Youth-friendly services was the magic: Experiences of adolescent girls and young women in the community PrEP study, South Africa.

Adherence to daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been challenging for adolescent girls and young women (AGYW). As part of The Community PrEP Study (CPS), AGYW were randomised to HIV-prevention empowerment counselling (intervention) or basic medication pick-up (control). In this qualitative sub-study, we interviewed AGYW participants (n = 39) to explore PrEP use and study experiences by study arm, and study staff (n = 7) to explore study implementation, site environment, and participant engagement. Data were thematically analysed using a constant comparison approach. Comparative matrices assessed similarities and differences in study experiences and PrEP support preferences. Friendly, non-judgmental, non-stigmatizing study staff were described as central to participant's positive experiences. Participants highly valued CPS staff's holistic health support (e.g. physical and psycho-social). Intervention participants described empowerment counselling as helpful in supporting PrEP disclosure. However, control participants also described disclosing PrEP use to trusted individuals. Participants and staff recommended public-sector PrEP services provide holistic, confidential, and integrated sexual and reproductive health services, and community sensitisation. An adolescent and youth-friendly environment was the primary factor motivating AGYW's study engagement. While HIV-prevention empowerment counselling was well received, welcoming, respectful and non-judgmental staff may be the 'secret sauce' for implementing effective PrEP services to AGYW.

The relationship between anti-LGBTQ+ legislation and HIV prevention among sexual and gender minoritized youth.

OBJECTIVE: Estimate the longitudinal associations of state-level anti-LGBTQ+ policies and county-level politics with individual HIV prevention outcomes among sexual and gender minoritized (SGM) youth. DESIGN: Keeping it LITE-1 prospectively enrolled 3,330 SGM youth and young adults (ages 13-34) at increased risk of HIV throughout the United States from 2017-2022. METHODS: Semiannual surveys collected self-reported HIV prevention measures (current PrEP use, weekly PrEP adherence, HIV/STI testing in the past 6 months). Geolocation was linked with state-level LGBTQ+ policy data and county-level election data. Generalized linear models with GEE estimated the single and joint longitudinal associations for 2 exposures [state-level policy climate (more discriminatory vs. less discriminatory) and county-level political majority (Democratic/swing vs. Republican)] with each outcome. RESULTS: Among participants living in a state with more discriminatory laws, those in a Democratic/swing county had a 6-percentage point increase in PrEP use (95% CI: 0.02, 0.09) compared to those in a Republican county. Those living in a Republican county but a state with less discriminatory laws saw a similar increase (0.05; -0.02,0.11). Residing in both a Democratic/swing county and a state with less discriminatory laws, relative to a Republican county and a state with more discriminatory laws, was associated with a 10-percentage point increase in PrEP use (0.10; 0.06,0.14) and a 5-percentage point increase in HIV/STI testing (0.05; 0.00,0.09). CONCLUSIONS: More progressive state and local policies were each associated with increased PrEP use, and together, doubled the magnitude of this association. PrEP is underutilized among SGM youth, and anti-LGBTQ+ policies may exacerbate this gap in coverage.

High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa.

In Southern and Eastern Africa, initiation of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been high among adolescent girls and young women (AGYW) offered PrEP. However, persistence and prevention-effective use of PrEP among this critical group continues to be a challenge. We conducted a qualitative sub-study of AGYW from the Community PrEP Study in Eastern Cape Province, South Africa who had high rates of pick up for monthly PrEP refills over two years, but differing levels of PrEP adherence based on tenofovir-diphosphate (TFV-DP) measurements in dried blood spots (DBS). Contrasting 22 AGYW with low versus high levels of TFV-DP in DBS, we qualitatively explored factors which influenced PrEP persistence vs. non-persistence, unique patterns of PrEP use (e.g., discarding or stockpiling), and participant recommendations for improving AGYW prevention-effective use of PrEP in the future. Results showed that PrEP misconceptions and mistrust among participants' social networks negatively influenced adherence. In comparison, supportive families and/or partners and personal trust that PrEP works positively influenced adherence. Those with low adherence described being motivated to come to the site for other study benefits (e.g., reimbursement money, snacks, sanitary pads) and discarding PrEP to avoid stigma associated with being seen with pills. Future PrEP implementation strategies should focus on involving families and partners in PrEP support for AGYW and minimizing PrEP stigma at a community level.Trial registration NCT03977181. Retrospectively registered on June 6, 2019.

