Discussion
depression, alcohol abuse, depressive symptoms
STIS
The vanguard REACH crossover trial of the ring and oral PrEP implemented at four sites in three countries in Southern and East Africa demonstrates the feasibility of enrolling sexually active AGYW in Africa, with and without parental consent. Written informed assent and parental/guardian consent was obtained from all minors aged 16–17, and those who turned 18 during the study subsequently signed the ICF. The REACH cohort was diverse geographically with 34% of minors (16–17) and with an average age of 18 years old, an age group which experienced high HIV incidence in sub-Saharan Africa and poor adherence to oral PrEP and ring in previous studies [Prevalence of STIs in this cohort was high with similarly high rates of STIs being reported in studies of AGYW in other SSA settings [The median age of sexual debut was a year earlier, on average, than starting contraceptive. A gap in protection against unintended pregnancy- which may explain the 40% who reported to ever been pregnant at this young age. This unmet need for contraception coupled with the high HIV risk highlights once again the twin challenges faced by these young women in SSA. Therefore, multipurpose technology products currently in development could be ideal for this population.Multiple HIV prevention trials among AGYW have shown that adherence to oral PrEP and the ring can be challenging for AGYW [Mental health conditions, especially depression, have been shown to negatively affect adherence to oral PrEP, as well as ART initiation and continuation [Disclosure of study products use reduces PrEP stigma and opposition, thereby improving adherence [This work has several limitations. Firstly, this study assessed cross sectionally stated preferences of prevention products at baseline before they had experienced using them. Future analysis from REACH will report informed preferences. Secondly our findings can only be generalizable to a narrow age group of AGYW aged 16–21, and to only two PrEP products; relative preferences for prevention products could differ for other age groups and as prevention options expand. Furthermore, the small sample size limited our ability to detect significant associations between baseline characteristics and product preferences. Thirdly, oral PrEP was already available in study countries when the trial began, whereas the ring was still under review by the regulatory authorities. It is possible that AGYW were more familiar with oral PrEP than the ring and that some participants had actually used PrEP before the trial, although this was not measured. These differences may have impacted initial responses. Despite these limitations, we were able to recruit a large proportion of minors [accompanied with parental consent], who were included for the first time in a ring trial, which will provide important safety, adherence and preference data for oral PrEP and the ring.In conclusion, baseline data for REACH indicates that our cohort had important biological and behavioral vulnerability to HIV and thus an ongoing need for effective HIV prevention strategies. Additionally, a significant proportion of the AGYW exhibited low HIV risk perception and exhibited characteristics that have been shown to affect HIV prevention product adherence, such as depressive symptoms, alcohol abuse and lack of disclosure to partners. The balanced preference between the ring and oral PrEP suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs. Therefore, the REACH study is poised to provide important safety and adherence data among AGYW paving way for rollout of multiple PrEP options for this population.