Clinical trial NCT02335138: Project Nexus: Providing Online Counseling for Home-Based HIV Testing
Official title: Project Nexus: Providing Online Counseling for Home-Based HIV Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Couples
Keywords: HIV
MSM
Couples
Home Testing
Sexual Agreements
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Miami
name: University of Rochester
First posted: 2015-01-09
Enrollment: 800
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed research aims to address the question: Compared to the current standard of care for home-based HIV tests, in which persons conduct and interpret HIV tests without counseling, does the addition of video conferencing with a remote counselor increase health-enhancing, protective behaviors among male-male couples and facilitate linkage to care for those who test positive?

Detailed description: The investigators propose to address four specific aims through a randomized controlled trial (RCT) to take place over a four-year period. The investigators plan to enroll and maintain a cohort of 350 men who have sex with men (MSM) couples: 175 self-reported concordant HIV-negative and 175 self-reported HIV-discordant couples. Within this sample, the proposed study will examine the impact of home-testing with video-based Couples HIV Testing and Counseling (CHTC) (intervention) versus home-testing alone (control) on changes in: sexual risk-taking (e.g., UAI), formation and adherence to explicit agreements about sex, relationship functioning for the management of HIV risk, and linkage to care for newly diagnosed HIV positives among MSM couples who live throughout the US. To assess these specific changes, couples will complete online surveys at 3 time points (baseline, 3 months and 6 months).

Eligibility criteria: Inclusion Criteria:

* Male sex at birth
* 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:

* Sex at birth other than male
* 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

Primary outcomes:
measure: Process and use of communal coping - Outcome Efficacy to Reduce HIV Threat
timeFrame: 6 months
measure: Process and use of communal coping - Couple Efficacy to Reduce HIV Threat
timeFrame: 6 months
measure: Process and use of communal coping - Communal Coping to Reduce HIV Threat
timeFrame: 6 months
measure: Changes in Sexual Agreements
timeFrame: 6 months
measure: Changes in Sexual Behavior
timeFrame: 6 months
Secondary outcomes:
measure: Linkage to Care
timeFrame: 6 months
Other outcomes:
measure: Predisposing couple factors - Perceived Severity of HIV
timeFrame: 6 months
measure: Predisposing couple factors - Preferences for General Lifestyle
timeFrame: 6 months
measure: Predisposing couple factors - Preferences for General Sexual Health
timeFrame: 6 months
measure: Predisposing couple factors - Conflict Style
timeFrame: 6 months
measure: Predisposing couple factors - Communication Style
timeFrame: 6 months
measure: Predisposing couple factors - Problem-solving Skills
timeFrame: 6 months
measure: Partner's transformation of motivation - Emotional Response
timeFrame: 6 months
measure: Partner's transformation of motivation - Cognitive Response
timeFrame: 6 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Center for Sexuality & Health Disparities (SexLab)
state: Michigan
Study officials:
affiliation: University of Michigan School of Nursing Department of Health Behavior and Biological Sciences
name: Rob Stephenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.