Low adherence to preventative medications against life-long health conditions is a major contributor to global morbidity and mortality. We implemented a pilot randomized controlled trial in Mexico to measure the extent to which conditional economic incentives help male sex workers increase their adherence to pre-exposure prophylaxis (PrEP) for HIV prevention. We followed n = 110 male sex workers over 6 months. At each quarterly visit (at months 0, 3, and 6), all workers received a $10 transport reimbursement, a free 3-month PrEP supply, and completed socio-behavioral surveys. The primary outcome was an objective biomarker of medication adherence based on tenofovir (TFV) drug concentration levels in hair collected at each visit. Individuals randomized to the intervention received incentives based on a grading system as a function of PrEP adherence: those with high (> 0.043 ng/mg TFV concentration), medium (0.011 to 0.042 ng/mg), or low (< 0.011 ng/mg) adherence received $20, $10, or $0, respectively. Six-month pooled effects of incentives on PrEP adherence were analyzed using population-averaged gamma generalized estimating equation models. We estimated heterogeneous treatment effects by sex worker characteristics. The incentive intervention led to a 28.7% increase in hair antiretroviral concentration levels over 6 months consistent with increased PrEP adherence (p = 0.05). The effect of incentives on PrEP adherence was greater for male sex workers who were street-based (vs. internet) workers (p < 0.10). These pilot findings suggest that modest conditional economic incentives could be effective, at scale, for improving PrEP adherence among male sex workers, and should be tested in larger implementation trials. ClinicalTrials.gov Identifier: NCT03674983.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania.
METHODS: This study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania\'s implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials.
CONCLUSIONS: The knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts. Trial registration This study was registered on ClinicalTrials.gov, identifier NCT05323123 , on March 25, 2022.

UNASSIGNED: Young gay, bisexual, and other men who have sex with men (YMSM) in Latin America experience disproportionately high rates of HIV. While new case numbers have stabilised in other demographics, the incidence of HIV in this particular group continues to rise. We estimated the prevalence of HIV and sexually transmitted infections (STI) and identified correlates of new HIV diagnoses among YMSM in Brazil.
UNASSIGNED: Conectad@s was a respondent-driven sampling-based study to recruit and engage YMSM in HIV prevention and treatment services in Rio de Janeiro, Brazil (November 2021-October 2022). Eligibility criteria were age 18-24 years and self-identification as MSM (cis/trans) or non-binary person who have sex with men. Participants underwent HIV/STI testing and completed a socio-behavioural questionnaire. We described baseline characteristics by HIV status and used logistic regression models to identify correlates of new HIV diagnoses. Trial ID: DERR1-10.2196/34885.
UNASSIGNED: Among 409 participants, 370 (90.5%) self-identified as cisgender men, nine (2.2%) transgender men, and 30 (7.3%) non-binary. Median age was 21 years (IQR: 20-23), with 80 (19.6%) aged 18-19 years. Most self-identified as Black or Pardo (70.6%); 109 (26.7%) never tested for HIV. HIV prevalence was 9.8%; 50% (n = 20/40) were newly diagnosed with HIV. Only nine participants ever used PrEP and three were currently using it. Overall, 133 (32.5%) reported sexual violence in their lifetime and 102 (24.9%) reported a suicide attempt. Prevalence of active syphilis, chlamydia, and gonorrhoea were 14.4%, 15.9%, and 14.7%, respectively. New HIV diagnoses were positively associated with engaging in high-risk behaviour (aOR 4.88 [95% CI: 1.88-13.40]) and anxiety (aOR 2.67 [95% CI: 1.01-7.70]), and negatively associated with ever disclosing sexual orientation (aOR 0.19 [95% CI: 0.04-0.92]) and HIV knowledge (aOR 0.77 [95% CI: 0.59-1.01]).
UNASSIGNED: High prevalence of HIV coupled with a high proportion of new HIV diagnoses underscore a potentially growing HIV epidemic among YMSM in Brazil.
UNASSIGNED: National Institutes of Health (NIH), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and Ministry of Health of Brazil.

