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

HIV Clinical Trial

— CVCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861210
• Other study ID #: IRB00043714
• Secondary ID: R34MH086331CVCTM
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: May 20, 2015
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Couples Voluntary HIV Counseling and Testing

• Individual Counseling and Testing

Locations

Country	Name	City	State
United States	AID Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	Yes