Online HIV Prevention for Young Male Couples

Hiv Clinical Trial

— 2GETHER  

Official title:

A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284541
• Other study ID #: DP2DA042417
• Status: Completed
• Phase: Phase 2
• Start date: April 5, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• 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, they 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 investigators 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. This RCT will be implemented online; both the experimental and control condition will be administered via video-conferencing technology to couples across the United States. The investigators will conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on the HIV status of individuals in the dyad. Couples in which both members are HIV-negative will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol. Couples in which both members are HIV-positive will receive the single session Life-Steps medication adherence protocol. Couples with discordant HIV statuses will receive both interventions jointly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

• At least one member of the couple reports an episode of binge-drinking or illicit drug use during the last 30 days

• 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 during the past 3 months

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• Hiv

Intervention

Behavioral:
• 2GETHER
Communication skills, coping skills, problem-solving, acceptance, HIV prevention
• Existing Public Health Practice
HIV testing, medication adherence, HIV risk reduction

Locations

Country	Name	City	State
United States	Northwestern University-Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

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	Antiretroviral Medication Adherence	change in ART medication adherence among HIV-positive participants	Baseline, 3-, 6-, 9-, 12-months
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 have have initiated pre-exposure prophylaxis	Baseline, 3-, 6-, 9-, 12-months
Primary	Condomless anal sex	change in number of condomless anal sex acts with serodiscordant or unknown status partners	12-months
Primary	Occurrence of Sexually Transmitted Infections	the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months	12-months
Secondary	HIV Testing	frequency of HIV testing among HIV-negative or unknown status participants	Baseline, 3-, 6-, 9-, 12-months
Secondary	HIV Viral Load	change in serum viral load among HIV-positive participants	Baseline, 12-months
Secondary	Alcohol and Drug Use Problems	change in problems associated with alcohol, marijuana and other illicit drug use	Baseline, 3-, 6-, 9-, 12-months
Secondary	Relationship Satisfaction	change in relationship satisfaction	Baseline, 3-, 6-, 9-, 12-months
Secondary	Communication Skills	change in communication skills with romantic partners	Baseline, 3-, 6-, 9-, 12-months