Scale-up of an Internet-Delivered Randomized Controlled Trial for HIV+ Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,197
- 试验地点
- 1
- 主要终点
- SDCAS
研究概览
简要总结
Although HIV testing and highly effective antiretroviral therapy (ART) have improved survival with HIV, the relatively low level of ART adherence presents a significant public health challenge in terms of the potential to transmit HIV. Preventing transmission in virally unsuppressed HIV+ MSM who have condomless anal sex (CAS) with serodiscordant partners can have a great public health impact. As new HIV infections in MSM have been attributed in part to increased access to sex partners online, it is critical to deliver behavioral interventions to HIV+ MSM online to reach many high-risk men at a relatively low cost.
The investigators' theoretically-grounded HIV prevention videos about CAS, HIV disclosure, and testing in MSM were rigorously evaluated among MSM recruited online. Findings indicated significant reductions in CAS and significant increases in HIV status disclosure at 3-month follow-up, compared to baseline. In a subsequent online, randomized controlled trial (RCT) for MSM, investigators found significant reductions in CAS among MSM in the video arm at 60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including serodiscordant CAS (SDCAS) at 60-day follow-up, compared to baseline. Based on these findings, investigators worked with POZ.com (POZ), the largest website for HIV+ individuals, to test whether they could recruit ethnically diverse HIV+ MSM and were very successful. The investigators have identified a potentially highly effective and feasible risk reduction intervention approach for HIV+ MSM.
With the commitment of POZ and a strong team of experts, the investigators propose to reshoot the videos to show the perspective of an HIV-positive man's experience with relationships and struggle ART adherence. The intervention videos will provide short doses for 10 online sessions (including boosters). We will target HIV+ MSM who are virally unsuppressed and monitor self-reported clinical indicators (i.e., viral load). Further, we will target online recruitment by race/ethnicity to enroll equal numbers of HIV+ White, Black and Hispanic MSM for balanced representation; improving retention with incentives and a proven online platform; including educational information about ART adherence; and cost and cost-effectiveness analyses for potentially averted HIV infections to determine health-related cost savings. Online, the investigators will recruit and follow a national sample of 1,500 high-risk, virally unsuppressed HIV+ MSM for 12 months.
详细描述
Study Design. For the primary outcomes (reduction in SDCAS and increase in HIV disclosure to sex partners), the proposed online study utilizes a 2-arm RCT design, with 10 intervention video vignettes grounded in SLT/SCT, to evaluate an innovative, multisession, video-based online intervention tailored to 1,500 English-speaking virally unsuppressed HIV+ White, Black and Hispanic MSM. Men will be randomized to receive 10 sessions of theory-driven video treatments or "attention" video controls. Men will be classified as White, Black, or Hispanic based on self-identification, and computerized randomization will occur within race/ethnicity to assure balanced representation across the experimental arms. All participants will receive online surveys at baseline, 3-, 6-, 9- and 12-month follow-up. All participants will receive incentives after completion of each online survey.
Preparation for Online RCT (AIM 1) (Months 1 - 12). In AIM 1 the investigators will finalize intervention materials for the RCT, plan online recruitment, program and test the online platform and work with the CAG to ensure appropriate literacy levels of the materials and surveys.
Theory-Driven Treatment Videos:
Employing a dramatic video series grounded in Social Learning and Social Cognitive theories, the Sex Positive![+] study engages learners through storytelling and promotes critical thinking on issues of HIV disclosure to sex partners, medication adherence and viral suppression, and serodiscordant condomless anal sex (CAS). In collaboration with a local production team, including a script writer, producer, and director, we produced Just a Guy, a six-episode video series that follows the story of "Guy", an openly gay man living with HIV in Brooklyn, NY. The video series is based, in part, on the HIV Big Deal project described above, which was launched online in 2008.
Attention Control Videos: The control arm receives ten healthy living videos that cover a range of topics including nutrition, physical exercise, smoking, and sleep quality. Attention control videos were selected from video-sharing websites and voted on by members of the research team.
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
- None
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
- •biologically male
- •age 18 or over
- •able to read and respond in English
- •reside within the U.S.
- •report CAS with any HIV-negative or unknown status male partners in the past 6 months
- •identify as HIV-positive
- •in the past year, report a detectable viral load OR report not being on ART and not knowing their viral load OR report past month suboptimal ART adherence
- •report their race and ethnicity as White, Black or Hispanic
- •be willing to participate in an online intervention study for 12 months
- •have a working email address and cell phone number for intervention follow-up
排除标准
- •HIV-negative or untested MSM
- •transgender persons
- •anyone under age 18
研究组 & 干预措施
Intervention
The Video Treatment arm will complete baseline, 3-, 6-, 9-, and 12-month online survey assessments. Between baseline and 3-month follow-up, men will view 6 video vignettes (participants will receive a link to view a video vignette once a week for 6 weeks). Based on our team's experience of attenuated intervention effects at 6 months, men will receive 4 video boosters, spaced 1 week apart, after the 6-month assessment survey. Spacing the dose over time can improve critical thinking. The additional videos will be a continuation of the dramatic series plus additional video scenes on disclosure and serodiscordant partnerships.
干预措施: Video treatments (Behavioral)
Control
The video control arm will complete baseline, 3-, 6-, 9-, and 12-month online survey assessments. The control arm will receive the same number (and timing of) video clips as the intervention arm, but from a non-theoretically driven gay-oriented show with videos that are similar in length in order to preserve dosing equality across both arms. As the video treatment arm will be provided efficacious theory-driven videos, investigators expect to find a significant decrease in sexual risk behaviors in the intervention arm, compared to the control arm. Should this occur by month 6, with agreement from the data safety monitoring board (DSMB), investigators will provide the control arm with the video treatments.
干预措施: Video treatments (Behavioral)
结局指标
主要结局
SDCAS
时间窗: 3 months, 6 months, 9 months, 12 months
We will measure whether there is a reduction, increase, or no change in serodiscordant condomless anal sex with HIV-negative or unknown status male sex partners across the two study arms.
次要结局
- HIV disclosure(3 months, 6 months, 9 months, 12 months)
研究者
Sabina Hirshfield
Senior Research Scientist
Public Health Solutions