Longitudinal relationship between pre-exposure prophylaxis motivation and change in adherence among men who have sex with men in Western China.

INTRODUCTION: The efficacy of pre-exposure prophylaxis (PrEP) is highly dependent on adherence, and adherence behavior is influenced by motivation. The aim of this study was to explore the longitudinal relationship between PrEP motivation and change in adherence among men who have sex with men (MSM) in Western China. METHODS: From November 2019 to June 2021, we conducted a PrEP prospective cohort study. Motivation to take medicine was measured by the PrEP Motivation Scale at baseline, and was grouped into different levels of latent categories by Latent Profile Analysis (LPA). A multinomial logistic regression model was used to explore the longitudinal relationship between change in adherence (improvement, decline, no change) and different levels of PrEP motivation. RESULTS: MSM were divided into two categories of PrEP motivation, a "high motivation group" (n = 506, 69.89%) and a "low motivation group" (n = 218, 30.11%). High PrEP motivation had no significant effect on the change in short-term adherence, however, it contributed to the improvement in long-term adherence [odds ratio (OR) = 3.028 (1.100-8.332), p = 0.031]. The predictive power of the adherence model was significantly enhanced with the addition of the PrEP motivation factor. CONCLUSIONS: There was a positive correlation between high PrEP motivation at baseline and an improvement in long-term adherence. Surveillance and intervention of PrEP motivation in MSM can increase their adherence, and then promote PrEP efficacy.

Factors associated with university students' knowledge about HIV and preand post-exposure prophylaxis.

OBJECTIVES: to analyze the factors associated with university students' knowledge about HIV and preand post-exposure prophylaxis. METHODS: a cross-sectional study was conducted with 503 university students from a southern state in Brazil; data were collected using a characterization tool and a questionnaire containing 16 statements about the topic; descriptive measures and Poisson regression models with robust variance were used for analysis. RESULTS: the prevalence of adequate knowledge (i.e., scoring more than 12 correct answers) was 27.83%; students older than 24 years, enrolled in health-related courses, who had not engaged in sexual relations in the last quarter, with a history of rapid HIV testing, and who knew or had heard about the prophylaxes showed a higher likelihood of scoring more than 12 correct answers. CONCLUSIONS: generally, the knowledge of young people about HIV and its prophylaxes was found to be inadequate and influenced by sociodemographic, educational, and behavioral factors.

Knowledge and Attitudes About HIV Pre-Exposure Prophylaxis Among Sexually Active Black and Latina Cisgender Women: Findings from the 2017 and 2018 New York City Sexual Health Survey.

Pre-exposure prophylaxis (PrEP) is a highly effective tool to prevent HIV, yet it is underutilized among women. The current study aims to evaluate the awareness, attitudes, and perceptions of PrEP among a large survey sample of Black and Latina women in New York City (NYC). Interviewer-administered surveys were conducted in high HIV incidence neighborhoods in NYC among Black, Latina, and Afro-Latina women who reported recent sex with a man in 2017 (n = 398) and 2018 (n = 405). About 40% of participants were aware of PrEP, whereas 30.4% indicated interest in using it. The top reason for not utilizing it was low HIV risk perception. However, most participants supported the idea that using PrEP meant asserting control over their health (94.1%). Primary care providers and obstetricians/gynecologists were participants' preferred sources for PrEP (91.6%). Across survey cycles, compared to non-Black Latina participants, Black participants had significantly higher PrEP awareness (44.4% vs. 29.1%). PrEP awareness was also significantly higher among survey participants in 2018 (45.2%) than in 2017 (34.3%). Less than half of the participants were aware of PrEP, but those who were aware expressed largely positive attitudes toward the medication. Our findings may inform future PrEP implementation strategies to optimize awareness and access to PrEP among women disproportionately affected by HIV, like focusing on personal empowerment instead of risk-based messaging and training women's sexual health care providers in PrEP provision.

Mixed-methods protocol for the WiSSPr study: Women in Sex work, Stigma and psychosocial barriers to Pre-exposure prophylaxis in Zambia.

