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

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ClinicalTrials.gov Identifier: NCT01861210
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Behavioral: Couples Voluntary HIV Counseling and Testing Behavioral: Individual Counseling and Testing

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Couples HIV Counseling and Testing for Male Couples in the United States
Study Start Date : September 2010
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Intimate partner violence [ Time Frame: 3 months ]
    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 :
  1. Relationship dissolution [ Time Frame: 3 months, or at the time of followup survey ]
    Either or both partners reported that the relationship ended after their participation in the study


Other Outcome Measures:
  1. Satisfaction with counseling service [ Time Frame: Within 30 minutes after the service ]

    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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

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): NCT01861210


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

Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01861210     History of Changes
Other Study ID Numbers: IRB00043714
R34MH086331 ( U.S. NIH Grant/Contract )
CVCTMSM ( Other Identifier: Other )
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Patrick S Sullivan, Emory University:
Homosexuality, Male