Recruiting
Phase 1

HIV Prevention

Sponsor:

San Francisco State University

Code:

NCT03189394

Conditions

HIV Infections

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRIDE

ePRIDE

Men's Health

Study Details

Brief summary:

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.

Conditions

HIV Infections

Study ID

NCT03189394

Start date

Jul 1, 2017

Status verified date

Dec, 2018

Completion date

Sep 1, 2022

Anticipated

Primary completion date

Sep 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PRIDE

The in-person experimental condition, PRIDE, consists of in-person intervention activities that are scheduled over two Saturdays, back to back, approximately 3 hours each (6 hours total). This intervention consists of relationship-focused activities for couples to take part in together, focusing on relationship communication, dynamics, and sexual agreements.

experimental: ePRIDE

ePRIDE is an online adaptation of the experimental condition, PRIDE, and consists of online intervention activities that are scheduled to be completed over two weeks, lasting approximately 6 hours total. This intervention consists of relationship-focused activities for couples to take part in together, focusing on relationship communication, dynamics, and sexual agreements, and is designed for couples to take together sitting side by side.

active comparator: Men's Health

Men's Health is the active comparator group. Participants in this group go through in-person intervention days, scheduled on Saturdays back to back, but differ from the PRIDE arm because this intervention does not focus on relationship dynamics. Instead, these two Saturday intervention days focus on general men's health, including heart health, cancer, and STDs.

Interventions

PRIDE

A couples curriculum that is relationship-focused and in-person, aimed at helping to reduce the odds of a composite HIV risk variable among gay couples.

ePRIDE

A couples curriculum that is relationship-focused and online, aimed at helping to reduce the odds of a composite HIV risk variable among gay couples.

Men's Health

A men's health curriculum that is individualized and in-person, aimed at helping participants to focus on gay men's health.

Primary outcome measure

  • Composite Risk for HIV (CR-HIV) [ Time Frame: 9 months (baseline, 3, 6, and 9 month followups) ]

Central Contacts and Locations

Central contacts

Cameron Michels, MA

415.817.4520cmichels@sfsu.edu

Locations

Center for Research and Education on Gender and Sexuaity (CREGS) At San Francisco State University

Recruiting

San Francisco, California, United States, 94103

Contacts

Cameron Michels, MA

415-817-4520cmichels@sfsu.edu

Colleen Hoff, PhD

4158174540choff@sfsu.edu

More Information

Sponsor

San Francisco State University

Last update posted

Dec 11, 2018

Last verified

Dec, 2018

Keywords

  • HIV
  • gay couples
  • relationships
  • dyads

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Francisco State University on 2018-12-11.