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In this randomized, controlled trial involving women in South Africa and Uganda, twice-yearly subcutaneous lenacapavir was superior to daily oral emtricitabine–tenofovir disoproxil fumarate in preventing HIV infection.

Twice-yearly subcutaneous lenacapavir has been shown to be efficacious for prevention of human immunodeficiency virus (HIV) infection in cisgender women. The efficacy of lenacapavir for preexposure prophylaxis (PrEP) in cisgender men, transgender women, transgender men, and gender-nonbinary persons is unclear. In this phase 3, double-blind, randomized, active-controlled trial, we randomly assigned participants in a 2:1 ratio to receive subcutaneous lenacapavir every 26 weeks or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF). The primary efficacy analysis compared the incidence of HIV infection in the lenacapavir group with the background HIV incidence in the screened population. The secondary efficacy analysis compared the incidence of HIV infection in the lenacapavir group with that in the F/TDF group. Among 3265 participants who were included in the modified intention-to-treat analysis, HIV infections occurred in 2 participants in the lenacapavir group (0.10 per 100 person-years; 95% confidence interval [CI], 0.01 to 0.37) and in 9 participants in the F/TDF group (0.93 per 100 person-years; 95% CI, 0.43 to 1.77). The background HIV incidence in the screened population (4634 participants) was 2.37 per 100 person-years (95% CI, 1.65 to 3.42). The incidence of HIV infection in the lenacapavir group was significantly lower than both the background incidence (incidence rate ratio, 0.04; 95% CI, 0.01 to 0.18; P<0.001) and the incidence in the F/TDF group (incidence rate ratio, 0.11; 95% CI, 0.02 to 0.51; P = 0.002). No safety concerns were identified. A total of 26 of 2183 participants (1.2%) in the lenacapavir group and 3 of 1088 (0.3%) in the F/TDF group discontinued the trial regimen because of injection-site reactions. The HIV incidence with twice-yearly lenacapavir was significantly lower than the background incidence and the incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 2 ClinicalTrials.gov number, NCT04925752.).

Background HIV risk remains unacceptably high among adolescent girls and young women (AGYW) in southern and eastern Africa, reflecting structural and social inequities that drive new infections. In 2015, PEPFAR (the United States President’s Emergency Plan for AIDS Relief) with private-sector partners launched the DREAMS Partnership, an ambitious package of interventions in 10 sub-Saharan African countries. DREAMS aims to reduce HIV incidence by 40% among AGYW over two years by addressing multiple causes of AGYW vulnerability. This protocol outlines an impact evaluation of DREAMS in four settings. Methods To achieve an impact evaluation that is credible and timely, we describe a mix of methods that build on longitudinal data available in existing surveillance sites prior to DREAMS roll-out. In three long-running surveillance sites (in rural and urban Kenya and rural South Africa), the evaluation will measure: (1) population-level changes over time in HIV incidence and socio-economic, behavioural and health outcomes among AGYW and young men (before, during, after DREAMS); and (2) causal pathways linking uptake of DREAMS interventions to ‘mediators’ of change such as empowerment, through to behavioural and health outcomes, using nested cohort studies with samples of ~ 1000–1500 AGYW selected randomly from the general population and followed for two years. In Zimbabwe, where DREAMS includes an offer of pre-exposure HIV prophylaxis (PrEP), cohorts of young women who sell sex will be followed for two years to measure the impact of ‘DREAMS+PrEP’ on HIV incidence among young women at highest risk of HIV. In all four settings, process evaluation and qualitative studies will monitor the delivery and context of DREAMS implementation. The primary evaluation outcome is HIV incidence, and secondary outcomes include indicators of sexual behavior change, and social and biological protection. Discussion DREAMS is, to date, the most ambitious effort to scale-up combinations or ‘packages’ of multi-sectoral interventions for HIV prevention. Evidence of its effectiveness in reducing HIV incidence among AGYW, and demonstrating which aspects of the lives of AGYW were changed, will offer valuable lessons for replication.

