HIVCVCTNCT01861210
Couples HIV Counseling and Testing for Male Couples in the United States
A study testing Couples Voluntary HIV Counseling and Testing and Individual Counseling and Testing in people with HIV, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Couples Voluntary HIV Counseling and Testing and Individual Counseling and Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Couples Voluntary HIV Counseling and Testing, Individual Counseling and Testing
- Keywords
- Homosexuality, Male
- Medical subject headings
- Homosexuality, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Voluntary HIV Counseling and TestingBehavioural
Also called Couples HIV Testing and Counseling
Individual Counseling and TestingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Couples Counseling and Testing | Experimental | Couples Voluntary HIV Counseling and Testing, adapted for use with male couples from the standard African couples testing service. Receives: 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. Receives: Behavioral: Individual Counseling and Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Relationship dissolution
Either or both partners reported that the relationship ended after their participation in the study
Measured: 3 months, or at the time of followup survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startSep 2010
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick S Sullivan, PhD, Principal investigator, Emory University Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861210
- Sponsor's protocol ID
- IRB00043714
- Other IDs
- R34MH086331, CVCTMSM
- Acronym
- CVCT
- Status last verified
- May 2015
- First submitted
- 21 May 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples HIV Counseling and Testing for Male Couples in the United States
- ClinicalTrials.gov ID
- NCT01861210
- Acronym / sponsor ID
- CVCT / IRB00043714
- Conditions
- HIV
- Keywords
- Homosexuality, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples Counseling and Testing | Experimental | Behavioral: Couples Voluntary HIV Counseling and TestingCouples Voluntary HIV Counseling and Testing, adapted for use with male couples from the standard African couples testing service. |
| Individudal Counseling and Testing | Active comparator | Behavioral: Individual Counseling and TestingIndividual 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples Voluntary HIV Counseling and TestingAlso: Couples HIV Testing and Counseling | Behavioural | Couples Counseling and Testing |
| Individual Counseling and Testing | Behavioural | Individudal Counseling and Testing |
Primary outcome
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.
1 secondary outcome
Relationship dissolution
Time frame: 3 months, or at the time of followup survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick S Sullivan, PhD principal investigator
Emory University Rollins School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples Voluntary HIV Counseling and Testing and Individual Counseling and Testing in people with HIV, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intimate partner violence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.