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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
- Source :
- Trials, Vol 21, Iss 1, Pp 1-11 (2020), Trials
- Publication Year :
- 2020
- Publisher :
- BioMed Central, 2020.
-
Abstract
- BackgroundHIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake. The cost of a non-inferiority phase III trial is likely to be prohibitive, and thus, it is essential to select the best possible drug, dose and schedule in advance. The aim of this study, the Combined HIV Adolescent PrEP and Prevention Study (CHAPS), is to investigate the drug, dose and schedule of pre-exposure prophylaxis (PrEP) required for the protection against HIV and the acceptability of PrEP amongst young people in sub-Saharan Africa, and hence to inform the choice of intervention for future phase III PrEP studies and to improve strategies for PrEP implementation.MethodsWe propose a mixed-methods study amongst young people aged 13–24 years. The first component consists of qualitative research to identify the barriers and motivators towards the uptake of PrEP amongst young people in South Africa, Uganda and Zimbabwe. The second component is a randomised clinical trial (ClinicalTrials.gov NCT03986970, June 2019) using a novel ex vivo HIV challenge method to investigate the optimal PrEP treatment (FTC-TDF vs FTC-TAF), dose and schedule. We will recruit 144 amongst HIV-negative uncircumcised men aged 13–24 years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms. One group will receive no PrEP prior to surgery; the other arms will receive either FTC-TDF or FTC-TAF, over 1 or 2 days, and with the final dose given either 6 or 20 h prior to surgery. We will conduct an ex vivo HIV challenge on their resected foreskin tissue.DiscussionThis study will provide both qualitative and quantitative results to help decide the optimum drug, dose and schedule for a future phase III trial of PrEP. The study will also provide crucial information on successful strategies for providing PrEP to young people in sub-Saharan Africa.Trial registrationClinicalTrials.govNCT03986970. Registered on 14 June 2019
- Subjects :
- Male
Zimbabwe
medicine.medical_specialty
Adolescent
Anti-HIV Agents
Human immunodeficiency virus (HIV)
Medicine (miscellaneous)
HIV Infections
CHAPS team
medicine.disease_cause
Adolescents
law.invention
03 medical and health sciences
Pre-exposure prophylaxis
Study Protocol
South Africa
0302 clinical medicine
Randomized controlled trial
law
Intervention (counseling)
General & Internal Medicine
medicine
Humans
Pharmacology (medical)
Uganda
030212 general & internal medicine
1102 Cardiorespiratory Medicine and Haematology
Randomized Controlled Trials as Topic
Protocol (science)
0303 health sciences
lcsh:R5-920
030306 microbiology
business.industry
Public health
HIV
1103 Clinical Sciences
PrEP
Clinical trial
Cardiovascular System & Hematology
Family medicine
Pre-Exposure Prophylaxis
business
lcsh:Medicine (General)
Qualitative research
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Trials, Vol 21, Iss 1, Pp 1-11 (2020), Trials
- Accession number :
- edsair.doi.dedup.....4bfaa6bce93b386088dc2c769a753846