The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.
Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.
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Parallel
APRETUDE (cabotegravir) 600 mg\3 mL
Drugchoice of 2-monthly injectable long acting cabotegravir. The initial visit will be followed by planned visit for the first injection, one month visit for second injection, and then 2-monthly CAB LA injections with repeat HIV testing and pregnancy testing, and referral to peer navigators for adherence and retention support. We will conduct HIV testing, STI testing, Hep B, Hep C, and safety bloods (Full Blood Count, Creatinine, Liver Function Tests) at baseline, HIV testing two monthly, and annual safety bloods, alongside annual STI testing.
DAPIRING (Dapivirine) 25mg Vaginal Ring
DrugThe initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing
tenofovir disoproxil and emtricitabine
DrugThe initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing
Tenofovir Disoproxil, Lamuvidine and Dolutegravir
DrugThe initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing
Uptake PrEP
Defined as the proportion of all young people (aged 15-30) residing in the trial area (the 40 clusters) who have received any PrEP (oral, injectable, ring, or PEP) through study-linked clinics
Retention on PrEP
Defined as the proportion of participants enrolled at least 4 months before the end of the trial, attending at least one follow-up appointment after PrEP/PEP initiation.
The prevalence of transmissible HIV.
We will measure this outcome as the proportion of those living with HIV and have a detectable HIV viral load, defined as having an HIV viral load of \>= 400 copies per ml, during our final survey round.
Uptake of risk informed HIV prevention
Defined as the proportion of 15-30 year olds who are aware of their HIV status and are either on PrEP, if HIV negative, or are on antiretroviral therapy if living with HIV, during final survey round.
Uptake of contraception
Proportion of women aged 15-30 who report currently using any contraception during final survey round
Teenage Pregnancy
Proportion of adolescent girls aged 15-19 years who self-report currently being pregnant in the final survey round.
Improved socioeconomic outcomes
Defined as proportion in school (aged \<= 18) or unemployed (aged \>18) and/or food secure (no recent experience of hunger) in each arm.
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