INTRODUCTION: Women engaging in sex work (WESW) have 21 times the risk of HIV acquisition compared with the general population. However, accessing HIV pre-exposure prophylaxis (PrEP) remains challenging, and PrEP initiation and persistence are low due to stigma and related psychosocial factors. The WiSSPr (Women in Sex work, Stigma and PrEP) study aims to (1) estimate the effect of multiple stigmas on PrEP initiation and persistence and (2) qualitatively explore the enablers and barriers to PrEP use for WESW in Lusaka, Zambia. METHODS AND ANALYSIS: WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). We will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). We will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. We seek to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. ETHICS AND DISSEMINATION: WiSSPr was approved by the Institutional Review Boards of the University of Zambia (#3650-2023) and University of North Carolina (#22-3147). Participants must give written informed consent. Findings will be disseminated to the CAB, who will determine how to relay them to the community and stakeholders.

Increasing providers' PrEP prescription for Black cisgender women: A qualitative study to improve provider knowledge and competency via PrEP training.

BACKGROUND: Awareness and uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) remains low among Black/African American cisgender women, partly due to low self-reported PrEP knowledge and comfort among primary care providers. Ensuring providers are trained on PrEP is crucial, as increased PrEP knowledge is associated with higher rates of PrEP prescription. OBJECTIVE: We aimed to develop a PrEP training for providers to improve their self-efficacy in discussing and prescribing PrEP for Black women, with the ultimate goal of increasing PrEP awareness and utilization among Black women. DESIGN: In this qualitative study, we conducted focus groups with medical providers at three federally qualified health centers in the Southern and Midwestern United States to identify themes informing the development of a provider PrEP training. METHODS: Providers were asked for input on content/design of PrEP training. Transcripts underwent rapid qualitative analysis using the Stanford Lightning Report Method. Themes were identified and presented under the domains of the Consolidated Framework for Implementation Research. RESULTS: Ten providers completed four focus groups. Themes included the individual characteristics of providers (low comfort initiating PrEP discussions, particularly among White providers) and the outer setting of client attitudes (perceptions of potential provider bias/racism, varying levels of concern about HIV acquisition). Opportunities were identified to maximize the benefit of training design (e.g., developing case scenarios to enhance providers' cultural competency with Black women and PrEP knowledge). CONCLUSION: This comprehensive PrEP training features both didactic material and interactive role-plays to equip providers with the clinical knowledge for prescribing PrEP while building their competency discussing PrEP with Black women. This training is particularly important for providers who have racial or gender discordance with Black women and express lower comfort discussing PrEP with these clients. Provider training could lead to minimizing racial- and gender-based inequities in PrEP use.

Increasing the use of pre-exposure prophylaxis (PrEP) among Black women: a study to improve provider knowledge through PrEP trainingWhy was the study done? Use of pre-exposure prophylaxis (PrEP), a medication that can prevent the transmission of human immunodeficiency virus (HIV), is low among Black/African American women. Part of the reason why is because primary care providers (PCPs) report lower knowledge about PrEP and lower comfort talking about PrEP with clients. Making sure PCPs are trained on PrEP could help increase PrEP use among Black women. What did the researchers do? The research team held focus groups, during which they asked medical providers at federally qualified health centers (FQHCs) in the Southern and Midwestern United States questions about their experiences with discussing PrEP and what information should be included in a training about PrEP for providers to make sure the training would be helpful for them. What did the researchers find? A total of ten providers completed four focus groups. Important points mentioned in the focus groups included low comfort among providers when bringing up PrEP to clients, especially among White providers, as well as different levels of concern about HIV and feelings of potential provider bias/racism among clients. These points helped the researchers design a PrEP training that addresses providers' needs (such as creating case scenarios that help providers practice discussing PrEP with Black women and answering common questions about PrEP). What do the findings mean? A PrEP training for providers should have both information about prescribing PrEP and interactive role-plays to build providers' PrEP knowledge while improving their confidence and skill in talking about PrEP with Black women. This training is particularly important for providers who are a different race or gender than Black women and express lower rates of comfort discussing PrEP with these clients. Provider training could eventually lead to higher PrEP use among Black women.

Associations Between PrEP Stigma, PrEP Confidence, and PrEP Adherence: Conditional Indirect Effects of Anticipated HIV Stigma.

