A Randomized Trial to Prevent HIV Among Gay Couples
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/13/2018 |
| Start Date: | July 1, 2017 |
| End Date: | September 1, 2022 |
| Contact: | Cameron Michels, MA |
| Email: | cmichels@sfsu.edu |
| Phone: | 415.817.4520 |
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.
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.
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.
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.
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.
We found this trial at
1
site
835 Market Street
San Francisco, California 94103
San Francisco, California 94103
Phone: 415-817-4520
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