HIV/AIDS
Conditions
Interventions
Cabotegravir Long acting
Dapivirine Vaginal PrEP Ring
Oral PrEP
Sponsors
Desmond Tutu Health Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 15-29 years Member of a target population: adolescent girls and young women, young key populations (young people who trade sex; young gender and sexually diverse populations), or intimate partners of these populations. Pregnant and breastfeeding women HIV negative Body weight >= 35 kg at baseline Currently residing in the study criteria Able to provide written, informed voluntary consent to partake in the study and willing Able to receive a PrEP product
Exclusion criteria
Exclusion criteria: Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection Weight <35kg Clinical conditions - pregnant women cannot use the vaginal ring; individuals with inflammatory skin conditions that could compromise the safety of an intramuscular injection. Allergy to any of the study products Use of contraindicated medications (e.g. Rifampicin should not be co-administered with CAB-LA). Do not spend a reasonable amount of time in the study area as residents, for school, or work, or are otherwise unable to participate in study visits for geographical reasons, according to the site investigator Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare short term persistence across PrEP modalities overall and across different young population groups. ;To determine what combination of implementation strategies best achieve PrEP adoption, active implementation (initiation), and persistence (sustainment) outcomes over the short term (6 months) and the long term (18 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare durable persistence across PrEP modalities overall and across different young population groups;Time on PrEP based on expected vs. actual PrEP coverage based on oral/vaginal PrEP collection and injections. ;To describe the safety, tolerability, and acceptance of all three methods, determined by self-reported adverse side effects, adverse events (including intimate partner violence), and reasons for PrEP pause or discontinuation. ;An exploratory aim will be to describe and compare HIV incidence across the three PrEP modality arms. The sample size of the study is insufficient to allow for a formal analysis of these outcomes. Resistance testing will be conducted for all participants that sero-convert while initiated on any PrEP product. | — |
Countries
South Africa
Contacts
Public ContactCarey Pike
Researcher
Outcome results
None listed