Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03284541
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2017-06-23
Brief Title:
Online HIV Prevention for Young Male Couples
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2GETHER
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 gaybisexual 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 eg HIV testing condom use pre-exposure prophylaxis and transmission eg 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 N114 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 N400 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
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 eg HIV testing condom use pre-exposure prophylaxis and transmission eg 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 N114 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 N400 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None