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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01861210
Acronym
CVCT
Enrollment
216
Registered
2013-05-23
Start date
2010-09-30
Completion date
2012-06-30
Last updated
2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Homosexuality, Male

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.

Interventions

BEHAVIORALCouples Voluntary HIV Counseling and Testing
BEHAVIORALIndividual Counseling and Testing

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intimate partner violence3 monthsHaving 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

MeasureTime frameDescription
Relationship dissolution3 months, or at the time of followup surveyEither or both partners reported that the relationship ended after their participation in the study

Other

MeasureTime frameDescription
Satisfaction with counseling serviceWithin 30 minutes after the serviceSeven 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026