Project Nexus: Providing Online Counseling for Home-Based HIV Testing
NCT ID: NCT02335138
Last Updated: 2019-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
800 participants
INTERVENTIONAL
2016-04-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control Arm
Each participant will receive an at-home test kit and will be asked to test and return results to investigator.
at-home test kit
Male couples in the control group will receive test kits, but will not receive any testing intervention. Once individual results are reported,participants will be contacted via phone by study staff with options for referrals to services for the reactive partner(s). Participants will complete follow-up surveys at 3 and 6 months post-testing.
Intervention Arm
Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online CHTC session.
Couples HIV Testing and Counseling (CHTC, CVCT)
Male couples randomized to the experimental group (Couples HIV Testing and Counseling, CHTC/CVCT) will receive HIV counseling and testing as a couple via an online, HIPPA-compliant videoconferencing service. The dyad-centered session will last less than one hour and focus on couples agreement, prevention strategies, and/or linkage to HIV care, depending on each couple's test results. Participants will complete follow-up surveys at 3 and 6 months post-testing.
Interventions
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Couples HIV Testing and Counseling (CHTC, CVCT)
Male couples randomized to the experimental group (Couples HIV Testing and Counseling, CHTC/CVCT) will receive HIV counseling and testing as a couple via an online, HIPPA-compliant videoconferencing service. The dyad-centered session will last less than one hour and focus on couples agreement, prevention strategies, and/or linkage to HIV care, depending on each couple's test results. Participants will complete follow-up surveys at 3 and 6 months post-testing.
at-home test kit
Male couples in the control group will receive test kits, but will not receive any testing intervention. Once individual results are reported,participants will be contacted via phone by study staff with options for referrals to services for the reactive partner(s). Participants will complete follow-up surveys at 3 and 6 months post-testing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male gender
* 18 or older
* In a relationship with a male sexual partner of duration six months or longer
* Negative or unknown HIV status and not having tested in the last 6 months, with a partner meeting the same criteria OR in a sero-discordant with the negative/unknown partner reporting not having tested in the past 6 months
* No recent (past year) severe intimate partner violence (IPV) reported within the couple. IPV will be determined by responses to the below questions, in addition to parallel questions addressing perpetration of the specified acts:
1. Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has \[your partner\] punched, hit, or slapped you?
2. Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has \[your partner\] kicked you?
3. Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has \[your partner\] used force or threats of force to make you do something sexual that you didn't want to do?
4. Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has \[your partner\] raped you? \[Follow up question: Do you feel safe in your relationship?\]
* Willingness to have HIV test kits delivered to a home address they provide
* Willingness to be tested for HIV with one's male sexual partner
* Willingness to be randomized to either study arm
* Willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, Internet access)
Exclusion Criteria
* Gender other than male
* Either partner aged 17 or younger
* Does not have a main male sex partner or has a main male sex partner of relationship duration less than 6 months
* Both partners within the couple report known, positive HIV status OR one or both partners reports having tested negative for HIV within 6 months
* Either partner reports experiencing or perpetrating intimate partner violence within the couple within the past year
* Either partner expresses unwillingness to have HIV test kits delivered to a home address
* Either partner expresses unwillingness to test for HIV together with his male sexual partner
* Either partner expresses unwillingness to be randomized
* Unwillingness or inability to participate in video-based counseling
18 Years
MALE
Yes
Sponsors
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University of Miami
OTHER
University of Rochester
OTHER
University of Michigan
OTHER
Responsible Party
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Robert Stephenson
Professor
Principal Investigators
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Rob Stephenson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan School of Nursing Department of Health Behavior and Biological Sciences
Locations
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University of Michigan Center for Sexuality & Health Disparities (SexLab)
Ann Arbor, Michigan, United States
Countries
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References
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Stephenson R, Freeland R, Sullivan SP, Riley E, Johnson BA, Mitchell J, McFarland D, Sullivan PS. Home-Based HIV Testing and Counseling for Male Couples (Project Nexus): A Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 30;6(5):e101. doi: 10.2196/resprot.7341.
Other Identifiers
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IRB00072655
Identifier Type: -
Identifier Source: org_study_id
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