrolling an equal number of pregnant women with and without HIV from public ANC clinics who were randomized 1:1 to intervention or standard‐of‐care (SOC) with delayed intervention after 1 month. (ClinicalTrials.gov ID, NCT05388084). The intervention consisted of male peer counsellors calling male partners of consenting pregnant women and inviting them to test for HIV. In the SOC, pregnant women received an invitation letter to deliver to their partners for fast‐track HIV testing, per national guidelines. We conducted an intention‐to‐treat analysis using modified Poisson regression, comparing the proportion of male partners tested for HIV by month 1 across arms overall and by female's HIV status. A secondary analysis compared the proportion tested for HIV by 3 months after both arms received the intervention. Results Between May 2022 and March 2023, we enrolled 150 pregnant women (76 in intervention, 74 in SOC). At 1 month, 18% more males in the intervention arm tested for HIV compared to SOC (32% vs. 14%; risk difference [RD] = 0.18; 95% confidence interval [CI]: 0.05–0.31). This association remained significant after stratifying by female HIV status. HIV testing was 22% higher among male partners of HIV‐negative women in the intervention arm compared to SOC (46% vs. 24%; RD = 0.22; 95% CI: 0.004–0.430) and 15% higher among partners of pregnant women with HIV (18% vs. 3%; RD = 0.15; 95% CI: 0.02–0.28). At 3 months, 50% (38/76) of male partners tested in the intervention versus 35% (26/74) in the SOC/delayed intervention (RD = 0.15; 95% CI: −0.01 to 0.31). Conclusions Male peer outreach is a promising intervention to increase knowledge of HIV status among partners of pregnant women. Additional support is needed to increase HIV testing among partners of women with HIV.