Daily Oral HIV Pre-exposure Prophylaxis Among Young Men Who Have Sex With Men in the United States: Cost-saving at Generic Drug Price.

BACKGROUND: Adherence and retention concerns raise questions about the effectiveness and cost-effectiveness of oral HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). METHODS: Using an adolescent-focused simulation model, we compared annual HIV screening alone with tenofovir disoproxil fumarate/emtricitabine-based oral PrEP with every 3-month HIV screening in YMSM (aged 15-24) at increased risk of HIV. Data derived from published sources included: age-stratified HIV incidence/100 person-years (PY) on- or off-PrEP (0.6-10.1 or 0.4-6.4), PrEP retention at 6 years (28%), transmissions by HIV RNA level (0.0-78.4/100PY) and annual costs of antiretroviral therapy ($32 000-69 000), HIV care ($3100-34 600), and PrEP program/generic drug ($900/360). Outcomes included transmissions (percent of cohort infected), quality-adjusted life-years (QALYs), costs ($), and incremental cost-effectiveness ratios ($/QALY). We explored the sensitivity of findings to variation in HIV incidence and drug prices. RESULTS: Compared with annual screening alone, PrEP would increase QALYs (9.58 to 9.67), reduce new infections (37% to 30%), and decrease costs (by $5000) over 10 years. PrEP would remain cost-saving for HIV incidence off-PrEP ≥5.1/100PY or annual PrEP price ≤$1200. Over a lifetime horizon, PrEP would be cost-saving for HIV incidence off-PrEP ≥1.0/100PY, across all retention assumptions examined. PrEP would not be cost-effective at HIV incidence ≤0.1/100PY, regardless of drug price, due to programmatic costs. CONCLUSIONS: In US YMSM at increased risk of HIV, generic oral PrEP and every-3-month screening would be cost-saving compared with annual screening alone, even with high discontinuation and low adherence, over a range of HIV incidences.

"It's already in your body and it's preventing": a qualitative study of African female adolescent's acceptability and preferences for proxy HIV prevention methods in Cape Town, South Africa.

BACKGROUND: Advances in biomedical HIV prevention will soon offer young women a choice of HIV prevention methods, including various pre-exposure prophylaxis (PrEP) modalities such as daily oral pills, dapivirine vaginal ring, and long-acting injectable agents. By understanding preferences for contraceptive methods, we may draw analogies for the HIV prevention needs of young women. The UChoose Study was an open-label randomised cross-over study designed to evaluate the acceptability and preference for several contraceptive options as a proxy for HIV prevention methods that use similar types of administration. The study enrolled healthy HIV uninfected young women aged 15 to 19 years. At enrolment, participants were randomly assigned to a contraceptive method for a period of 16 weeks in the form of monthly Nuvaring® (vaginal ring), daily combined oral contraceptive (daily pills), or bi-monthly injectable contraceptive (injectable). After 16 weeks, participants crossed over to another contraceptive method, and those who had received the injectable and the daily pills received the vaginal ring for another 16 weeks, whereas those who had received the vaginal ring were able to choose between the injectable and daily pills, to ensure that all participants tried the vaginal ring-the least familiar option to the study population. RESULTS: Thirty-three participants were purposively recruited to participate in seven focus group discussions (FGD) and completed a pre-survey for their assigned group. Our sample comprised 14 participants randomised to use of the vaginal ring and daily pills and 19 participants randomised to use of the vaginal ring and injectable. For most participants, their preferences for a prevention method were based primarily on their desire to avoid negative aspects of one method rather than their positive user experience with another method. Most participants expressed initial hesitancy for trying new contraception method products; however, a lack of familiarity was moderated by a strong interest in diverse user-controlled prevention methods. Participants valued methods that had infrequent dosing and simplified use requirements. The injection and vaginal ring were preferred over daily pills as a potential HIV prevention method. CONCLUSION: Expanding the availability of diverse products could provide adolescents with multiple choices in HIV prevention for the uninitiated. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02404038 ). Registered March 31, 2015-Registered.

How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub-Saharan Africa: a mixed methods analysis.

