About this trial
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.
Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.
The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.
Eligibility criteria
Qualifiers
All participants must be HIV negative at baseline
All participants must have a body weight ¬> 35kg at baseline
All participants must be older than 15 years. Specific age criteria will be applied to certain population groups.
All participants must be currently resident in the study area
Disqualifiers
Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection
Clinical conditions contraindicated for the chosen PrEP product as per SAHPRA regulations, including use of known contraindicated medications.
Allergy to any of the study products
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 clinical or study visits for geographical reasons, according to the site investigator
Trial design
Treatments tested in this trial
- Cabotegravir long-acting
- Tenofovir emtricitabine
- Dapivirine containing vaginal ring
Treatment groups
Sponsors and collaborators
Desmond Tutu HIV Foundation
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
ViiV Healthcare
Collaborator