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

Emory University

Status: Completed

Conditions: HIV

Treatments: Behavioral: Individual Counseling and Testing; Behavioral: Couples Voluntary HIV Counseling and Testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01861210

CVCTMSM (Other Identifier)

IRB00043714

R34MH086331 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Couples Counseling and Testing

Experimental group

Description:

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

Treatment:

Behavioral: Couples Voluntary HIV Counseling and Testing

Individudal Counseling and Testing

Active Comparator group

Description:

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.

Treatment:

Behavioral: Individual Counseling and Testing