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

扩大互联网上针对艾滋病毒男性的随机对照试验

• 批准号: 8990502
• 负责人: SABINA HIRSHFIELD
• 金额: $ 55.79万
• 依托单位: PUBLIC HEALTH SOLUTIONS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8990502
• 关键词: AIDS prevention; AIDS/HIV problem; Accounting; Anus; Behavior Therapy; Bisexual; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Clinical; Cognitive; Collaborations; Cost Effectiveness Analysis; Cost Savings; Disclosure; Dose; Economics; Enrollment; Equilibrium; Ethnic Origin; Evidence based intervention; Expectancy; Gays; Goals; HIV; HIV Infections; Health; Hispanics; Human immunodeficiency virus test; Incentives; Individual; Infection; Internet; Intervention; Language; Measures; Medical Care Costs; Monitor; Outcome; Patient Self-Report; Public Health; Quality-Adjusted Life Years; Race; Randomized Controlled Trials; Recruitment Activity; Reporting; Risk; Risk Reduction; Sampling; Schedule; Self Efficacy; Self-Administered; Sexual Partners; Structure; Tablet Computer; Target Populations; Testing; Translating; United States National Institutes of Health; Viral Load result; Work; antiretroviral therapy; arm; base; condoms; cost; cost effective; cost effectiveness; design; ethnic diversity; follow-up; high risk; high risk men; improved; intervention program; male; meetings; men; men who have sex with men; prevent; primary outcome; scale up; sex; skills; social; success; theories; therapy adherence; transmission process; web site

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.

描述（由申请人提供）：尽管 HIV 检测和高效抗逆转录病毒治疗 (ART) 提高了 HIV 感染者的生存率，但相对较低的 ART 依从性在传播 HIV 的可能性方面提出了重大的公共卫生挑战。 2011 年，美国新感染病例中，男男性行为者 (MSM) 占 65%。更令人担忧的是，60% 的 HIV+ MSM 没有坚持接受 ART。预防病毒未受抑制的 HIV+ MSM 与血清不一致的伴侣进行无保护肛交 (UAI) 的传播可以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 计划减少新发艾滋病毒感染的目标。由于 MSM 中新增的 HIV 感染部分归因于在线接触性伴侣的机会增加，因此对 HIV+ MSM 在线提供行为干预至关重要，以便以相对较低的成本接触到许多高危男性，并在 HIV+ MSM 遇到性行为时与他们接触合作伙伴，并使男性能够按照自己的日程安排通过计算机、平板电脑或智能手机私下参与，而不是在结构化的临床环境中。 我们的 3 个关于 UAI、HIV 披露和 MSM 检测的基于理论的 HIV 预防视频中的第一个在网上招募的 MSM 中进行了严格评估。在我们针对 971 名 MSM 的单次在线视频试点中，我们发现与基线相比，最近一次接触中的 UAI 显着减少，并且在 3 个月的随访中 HIV 状况披​​露显着增加。在我们随后针对 3,092 名 MSM 进行的在线单次随机对照试验 (RCT) 中，我们发现在 60 天的随访中，与基线相比，视频组中 MSM 的 UAI 显着降低；与基线相比，视频组中的 HIV+ MSM 减少了 UAI，包括 60 天随访时的血清不一致 UAI (SDUAI)。根据我们对 HIV+ MSM 的随机对照试验结果，我们测试了招募不同种族 HIV+ MSM 的能力。我们与最大的艾滋病病毒感染者网站 POZ.com (POZ) 的合作非常成功。 通过我们之前的工作，我们已经确定了一种潜在的高效且可行的方法 HIV+ MSM 的风险降低干预方法。我们在吸引目标人群方面也取得了成功。在 POZ 和强大专家团队的承诺下，我们建议通过将 3 个 HIV 预防视频编辑成 10 个在线课程（包括强化课程）的短剂量来完善我们的干预措施；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）；针对不同种族和种族的在线招聘目标，招收同等数量的艾滋病病毒感染者白人、黑人和西班牙裔男男性行为者，以实现平衡的代表性；通过激励措施和经过验证的在线平台提高保留率；包括有关 ART 依从性的教育信息；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 1,500 名高风险、病毒未抑制的 HIV+ MSM 进行为期 12 个月的全国样本跟踪。