Clinical trial NCT03986970: The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
Official title: Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV/AIDS
Keywords: Pre-exposure prophylaxis
Lead sponsor: Wits Health Consortium (Pty) Ltd
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: University of Liverpool
name: Imperial College London
name: MRC/UVRI Uganda Research Unit
name: Karolinska Institutet
name: King's College London
name: London School of Hygiene and Tropical Medicine
First posted: 2019-06-14
Enrollment: 72
Sex: MALE
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomised controlled trial (RCT)
Primary purpose: PREVENTION

Brief 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.

Detailed description: 1. 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
2. Determine blood, rectal fluid and foreskin tissue concentrations of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
3. Evaluate inflammation, cellular activation, foreskin mucosal integrity, gene expression and microbiome in foreskin tissue following oral in vivo PrEP and in vitro PEP
4. Evaluate the efficacy of in vitro post exposure dosing with PrEP in protection against ex vivo HIV infection using the explant model
5. To investigate sexual behaviour, PrEP acceptability and feedback on HIV prevention trials implementation

Eligibility 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

Primary outcomes:
measure: HIV Infection free
timeFrame: 15 days
Secondary outcomes:
measure: Timing
timeFrame: 1 year
measure: Dose
timeFrame: 1 year
measure: Blood PrEP Concentrations
timeFrame: 1 year
measure: Rectal Fluid PrEP concentrations
timeFrame: 1 year
measure: Foreskin tissue PrEP concentration
timeFrame: 1 year
measure: Efficacy of post-exposure PrEP
timeFrame: 1 year
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: The Perinatal HIV Research Unit
state: Gauteng
Study officials:
affiliation: Perinatal HIV Research Unit
name: Neil A Martinson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nash S, Dietrich J, Ssemata AS, Herrera C, O'Hagan K, Else L, Chiodi F, Kelly C, Shattock R, Chirenje M, Lebina L, Khoo S, Bekker LG, Weiss HA, Gray C, Stranix-Chibanda L, Kaleebu P, Seeley J, Martinson N, Fox J; CHAPS team. Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa-study protocol for a mixed-methods study including a randomised controlled trial. Trials. 2020 Oct 30;21(1):900. doi: 10.1186/s13063-020-04760-x.