Evaluating Truvada PrEP Effectiveness in GBMSM

PROUD was an open-label waitlist design trial to evaluate the effectiveness of daily Truvada as PrEP. Recruitment took place from November 2012 to April 2014 at 13 sexual health clinics in England. Eligible participants were HIV-negative gay bisexual or other MSM (GBMSM) or TGW, who reported condomless anal sex in the last three months and anticipated it again in the next three months. Participants were randomised 1:1 to receive PrEP immediately (immediate arm) or to a deferred start after 12 months (deferred arm). PrEP was prescribed in the form of a single daily tablet containing tenofovir disproxil fumarate and emtricitabine (Truvada; Gilead Sciences, Foster City, CA, USA). However, on 13th October 2014 the trial steering committee recommended that deferred participants be offered PrEP due to early results demonstrating its effectiveness. The study design, results and the cohort’s baseline characteristics are reported elsewhere [5 (link), 24 (link)].

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Arnold-Forster D., Horne R., Nutland W., Wayal S., Rayment M., Rae C., Desai M., Clarke A., Sullivan A., McCormack S, & Gafos M. (2022). Perceptions and Practicalities Influencing Pre-exposure Prophylaxis Adherence Among Men Who Have Sex with Men in England. AIDS and Behavior, 26(8), 2768-2782.

Publication 2022

Truvada

Bisexual Emtricitabine Fumarate Sexual health Tablet Tenofovir Truvada

Corresponding Organization :

Other organizations : London School of Hygiene & Tropical Medicine, University of London, University College London, Chelsea and Westminster Hospital NHS Foundation Trust, National Institute for Health and Care Excellence, Royal Sussex County Hospital, MRC Clinical Trials Unit at UCL, Medical Research Council

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Variable analysis

independent variables

Immediate PrEP arm vs. Deferred PrEP arm

dependent variables

Effectiveness of daily Truvada as PrEP

control variables

Eligibility criteria: HIV-negative gay bisexual or other MSM (GBMSM) or TGW, who reported condomless anal sex in the last three months and anticipated it again in the next three months

controls

Positive control: Immediate PrEP arm
Negative control: Deferred PrEP arm (initially)

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