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Online HIV Prevention for Young Male Couples (2GETHER)

Primary Purpose

Hiv, Chlamydia, Gonorrhea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2GETHER
Existing Public Health Practice
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hiv

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University-Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2GETHER

Existing Public Health Practice

Arm Description

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.

The control condition consists of the single-session Couples-Based HIV Counseling and Testing protocol for HIV-negative couples, the single-session Life-Steps medication adherence protocol for HIV-positive couples, or both intervention delivered jointly to serodiscordant couples

Outcomes

Primary Outcome Measures

Condomless anal sex
change in number of condomless anal sex acts with serodiscordant or unknown status partners
Occurrence of Sexually Transmitted Infections
the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months

Secondary Outcome Measures

HIV Testing
frequency of HIV testing among HIV-negative or unknown status participants
HIV Viral Load
change in serum viral load among HIV-positive participants
Alcohol and Drug Use Problems
change in problems associated with alcohol, marijuana and other illicit drug use
Relationship Satisfaction
change in relationship satisfaction
Communication Skills
change in communication skills with romantic partners

Full Information

First Posted
June 23, 2017
Last Updated
July 25, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03284541
Brief Title
Online HIV Prevention for Young Male Couples
Acronym
2GETHER
Official Title
A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Chlamydia, Gonorrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Couples are randomized into an experimental condition or control (existing public health practice).
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2GETHER
Arm Type
Experimental
Arm Description
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.
Arm Title
Existing Public Health Practice
Arm Type
Active Comparator
Arm Description
The control condition consists of the single-session Couples-Based HIV Counseling and Testing protocol for HIV-negative couples, the single-session Life-Steps medication adherence protocol for HIV-positive couples, or both intervention delivered jointly to serodiscordant couples
Intervention Type
Behavioral
Intervention Name(s)
2GETHER
Intervention Description
Communication skills, coping skills, problem-solving, acceptance, HIV prevention
Intervention Type
Behavioral
Intervention Name(s)
Existing Public Health Practice
Intervention Description
HIV testing, medication adherence, HIV risk reduction
Primary Outcome Measure Information:
Title
Condomless anal sex
Description
change in number of condomless anal sex acts with serodiscordant or unknown status partners
Time Frame
12-months
Title
Occurrence of Sexually Transmitted Infections
Description
the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months
Time Frame
12-months
Secondary Outcome Measure Information:
Title
HIV Testing
Description
frequency of HIV testing among HIV-negative or unknown status participants
Time Frame
Baseline, 3-, 6-, 9-, 12-months
Title
HIV Viral Load
Description
change in serum viral load among HIV-positive participants
Time Frame
Baseline, 12-months
Title
Alcohol and Drug Use Problems
Description
change in problems associated with alcohol, marijuana and other illicit drug use
Time Frame
Baseline, 3-, 6-, 9-, 12-months
Title
Relationship Satisfaction
Description
change in relationship satisfaction
Time Frame
Baseline, 3-, 6-, 9-, 12-months
Title
Communication Skills
Description
change in communication skills with romantic partners
Time Frame
Baseline, 3-, 6-, 9-, 12-months
Other Pre-specified Outcome Measures:
Title
Antiretroviral Medication Adherence
Description
change in ART medication adherence among HIV-positive participants
Time Frame
Baseline, 3-, 6-, 9-, 12-months
Title
Pre-Exposure Prophylaxis
Description
initiation of pre-exposure prophylaxis among HIV-negative or unknown status participants
Time Frame
Baseline, 3-, 6-, 9-, 12-months
Title
Pre-Exposure Prophylaxis Adherence
Description
change in pre-exposure prophylaxis adherence among participants have have initiated pre-exposure prophylaxis
Time Frame
Baseline, 3-, 6-, 9-, 12-months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Both members of the dyad must be assigned male at birth and currently identify as male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Newcomb, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Carey, MPH
Organizational Affiliation
Northwestern University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ricky Hill, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University-Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19417579
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.
Results Reference
background
PubMed Identifier
25678895
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.
Results Reference
background
PubMed Identifier
24980246
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.
Results Reference
background
PubMed Identifier
22283386
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.
Results Reference
background
PubMed Identifier
28083833
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.
Results Reference
background
PubMed Identifier
32012111
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.
Results Reference
derived

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Online HIV Prevention for Young Male Couples

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