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

NCT01861210 | Completed

• 3 other identifiers: IRB00043714R34MH086331CVCTMSM
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Homosexuality, Male

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relationship dissolution

  3 months, or at the time of followup survey

Other Outcomes (1)

• Satisfaction with counseling service

  Within 30 minutes after the service

Study Arms (2)

Couples Counseling and Testing

EXPERIMENTAL

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

Individudal Counseling and Testing

ACTIVE COMPARATOR

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

Interventions

Couples Voluntary HIV Counseling and Testing BEHAVIORAL

Also known as: Couples HIV Testing and Counseling

Couples Counseling and Testing

Individual Counseling and Testing BEHAVIORAL

Individudal Counseling and Testing

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

AID Atlanta

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Homosexuality, Male

Interventions

Counseling

Condition Hierarchy (Ancestors)

Homosexuality; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Patrick S Sullivan, PhD

  Emory University Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: September 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (1)