HIV Infections Clinical Trial
Official title:
A Randomized Trial to Prevent HIV Among Gay Couples
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older - speak English - live in the San Francisco Bay Area - have knowledge of their own and their partner's serostatus - are in a concordant HIV-negative or discordant relationship - at least one partner has had condomless anal sex (CAS) in the last three months - identify as biologically male and not transgender - in a committed relationship (defined as two men who are committed to each other above anyone else and have had sex with each other) with their primary male partner (who they will participate in the study with) for at least 3 months. Exclusion Criteria: - under 18 - do not speak English - do not live in the San Francisco Bay Area - do not know their own or their partner's HIV status - are in a relationship where both partners are HIV positive, neither partner reports CAS in the last three months - identifies as transgender - is of female sex - not in a current committed relationship for at least 3 months. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Research and Education on Gender and Sexuaity (CREGS) At San Francisco State University | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
San Francisco State University | Johns Hopkins University, University of California, San Francisco, University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Risk for HIV (CR-HIV) | The primary outcome variable will be a binary indicator of any HIV-risk (no vs. yes) in the past three months at baseline, 3, months, 6 months, and 9 months--based on a composite of self-reported sexual risk behavior (defined as CAS with a discordant or unknown HIV status partner as well as HIV-positive partner's ART interruption (defined as missing all ART doses over a 4-day period in the past three months 70) and suppressed viral load. We will rely on self-reports of viral load because sexual risk behavior is based on one's perception of one's own or the partners' viral load. Regular viral load tests will be emphasized in PRIDE and ePRIDE to encourage participants to be proactive about their lab work. Baseline, 3 months, 6 months, and 9 months will be assessed for change over time past the date of the intervention. | 9 months (baseline, 3, 6, and 9 month followups) |
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