Project Nexus: Providing Online Counseling for Home-Based HIV Testing

University of Michigan

Status: Completed

Conditions: Couples

Treatments: Behavioral: Couples HIV Testing and Counseling (CHTC, CVCT); Behavioral: at-home test kit

Study type: Interventional

Funder types: Other

Identifiers

NCT02335138

IRB00072655

Details and patient eligibility

About

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?

Full 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).

Enrollment: 800 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups, including a placebo group

Control Arm

Placebo Comparator group

Description:

Each participant will receive an at-home test kit and will be asked to test and return results to investigator.

Treatment:

Behavioral: at-home test kit

Intervention Arm

Active Comparator group

Description:

Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online CHTC session.

Treatment:

Behavioral: Couples HIV Testing and Counseling (CHTC, CVCT)