We evaluated correlates of adherence to PrEP, including daily oral tenofovir disoproxil fumarate in combination emtricitabine (oral FTC/TDF) and the monthly dapivirine ring (ring)among adolescent girls and young women (AGYW) in the MTN-034/REACH study. We enrolled 247 AGYW aged 16-21 years in South Africa, Uganda and Zimbabwe (ClinicalTrials.gov: NCT03074786). Participants were randomized to the order of oral FTC/TDF or ring use for 6 months each in a crossover period, followed by a 6-month choice period. We assessed potential adherence correlates-individual, interpersonal, community, study, and product-related factors-quarterly via self-report. We measured biomarkers of adherence monthly; high adherence was defined as > 4 mg dapivirine released from returned rings or intracellular tenofovir diphosphate levels ≥ 700 fmol/punch from dried blood spots (DBS). We tested associations between correlates and objective measures of high adherence using generalized estimating equations. High adherence to oral FTC/TDF was significantly associated with having an older primary partner (p = 0.04), not having exchanged sex in the past 3 months (p = 0.02), and rating oral FTC/TDF as highly acceptable (p = 0.003). High ring adherence was significantly associated with unstable housing (p = 0.01), disclosing ring use to a male family member (p = 0.01), and noting a social benefit from study participation (p = 0.03). All associations were moderate, corresponding to about 6%-10% difference in the proportion with high adherence. In our multinational study, correlates of adherence among African AGYW differed for oral FTC/TDF and the ring, highlighting the benefit of offering multiple PrEP options.

BACKGROUND: In Africa, the delivery of HIV pre-exposure prophylaxis (PrEP) at public healthcare clinics is challenged by understaffing, overcrowding, and HIV-associated stigma, often resulting in low PrEP uptake and continuation among clients. Giving clients the option to refill PrEP at nearby private pharmacies, which are often more convenient and have shorter wait times, may address these challenges and improve PrEP continuation.
METHODS: This mixed methods study used an explanatory sequential design. At two public clinics in Kiambu County, Kenya, clients ≥ 18 years initiating PrEP were given the option to refill PrEP at the clinic where they initiated for free or at one of three nearby private pharmacies for 300 Kenyan Shillings (~ $3 US Dollars). The providers at these pharmacies (pharmacists and pharmaceutical technologists) were trained in PrEP service delivery using a prescribing checklist and provider-assisted HIV self-testing, both with remote clinician oversight. Clients were followed up to seven months, with scheduled refill visits at one, four, and seven months. The primary outcomes were selection of pharmacy-based PrEP refills and PrEP continuation. Following pilot completion, 15 in-depth interviews (IDIs) with clients who refilled PrEP were completed. We used descriptive statistics and thematic analysis to assess study outcomes.
RESULTS: From November 2020 to November 2021, 125 PrEP clients were screened and 106 enrolled. The majority (59%, 63/106) of clients were women and the median age was 31 years (IQR 26-38 years). Over 292 client-months of follow-up, 41 clients (39%) refilled PrEP; only three (3%) at a participating pharmacy. All clients who completed IDIs refilled PrEP at clinics. The reasons why clients did not refill PrEP at pharmacies included: a preference for clinic-delivered PrEP services (i.e., pre-existing relationships, access to other services), concerns about pharmacy-delivered PrEP services (i.e., mistrust, lower quality care, costs), and lack of knowledge of this refill location.
CONCLUSIONS: These findings suggest that clients who initiate PrEP at public clinics in Kenya may have already overcome barriers to clinic-delivered PrEP services and prefer PrEP access there. To reach new populations that could benefit from PrEP, a stand-alone model of pharmacy-delivered PrEP services may be needed.
BACKGROUND: ClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

Young MSM (YMSM), aged 15-24, account for nearly half of new HIV infections in Thailand. Pre-exposure prophylaxis (PrEP) is an effective prevention medicine for populations at substantial HIV risk, yet YMSM frequently have suboptimal uptake of and adherence to PrEP. We conducted 35 in-depth interviews with YMSM to explore barriers and facilitators of both PrEP initiation and adherence. Interviews also elicited the perceptions and experiences of healthcare providers (HCPs) working with YMSM at three clinics in Bangkok. Primary barriers to PrEP initiation were limited accessibility, insufficient knowledge, and efficacy concerns; HCPs identified no-to-low self-perception of HIV risk, pre-existing health problems, fears of side effects, and living in distant provinces as barriers to PrEP initiation. YMSM primarily reported PrEP information and self-perceptions of elevated HIV risk as facilitators to PrEP initiation. Additionally, forgetfulness and low HIV risk awareness were common barriers to PrEP adherence. Reminders were a prominent facilitator of PrEP adherence alongside disclosure to close relationships, the routinization of regimens, and convenient facilities. HCPs regarded counseling as the leading facilitator of PrEP adherence. By understanding the barriers/facilitators of PrEP use, the current study seeks to help develop evidence-informed PrEP intervention programs among YMSM while considering cultural sensitivity.

