Clinical Trial – A Randomized Trial to Prevent HIV Among Gay Couples – HIV

The proposed study is a randomized controlled intervention to reduce sexual risk for HIV among HIV-negative concordant and HIV discordant gay couples. There are three arms of the study: 1) the in-person experimental condition, PRIDE, 2) the online adaptation of the experimental condition, ePRIDE, and 3) the time- and attention-matched in-person control condition, Men’s Health. Participants (N = 300 couples) will be randomized equally into one of the three study conditions and assessed via surveys at baseline and at 3-, 6- and 9-months after completion of the intervention sessions.

Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: On completion of the baseline survey and testing, couples will be randomized to one of the three arms of the study (PRIDE, ePRIDE, or Men’s Health). Couples will be randomized in blocks with the block size randomly permuted via a SAS computer program based on a pseudo-random number generator. Each arm of the intervention will begin on the same date and run for two weeks. Couples randomized to ePRIDE will be sent a link on the same day that PRIDE and Men’s Health sessions are scheduled and will have two weeks to complete the program.
Masking: Single (Participant)
Masking Description: Participants will be aware that there are online and in-person aspects of the study as seen in the consent form, but will be randomized to a group and unaware of which arm they are in.
Primary Purpose: Prevention
Official Title: A Randomized Trial to Prevent HIV Among Gay Couples
Actual Study Start Date  : July 1, 2017
Estimated Primary Completion Date  : September 1, 2021
Estimated Study Completion Date  : September 1, 2022
Contacts
Contact: James Lykens, MA 415.817.4540 jlykens@sfsu.edu
Locations
United States, California
Center for Research and Education on Gender and Sexuaity (CREGS) At San Francisco State University Recruiting
San Francisco, California, United States, 94103
Contact: James Lykens, MA    415-817-4520    jlykens@sfsu.edu
Contact: Colleen Hoff, PhD    4158174540    choff@sfsu.edu
ClinicalTrials.gov Identifier: NCT03189394
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