INTRODUCTION: Effective use of pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub-Saharan Africa. The MTN-034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings. METHODS: REACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV-negative AGYW (ages 16-21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug-level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check-ins, peer support clubs, "peer buddies" and additional counselling. Counsellors documented adherence support choices and counselling content on standardized forms. Through focus groups, serial in-depth interviews (IDIs) and single IDIs (n = 119 total), we explored participants' experiences with adherence support and how it encouraged product use. RESULTS: Participants received counselling at nearly all visits. DLF was provided at 54.3% of sessions and, across sites, 49%-68% received results showing high adherence for oral PrEP, and 73%-89% for the ring. The most popular support strategies were in-person clubs and weekly calls, followed by online clubs, additional counselling and SMS. Preferences differed across sites but were similar for both products. Qualitative results demonstrated that the REACH strategies supported adherence by providing information about HIV and PrEP, continually motivating participants, and supporting the development of behavioural skills and self-efficacy, aligning with the Information, Motivation, and Behavioural Skills (IMB) model. Effectiveness was supported by three foundational pillars: strong interpersonal relationships with counsellors; ongoing, easily accessible support and resources; and establishing trust in the counsellors and study products through counsellor relationships, peer-to-peer exchange and DLF. CONCLUSIONS: Implementation programmes could support effective PrEP use by offering a small menu of counsellor- and peer-based support options that are youth-friendly and developmentally appropriate. The same menu options can support both ring and oral PrEP users, though content should be tailored to the individual products.

Changes in Sexual Behaviors Due to Mpox: a Cross-Sectional Study of Sexual and Gender Minority Individuals in Illinois.

The spread of the monkeypox virus (mpox) in 2022 primarily within the sexual networks of men who have sex with men (MSM) triggered a potentially stigmatizing public health response in the USA. Despite mpox being primarily spread through skin-to-skin contact, most messaging has promoted abstinence and/or reduction in sexual risk behaviors. More research is needed on decreases in sexual risk behaviors among sexual and gender minority (SGM) youth and young adults (YYA) related to the most recent mpox epidemic and whether there are factors associated with these decreases in sexual risk behavior. Participants within an ongoing cohort study of SGM YYA who reside in Illinois were offered the opportunity to participate in an mpox survey between September 10th and September 20th, 2022. Analyses looked at demographic factors associated with sexual activity since the start of the outbreak, as well as associations with two sexual risk reduction factors. Survey participation was 68.7% (322/469). Three-quarters of participants (82.6%) reported sexual activity since June 1st. Most sexually active participants (83.5%) adopted at least one sexual risk reduction behavior due to mpox. Black and Latinx individuals were less likely to be sexually active but more likely to report risk reduction behaviors (31.3% and 22.6%, respectively). Participants who received the mpox vaccine were more likely to report sexual activity. SGM YYA in Illinois reported that their sexual behaviors were impacted by the mpox outbreak. However, associations between vaccination and sexual behavior demonstrate that those who are vaccinated do adopt protective methods despite not decreasing sexual activity. Therefore, sex-positive communications and harm reduction messaging may be more appropriate as opposed to abstinence-only prevention, which can further stigmatize an already marginalized group.

Monkeypox-Induced Secondary Traumatic Stress: An Exploratory Analysis of Young Sexual and Gender Minority Adults Living in Illinois.

Objective: Prior epidemic literature suggests that the rapid proliferation of Monkeypox (Mpox) within the United States may trigger severe stress reactions that increase the risk of developing secondary traumatic stress among young adults most at risk of exposure. The present exploratory study aimed to investigate the degree to which proximity to Mpox (i.e. knowing people who acquired Mpox), was associated with symptoms of secondary traumatization. Method: An online survey was administered to 253 participants enrolled in Keeping it LITE, a prospective U.S. cohort study of ethnically diverse, sexually active, sexual and gender minority persons ages 19-39 in September 2022. A multiple linear regression was used to examine the association between proximity to Mpox and secondary traumatic stress (STS) symptoms. Results: Study findings demonstrated that Mpox morbidity was low (1%); however, 37% of participants reported knowing at least one person diagnosed with Mpox. For most individuals, this person was a friend (28%). 16% of participants were found to have at least one indicator of Mpox-related STS. Results of our multiple linear regression demonstrated a positive association between an individual's indirect exposure to Mpox via their interpersonal relationships and STS symptoms. Conclusions: Findings suggest that the more adults' interpersonal relationships are saturated with people who have acquired Mpox, the more likely they are to develop symptoms of secondary traumatization. These findings provide tentative initial evidence that secondary exposure to Mpox via one's social network may undermine adults' mental health even after the conclusion of the outbreak.

Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial.

BACKGROUND: Half of new HIV acquisitions in Africa occur in adolescent girls and young women. Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate plus emtricitabine or the monthly dapivirine vaginal ring is efficacious but has lower adherence and effectiveness among adolescent girls and young women. We aimed to assess product adherence, safety, and choice of oral PrEP compared with the dapivirine ring among African adolescent girls and young women. METHODS: MTN-034/REACH was a randomised, open-label, phase 2a crossover trial among HIV-seronegative, non-pregnant adolescent girls and young women aged 16-21 years at four clinical research sites in South Africa, Uganda, and Zimbabwe. Participants were randomly assigned (1:1) to either the dapivirine ring or daily oral PrEP (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) for 6 months, then switched to the other product option for 6 months, followed by a third 6-month period in which participants were given a choice of oral PrEP, the dapivirine ring, or neither. Fixed block randomisation was used, stratified by site. The primary adherence endpoint was use of each product during the randomised periods, with high use defined as tenofovir-diphosphate concentrations greater than or equal to 700 fmol/punch (associated with taking an average of four or more tablets per week in the previous month) and greater than or equal to 4 mg dapivirine released from the returned ring (continuous use for 28 days in the previous month) based on residual drug concentrations. The primary safety endpoint was grade 2 or higher adverse events during each randomised period of 24 weeks of ring and oral PrEP. This trial is registered at ClinicalTrials.gov, NCT03593655. FINDINGS: From Feb 6, 2019 to Sept 9, 2021, 396 adolescent girls and young women were screened, 247 of whom were enrolled and randomly assigned (6 months of the ring followed by 6 months of oral PrEP n=124; 6 months of oral PrEP followed by 6 months of the ring n=123). Median age was 18 years (IQR 17-19). 54 grade 2 or higher product-related adverse events were reported during oral PrEP and five during dapivirine ring use, with no product-related serious adverse events. High adherence was observed in 753 (57%) of the 1316 oral PrEP visits and 806 (57%) of the 1407 dapivirine ring visits. Four women acquired HIV during follow-up. INTERPRETATION: Adherence was moderately high and similar between oral PrEP and the dapivirine ring with favourable safety and tolerability. Oral PrEP and the dapivirine ring are effective, safe, and well tolerated HIV prevention options for adolescent girls and young women who would benefit from a choice of PrEP formulations to meet their needs and preferences. FUNDING: National Institutes of Health.

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.

INTRODUCTION: Adolescent girls and young women (AGYW) face barriers that jeopardize their prevention-effective use of daily oral pre-exposure prophylaxis (PrEP). We sought to understand factors that influence AGYW's prolonged breaks in PrEP use, and their decisions to re-initiate or discontinue using PrEP in the context of a community-based adherence support intervention. METHODS: In-depth interviews (IDIs) were conducted between December 2019 and April 2021 with purposively selected AGYW (aged 16-25) enrolled in the Community PrEP Study (CPS) in Buffalo City Metro Health District, Eastern Cape Province, South Africa. AGYW were offered monthly PrEP for 24 months at two community-based study sites. Interview guides were informed by the Information-Motivation-Behavioural Skills Model, and data were analysed using illustrative code reports and a case analysis. RESULTS: A total of 603 participants were enrolled and initiated on PrEP in the parent study. Fifty-three IDIs were conducted with 50 CPS participants. Findings revealed that external factors (e.g. local movement, school holidays and medication side-effects) and social conflicts (e.g. discretion and partner mistrust) directly influenced breaks in PrEP usage. A decrease in one's self-perception of HIV risk prolonged the duration of these "PrEP breaks." Once PrEP refill visits were missed, some AGYW delayed returning for refills out of fear of being scolded by study staff. The differences between those participants who eventually re-initiated PrEP and those who disengaged from PrEP use can be attributed to social support and encouragement, level of familiarity with PrEP, risk perceptions, self-initiated discussions with staff and diminishing side effects. CONCLUSIONS: Despite implementing a community-based PrEP delivery platform and behavioural intervention that included support for daily oral PrEP adherence and disclosure, participants struggled with consistent daily oral PrEP use. Unpredictable life events, including local movement and schooling schedules, in addition to being judged for their perceived behaviours, pose a challenge for consistent pill pick-up for AGYW and habit formation. Long-acting injectable PrEP may mitigate a number of these external barriers. Interventions that integrate long-term planning skills, how to navigate existing social judgements and how to access sources of social support may further improve habit formation for PrEP use, regardless of its formulation.