BACKGROUND: Research has linked stigma surrounding preexposure prophylaxis (PrEP) to poor HIV prevention outcomes, including PrEP adherence. However, there remains a limited understanding of the mechanisms through which PrEP stigma affects PrEP adherence, specifically among sexual and gender minority (SGM) youth. In this study, we aimed to investigate the indirect effect of PrEP stigma on PrEP adherence through PrEP confidence and the moderating role of anticipated HIV stigma. METHODS: Participants included 235 SGM youth, assigned male sex at birth, aged 16-24, and self-reported HIV-negative, with an active PrEP prescription from the Prepared, Protected, emPowered randomized controlled trial. Participants were recruited from 9 clinics in the United States between 2019 and 2021. Using baseline data, we tested cross-sectional indirect and conditional indirect effects using the Statistical Package for the Social Sciences Process with confidence intervals and 2000 resamples. RESULTS: We found significant indirect effects, suggesting that PrEP stigma was negatively associated with PrEP confidence, which in turn resulted in both monthly and weekly optimal PrEP adherence (Indirect effects: B = -0.11, Standard Error [SE] = 0.05, CI: [-0.244 to -0.032]; B = -0.09, SE = 0.04, CI: [-0.191 to -0.014], respectively). Anticipated HIV stigma moderated these indirect effects (B = -0.11, SE = 0.08, CI: [-0.315 to -0.001]; B = -0.09, SE = 0.06, CI: [-0.245 to -0.001], respectively), suggesting that the conditional indirect effects were significant at high but not low levels of anticipated HIV stigma. CONCLUSION: Results suggest that SGM youth who are on PrEP anticipating HIV stigma experience a compounding effect of PrEP stigma on PrEP confidence, consequently leading to suboptimal adherence. Interventions addressing the intersectionality of PrEP and HIV stigmas and enhancing confidence could improve PrEP adherence, particularly among SGM youth.

Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial.

BACKGROUND: Peer-delivered HIV self-testing (HIVST) and sexually transmitted infection self-sampling (STISS) may promote adherence to oral pre-exposure prophylaxis (PrEP), but no studies have analyzed this approach among transgender women (TGW) in sub-Saharan Africa. SETTING: The Peer study was a cluster randomized trial in Uganda (October 2020-July 2022; NCT04328025). METHODS: Ten TGW peer groups, each with 1 TGW peer and 8 TGW, were randomized 1:1 to receive quarterly in-clinic HIV testing with PrEP refills as standard-of-care (SOC) or SOC plus monthly peer delivery of oral-fluid HIVST, STISS, and PrEP refills (intervention). Participants were followed for 12 months. The primary outcome was PrEP adherence. RESULTS: We screened 85 TGW and enrolled 82 (41 per arm). The median age was 22 years (interquartile range [IQR] 20-24). Twelve-month retention was 88% (72/82). At the 3, 6, 9, and 12-month clinic visits, 10%, 5%, 5%, and 0% of TGW in the intervention arm had TFV-DP levels ≥700 fmol/punch, versus 7%, 15%, 7%, and 2% in the SOC arm, respectively (P = 0.18). At all visits, any detectable TFV-DP levels were significantly higher in SOC than the peer delivery group (P < 0.04). PrEP adherence was associated with sex work (incidence rate ratio 6.93; 95% CI: 2.33 to 20.60) and >10 years of schooling (incidence rate ratio 2.35; 95% CI: 1.14 to 4.84). There was a strong correlation between tenofovir detection in dried blood spots and urine (P < 0.001). No HIV seroconversions occurred. CONCLUSIONS: Peer-delivered HIVST and STISS did not increase low levels of oral PrEP adherence among TGW in Uganda. Long-acting PrEP formulations should be considered for this population.

A Mixed Methods Evaluation of Pharmacists' Readiness to Provide Long-Acting Injectable HIV Pre-exposure Prophylaxis in California.

