A Randomized Trial to Prevent HIV Among Gay Couples
试验速览
- 阶段
- 1 期
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Composite Risk for HIV (CR-HIV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be aware that there are online and in-person aspects of the study as seen in the consent form, but will be randomized to a group and unaware of which arm they are in.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite Risk for HIV (CR-HIV)
时间窗: 9 months (baseline, 3, 6, and 9 month followups)
The primary outcome variable will be a binary indicator of any HIV-risk (no vs. yes) in the past three months at baseline, 3, months, 6 months, and 9 months--based on a composite of self-reported sexual risk behavior (defined as CAS with a discordant or unknown HIV status partner as well as HIV-positive partner's ART interruption (defined as missing all ART doses over a 4-day period in the past three months 70) and suppressed viral load. We will rely on self-reports of viral load because sexual risk behavior is based on one's perception of one's own or the partners' viral load. Regular viral load tests will be emphasized in PRIDE and ePRIDE to encourage participants to be proactive about their lab work. Baseline, 3 months, 6 months, and 9 months will be assessed for change over time past the date of the intervention.
次要结局
未报告次要终点