Offering different HIV prevention options to adolescents in Cape Town

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Desmond Tutu Health Foundation
  Cape Town, Western Province, South Africa Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.