BACKGROUND: Pre-exposure prophylaxis (PrEP) uptake remains low among people who could benefit, some of whom may prefer alternatives to oral PrEP, such as long-acting injectable pre-exposure prophylaxis (LAI-PrEP). We evaluated the potential for LAI-PrEP provision in pharmacies through a mixed methods study of pharmacists in California, where Senate Bill 159 enables pharmacists to independently provide oral PrEP. METHODS: In 2022-2023, we conducted an online cross-sectional survey of California pharmacists and pharmacy students (n = 919) and in-depth interviews with pharmacists (n = 30), both of which included modules assessing attitudes about PrEP provision. Using log-binomial regression, we estimated prevalence ratios (PRs) comparing survey participants' willingness to provide LAI-PrEP by pharmacy- and individual-level characteristics. Qualitative interview data were analyzed using Rapid Qualitative Analysis to identify factors that may affect pharmacists' provision of LAI-PrEP. RESULTS: Half of the survey participants (53%) indicated that they would be willing to administer LAI-PrEP using gluteal injection in their pharmacy. Willingness was higher among participants who worked in pharmacies that provided vaccinations or other injections (56% vs. 46%; PR: 1.2; 95% confidence interval: 1.0-1.4) and/or oral PrEP under Senate Bill 159 (65% vs. 51%; PR: 1.3; 95% confidence interval: 1.1-1.5) than among participants whose pharmacies did not. Interviewed participants reported barriers to LAI-PrEP provision, including the need for increased training and staffing, a private room for gluteal injections, better medication access, and payment for services. CONCLUSION: Pharmacies offer a promising setting for increased LAI-PrEP access. However, pharmacists may require additional training, resources, and policy changes to make implementation feasible.

Reported Side Effects and Adherence of Daily HIV Pre-Exposure Prophylaxis Users in Ontario, Canada: An Analysis of the Ontario Pre-Exposure Prophylaxis Cohort Study.

Side effects are a common concern of current and potential HIV pre-exposure prophylaxis (PrEP) users, potentially leading to missed doses. We examined the relationship between reported side effects and adherence in the Ontario PrEP Cohort Study (ON-PrEP). In total, 600 predominantly gay (87.3%), White (65.8%), and male (95.0%) participants completed questionnaires assessing the presence and severity of five side effect categories (nausea, diarrhea, headache, abdominal pain, and "other") as well as their adherence to daily PrEP (any missed doses in the previous 4 days). In total, 175 participants (29%) ever reported experiencing side effects: most commonly diarrhea (7.5% of study visits), and most were of mild severity. Lower incomes (p = 0.01), identifying as bisexual (p = 0.04), and baseline concern about side effects (p < 0.001) were associated with ever reporting side effects. The odds of reporting any side effects decreased by a factor of 0.44 (95% confidence interval 0.25-0.80) with each additional year of PrEP use, however 1 in 10 participants still reported side effects after 1 year of use. The odds of reporting optimal adherence were 0.48 (0.28-0.83) times lower for participants reporting any side effects, 0.67 (0.51-0.89) times lower per additional side effect category reported, and 0.78 (0.65-0.97) times lower per incremental increase in side effect severity ratings. We found some evidence of interaction between side effect measures and duration of PrEP use, suggesting that these relationships were stronger for participants taking PrEP for longer. Clinicians should make efforts to ascertain patients' experience of side effects and consider risk counseling and alternative PrEP regimens to promote adherence.

Lower PrEP Retention among Young and Black Clients Accessing PrEP at a Cluster of Safety Net Clinics for Gay and Bisexual Men.

Young men of color who have sex with men are vulnerable to HIV and experience poor PrEP uptake and retention. We conducted a secondary data analysis and calculated adjusted Prevalence Odds Ratios (aPORs) for PrEP retention along with 95% CIs at 90, 180, and 360 days at an organization running safety net clinics in Texas for gay and bisexual men. We found statistically significant association with age, race, in-clinic versus telehealth appointments, and having healthcare insurance. White clients had an aPOR of 1.29 [1.00, 1.67] as compared to Black clients at 90 days. Age group of 18-24 had a lower aPOR than all other age groups except 55 or older at all three time periods. Clients who met providers in person had an aPOR of 2.6 [2.14, 3.19] at 90, 2.6 [2.2, 3.30] at 180 days and 2.84 [2.27, 3.54] at 360 days. Our findings highlight the need for population-specific targeted interventions.

Lower PrEP retention for black and young MSM in TexasOur study findings suggest that of all clients who start PrEP, Black clients and younger clients had a higher chance of not continuing PrEP as compared to White clients and older clients respectively. This analysis was done for a clinic that pre-dominantly offers services to gay and bisexual men. We also found that those who were attending clinic in person had higher chances of continuing. Further those who are insured also had higher chances of continuing.

Oral HIV pre-exposure prophylaxis use and resistance-associated mutations among men who have sex with men and transgender persons newly diagnosed with HIV in the Netherlands: results from the ATHENA cohort, 2018 to 2022.

BackgroundIn the Netherlands, HIV pre-exposure prophylaxis (PrEP) has been available since 2019. However, the extent of PrEP use prior to HIV diagnosis and development of PrEP-resistance-associated mutations (RAMs) is not known.AimWe assessed prior PrEP use and potential transmission of PrEP RAMs among men who have sex with men (MSM) and transgender persons (TGP) with a new HIV diagnosis in the Netherlands.MethodsData on prior PrEP use between 1 January 2018 and 31 December 2022 were available from the Dutch national ATHENA cohort. We assessed proportion of prior PrEP use, detected PrEP associated RAMs and assessed potential onward transmission of RAMs between 2010 and 2022 using a maximum likelihood tree.ResultsData on prior PrEP use were available for 583/1,552 (36.3%) individuals, with 16% (94/583) reporting prior PrEP use. In 489 individuals reporting no prior PrEP use, 51.5% did not use PrEP due to: low HIV-risk perception (29%), no access (19.1%), personal preference (13.1%), and being unaware of PrEP (19.1%). For PrEP users, 13/94 (13.8%) harboured a M184V/I mutation, of whom two also harboured a K65R mutation. In people with a recent HIV infection, detection of PrEP RAMs increased from 0.23% (2/862) before 2019 to 4.11% (9/219) from 2019. We found no evidence of onward transmission of PrEP RAMs.ConclusionThe prevalence of PrEP-associated RAMs has increased since PrEP became available in the Netherlands. More widespread access to PrEP and retaining people in PrEP programmes when still at substantial risk is crucial to preventing new HIV infections.

Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial.

BACKGROUND: HIV prevention is a public health priority. Despite progress in recent years, pre-exposure prophylaxis (PrEP) use remains suboptimal especially among groups disproportionately impacted by new HIV diagnoses such as gender and sexual minorities of color. Multiple barriers including a lack of PrEP providers and challenges with attending quarterly monitoring visits contribute to low PrEP uptake and retention. Home-based PrEP (HB-PrEP) services could reduce stigma, increase convenience, expand health system capacity for PrEP care, and improve PrEP retention. OBJECTIVE: Home Option Testing for PrEP (HOT4PrEP) is a hybrid randomized controlled trial (RCT) that aims to examine whether HB-PrEP care is acceptable to PrEP users, feasible to implement in a sexual health clinic setting, and impacts PrEP retention. METHODS: The RCT will recruit 458 persons currently taking or soon to initiate PrEP at a sexual health clinic in Seattle, Washington, and randomize them to continue the standard of care or have the option to use HB-PrEP for 2 of 3 triannual PrEP follow-up visits. Participants in the intervention arm will be sent home kits containing gonorrhea and chlamydia swabs and Tasso devices for blood self-collection. The primary outcome is PrEP retention between groups at 20 months; secondary outcomes include user satisfaction and acceptability, feasibility, self-reported PrEP adherence, and sexually transmitted infection (STI) incidence. Interviews with PrEP users and clinic staff will elucidate barriers and facilitators of implementation. RESULTS: The HOT4PrEP RCT began enrolling in March 2022, was on hold during the height of the US mpox epidemic, then resumed enrollment in December 2022. Of the first 100 enrollees, the median age is 34 years, and most are cisgender gay men (89/100, 89%) with at least some college education (91/100, 91%). Among the 49 participants randomized to the HB-PrEP option, 33 (67%) chose to self-collect samples at home at least once, of whom 27 (82%) successfully returned test kits for HIV and STI testing. Primary PrEP retention and qualitative analyses are ongoing. CONCLUSIONS: Implementation of HB-PrEP into a high-volume sexual health clinic seems to be feasible and acceptable to early RCT enrollees. This strategy has the potential to address individual and systemic barriers associated with initiating and persisting on PrEP, such as increasing sexual health agency and expanding clinical capacity to serve greater numbers of PrEP users. TRIAL REGISTRATION: ClinicalTrials.gov NCT05856942; https://clinicaltrials.gov/study/NCT05856942. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56587.

