The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

• Investigate the timing and dose of FTC-TDF and FTC-TAF as oral PrEP and in vitro PEP (applied directly to removed foreskin tissue) required to prevent ex vivo HIV infection in foreskin tissue and blood using the explant model
• Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
• Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP
• Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against ex vivo HIV infection using the explant model
• To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention trials implementation

Inclusion criteria

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

• Clinically eligible for either forceps guided, or dorsal slit circumcision
• 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
• Male sex at birth
• Age 13- 24 years
• Haemoglobin >9g/dL
• Weight >35Kg
• Two negative rapid HIV antibody tests results (manufactured by different companies), dating from 21 days or less prior to VMMC
• Two locator information details (including physical address, telephone contacts, email) for contacting of either patient or their parent

Exclusion criteria

• 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
• Any evidence that participant is not suitable for VMMC