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Evaluating the Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Healthy, HIV-Uninfected Adolescents (CHAMPS Pilot Study B)

Status
Ongoing
Phase
II
Principal Investigator(s)
Linda-Gail Bekker, MBChB, PhD
Objective

Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of age.

Prevention Option(s)
PrEP
Study Design
Open label
Arms and Assigned Interventions
Description
All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Official Code
NCT02213328
Similar Trials
CHAMPS
Trial Sponsors
NIAID
April 2015
April 2017
Enrollment
150
15
Years
19
Years
Sites

Desmond Tutu HIV Foundation Non-Network CRS

Cape Town
South Africa

Perinatal HIV Non-network Research CRS

Soweto
South Africa