The Effect of Disclosure of PrEP Use on Adherence Among African Young Women in an Open-Label PrEP Study: Findings from HPTN 082.

To develop effective PrEP adherence interventions, it is important to understand the interplay between disclosure of pre-exposure prophalxis (PrEP) use, social support, and PrEP adherence. We leveraged the HPTN 082 study conducted among 451 adolescent girls and young women (AGYW) (ages 16 to 25 years, 2016 to 2019) in South Africa and Zimbabwe. Among the 349 who had month three disclosure and PrEP adherence data, 60% (n = 206) felt supported by adults, and 89% (n = 309) disclosed PrEP use to at least one person. PrEP disclosure was not associated with increased adherence, measured by intracellular tenofovir-diphosphate concentrations in dried blood spots. Women who reported having supportive adults, and disclosed to their parents, had higher adherence at 6 months with an increase of 177 fmol/punch (95% CI 12 to 343, t = 2.11, p = 0.04). PrEP interventions that help AGYW identify supportive relationships and effectively communicate the benefits of PrEP may improve PrEP adherence.Clinicaltrials.gov ID number: NCT02732730.

Baseline preferences for oral pre-exposure prophylaxis (PrEP) or dapivirine intravaginal ring for HIV prevention among adolescent girls and young women in South Africa, Uganda and Zimbabwe (MTN-034/IPM-045 study).

INTRODUCTION: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. METHODS: AGYW aged 16-21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP). RESULTS: Of the 247 AGYW enrolled in REACH, 34% were aged 16-17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally. CONCLUSIONS: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs.

Access to healthcare among sexual and gender minority youth at risk for HIV: barriers and experiences of discrimination.

This study examined experiences of healthcare inaccessibility and lesbian, gay, bisexual, transgender, queer, plus (LGBTQ+) discrimination among sexual and gender minority youth at elevated risk for HIV in the United States. Participants for this cross-sectional survey study (N = 3330) were cisgender men, transgender men and women, and nonbinary individuals ages 18-34 recruited for a larger study examining HIV risk behavior between December 2017 and December 2019. Results indicated that 41.1% of participants had at least one lifetime experience of LGBTQ + healthcare discrimination, and 44.1% reported past 6-month experiences of discrimination or problems accessing healthcare. Transgender men and women were more likely than cisgender men and nonbinary participants to report experiences of discrimination, and transgender men were more likely to report problems accessing healthcare. A majority of participants (72.8%) reported that their most recent healthcare provider was aware of their sexual or gender identity. These results indicate a high prevalence of structural barriers in healthcare access for sexual and gender minority youth at elevated risk for HIV, including finical and logistical barriers as well as anticipated and experienced discrimination. We discuss these findings and highlight the importance of easily accessible and culturally competent care for this community.

Predictors of Mpox vaccine uptake among sexual and gender minority young adults living in Illinois: Unvaccinated vs. double vs. single dose vaccine recipients.

INTRODUCTION: The 2022 global outbreak of Monkeypox virus (Mpox), which has primarily spread through the sexual networks of sexual and gender minority (SGM) individuals, has introduced new public health challenges. While an efficacious Mpox vaccine is in active circulation, few Mpox vaccine studies have examined its uptake among SGM groups. The aims of this study were to investigate (a) the prevalence of Mpox vaccine uptake among SGM and (b) the contextual, Mpox-disease specific, and Mpox-vaccine specific factors associated with Mpox vaccine among SGM. METHODS: We conducted a cross-sectional survey in Illinois, USA in September 2022; 320 young SGM completed self-administered questionnaires. Multinomial logistic regression was used to assess the contextual, Mpox-disease specific, and Mpox-vaccine specific factors associated with Mpox vaccine uptake. Adjusted Odds Ratios (aORs) and 95 % Confidence Intervals (CI) are reported. RESULTS: Approximately 50 % of the SGM participants included in this study had received at least their first dose of the Mpox vaccine. Multinomial regression analysis showed that individuals who had recently experienced food insecurity, had higher degrees of fear of social rejection due to Mpox acquisition, and were more Mpox-vaccine hesitant were more likely to be unvaccinated. Conversely, knowing people who have contracted Mpox, having higher formal educational attainment, having higher degrees of Mpox-related internalized heterosexism, and being more concerned about one's safety regarding Mpox morbidity were more likely to be double-dosers. CONCLUSION: Approximately 50 % of the SGMs included in this study received at least their first dose of the Mpox vaccine; however, only one-quarter of participants completed the recommended 2-dose Mpox regimen. Our findings indicate that socioeconomic stability, fear of social rejection due to disease acquisition, and Mpox-specific vaccine hesitancy may be important structural targets to consider when developing vaccine-uptake prevention and intervention strategies tailored to the needs of sexual and gender minorities.

