Couples HIV Counseling and Testing for Male Couples in the United States (CVCT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University
ClinicalTrials.gov Identifier:
NCT01861210
First received: May 21, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

This is a study to determine whether testing for HIV together as a couple, as opposed to testing separately, in acceptable to men in male couples, and is a safe prevention service. Testing of couples together has been provided for decades in Africa, but has never been tested in the United States. In this study, male couples will be enrolled and randomly assigned to be tested together in the same room, or separately. At the time of testing, investigators will ask questions about how they felt about the service they received. Three months later, investigators will survey the men again, and determine whether they had any problems after the testing, like violence in the relationship or the relationship breaking up. The main outcomes are being satisfied with the testing service, and safety (lack of intimate partner violence or relationship termination). Although the study is not designed to determine if the service reduces risk behaviors for HIV transmission, investigators will examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at least as satisfied with couples testing as they are with individual testing; and (2) men tested as couples will not experience higher rates of intimate partner violence or relationship dissolution, relative to men tested separately.


Condition Intervention
HIV
Behavioral: Couples Voluntary HIV Counseling and Testing
Behavioral: Individual Counseling and Testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Couples HIV Counseling and Testing for Male Couples in the United States

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Intimate partner violence [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Having been punched, hit, or kicked by the partner he tested with, injured to the point of feeling physical pain the day after a fight, or inflicting any of these acts on his partner in the preceding three months.


Secondary Outcome Measures:
  • Relationship dissolution [ Time Frame: 3 months, or at the time of followup survey ] [ Designated as safety issue: Yes ]
    Either or both partners reported that the relationship ended after their participation in the study


Other Outcome Measures:
  • Satisfaction with counseling service [ Time Frame: Within 30 minutes after the service ] [ Designated as safety issue: No ]

    Seven items asked on a 5-point Likert scale:

    • Quality of the session
    • Relevance of the session
    • Appropriateness of the format
    • Degree to which the session met personal needs
    • Usefulness of the session
    • Satisfaction with the session
    • Likelihood of recommending the service to a friend


Enrollment: 216
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Couples Counseling and Testing
Couples Voluntary HIV Counseling and Testing, adapted for use with male couples from the standard African couples testing service.
Behavioral: Couples Voluntary HIV Counseling and Testing
Other Name: Couples HIV Testing and Counseling
Active Comparator: Individudal Counseling and Testing
Individual Voluntary Counseling and Testing involves HIV testing and individual, client-centered HIV prevention counseling. This service is provided by counselors trained in Centers for Disease Control and Prevention's "Fundamentals of HIV Prevention Counseling" training.
Behavioral: Individual Counseling and Testing

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male at birth
  • currently self-identify as male
  • at least 18 years of age
  • have been in a couple with a man for at least 3 months
  • willing to complete a follow-up study visit in 3 months
  • able to complete study assessments in English.

Exclusion Criteria:

  • known to be HIV-positive
  • over 39 years of age
  • either partner being unwilling to accept randomization to the couples testing arm
  • either partner planning to move from the Atlanta area within 3 months of the initial study visit
  • either partner reporting a history of intimate partner violence
  • either partner reporting feeling coerced to tested with his partner
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861210

Locations
United States, Georgia
AID Atlanta
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Patrick S Sullivan, PhD Emory University Rollins School of Public Health
  More Information

No publications provided

Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01861210     History of Changes
Other Study ID Numbers: IRB00043714, R34MH086331, CVCTMSM
Study First Received: May 21, 2013
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Homosexuality, Male

ClinicalTrials.gov processed this record on October 21, 2014