The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

• Status: Recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fatima Mayat; Wits Health Consortium (Pty) Ltd
• Collaborators: Imperial College London; Karolinska Institutet; King's College London; London School of Hygiene and Tropical Medicine; MRC/UVRI Uganda Research Unit; University of Cape Town; University of Liverpool
• Treatments: Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

Participants must satisfy all the following criteria within 21 days prior to their circumcision visit:

1. Clinically eligible for either forceps guided, or dorsal slit circumcision

2. The ability to understand and sign a written informed consent form by participant (and participant's legal guardian if younger than 18 years) prior to participation in any study procedures and to comply with all trial requirements

3. Male sex at birth

4. Age 13- 24 years

5. Haemoglobin >9g/dL

6. Weight >35Kg

7. Two negative rapid HIV antibody tests results (manufactured by different companies), dating from 21 days or less prior to VMMC

8. Two locator information details (including physical address, telephone contacts, email) for contacting of either patient or their parent

Exclusion Criteria:

1. Any significant acute or chronic medical illness and current therapy that in the opinion of the site investigator would preclude receipt either of investigational products, or VMMC

2. Any evidence that participant is not suitable for VMMC