Trust in the provider and accurate self-reported PrEP adherence among adolescent girls and young women in South Africa and Zimbabwe: HPTN 082 study.

BACKGROUND: Trust is an important cornerstone of patient-provider communication. Accurate reporting of pre-exposure prophylaxis (PrEP) adherence is vital for providers to determine who needs adherence support, especially adolescent girls and young women (AGYW) disproportionately affected by newly diagnosed HIV. METHODS: This is a secondary analysis of the HPTN 082 open-label PrEP demonstration trial. From 2016-2018, 451 AGYW aged 16-25 years were enrolled in South Africa (Cape Town and Johannesburg) and Zimbabwe (Harare). PrEP was initiated by 427, and 354 (83%) had month three patient-reported adherence responses and intracellular tenofovir diphosphate (TFV-DP) measurements. The patient-reported adherence response to 'In the past month, how often did you take the tablet?' was dichotomized as 'high' if the response was every day or most days, and 'low' if some days or not many days or never. The biomarker marker evidence of adherence in dried blood spots was defined as 'high' if TFV-DP ≥ 700, and 'low' if < 350 fmol/punch. We used multinomial logistic regression to examine if trust in the PrEP provider was associated with concordance between patient-reported adherence and intracellular tenofovir-diphosphate (TFV-DP). RESULTS: AGYW who reported trust in their providers were almost four-fold (aOR 3.72, 95% CI 1.20-11.51) more likely to have concordant adherence (high self-reported adherence and high TFV-DP concentrations) compared to discordant non-adherence (high self-reported adherence and low TFV-DP concentrations). CONCLUSION: Education and training of providers to build trusting relationships with AGYW may lead to more accurate reporting of PrEP adherence. With accurate reporting, adequate support can be provided to bolster adherence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02732730.

Prediction of Sex and the Potential Use of On-Demand PrEP Among Young Men Who Have Sex With Men in the United States.

BACKGROUND: On-demand dosing of preexposure prophylaxis (PrEP) requires accurate prediction of sex; however, prediction abilities among young men who have sex with men (YMSM) have not been characterized. SETTING: A nationally recruited prospective cohort of YMSM ages 16-24 years. METHODS: We followed 120 YMSM for 8 weeks using digital daily surveys (DDSs) to measure engagement in and prediction of anal sex over 24 hours, along with condom use and other encounter-level circumstances. Our main outcome, an "unpredicted spontaneous encounter," was defined as an anal sex encounter that occurred without sufficient prior knowledge to (hypothetically) enable protective on-demand PrEP use according to dosing guidelines. We operationalized this outcome as an anal sex encounter for which a participant indicated: (1) on the prior day's DDS that there was a low likelihood of sex occurring in the subsequent 24 hours (unpredicted) and (2) on the current day's DDS that he knew ≤2 hours in advance that the encounter would occur (spontaneous). RESULTS: Approximately one-third of all anal sex encounters during the study period were unpredicted and spontaneous and would not have been protected (hypothetically) by on-demand dosing. More than two-thirds of participants experienced such an encounter and almost three-quarters of all acts were condomless. CONCLUSIONS: On-demand PrEP to prevent HIV acquisition may be challenging for many YMSM. Clinical and public health approaches that account for patients' predictive abilities alongside their dosing preferences may help to optimize selection of and adherence to PrEP dosing strategies.

"I know why I am taking this pill": Young women navigation of disclosure and support for PrEP uptake and adherence in Eastern Cape Province, South Africa.

