The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV/AIDS
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open-label, randomised controlled trial (RCT)Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 13 years and 24 years
- Gender
- Only males
Description
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, T...
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
Tracking Information
- NCT #
- NCT03986970
- Collaborators
- University of Cape Town
- University of Liverpool
- Imperial College London
- MRC/UVRI Uganda Research Unit
- Karolinska Institutet
- King's College London
- London School of Hygiene and Tropical Medicine
- Investigators
- Principal Investigator: Neil A Martinson Perinatal HIV Research Unit
Get Well Soon