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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03186534
Other study ID # R01AA024065
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 21, 2017
Est. completion date June 30, 2022

Study information

Verified date February 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
2GETHER
Communication skills, coping skills, problem-solving, acceptance, HIV prevention
Positive Affect Enhancement
coping skills for enhancing positive emotions, mindfulness

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University Howard Brown Health Center, University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (5)

Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. "Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2. — View Citation

Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7. — View Citation

Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x. — View Citation

Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0. — View Citation

Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Pre-Exposure Prophylaxis initiation of pre-exposure prophylaxis among HIV-negative or unknown status participants Baseline, 3-, 6-, 9-, 12-months
Other Pre-Exposure Prophylaxis Adherence change in pre-exposure prophylaxis adherence among participants who have initiation pre-exposure prophylaxis Baseline, 3-, 6-, 9-, 12-months
Other HIV Viral Load change in serum viral load among HIV-positive participants Baseline, 12-months
Other Relationship Satisfaction change in relationship satisfaction Baseline, 3-, 6-, 9-, 12-months
Other Relationship Communication change in use of effective and ineffective communication Baseline, 3-, 6-, 9-, 12-months
Primary Condomless anal sex change in number of condomless anal sex acts with serodiscordant or unknown status partners Baseline, 3-, 6-, 9-, 12-months
Primary Sexual Agreement Concordance change in concordance between each member of the dyad in the rules of their sexual agreement (monogamy or non-monogamy agreement) Baseline, 3-, 6-, 9-, 12-months
Primary Sexual Agreement Breaks occurrence of breaks in the rules of couples' sexual agreement (monogamy or non-monogamy agreement) Baseline, 3-, 6-, 9-, 12-months
Primary Occurrence of Sexually Transmitted Infections the incidence (number of new cases or diagnoses) of Chlamydia and Gonorrhea at 12 months Baseline, 12-months
Secondary HIV Testing frequency of HIV testing among HIV-negative or unknown status participants Baseline, 3-, 6-, 9-, 12-months
Secondary Antiretroviral Medication Adherence change in ART medication adherence among HIV-positive participants Baseline, 3-, 6-, 9-, 12-months
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