Couples HIV Counseling and Testing for Male Couples in the United States

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Couples Voluntary HIV Counseling and Testing; Behavioral: Individual Counseling and Testing

• Registration Number: NCT01861210
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 216

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Couples Counseling and Testing	Couples Voluntary HIV Counseling and Testing	Couples Voluntary HIV Counseling and Testing, adapted for use with male couples from the standard African couples testing service.
Individudal Counseling and Testing	Individual 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.

Primary Outcome Measures

Name	Time	Method
Intimate partner violence	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

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

Trial Locations

Locations (1)

AID Atlanta; 🇺🇸 Atlanta, Georgia, United States