Clinical trial NCT03189394: A Randomized Trial to Prevent HIV Among Gay Couples
Official title: A Randomized Trial to Prevent HIV Among Gay Couples
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
gay couples
relationships
dyads
Lead sponsor: San Francisco State University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of Colorado, Denver
name: Johns Hopkins University
First posted: 2017-06-16
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: On completion of the baseline survey and testing, couples will be randomized to one of the three arms of the study (PRIDE, ePRIDE, or Men's Health). Couples will be randomized in blocks with the block size randomly permuted via a SAS computer program based on a pseudo-random number generator. Each arm of the intervention will begin on the same date and run for two weeks. Couples randomized to ePRIDE will be sent a link on the same day that PRIDE and Men's Health sessions are scheduled and will have two weeks to complete the program.
Primary purpose: PREVENTION

Brief summary: The proposed study is a randomized controlled intervention to reduce sexual risk for HIV among HIV-negative concordant and HIV discordant gay couples. There are three arms of the study: 1) the in-person experimental condition, PRIDE, 2) the online adaptation of the experimental condition, ePRIDE, and 3) the time- and attention-matched in-person control condition, Men's Health. Participants (N = 300 couples) will be randomized equally into one of the three study conditions and assessed via surveys at baseline and at 3-, 6- and 9-months after completion of the intervention sessions.

Detailed description: Participants (N = 300 couples) will be randomized equally into one of the three study conditions and assessed via surveys at baseline and at 3-, 6- and 9-months after completion of the intervention sessions. All participants will complete a baseline survey, administered a fluid (swab) OraQuick HIV test, administered a viral load (VL) or PrEP adherence dry blood spot test using the HemaSpot collection device they will be randomized to one of three intervention arms, and then follow-up surveys will measure short and long term impact of the intervention at 3, 6, and 9 months.

They will first be provided with a brief overview of the study focusing on the goals of the study, randomization, participation details and timeline, and if they wish to proceed, will then be screened for eligibility. Our goal will be to screen and baseline cohorts of 30 couples (10 couples for each arm of the intervention) within a 6-week window (recruitment will be on-going).

Eligible couples will be scheduled to come into the study offices to complete a baseline survey. On arrival, couples will be informed in detail about the study and what their participation entails. Study staff will answer any outstanding questions, informed consent will be obtained, the participants will be given a fluid (swab) OraQuick rapid HIV test in a private CREGS office with HIV counseling-certified staff, then will give a DBS specimen for testing either viral load for HIV-positive participants or PrEP levels for HIV-negative participants. For consented and eligible participants, the baseline survey will then be administered and the baseline online survey will be administered on study computers.

On completion of the baseline survey and testing, couples will be randomized to one of the three arms of the study (PRIDE, ePRIDE, or Men's Health). Couples will be randomized in blocks with the block size randomly permuted via a SAS computer program based on a pseudo-random number generator. Each arm of the intervention will begin on the same date and run for two weeks. Couples randomized to ePRIDE will be sent a link on the same day that PRIDE and Men's Health sessions are scheduled and will have two weeks to complete the program. Access to ePRIDE will be deactivated at the end of two weeks.

Participants who have a positive test result for HIV during the baseline visit will be given their results by HIV counseling-certified staff and referred for free confirmatory testing at our nearby partner, Alliance Health Project clinic, where they will also receive clinical care and support services. If the newly HIV-positive person is in a relationship with a confirmed HIV-positive partner, they will be considered ineligible. If the partner is HIV-negative, they will be eligible to participate in the study.

Short and long term impact of the intervention will be measured at 3-, 6- and 9-months post completion of the intervention. Follow-up surveys for all three arms will be administered online in-person at the downtown CREGS offices. Couples will be sent a link to the survey with a unique identification number and password and will have 7 days to complete each survey; reminders will be sent every two days contacted and scheduled to come in together to complete follow-up surveys on provided computers. Couples who take fail to come in and complete follow-ups longer than 7 days will be flagged so differential outcomes can be assessed as needed and their link to the survey will be disabled after 14 days.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* speak English
* live in the San Francisco Bay Area
* have knowledge of their own and their partner's serostatus
* are in a concordant HIV-negative or discordant relationship
* at least one partner has had condomless anal sex (CAS) in the last three months
* identify as biologically male and not transgender
* in a committed relationship (defined as two men who are committed to each other above anyone else and have had sex with each other) with their primary male partner (who they will participate in the study with) for at least 3 months.

Exclusion Criteria:

* under 18
* do not speak English
* do not live in the San Francisco Bay Area
* do not know their own or their partner's HIV status
* are in a relationship where both partners are HIV positive, neither partner reports CAS in the last three months
* identifies as transgender
* is of female sex
* not in a current committed relationship for at least 3 months.

Primary outcomes:
measure: Composite Risk for HIV (CR-HIV)
timeFrame: 9 months (baseline, 3, 6, and 9 month followups)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Center for Research and Education on Gender and Sexuaity (CREGS) At San Francisco State University
state: California
Study officials:
affiliation: CREGS, San Francisco State University
name: Colleen Hoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: