Offering different HIV prevention options to adolescents in Cape Town
PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.
This study is testing whether giving young people in Cape Town a choice between three different HIV prevention methods helps them stick with their chosen option better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Desmond Tutu HIV Foundation Academic / other |
| Locations | 1 site (Cape Town, Western Province) |
| Trial ID | NCT06807736 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to provide adolescents and young people in Cape Town, South Africa, with a choice of three HIV pre-exposure prophylaxis (PrEP) products: a daily oral tablet, a monthly vaginal ring, and an injectable option. Over an 18-month period, the study will track how well participants adhere to their chosen PrEP method and identify factors that influence their decision to start and continue using PrEP. The study will recruit 1800 participants, including young women and key populations of young men, and will follow them to assess both short-term and long-term persistence in using the selected PrEP product.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-negative adolescents and young adults aged 15-29 living in Cape Town, including specific populations such as young women and men who have sex with men.
Not a fit: Patients who are HIV-positive or have contraindications to the study products will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance HIV prevention strategies by identifying effective ways to promote adherence to PrEP among young people.
How similar studies have performed: Other studies have shown promise in implementing various PrEP options, but this specific approach of offering multiple choices in a real-world setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cape Town, Western Province
- Desmond Tutu Health Foundation — Cape Town, Western Province, South Africa (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.