Background Youth in southern Africa continue to be at high risk of HIV infection. We investigated the awareness of, access to, and uptake of HIV prevention interventions (pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), voluntary medical male circumcision and condoms) among youth in Zimbabwe. Methods A population-based survey of youth aged 18–24 years in 24 communities across three provinces was conducted between October 2021 and June 2022. An interviewer-administered questionnaire collected sociodemographic and sexual behaviour data including awareness of, access to, and use of HIV preventative interventions. Data were analysed using descriptive statistics and mixed-effects logistic regression weighted for clustering. Results We recruited 17,682 youth (60.8% female, median age 20 years (Interquartile range 19–22)). Altogether 46.8% ( n  = 3634) of unmarried youth and 5.6% ( n  = 3538) of married youth reported consistent condom use and 49.8% ( n  = 3369) of men reported being circumcised. Awareness of PrEP and PEP was 11.2% and 11.9% respectively. 6900 participants (38.4%) reported at least one eligibility criterion for PrEP. Eligibiltiy criteria included having multiple partners or receiving money or goods for sex in the last year, HIV-negative individuals in serodiscordant relationships, those who had ever been treated for an STI, ever injected drugs, been pregnant or taken PEP. In comparison to the non-eligible population ( n  = 10782), the eligible population were more likely to have heard of PrEP (13.5% vs. 9.9%, p  < 0.001), been offered PrEP if they had heard of it (17.0% vs. 6.3%, p  < 0.001) and to have ever taken PrEP if offered it (60.7% vs. 27.0%, p  < 0.001). Those in the richest wealth quintiles and with higher education level were more likely to have heard of PrEP and report regular condom use. Forty-two of 199 (20.2%) who reported having experienced forced sex in the last year sought healthcare afterwards, of these 17 of 42 (36.0%) had been offered PEP and 12 of 17 (63.7%) had ever taken it. Conclusions Use of HIV preventive interventions remains limited among youth despite longstanding HIV programmes. Lack of awareness limits use of PrEP and PEP. There are underlying socioeconomic barriers limiting awareness of and demand for condoms, circumcision and pharmacological prophylaxis. These must be urgently addressed. Trial registration number NCT03719521.

Background Women in South Africa have a high burden of HIV infections, STIs, and unintended pregnancies. Women congregate regularly in hair salons, which may be useful venues for HIV and sexual and reproductive health (SRH) services. Our objective was to assess the uptake of PrEP and contraception in hair salons in South Africa. Methods We conducted a pilot cluster randomized controlled trial to evaluate uptake of a hair stylist-initiated, nurse-supported intervention offering a dynamic choice of contraception (oral or injectable), STI testing and treatment, and oral PrEP in 3 salons in urban KwaZulu-Natal. Rapid HIV testing was performed in a private area at enrollment and each PrEP dispensing. Women could receive contraception and/or oral PrEP at the initial visit or opt in at a later visit. We defined uptake as the proportion of eligible women who accepted salon-based PrEP and/or salon-based contraception at any visit. Control salon participants completed surveys and were referred to clinic. We assessed predictors of PrEP uptake among intervention participants using univariate logistic regression and multivariable logistic regression with age and potential predictors from the univariate analyses. Results Among 134 participants in intervention salons, the median age was 26 years (IQR 22–29). 75% reported visiting the salon at least every 2 months. 27% were using hormonal contraception at enrollment, 31% reported a self-perceived moderate or great chance of getting HIV in the next year, 33% thought their primary sex partner had other partners, 65% did not use condoms in the past month, and 11% reported intimate partner violence (IPV). About half (49%) accepted salon-based PrEP, and 89% accepted salon-based contraception during the study. Adjusting for age, uptake of salon-based PrEP was associated with experiencing IPV (aOR 4.20, 95%CI: 1.02, 17.36). Conclusions When offering a dynamic choice of integrated SRH services in urban hair salons in South Africa, we reached young women with risk factors for HIV, STIs, and unintended pregnancies. Hair salons are a novel venue for reaching young women who may not perceive themselves at risk for HIV, STIs, and unintended pregnancies. Trial Registration Clinicaltrials.gov identifier: NCT04222504. Registered 01-08-2020.

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.

Daily emtricitabine/tenofovor is effective at preventing HIV acquisition and is approved for HIV pre-exposure prophylaxis (PrEP). Blacks in the United States have a disproportionately high rate of HIV, and uptake of PrEP has been very low in this population. We conducted a pilot study in a high-prevalence city to test whether a culturally-tailored counseling center for young Black men who have sex with men (BMSM) positively impacted their access and uptake of PrEP. 50 young BMSM were randomized to either a PrEP counseling center group or a control group, and were then encouraged to obtain PrEP from a PrEP provider. At the end of 3 month study, six participants in the intervention group compared with none in the control group had initiated PrEP (p = 0.02). This pilot study demonstrates that a culturally-tailored counseling center might be an effective at increasing the uptake of PrEP in young BMSM.

Background Pre-exposure prophylaxis (PrEP) is an effective biomedical strategy to prevent transmission of HIV infection, although medication adherence remains a challenge. We present the protocol for a multicentre randomised controlled trial to measure the effectiveness of a real-time monitoring and just-in-time intervention on medication adherence among PrEP users in China. Methods Study participants will include 1000 men who have sex with men (MSM) from four cites in China (Shenyang, Beijing, Chongqing and Shenzhen) attending a tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) PrEP project as part of a real-world, prospective multicentre cohort study ( CROPrEP ). Participants will be randomised into the intervention and control arms in a 1:1 ratio. Participants in the intervention arm will be provided with remote real-time monitoring equipment that triggers twice just-in-time SMS (Short Messaging Service) medication reminders to PrEP users every half an hour when a scheduled dosage is missed, and followed with just-in-time SMS medication reminders to clinicians half an hour when there is no supplement after the second just-in-time SMS reminder to PrEP users. Clinicians will initiate individualised telephone intervention as soon as possible upon receipt of the just-in-time SMS missed dose alert. Those in the control arm will only receive generic weekly SMS reminders. The study will last 6 months. Participants will be seen at follow-up visits at three and 6 months. Trial outcomes to be measured include self-reported adherence assessed via questionnaire and pill counts, as well as drug concentration test results. Discussion Medication adherence is critical to achieve optimal benefits from PrEP. This study will be the first individualised behaviour intervention using real-time technology to increase adherence among MSM PrEP users globally. If found effective, a real-time monitoring and just-in-time intervention system may be utilized for improving adherence and thus effectiveness of global PrEP application. Trial registration This study registered at ClinicalTrials.gov ( ChiCTR1900025604 ) on September 2, 2019.

