PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
Recruiting · NCT06807736 · Observational (researchers observe without assigning treatment) · Lead sponsor: Desmond Tutu HIV Foundation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- All participants must be able to provide written, informed voluntary consent to partake in the study and willing and able to receive an injectable pre-exposure prophylaxis (PrEP) product
Exclusion criteria
- 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
- 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)
- Current enrolment in another HIV prevention clinical trial that in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (as verified by registration on the South African Medical Research Council biometric co-enrolment prevention system).
Where it is running
1 location listed.
- Desmond Tutu Health Foundation - Cape Town, Western Province, South Africa