Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.

ABSTRACT:

Objectives

The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection.

Methods

MSM and TGW aged 18-30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel.

Results

248 partici

SUBMITTER: McGowan I 

PROVIDER: S-EPMC4928823 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature