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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Couples Voluntary HIV Counseling and Testing
* Behavioral: Individual Counseling and Testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Couples Counseling and Testing<br>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<br> <br> * Other names: Couples HIV Testing and Counseling;|
| Active Comparator: Individudal Counseling and Testing<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homosexuality, Male