Peer-to-peer chain recruitment has been used for descriptive studies, but few intervention studies have employed it. We used this method to enroll sexually active women ages 18 to 25 into an online Pre-Exposure Prophylaxis (PrEP) information and motivation intervention pilot in eThekwini (Durban), South Africa. Seeds (N = 16) were recruited by study staff and randomized to Masibambane, Ladies Chat, a Gender-Enhanced group-based WhatsApp Workshop (GE), or Individual-Access (IA), a control condition that provided participants with online information/motivation materials only. Each seed could recruit up to three women to participate in the same study condition, with an incentive for each enrolled woman; participants in subsequent waves could choose to recruit or not. We evaluated if peer-to-peer recruitment was self-sustaining and resulted in enrolling women who, in subsequent waves, had less contact with the health care system and less knowledge about PrEP than the initial seeds. Over three recruitment waves beyond the seeds, 84 women were recruited. Almost 90% of women became recruiters, with each recruiting on average 1.90 women and 1.26 eligible enrolled women. The approach was successful at reaching women with less education but not women with less health system contact and PrEP knowledge across waves. IA participants had a slightly higher, though non-significantly different, percentage of individuals who became Peer Health Advocates (PHAs) than GE participants and, on average, they recruited slightly more women who enrolled. Our findings demonstrated that peer-to-peer recruitment is a feasible and self-sustaining way to recruit SA young women into a PrEP intervention study.

BACKGROUND: Pre-exposure Prophylaxis (PrEP) and Treatment as Prevention (TasP) are effective strategies to prevent HIV transmission within serodifferent couples. However, limited usage of PrEP, knowledge and interest has been amongst the barriers for men, alongside testing and treatment adherence. We explored the perceptions of PreP for HIV prevention with Men living with HIV (MWH) who have reproductive goals, to understand awareness and experiences related to PrEP use in the context of HIV prevention with their partners.
METHODS: We undertook a qualitative study with 25 MWH aged 18 to 65 between April and September 2021 in South Africa. Potential participants were screened for eligibility and scheduled to participate in telephonic interviews. Interviews were audio recorded, transcribed, translated and thematically analysed.
RESULTS: Themes were organized into opportunities and barriers that men with HIV articulate as important for using PrEP to meet individual, couple, and community reproductive goals. At the individual level, some men were willing to discuss PrEP with their partners to protect their partners and babies from acquiring HIV. Lack of knowledge about PrEP among men was a potential barrier to promoting PrEP among their female partners. At the couple level, PrEP use was seen as a way to strengthen relationships between partners, signifying care, trust, and protection and was seen as a tool to help serodifferent couples meet their reproductive goals safely. At the community level, PrEP was viewed as a tool to promote HIV testing and prevention efforts, especially among men, but participants emphasized the need for more education and awareness.
CONCLUSIONS: Despite PrEP implementation in South Africa, awareness of PrEP among men with HIV in rural areas remains low. Engaging MWH to support their partners in accessing PrEP could be an innovative strategy to promote HIV prevention. Additionally, providing men with comprehensive reproductive health information can empower them to make more informed decisions, adopt safer sexual practices, and challenge societal norms and stigmas around HIV.

BACKGROUND: Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women.
METHODS: The Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16-24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16-24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants\' perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention\'s fidelity and cost.
CONCLUSIONS: Evidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings.
BACKGROUND: ClinicalTrials.gov NCT04982250. Registered on July 29, 2021.

Antiretroviral pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV. Despite its promise, PrEP use is low, especially among young Black men who have sex with men (YBMSM). The prevalence of HIV in Mississippi (MS) is among the highest in the United States, with the bulk of new infections occurring amongst YBMSM living in Jackson, MS. We recruited 20 PrEP-eligible YBMSM and 10 clinic staff from MS health clinics between October 2021 and April 2022. Data were collected remotely using in-depth interviews and a brief survey, which lasted approximately 45-60 min. Interview content included PrEP knowledge/experiences, HIV risk perception, and PrEP use barriers and facilitators. Qualitative data were coded then organized using NVivo. Using thematic analysis methodology, data were assessed for current barriers to PrEP use. An array of barriers were identified by participants. Barriers included structural factors (cost of PrEP, lack of discreet clinics, time commitment, competing interests); social factors (unaware of HIV risk, stigma and homophobia, fear that partners would find out about PrEP use, not knowing anyone on PrEP); behavioral factors (sexual risk factors, denial, less priority for prevention vs treatment); and clinical factors (misunderstood side effects, fear PrEP won\'t work). Significant barriers to PrEP use among YBMSM stem from structural, social, behavioral, and clinical factors. These results will inform intervention efforts tailored to mitigate barriers and improve PrEP uptake among YBMSM in the southern United States.