A PrEP decision aid for women survivors of intimate partner violence: Task-shifting implementation to domestic violence service settings.

BACKGROUND: Women exposed to intimate partner violence (IPV) experience multiple social and structural barriers to accessing HIV pre-exposure prophylaxis (PrEP), despite being at increased risk for HIV. In addition, few existing HIV prevention interventions address IPV. A recently developed PrEP decision aid for women has the potential to reach IPV survivors at risk for HIV if it could be integrated into existing domestic violence agencies that prioritize trust and rapport with female IPV survivors. Leveraging non-traditional service delivery mechanisms in the community could expand reach to women who are IPV survivors for PrEP. METHODS: We conducted qualitative interviews and online qualitative surveys with 33 IPV survivors and 9 domestic violence agency staff at two agencies in Connecticut. We applied the Consolidated Framework for Implementation Research (CFIR) to understand barriers and facilitators to delivering a novel PrEP decision aid to IPV survivors in the context of domestic violence service agencies. RESULTS: Most IPV survivors and agency staff thought the PrEP decision aid intervention could be compatible with agencies' existing practices, especially if adapted to be trauma-responsive and delivered by trusted counselors and staff members. PrEP conversations could be packaged into already well-developed safety planning and wellness practices. Agency staff noted some concerns about prioritizing urgent safety needs over longer-term preventive health needs during crisis periods and expressed interest in receiving further training on PrEP to provide resources for their clients. CONCLUSIONS: IPV survivors and agency staff identified key intervention characteristics of a PrEP decision aid and inner setting factors of the service agencies that are compatible. Any HIV prevention intervention in this setting would need to be adapted to be trauma-responsive and staff would need to be equipped with proper training to be successful.

Perspectives on a peer-driven intervention to promote pre-exposure prophylaxis (PrEP) uptake among men who have sex with men in southern New England: a qualitative study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is a highly effective pharmaceutical intervention that prevents HIV infection, but PrEP uptake across the US has been slow among men who have sex with men (MSM), especially among Black/African American (B/AA) and Hispanic /Latino (H/L) MSM. This study investigates the acceptability and essential components of a peer-driven intervention (PDI) for promoting PrEP uptake among MSM, with a specific focus on B/AA and H/L communities. METHODS: We conducted 28 semi-structured, qualitative interviews with MSM in southern New England to explore the components of a PDI, including attitudes, content, and effective communication methods. A purposive sampling strategy was used to recruit diverse participants who reflect the communities with the highest burden of HIV infection. RESULTS: Of 28 study participants, the median age was 28 years (interquartile range [IQR]: 25, 35). The sample comprised B/AA (39%, n = 11) and H/L (50%, n = 14) individuals. Notably, nearly half of the participants (46%) were current PrEP users. We found that many participants were in favor of using a PDI approach for promoting PrEP. Additionally, several participants showed interest in becoming peer educators themselves. They emphasized the need for strong communication skills to effectively teach others about PrEP. Moreover, participants noted that peer education should cover key topics like how PrEP works, how effective it is, and any possible side effects. CONCLUSIONS: Our study shows that effective PDIs, facilitated by well-trained peers knowledgeable about PrEP, could enhance PrEP uptake among MSM, addressing health disparities and potentially reducing HIV transmission in B/AA and H/L communities.

Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol.

