A Randomized Trial to Prevent HIV Among Gay Couples

NCT03189394 | Unknown Phase 1 DMC

• 1 other identifier: 20419000
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; gay couples; relationships; dyads

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

PRIDE

EXPERIMENTAL

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.

Behavioral: PRIDE

ePRIDE

EXPERIMENTAL

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.

Behavioral: ePRIDE

Men's Health

ACTIVE COMPARATOR

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.

Behavioral: Men's Health

Interventions

PRIDE BEHAVIORAL

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.

PRIDE

ePRIDE BEHAVIORAL

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.

ePRIDE

Men's Health BEHAVIORAL

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

Men's Health

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as biologically male and not transgender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Francisco State University: lead
• University of California, San Francisco: collaborator
• University of Colorado, Denver: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

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

San Francisco, California, 94103, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Men's Health

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Colleen Hoff, PhD

  CREGS, San Francisco State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cameron Michels, MA

CONTACT

415.817.4520; cmichels@sfsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: June 16, 2017
• Study Start: July 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)