The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2021-02-25

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, randomised controlled trial (RCT)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1: Control

Intervention Type DRUG

Pre-exposure prophylaxis

Interventions

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Tenofovir

Pre-exposure prophylaxis

Intervention Type DRUG

Other Intervention Names

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Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

24 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes