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: 8788375
• 负责人: SABINA HIRSHFIELD
• 金额: $ 56.42万
• 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 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8788375
• 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; 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）：尽管艾滋病毒测试和高效的抗逆转录病毒疗法（ART）提高了与艾滋病毒的生存率，但相对较低的艺术水平在传播艾滋病毒的潜力方面却引起了重大的公共健康挑战。与男性发生性关系的男性（MSM）在2011年在美国占新感染的65％。更令人担忧的是，60％的HIV+ MSM不遵守艺术。防止病毒未受抑制的艾滋病毒+ MSM的传播，这些艾滋病毒+ MSM与肛门性交（UAI）与Seridiscordant伴侣的传播可能会产生巨大的公共卫生影响。拟议的研究有可能具有成本效益和可扩展性，这是国家艾滋病毒/艾滋病战略的目标，以及2013年跨NIH降低新艾滋病毒感染的计划。由于MSM中的新艾滋病毒感染已被部分归因于在线上与性伴侣的机会增加，因此至关重要的是，向HIV+ MSM进行行为干预，以相对较低的成本吸引许多高风险的男性，与HIV+ MSM互动，在那里与性伴侣会面，并使男人能够私下参与计算机，平板电脑，平板电脑，平板电脑，智能手机或智能手机，以相反的范围逐步进行，并在结构上进行临时工作。 我们在网上招募的MSM中对三个理论上基础的HIV预防预防视频和MSM的测试进行了严格评估。在我们的971 MSM的单课在线视频飞行员中，与基线相比，在最近的相遇中，UAI显着降低了UAI，HIV状况披露的大幅增加。在我们随后的在线，单课随机对照试验（RCT）的3,092 MSM中，与基线相比，在60天随访视频部门的MSM中，UAI显着降低了。与基线相比，视频组中的HIV+ MSM减少了UAI，包括60天随访的Serodiscordant UAI（SDUAI）。根据我们对HIV+ MSM的RCT发现，我们测试了招募种族多样化的HIV+ MSM的能力。我们与HIV+个人最大的网站Poz.com（POZ）的合作非常成功。 通过我们的先前工作，我们已经确定了潜在的高效和可行的 HIV+ MSM的风险降低干预方法。我们还显示出在吸引目标人群方面的成功。在POZ和一个强大的专家团队的承诺下，我们建议通过将3个艾滋病毒预防视频编辑成10个在线会议（包括助推器）来完善干预措施；靶向病毒不抑制的艾滋病毒+ MSM；监测自我报告的临床指标（即病毒负荷）；针对Rae和种族的在线招募，以招募相等数量的艾滋病毒+白人，黑人和西班牙裔MSM以平衡代表；通过激励措施和经过验证的在线平台改善保留率；包括有关艺术依从性的教育信息；以及可能避免艾滋病毒感染的成本和成本效益分析，以确定与健康相关的成本节省。在线，我们将在12个月内招募并遵循1,500个高风险，病毒不抑制的HIV+ MSM的全国样本。