PROUD (pilot trial)

Status:Completed
Phase:IV
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:Open label, Randomized
Arms and Assigned Interventions
DescriptionArm 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 DeliveryTablet
ARMsExperimental
DescriptionArm 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 DeliveryTablet
ARMs
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
Trial Sponsors: Medical Research Council (MRC)
Start Date
End Date
October 31, 2012
October 31, 2016
Enrollment:544
Age range: 18 Years ↔ any
Population:Cisgender Men, Gay and Bisexual Men Who Have Sex with Men