Scale-up of an Internet-Delivered Randomized Controlled Trial for HIV+ Men

描述（由申请人提供）：虽然艾滋病毒检测和高效的抗逆转录病毒疗法（ART）提高了艾滋病毒的生存率，但相对较低的ART依从性在传播艾滋病毒的可能性方面提出了重大的公共卫生挑战。2011年，男男性行为者（MSM）占美国新感染者的65%。更令人担忧的是，60%的艾滋病毒+男男性行为者不坚持抗逆转录病毒治疗。在病毒未受抑制的艾滋病毒+男男性行为者中预防传播，他们与血清不一致的伴侣进行无保护的肛交（UAI），可能会产生巨大的公共卫生影响。拟议的研究具有成本效益和可扩展性的潜力，这是国家艾滋病毒/艾滋病战略和2013年跨NIH计划减少新的艾滋病毒感染的目标。由于男男性行为者中新的艾滋病毒感染部分归因于在线性伴侣的增加，因此必须在线向艾滋病毒+男男性行为者提供行为干预措施，以相对较低的成本接触许多高风险男性，让艾滋病毒+男男性行为者在他们遇到性伴侣的地方参与，并使男性能够根据自己的时间表在计算机，平板电脑或智能手机上私下参与，而不是在结构化的临床环境中。 我们的第一个关于UAI，HIV披露和MSM测试的三个理论基础的HIV预防视频在网上招募的MSM中进行了严格的评估。在我们对971名MSM进行的单次在线视频试点中，我们发现与基线相比，最近一次接触的UAI显著降低，3个月随访时艾滋病毒状态披露显著增加。在我们随后对3，092名MSM进行的在线单次随机对照试验（RCT）中，我们发现视频组中MSM在60天随访时的UAI与基线相比显著降低;视频组中HIV+ MSM在60天随访时与基线相比降低了UAI，包括血清不一致UAI（SDUAI）。基于我们对HIV+ MSM的RCT研究结果，我们测试了招募种族多样性HIV+ MSM的能力。我们与最大的艾滋病毒阳性个人网站POZ.com（POZ）的合作非常成功。 通过我们之前的工作，我们已经确定了一个潜在的高度有效和可行的 减少艾滋病毒+男男性行为者风险的干预措施。我们还成功地吸引了目标人口。在POZ和强大的专家团队的承诺下，我们建议通过将我们的3个艾滋病毒预防视频编辑为10个在线会议的短剂量（包括助推器）来改进我们的干预措施;针对病毒未受抑制的HIV+ MSM;监测自我报告的临床指标（即，病毒载量）;按性别和种族进行在线招聘，招收同等数量的艾滋病毒阳性白色、黑人和西班牙裔男男性行为者，以实现均衡代表性;通过激励措施和经验证的在线平台提高保留率;包括关于坚持抗逆转录病毒疗法的教育信息;对可能避免的艾滋病毒感染进行成本和成本效益分析，以确定与健康相关的成本节约。我们将在网上招募并跟踪全国1,500名高风险、病毒未抑制的HIV+ MSM样本12个月。

DESCRIPTION (provided by applicant): 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. Men who have sex with men (MSM) accounted for 65% of new infections in the U.S in 2011. What is more concerning is that 60% of HIV+ MSM are not adherent to ART. Preventing transmission in virally unsuppressed HIV+ MSM who have unprotected anal intercourse (UAI) with serodiscordant partners can have a great public health impact. The proposed study has the potential to be cost-effective and scalable, which are goals of the National HIV/AIDS Strategy and the 2013 Trans-NIH Plan for reducing new HIV infections. 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, engage HIV+ MSM where they meet sex partners, and enable men to participate privately on a computer, tablet, or Smartphone on their own schedule, as opposed to in a structured clinical setting. The first of our 3 theoretically-grounded HIV prevention videos about UAI, HIV disclosure, and testing in MSM was rigorously evaluated among MSM recruited online. In our single-session online video pilot for 971 MSM, we found significant reductions in UAI in the most recent encounter and significant increases in HIV status disclosure at 3-month follow-up, compared to baseline. In our subsequent online, single-session randomized controlled trial (RCT) for 3,092 MSM, we found significant reductions in UAI among MSM in the video arm at 60-day follow-up, compared to baseline; HIV+ MSM in the video arm reduced UAI, including serodiscordant UAI (SDUAI) at 60-day follow-up, compared to baseline. Based on our RCT findings on HIV+ MSM, we then tested our ability to recruit ethnically diverse HIV+ MSM. Our collaboration with POZ.com (POZ), the largest website for HIV+ individuals, was very successful. Through our prior work, we have identified a potentially highly effective and feasible risk reduction intervention approach for HIV+ MSM. We have also demonstrated success in engaging the target population. With the commitment of POZ and a strong team of experts, we propose to refine our intervention by editing our 3 HIV prevention videos into short doses for 10 online sessions (including boosters); targeting HIV+ MSM who are virally unsuppressed; monitoring self-reported clinical indicators (i.e., viral load); targeting online recruitment by rae and 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, we will recruit and follow a national sample of 1,500 high-risk, virally unsuppressed HIV+ MSM for 12 months.