BACKGROUND: Incident HIV during the perinatal period significantly impedes elimination of Mother-to-Child HIV Transmission (eMTCT) efforts. Pre-Exposure Prophylaxis (PrEP) effectively reduces HIV acquisition, and new agents like injectable Cabotegravir (CAB-LA) offer potential advantages for pregnant and breastfeeding women. The Pregnancy, Infant, and Maternal health Outcomes (PrIMO) study will compare rates of composite adverse pregnancy outcomes, and infant adverse events, growth and neurodevelopment between mother-infant dyads receiving CAB-LA and those receiving oral PrEP in Malawi. METHODS: PrIMO is an observational cohort study involving: (1) the development of a PrEP Pregnancy Registry for longitudinal surveillance of pregnant women on PrEP in Malawi; and (2) the enrolment of a prospective safety cohort of 621 pregnant women initiating oral PrEP or CAB-LA and their subsequent infants. The registry will include all women continuing or initiating PrEP during pregnancy across targeted sites in Lilongwe and Blantyre districts. The safety cohort will enrol a subset of those women and their infants from Bwaila District Hospital in Lilongwe, Malawi. We hypothesize that CAB-LA's safety will be comparable to daily oral PrEP regarding adverse pregnancy outcomes, maternal/infant adverse events, and infant development. Participants in the cohort will choose either oral PrEP or CAB-LA and will be followed until 52 weeks post-delivery. Safety data will be collected from all mother-infant pairs and qualitative interviews will be conducted with a subset of purposively selected women (n = 50) to assess the acceptability of each PrEP modality. DISCUSSION: The PrIMO study will provide critical data on the safety of CAB-LA in pregnant and breastfeeding women and their infants. Results will guide clinical recommendations as the Malawi Ministry of Health prepares for the rollout of CAB-LA to this population. Evaluation of Registry implementation will inform its expansion to a nationwide safety monitoring system for PrEP use during pregnancy, with implications for similar systems in the region. TRIAL REGISTRATION NUMBER: NCT06158126. The study was prospectively registered (5 December 2023) in ClinicalTrials.gov.

Awareness of, willingness to use, and experiences with Pre-exposure prophylaxis among youth in Nigeria.

BACKGROUND: Youth (ages 14-24) in Nigeria have disproportionately high rates of new HIV infection. Pre-exposure prophylaxis could substantially reduce new infections among youth but has not been scaled up. This cross-sectional study aimed to assess Pre-exposure prophylaxis awareness, willingness to use, and prior use of Pre-exposure prophylaxis among youth in Nigeria. METHODS: This is a secondary analysis of cross-sectional data from a quasi-experimental pilot study (clinical trial NCT04070287). The analysis focused on Pre-exposure prophylaxis awareness, willingness to use, and prior use among 324 youth recruited between September 2019 to March 2020. Descriptive statistics were calculated as frequencies and percentages for categorical variables and means and standard deviations for continuous variables. RESULTS: Of the 324 participants, the mean age and standard deviation were 21.17 (± 2.20) years. The majority were 20-24 years old (75.9%) and male (57.7%). Only 30.7% used condoms consistently over three months. Regarding Pre-exposure prophylaxis awareness and willingness, 62.6% had never heard of Pre-exposure prophylaxis, and 158 (50.1%) reported willingness to use Pre-exposure prophylaxis. Only 10 (3.2%) reported having used Pre-exposure prophylaxis. CONCLUSION: Nigerian youth have low awareness of and prior use of Pre-exposure prophylaxis. Given the gap between prior use and willingness to use Pre-exposure prophylaxis, our findings suggest missed opportunities to prevent new HIV infections among youth in Nigeria. Efforts to increase awareness and uptake of Pre-exposure prophylaxis among this population should consider youth-led Pre-exposure prophylaxis outreach efforts and effectively communicate the benefits of Pre-exposure prophylaxis to this population. TRIAL REGISTRATION: NCT04070287, the Date of registration of the trial is 20-07-2019.

Formalized peer referral to HIV pre-exposure prophylaxis supported with self-testing: a mixed-methods pilot study among young Kenyan women.

