PROUD (pilot trial)

Status

Completed

Phase

Principal Investigator(s)

Prof Sheena McCormack

Objective

Enrolling 500 MSM, aims to assess: whether or not a large trial is feasible; the level of interest in PrEP in clinic populations; acceptability of randomization; who takes up offer of PrEP; risk behavior over time (self-report, STIs); change in risk following behavioral interventions; adherence behavior over time (self-report, pill count, and real time PK in a sub-set); facilitators and barriers to reducing risk and adhering to a daily pill.

Randomization stopped in October 2014 after an interim analysis showed that PrEP was protective against HIV. Participants in the deferred arm offered PrEP. Trial to continue for one year to look at long-term benefit and safety.

Prevention Option(s)

PrEP

Study Design

Randomized

Open label

Arms and Assigned Interventions

Description

Arm A: Immediate offer of Truvada-PrEP Immediate offer of Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC) Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)

Mode of Delivery

Tablet

Products

TDF/FTC (Truvada)

ARMs

Experimental

Description

Arm B: Deferred (12m) offer of Truvada-PrEP Access to Truvada from 12 months after enrolment Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)

Mode of Delivery

Tablet

Products

TDF/FTC (Truvada)

Results

PrEP reduced the risk of HIV infection by 86%

Official Code

NCT02065986

Related Publications

Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

Intimate partner violence, depression, and sexual behaviour among gay, bisexual and other men who have sex with men in the PROUD trial

Prevalence and correlates of depressive symptoms among gay, bisexual and other men who have sex with men in the PROUD randomised clinical trial of HIV pre-exposure prophylaxis