There is limited understanding of the dynamic interplay between adolescent girl's and young women's (AGYW) disclosure and social support for using oral pre-exposure prophylaxis (PrEP) and adherence. Towards this, we conducted interviews with 42 AGYW enrolled in The Community PrEP Study who exhibited either high or low blood concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots. Guided by Theories of Practice, interviews and analysis focused on AGYW perspectives and experiences with PrEP disclosure, support and adherence. AGYW with high TFV-DP blood concentrations described larger social support networks and disclosure events. In contrast, those with low TFV-DP blood concentrations described disclosing to fewer people, resulting in limited social support. Participants discussed partner support, however, this support was not described as consequential to adherence, irrespective of TFV-DP levels. Those with high levels of TFV-DP in their blood described the ability to navigate social scrutiny and changes in social support, while those with low levels of TFV-DP in their blood were more likely to question their own continued use of PrEP. To facilitate AGYW's prevention-effective use of PrEP, expanded skill-building for disclosure and resiliency against changes to social support should be examined as part of PrEP services.

Development of a tool to assess HIV prevention readiness of adolescent girls and young women in HPTN 082 study.

BACKGROUND: African adolescent girls and young women (AGYW) represent a large proportion of new HIV infections, a priority population for pre-exposure prophylaxis (PrEP), but adherence remains a challenge. A reliable, valid readiness tool would help identify AGYW motivated to take PrEP who need adherence support. METHODS: In the HPTN 082 open-label PrEP study (2016-2019), South African and Zimbabwean women ages 16-25 were administered an HIV prevention readiness measure (HPRM). The 25 items in the HPRM included medication beliefs, connection with care, disclosure of PrEP use, social support, and housing stability using a 5-point Likert scale. Exploratory factor analysis (EFA) using polychoric correlations, scale reliability, and predictive validity were performed on data from 315 participants who responded to all items. We assessed the predictive value of HPRM scores with PrEP adherence, defined as tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots, as a continuous measure and dichotomized as high PrEP adherence (≥700 fmol/punch). RESULTS: EFA yielded 23 items with three subscales: self-efficacy (16 items), PrEP disclosure (4 items), and social support (3 items). Cronbach's α ranged from 0.71 to 0.92 for the overall scale and the subscales. The average overall scale and the subscales were predictive of 3-month PrEP adherence for TFV-DP concentrations: for each unit increase of the HPRM score, TFV-DP concentration increased by 103 fmol/punch (95% CI: 16, 189, p = 0.02); the highest HPRM score equated with 608 fmol/punch on average. For the self-efficacy subscale, TFV-DP increased by 90 fmol/punch (95% CI: 7, 172, p = 0.03); PrEP disclosure, 68 fmol/punch (95% CI: 19, 117 p = 0.01); and social support, 58fmol/punch (95% CI: 2, 113, p = 0.04). Higher PrEP disclosure suggests high adherence (OR 1.36, 95% CI: 1.00, 1.86, p = 0.05) and predicted persistent high adherence at both months three and six (OR: 1.50, 95% CI: 1.03, 2.21, p = 0.04). CONCLUSIONS: The HPRM scale overall and the subscales individually demonstrated good internal consistency among African young women. PrEP disclosure subscale exhibiting significant association with persistent high PrEP adherence is an important finding for PrEP adherence support programs. Future work will assess replicability and expand self-efficacy and social-support subscales after item revision. TRIAL REGISTRATION: ClinicalTrials.gov NCT02732730.

Experiences of Online Racialized Sexual Discrimination among Sexual and Gender Minorities in the United States: Online Survey Data from Keeping It LITE.

This study sought to analyze prevalence and correlates of online racialized sexual discrimination (RSD), or sexualized discriminatory treatment, in the context of sexualized encounters, among cisgender men and transgender individuals who have sex with men at risk for HIV. Data were collected as part of a baseline survey from a large national sample (N = 2,166). Among participants of color (N = 1,042), 84.9% had experienced RSD in the past 6 months, and transgender participants experienced similar levels of RSD as cisgender men. Experience of RSD was associated with older age and more frequent experiences of general discrimination, but not with geographic location, mental health symptoms, sexual risk behavior, or internalized homonegativity. These findings confirm that RSD is highly prevalent among sexual and gender minority individuals of color who have sex with men. Implications and areas for future research are discussed.