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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
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)
Trial Sponsors
Medical Research Council
October 2012
October 2016
Enrollment
500
18
Years
Population
Men
MSM
Sites

MRC Clinical Trials Unit

London
United Kingdom