Young sexual minority men have among the highest rates of HIV in the United States; yet, the use of evidence-based prevention strategies, including routine HIV testing and pre-exposure prophylaxis (PrEP), remains low. Mobile apps have enormous potential to increase HIV testing and PrEP use among young sexual minority men. This study aims to assess the efficacy of 2 theory- and community-informed mobile apps-LYNX (APT Mobility) and MyChoices (Keymind)-to improve HIV testing and PrEP initiation among young sexual minority men. Between October 2019 and May 2022, we implemented a 3-arm, parallel randomized controlled trial in 9 US cities to test the efficacy of the LYNX and MyChoices apps against standard of care (SOC) among young sexual minority men (aged 15-29 years) reporting anal sex with cisgender male or transgender female in the last 12 months. Randomization was 1:1:1 and was stratified by site and participant age; there was no masking. The co-primary outcomes were self-reported HIV testing and PrEP initiation over 6 months of follow-up. A total of 381 young sexual minority men were randomized. The mean age was 22 (SD 3.2) years. Nearly one-fifth were Black, non-Hispanic (n=67, 18%), Hispanic or Latino men (n=67, 18%), and 60% identified as gay (n=228). In total, 200 (53%) participants resided in the Southern United States. At baseline, participants self-reported the following: 29% (n=110) had never had an HIV test and 85% (n=324) had never used PrEP. Sociodemographic and behavioral characteristics did not differ by study arm. Compared to SOC (n=72, 59%), participants randomized to MyChoices (n=87, 74%; P=.01) were more likely to have received at least 1 HIV test over 6 months of follow-up; those randomized to LYNX also had a higher proportion of testing (n=80, 70%) but it did not reach the a priori threshold for statistical significance (P=.08). Participants in both MyChoices (n=23, 21%) and LYNX (n=21, 20%) arms had higher rates of starting PrEP compared to SOC (n=19, 16%), yet these differences were not statistically significant (P=.52). In addition to facilitating earlier treatment among those who become aware of their HIV status, given the ubiquity of mobile apps and modest resources required to scale this intervention, a 25% relative increase in HIV testing among young sexual minority men, as seen in this study, could meaningfully reduce HIV incidence in the United States. ClinicalTrials.gov NCT03965221; https://clinicaltrials.gov/study/NCT03965221.

Pre-exposure prophylaxis (PrEP) programs have been implemented in multiple countries. Evidence from clinical trials and cohort studies has proven the safety and effectiveness of PrEP. However, minimizing drug-related adverse effects and cost should be primarily considered in PrEP. Most trials used tenofovir combined with emtricitabine as the intervention; yet, the use of tenofovir disoproxil fumarate (TDF) (ie, Tenofovir) alone has not been thoroughly evaluated. Furthermore, the medication regimen in most trials was used every day, with a few studies proposing an optimal medication regimen for PrEP. This study was designed to systematically evaluate the preventive efficacy and safety profile of TDF-based PrEP in the Chinese population. We also aimed to explore medication compliance, changes in sexual behavior, and hazard factors of HIV infection. We conducted a pragmatic randomized controlled trial (RCT) to evaluate the effectiveness and safety of TDF for HIV PrEP. Participants were randomly assigned (1:1:1) to a time-driven group (TDF 300 mg administered orally once daily), an event-driven group (TDF 300 mg administered orally 24 to 48 h before sexual activity and 2 hours after sexual activity, not exceeding 300 mg within 24 h), or an untreated control group. The primary outcomes were the effectiveness and safety of TDF during periods of PrEP use. Secondary outcomes focused on the effectiveness of TDF among participants with good compliance during PrEP use. Tertiary outcomes included the risk factors of HIV infection and behavioral changes from PrEP initiation to the last visit. For ethical reasons, all participants received condoms and health education. This study was registered with the Chinese Clinical Trial Registry (ChiCTR-TRC-13003849). A total of 1914 participants underwent randomization. During the follow-up of 3513.5 person-years from June 2013 to May 2016, HIV seroconversion was observed in 30 persons (2.02 per 100 person-years) in the time-driven group (time-driven vs control group: hazard ratio [HR] 0.93, 95% CI 058-1.51; P=.78), 35 (1.73 per 100 person-years) in the event-driven group (event-driven group vs control group: HR 0.83, 95% CI 0.52-1.31; P=.42), and 37 (2.06 per 100 person-years) in the control group. Post hoc analysis showed that participants with good medication compliance reduced their HIV infection risk by 53% (P=.01) and event-driven medication with good compliance reduced the risk by 62% (P=.009). We recorded no severe adverse events during the trial. For tertiary outcomes, low medication compliance, sexual role, no condom use, and more number of sexual partners remained significantly associated with HIV risk. The TDF-based PrEP is ineffective without good adherence. However, when medication compliance is achieved, event-driven dosing is recommended as an optimal PrEP regimen.