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Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples (2GETHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03186534
Recruitment Status : Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 15, 2017
University of Cincinnati
Howard Brown Health Center
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population.

Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, participants were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the research team developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple.

The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment.

The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. The investigators will conduct an RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or an attention-matched couples-based positive affect promotion program.

Condition or disease Intervention/treatment Phase
Hiv Chlamydia Gonorrhea Relation, Interpersonal Behavioral: 2GETHER Behavioral: Positive Affect Enhancement Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 2GETHER
2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 individualized couple session) administered over the course of 1 month (1 session per week). Group sessions focus on developing skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.
Behavioral: 2GETHER
Communication skills, coping skills, problem-solving, acceptance, HIV prevention

Active Comparator: Positive Affect Enhancement
The control condition is a positive affect enhancement program for couples. This is an active and attention-matched control condition. Group sessions focus on developing various coping skills that aim to enhance positive emotions in couples, and individualized couple sessions focus on skills implementation.
Behavioral: Positive Affect Enhancement
coping skills for enhancing positive emotions, mindfulness

Primary Outcome Measures :
  1. Condomless anal sex [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in number of condomless anal sex acts with serodiscordant or unknown status partners

  2. Sexual Agreement Concordance [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in concordance between each member of the dyad in the rules of their sexual agreement (monogamy or non-monogamy agreement)

  3. Sexual Agreement Breaks [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    occurrence of breaks in the rules of couples' sexual agreement (monogamy or non-monogamy agreement)

  4. Occurrence of Sexually Transmitted Infections [ Time Frame: Baseline, 12-months ]
    the incidence (number of new cases or diagnoses) of Chlamydia and Gonorrhea at 12 months

Secondary Outcome Measures :
  1. HIV Testing [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    frequency of HIV testing among HIV-negative or unknown status participants

  2. Antiretroviral Medication Adherence [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in ART medication adherence among HIV-positive participants

Other Outcome Measures:
  1. Pre-Exposure Prophylaxis [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    initiation of pre-exposure prophylaxis among HIV-negative or unknown status participants

  2. Pre-Exposure Prophylaxis Adherence [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in pre-exposure prophylaxis adherence among participants who have initiation pre-exposure prophylaxis

  3. HIV Viral Load [ Time Frame: Baseline, 12-months ]
    change in serum viral load among HIV-positive participants

  4. Relationship Satisfaction [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in relationship satisfaction

  5. Relationship Communication [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in use of effective and ineffective communication

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   participants required to be assigned male at birth and currently identify as male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Both members of the couple assigned male at birth and currently identify as male
  • Both members of the couples at least 18 years of age; at least one between the ages of 18-29 years
  • Both members of the couple identify one another as primary partners
  • Couple has had oral or anal sex with one another in the past 3 months
  • At least one member of the couple reports condomless anal sex with a serodiscordant or unknown status partner during the past 3 months
  • Both members of the couple read and speak English at 8th grade level or better
  • Both members have Internet access
  • Both members audio recording of intervention sessions

Exclusion Criteria:

  • Severe intimate partner violence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03186534

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Contact: Michael E Newcomb, Ph.D. 312-503-0702
Contact: Kathryn Macapagal, Ph.D. 312-503-3605

Sponsors and Collaborators
Northwestern University
University of Cincinnati
Howard Brown Health Center
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Principal Investigator: Michael E Newcomb, Ph.D. Northwestern University
Study Director: Jim Carey, MPH Northwestern University
Study Director: Ricky Hill, Ph.D. Northwestern University

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Responsible Party: Northwestern University Identifier: NCT03186534     History of Changes
Other Study ID Numbers: R01AA024065 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female