Back to resultsThe CHAPS Trial: Combined HIV Adolescent PrEP and Prevention (CHAPS)
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Tenofovir
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS focused on measuring Pre-exposure prophylaxis
Eligibility Criteria
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
Sites / Locations
- The Perinatal HIV Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1: Control
Arm 2: FTC-TDF
Arm 3: FTC-TDF
Arm 4: FTC-TDF
Arm 5: FTC-TDF
Arm 6: FTC-TAF
Arm 7: FTC-TAF
Arm 8: FTC-TAF
Arm 9: FTC-TAF
Arm Description
No PrEP.
FTC-TDF one day, 5 hours before circumcision.
FTC-TDF one day, 21 hours before circumcision.
FTC-TDF two days, 5 hours before circumcision.
FTC-TDF two days, 21 hours before circumcision.
FTC-TAF one day, 5 hours before circumcision.
FTC-TAF one day, 21 hours before circumcision.
FTC-TAF two days, 5 hours before circumcision.
FTC-TAF two days, 21 hours before circumcision.
Outcomes
Primary Outcome Measures
HIV Infection free
We will ascertain the proportion of patients' foreskin tissue that is not infected with HIV 15 days following our ex-vivo HIV challenge. We will use the concentration of p24 antigen (pg/mL) at day15 and also report the slope of the p24 curves from day 3 to 15 (pg/mL per day) and also the AUC day 3 to 15 (pg/mL days).
Secondary Outcome Measures
Timing
The delay between the timing of last dose of FTC-TDF and FTC-TAF as oral PrEP and the timing of circumcision.
Dose
The efficacy of preventing in-vitro HIV infection by dose of FTC-TDF and FTC-TAF as oral PrEP compared to no intervention
Blood PrEP Concentrations
Plasma concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.
Rectal Fluid PrEP concentrations
Rectal fluid concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.
Foreskin tissue PrEP concentration
Foreskin tissue concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
Efficacy of post-exposure PrEP
The proportion of participants' foreskin tissue that remains HIV infection free in the ex-vivo challenge model when additional doses of PrEP are added to that model.
Full Information
NCT ID
NCT03986970
First Posted
June 6, 2019
Last Updated
July 29, 2022
Sponsor
Wits Health Consortium (Pty) Ltd
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
1. Study Identification
Unique Protocol Identification Number
NCT03986970
Brief Title
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
Acronym
CHAPS
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wits Health Consortium (Pty) Ltd
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Pre-exposure prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomised controlled trial (RCT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Control
Arm Type
No Intervention
Arm Description
No PrEP.
Arm Title
Arm 2: FTC-TDF
Arm Type
Experimental
Arm Description
FTC-TDF one day, 5 hours before circumcision.
Arm Title
Arm 3: FTC-TDF
Arm Type
Experimental
Arm Description
FTC-TDF one day, 21 hours before circumcision.
Arm Title
Arm 4: FTC-TDF
Arm Type
Experimental
Arm Description
FTC-TDF two days, 5 hours before circumcision.
Arm Title
Arm 5: FTC-TDF
Arm Type
Experimental
Arm Description
FTC-TDF two days, 21 hours before circumcision.
Arm Title
Arm 6: FTC-TAF
Arm Type
Experimental
Arm Description
FTC-TAF one day, 5 hours before circumcision.
Arm Title
Arm 7: FTC-TAF
Arm Type
Experimental
Arm Description
FTC-TAF one day, 21 hours before circumcision.
Arm Title
Arm 8: FTC-TAF
Arm Type
Experimental
Arm Description
FTC-TAF two days, 5 hours before circumcision.
Arm Title
Arm 9: FTC-TAF
Arm Type
Experimental
Arm Description
FTC-TAF two days, 21 hours before circumcision.
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Other Intervention Name(s)
Emtricitabine, Tenofovir disoproxil, Tenofovir alafenamide
Intervention Description
Pre-exposure prophylaxis
Primary Outcome Measure Information:
Title
HIV Infection free
Description
We will ascertain the proportion of patients' foreskin tissue that is not infected with HIV 15 days following our ex-vivo HIV challenge. We will use the concentration of p24 antigen (pg/mL) at day15 and also report the slope of the p24 curves from day 3 to 15 (pg/mL per day) and also the AUC day 3 to 15 (pg/mL days).
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Timing
Description
The delay between the timing of last dose of FTC-TDF and FTC-TAF as oral PrEP and the timing of circumcision.
Time Frame
1 year
Title
Dose
Description
The efficacy of preventing in-vitro HIV infection by dose of FTC-TDF and FTC-TAF as oral PrEP compared to no intervention
Time Frame
1 year
Title
Blood PrEP Concentrations
Description
Plasma concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.
Time Frame
1 year
Title
Rectal Fluid PrEP concentrations
Description
Rectal fluid concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection.
Time Frame
1 year
Title
Foreskin tissue PrEP concentration
Description
Foreskin tissue concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection
Time Frame
1 year
Title
Efficacy of post-exposure PrEP
Description
The proportion of participants' foreskin tissue that remains HIV infection free in the ex-vivo challenge model when additional doses of PrEP are added to that model.
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male genital anatomical features.
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Martinson
Organizational Affiliation
Perinatal HIV Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Perinatal HIV Research Unit
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared with callaborators.
Citations:
PubMed Identifier
33121503
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.
Results Reference
derived
Links:
URL
http://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-020-04760-x.pdf
Description
Related Info
URL
https://www.croiconference.org/abstract/pharmacokinetic-and-pharmacodynamic-study-of-tfv-and-taf-for-prep-in-foreskin-tissue/
Description
Related Info
Learn more about this trial
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
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