The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

University of the Witwatersrand

Status and phase: Completed; Phase 2

Conditions: HIV/AIDS

Treatments: Drug: Tenofovir

Study type: Interventional

Funder types: Other

Identifiers

NCT03986970

The CHAPS Trial

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 patients

Sex: Male

Ages: 13 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 9 patient groups

Arm 1: Control

No Intervention group

Description:

No PrEP.

Arm 2: FTC-TDF

Experimental group

Description:

FTC-TDF one day, 5 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 3: FTC-TDF

Experimental group

Description:

FTC-TDF one day, 21 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 4: FTC-TDF

Experimental group

Description:

FTC-TDF two days, 5 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 5: FTC-TDF

Experimental group

Description:

FTC-TDF two days, 21 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 6: FTC-TAF

Experimental group

Description:

FTC-TAF one day, 5 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 7: FTC-TAF

Experimental group

Description:

FTC-TAF one day, 21 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 8: FTC-TAF

Experimental group

Description:

FTC-TAF two days, 5 hours before circumcision.

Treatment:

Drug: Tenofovir

Arm 9: FTC-TAF

Experimental group

Description:

FTC-TAF two days, 21 hours before circumcision.

Treatment:

Drug: Tenofovir