NCT03986970: CHAPS

The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention

Completed Phase 2 Last updated 2 August 2022

What this trial tests

Phase 2 trial testing Tenofovir in HIV/AIDS in 72 participants. Completed in 25 February 2021.

Timeline

11 November 2019

Primary endpoint
25 February 2021

25 February 2021

Quick facts

Lead sponsor	Wits Health Consortium (Pty) Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	72
Start date	11 November 2019
Primary completion	25 February 2021
Estimated completion	25 February 2021
Sites	1 location across South Africa

Drugs / interventions tested

• Tenofovir — full drug profile →

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Wits Health Consortium (Pty) Ltd

Who can join

Adults 13 to 24, male only, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The roles of histone modifications in tumorigenesis and associated inhibitors in cancer therapy.
   Yang Y, Zhang M, Wang Y. · · 2022 · cited 96× · PMID 39036551 · DOI 10.1016/j.jncc.2022.09.002
2. 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.
   Nash S, Dietrich J, Ssemata AS, Herrera C, et al · · 2020 · cited 18× · PMID 33121503 · DOI 10.1186/s13063-020-04760-x
3. Preferences for oral PrEP dosing among adolescent boys and young men in three sub-Saharan African countries.
   Kakande A, Ssemata AS, Muhumuza R, Atujuna M, et al · · 2023 · cited 14× · PMID 37812644 · DOI 10.1371/journal.pone.0285132
4. 4th HIV Research for Prevention conference (HIVR4P // Virtual), 27 & 28 January | 3 & 4 February 2021.
   · 2021 · cited 11× · PMID 33605533 · DOI 10.1002/jia2.25659
5. Short-term oral pre-exposure prophylaxis against HIV-1 modulates the transcriptome of foreskin tissue in young men in Africa.
   Petkov S, Herrera C, Else L, Lebina L, et al · · 2022 · cited 5× · PMID 36479111 · DOI 10.3389/fimmu.2022.1009978
6. Mobilization of systemic CCL4 following HIV pre-exposure prophylaxis in young men in Africa.
   Petkov S, Herrera C, Else L, Mugaba S, et al · · 2022 · cited 5× · PMID 35967369 · DOI 10.3389/fimmu.2022.965214
7. Bacterial microbiome and host inflammatory gene expression in foreskin tissue.
   Maust BS, Petkov S, Herrera C, Feng C, et al · · 2023 · cited 3× · PMID 38053902 · DOI 10.1016/j.heliyon.2023.e22145
8. Dose finding study for on-demand HIV pre-exposure prophylaxis for insertive sex in sub-Saharan Africa: results from the CHAPS open label randomised controlled trial.
   Herrera C, Serwanga J, Else L, Limakatso L, et al · · 2023 · cited 3× · PMID 37327677 · DOI 10.1016/j.ebiom.2023.104648