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?
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
800
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.
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.
University of Michigan Center for Sexuality & Health Disparities (SexLab)
Ann Arbor, Michigan, United States
Process and use of communal coping - Outcome Efficacy to Reduce HIV Threat
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. We created three subscales to capture the full range of outcome efficacy related to these three processes of communal coping. For the first subscale, Joint Effort, we used the stem, "My partner and I believe that 'working together' versus on our own is an effective strategy;" for the second subscale, Communication, we used the stem, "Communicating with my partner is an effective strategy for;" and for the third subscale, Planning and Decision-making, we used the stem, "My partner and I making decisions together rather than separately is an effective strategy." The items for each of the three subscales were the same as the items used for the Preference for Sexual Health Outcomes scale.
Time frame: 6 months
Process and use of communal coping - Couple Efficacy to Reduce HIV Threat
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. Couple efficacy is defined as a couple's confidence that together they can engage in communal coping efforts. We developed three subscales in parallel to Outcome Efficacy to Reduce HIV Threat Scale: Joint Effort, Communication, and Planning and Decision-making.
Time frame: 6 months
Process and use of communal coping - Communal Coping to Reduce HIV Threat
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. Scale: We developed three subscales in parallel to the Outcome Efficacy Scale and the Couple Efficacy Scale: Joint Effort, Communication, and Planning and Decision-making. All three subscales used the same six items from these other scales to capture the managing of reducing the health threat of HIV, but the stems were different.
Time frame: 6 months
Changes in Sexual Agreements
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We measure changes in sexual agreements using questions from previous studies of MSM couples' sexual agreements. Participants will be asked which of the following best describes their current sexual agreement with their main partner: "both of us cannot have sex with outside partners," "we can have sex with outside partners, without any conditions or restrictions," "we can have sex with outside partners, but with conditions or restrictions," and "we do not have an agreement." Additional items about agreements will further assess whether couples permitted (or did not permit) that certain sexual behaviors, namely UAI and oral sex, could occur with outside partners. In follow-up surveys, participants will be asked whether their agreement changed, and if so, to re-categorize their agreement type.
Time frame: 6 months
Changes in Sexual Behavior
We measure changes in sexual behavior using behavioral measures adapted from the NHBS behavioral inventory and previously used with thousands of MSM by our team will collect information both on sexual behaviors with the main sex partner in the 3 months before the interview, and on sexual behaviors with all sex partners outside the relationship. For sex with the main partner, men will be asked to estimate the number of anal sex acts with the main partner, and the number of those acts that were condom-protected. For outside the relationship, we will ask a series of questions about each outside partner, including HIV status of that partner (if known), whether the sex outside the relationship was disclosed to the main partner, the number and type of sex acts with each outside partner, and the proportion of those sex acts that were protected by condoms.
Time frame: 6 months
Linkage to Care
We will measure linkage to care with the following outcomes as indicators per the recent recommendations of the Institute of Medicine: within 3 months of HIV diagnosis (1) attending at least one clinical care appointment, (2) having at least one CD4 test performed, and (3) having at least one viral load test performed.
Time frame: 6 months