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.

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.

"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.

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.

Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study.

Home-based service delivery has been used to improve access to HIV testing and antiretroviral initiation across sub-Saharan Africa, but it has yet to be leveraged to improve pre-exposure prophylaxis (PrEP) uptake. We interviewed 37 adolescent girls and young women (AGYW) in Eastern Cape, South Africa to explore why they chose to initiate PrEP or not following home-based HIV testing and referral for PrEP, and what influenced time to PrEP initiation. Participants reported that home visits provided a source of trusted information and a way to involve family members in their PrEP initiation decisions, motivating some to start PrEP. AGYW who initiated PrEP were more likely to qualitatively perceive themselves to be at high risk for HIV compared with those who never initiated PrEP. Integrating home-based HIV testing with PrEP education and referral may be a valuable way to reduce familial barriers and boost PrEP uptake among AGYW in South Africa. Trial registration: NCT03977181. Retrospectively registered on June 6, 2019.

Experiences of oral pre-exposure prophylaxis (PrEP) use disclosure among South African adolescent girls and young women and its perceived impact on adherence.

INTRODUCTION: There is limited understanding of how social dynamics impact pre-exposure prophylaxis (PrEP) adherence among adolescent girls and young women (AGYW) in generalized HIV-epidemic settings. We examined experiences of oral PrEP use disclosure to various social groups with the goal of identifying supportive relationships that can be leveraged to promote adherence. METHODS: We used qualitative methods to explore experiences disclosing PrEP use and the perceived impact of disclosure on adherence among 22 South African AGYW (16-25 years) taking daily oral PrEP. Serial in-depth-interviews (IDIs) were conducted 1-, 3-, and 12-months post-PrEP initiation. Respondents also self-reported their disclosures separately for various social groups and adherence was assessed using intracellular tenofovir-diphosphate levels. RESULTS: Qualitative respondents had a median age of 20.5 years and reported disclosing their PrEP use to friends (n = 36 total disclosures), partners, siblings, other family members (n = 24 disclosures each), and parents (n = 19 disclosures). IDI data revealed that parents and partners provided the most support to respondents and a lack of support from these groups was most often perceived as negatively affecting PrEP use. AGYW described difficulties explaining PrEP to their mothers, who believed PrEP was HIV treatment or would lead to HIV infection. Disclosure to household members was notably meaningful for AGYW (both positively and negatively). Respondents reported leveraging supportive relationships for pill reminders. For respondents who perceived a household member would be unsupportive, however, non-disclosure was less feasible and PrEP use was often stigmatized. To avoid stigma, several respondents hid or discontinued PrEP. CONCLUSIONS: While supportive relationships may facilitate PrEP use, disclosure can also lead to stigma. Counselors should support AGYW in disclosing to key people in their social networks and provide AGYW with materials that lend credibility to explanations of PrEP. Community education is necessary to alleviate PrEP-related stigma and facilitate disclosure.

Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial.

BACKGROUND: HIV incidence among adolescents in southern Africa remains unacceptably high. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention but there are few data on its implementation among adolescents. We aimed to investigate the safety, feasibility, and acceptability of PrEP with oral tenofovir disoproxil fumarate and emtricitabine as part of a comprehensive HIV prevention package in an adolescent population in South Africa. METHODS: This open-label single-arm phase 2 study (PlusPills) was done in two research clinics in Cape Town and Johannesburg, South Africa. Adolescents aged 15-19 years were recruited into the study through recruitment events and outreach in the community. Potential participants were eligible for enrolment if they reported being sexually active. Exclusion criteria were a positive test for HIV or pregnancy at enrolment, breastfeeding, or any relevant co-morbidities. Participants were given oral tenofovir disoproxil fumarate and emtricitabine for PrEP to take daily for the first 12 weeks and were then given the choice to opt in or out of PrEP use at three monthly intervals during scheduled clinic visits. Participants were invited to monthly visits for adherence counselling and HIV testing during the study period. The primary outcomes were acceptability, use, and safety of PrEP. Acceptability was measured by the proportion of participants who reported willingness to take up PrEP and remain on PrEP at each study timepoint. Use was defined as the number of participants who continued to use PrEP after the initial 12-week period until the end of the study (week 48). Safety was measured by grade 2, 3, and 4 laboratory and clinical adverse events using the Division of AIDS table for grading the severity of adult and paediatric adverse events, version 1.0. Dried blood spot samples were collected at each study time-point to measure tenofovir diphosphate concentrations. This trial is registered with ClinicalTrials.gov, NCT02213328. FINDINGS: Between April 28, 2015, and Nov 11, 2016, 244 participants were screened, and 148 participants were enrolled (median age was 18 years; 99 participants [67%] were female) and initiated PrEP. PrEP was stopped by 26 of the 148 (18%) participants at 12 weeks. Cumulative PrEP opt-out, from the total cohort, was 41% (60 of 148 participants) at week 24 and 43% (63 of 148 participants) at week 36. PrEP was well tolerated with only minor adverse events (grade 2) thought to be related to study drug, which included headache (n=4, 3%), gastrointestinal upset (n=8, 5%), and skin rash (n=2, 1%). Two participants (1%) experienced grade 3 weight loss, which was deemed related to the study drug and resolved fully when PrEP was discontinued. Tenofovir diphosphate concentrations were detectable (>16 fmol/punch) in dried blood spot samples in 108 (92%) of 118 participants who reported PrEP use at week 12, in 74 (74%) of 100 participants at week 24, and in 22 (59%) of 37 participants by the study end at week 48. INTERPRETATION: In this cohort of self-selected South African adolescents at risk of HIV acquisition, PrEP appears safe and tolerable in those who continued use. PrEP use decreased throughout the course of the study as the number of planned study visits declined. Adolescents in southern Africa needs access to PrEP with tailored adherence support and possibly the option for more frequent and flexible visit schedules. FUNDING: National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.

An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).

INTRODUCTION: Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention. METHODS: UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring® or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring® (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods. RESULTS: Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring® (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring® users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring® , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill. CONCLUSIONS: Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.

'You'll always stay right': understanding vaginal products and the motivations for use among adolescent and young women in rural KZN.

The use of vaginal products may increase the risk of HIV infection by affecting the vaginal biome. Understanding what vaginal products young women are using, and why, is key to assessing the complexity of sexual health and risk. This study reports on findings from research with adolescent and young women in rural KwaZulu-Natal about the vaginal products they use and motivations for using them. The study identified over 26 products that young women used to enhance their sexual experience and found some young women spent time preparing and sourcing vaginal products in order to pleasure and retain partners. Opinions differed about vaginal product use. While some women perceived that vaginal products could provide a means of out-performing other women, retaining a partner and providing sexual autonomy, there was a stigma attached to using them. Study findings highlight the social value of using vaginal products, especially in settings where partner retention is linked to economic survival. Expanding our understanding of what products are used and the reasons young women use them warrants continued investigation.