Background: The uptake of daily oral HIV pre-exposure prophylaxis (PrEP)-a highly effective intervention-remains low among African adolescent girls and young women (AGYW) who could benefit. AGYW who initiate PrEP often do so through informal peer referral, which may be enhanced with formalized peer referral and peer-delivered HIV self-testing (HIVST). To understand the feasibility of this PrEP referral model among AGYW, we conducted a pilot study in Kenya. Method: From March to May 2022, we recruited AGYW (≥16-24 years) using PrEP (i.e., "peer providers") from public healthcare clinics in Kiambu County and trained them on HIV prevention, HIVST use, and peer-supported linkage to clinic-based HIV services. Following training, peer providers received eight HIVST kits and were encouraged to refer four peers (i.e., "peer clients") to PrEP. We completed surveys with peer providers and clients one month following intervention delivery to assess PrEP initiation among peer clients. Later, we conducted focus group discussions (FGDs) with peer providers and clients to identify factors that facilitated or challenged intervention outcomes. Results: We trained 16 peer providers (median age: 23 years, IQR 21-24) who reported delivering the intervention to 56 peer clients; 30 peer clients (median age: 21 years, IQR 19-22) contacted the study team and were enrolled. Most of the enrolled peer clients reported behaviors associated with HIV risk (e.g., condomless sex; 80%, 24/30) and were PrEP-naïve (87%, 26/30). At one-month, PrEP initiation among eligible PrEP-naïve peer clients was high, as reported by providers (78%, 43/55) and clients (85%, 22/26); recent HIVST use was also high among peer clients (provider report: 95%, 53/56; client report: 97%, 29/30). In the FGDs, participants reported that intervention outcomes were facilitated by close preexisting relationships, HIVST assistance, and being escorted to clinic-based HIV services by peer providers; intervention barriers included conflicting priorities and limited HIVST experience. Conclusion: A formalized model of peer referral with HIVST delivery supported PrEP initiation among Kenyan AGYW. These findings demonstrate the potential for peer-delivered interventions to engage AGYW in HIV prevention services; however, more research is needed on the effectiveness and sustainability of this approach at scale.

PrEP discontinuation, cycling, and risk: Understanding the dynamic nature of PrEP use among female sex workers in South Africa.

PrEP cycling among women is thought to be safe when there are distinct "seasons of risk." However, cyclical PrEP use over short periods may be associated with increased risk of HIV acquisition. We aimed to characterize key social ecological factors contributing toward PrEP cycling among female sex workers (FSW) in the context of high HIV risk. Semi-structured, in-depth interviews were conducted with 36 FSW at risk for HIV acquisition and 12 key informant (KI) service providers in eThekwini (Durban), South Africa from January-October 2020. FSW identified key factors driving temporary discontinuation of PrEP including relocation, lack of information on or difficulty coping with side effects, and delays in accessing PrEP. In many cases, FSW were motivated to restart PrEP once barriers were overcome. In contrast, KIs emphasized the importance of individual adherence to PrEP and reliance on personal risk assessments when counselling FSW on cycling decisions. FSW and KI perspectives highlight a disconnect between providers' recommendations on the potential for cyclical use of PrEP during periods of minimal risk and actual drivers among FSW causing temporary PrEP discontinuation. Further interventions supporting safe PrEP cycling are needed to ensure decisions around cycling are deliberate and guided by changes in HIV risk rather than external factors.

Perception and barriers to access Pre-exposure Prophylaxis for HIV/AIDS (PrEP) among the MSM (men who have sex with men) Brazilian Amazon: A qualitative study.

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy that consists in the use of antiretroviral drugs by seronegative people at risk of HIV. Negative perceptions, inadequate understanding, and access barriers have been associated with decreased medication adherence. Manaus is the largest city in the Brazilian Amazon, where the incidence of HIV/AIDS is high, and the rates of adherence to the antiretroviral treatment for HIV and PrEP are low. In this qualitative study among PrEP users, mostly MSM, we explored perceptions, knowledge, and access barriers. We conducted 21 in-depth interviews with an intentionally sampled group of participants who had used PrEP at least once in their lifetime, selected through the snowball technique, between April and July 2022. A thematic analysis was conducted with a predominantly inductive approach. We highlight three relevant themes: (i) access to information about PrEP and its influences on users, (ii) access, monitoring, and barriers encountered, and (iii) facilitators for PrEP adherence and sexual behaviors. One of the negative perceptions identified in the study involves a misunderstanding of the association between PrEP users and the HIV/AIDS status. Participants revealed that some non-PrEP users suspect that individuals claiming PrEP usage are concealing an HIV-positive status to engage in unprotected sex. Lack of information by health professionals regarding HIV prevention methods poses significant barriers to PrEP access and adherence. Participants emphasized social media's crucial role in PrEP awareness. The results suggest a need to increase digital outreach regarding PrEP, decentralize PrEP services, and provide comprehensive healthcare training to improve the effectiveness of the preventive measure.