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OpenTrials
Completed

NCT Number: NCT01861210

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AID Atlanta

Atlanta, Georgia, 30309, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Couples Voluntary HIV Counseling and Testing

Behavioral

Other names: Couples HIV Testing and Counseling

Individual Counseling and Testing

Behavioral

Primary outcomes

  1. Intimate partner violence

    Time frame: 3 months

    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.

Secondary outcomes

  1. Relationship dissolution

    Time frame: 3 months, or at the time of followup survey

    Either or both partners reported that the relationship ended after their participation in the study

Other outcomes

  1. Satisfaction with counseling service

    Time frame: Within 30 minutes after the 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: CVCT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 23, 2013
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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