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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Couples Voluntary HIV Counseling and Testing; Behavioral: Individual Counseling and Testing

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • AID Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intimate partner violence	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship dissolution	Either or both partners reported that the relationship ended after their participation in the study	3 months, or at the time of followup survey

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with counseling 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	Within 30 minutes after the service

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Patrick S Sullivan, PhD, Emory University Rollins School of Public Health

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Homosexuality, Male
• Other Study ID Numbers: IRB00043714; R34MH086331 (U.S. NIH Grant/Contract); CVCTMSM (Other Identifier: Other)