Clinical trial NCT03284541: Online HIV Prevention for Young Male Couples
Official title: A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hiv
Chlamydia
Gonorrhea
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples are randomized into an experimental condition or control (existing public health practice).
Primary purpose: PREVENTION

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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Condomless anal sex
timeFrame: 12-months
measure: Occurrence of Sexually Transmitted Infections
timeFrame: 12-months
Secondary outcomes:
measure: HIV Testing
timeFrame: Baseline, 3-, 6-, 9-, 12-months
measure: HIV Viral Load
timeFrame: Baseline, 12-months
measure: Alcohol and Drug Use Problems
timeFrame: Baseline, 3-, 6-, 9-, 12-months
measure: Relationship Satisfaction
timeFrame: Baseline, 3-, 6-, 9-, 12-months
measure: Communication Skills
timeFrame: Baseline, 3-, 6-, 9-, 12-months
Other outcomes:
measure: Antiretroviral Medication Adherence
timeFrame: Baseline, 3-, 6-, 9-, 12-months
measure: Pre-Exposure Prophylaxis
timeFrame: Baseline, 3-, 6-, 9-, 12-months
measure: Pre-Exposure Prophylaxis Adherence
timeFrame: Baseline, 3-, 6-, 9-, 12-months
Locations:
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael E Newcomb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Jim Carey, MPH
role: STUDY_DIRECTOR
affiliation: Northwestern University
name: Ricky Hill, Ph.D.
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.
citation: Newcomb ME, Sarno EL, Bettin E, Carey J, Ciolino JD, Hill R, Garcia CP, Macapagal K, Mustanski B, Swann G, Whitton SW. Relationship Education and HIV Prevention for Young Male Couples Administered Online via Videoconference: Protocol for a National Randomized Controlled Trial of 2GETHER. JMIR Res Protoc. 2020 Jan 27;9(1):e15883. doi: 10.2196/15883.