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Trial record 19 of 38 for:    Recruiting, Not yet recruiting, Available Studies | Chlamydia

Online HIV Prevention for Young Male Couples (2GETHER)

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ClinicalTrials.gov Identifier: NCT03284541
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Michael E. Newcomb, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Hiv Chlamydia Gonorrhea Behavioral: 2GETHER Behavioral: Existing Public Health Practice Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Couples are randomized into an experimental condition or control (existing public health practice).
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A New Approach to Integrating Primary and Secondary HIV Prevention in Young Male Couples
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 2GETHER
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.
Behavioral: 2GETHER
Communication skills, coping skills, problem-solving, acceptance, HIV prevention

Active Comparator: Existing Public Health Practice
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
Behavioral: Existing Public Health Practice
HIV testing, medication adherence, HIV risk reduction




Primary Outcome Measures :
  1. Condomless anal sex [ Time Frame: 12-months ]
    change in number of condomless anal sex acts with serodiscordant or unknown status partners

  2. Occurrence of Sexually Transmitted Infections [ Time Frame: 12-months ]
    the incidence (number of new cases or diagnoses) or Chlamydia and Gonorrhea at 12 months


Secondary Outcome Measures :
  1. HIV Testing [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    frequency of HIV testing among HIV-negative or unknown status participants

  2. HIV Viral Load [ Time Frame: Baseline, 12-months ]
    change in serum viral load among HIV-positive participants

  3. Alcohol and Drug Use Problems [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in problems associated with alcohol, marijuana and other illicit drug use

  4. Relationship Satisfaction [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in relationship satisfaction

  5. Communication Skills [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in communication skills with romantic partners


Other Outcome Measures:
  1. Antiretroviral Medication Adherence [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in ART medication adherence among HIV-positive participants

  2. Pre-Exposure Prophylaxis [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    initiation of pre-exposure prophylaxis among HIV-negative or unknown status participants

  3. Pre-Exposure Prophylaxis Adherence [ Time Frame: Baseline, 3-, 6-, 9-, 12-months ]
    change in pre-exposure prophylaxis adherence among participants have have initiated pre-exposure prophylaxis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both members of the dyad must be assigned male at birth and currently identify as male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284541


Contacts
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Contact: Michael E Newcomb, Ph.D. 312-502-0702 newcomb@northwestern.edu
Contact: Kathryn Macapagal, Ph.D. 312-503-3605 kathryn.macapagal@northwestern.edu

Locations
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United States, Illinois
Northwestern University-Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael E Newcomb, Ph.D.    312-503-0702    newcomb@northwestern.edu   
Contact: Kathryn Macapagal, Ph.D.    312-503-3605    kathryn.macapagal@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Michael E Newcomb, Ph.D. Northwestern University
Study Director: Jim Carey, MPH Northwestern University
Study Director: Ricky Hill, Ph.D. Northwestern University

Publications:
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Responsible Party: Michael E. Newcomb, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03284541     History of Changes
Other Study ID Numbers: DP2DA042417 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gonorrhea
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections