Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

May 21, 2013
January 23, 2014
September 2010
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01861210 on Archive Site
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
Same as current
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
Same as current
Couples HIV Counseling and Testing for Male Couples in the United States
Couples HIV Counseling and Testing for Male Couples in the United States

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.

Not Provided
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Behavioral: Couples Voluntary HIV Counseling and Testing
    Other Name: Couples HIV Testing and Counseling
  • Behavioral: Individual Counseling and Testing
  • Experimental: Couples Counseling and Testing
    Couples Voluntary HIV Counseling and Testing, adapted for use with male couples from the standard African couples testing service.
    Intervention: Behavioral: Couples Voluntary HIV Counseling and Testing
  • 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.
    Intervention: Behavioral: Individual Counseling and Testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
May 2012   (final data collection date for primary outcome measure)

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
18 Years to 39 Years
Contact information is only displayed when the study is recruiting subjects
United States
IRB00043714, R34MH086331, CVCTMSM
Patrick S Sullivan, Emory University
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Patrick S Sullivan, PhD Emory University Rollins School of Public Health
Emory University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP