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: 8657624
• 负责人: SABINA HIRSHFIELD
• 金额: $ 57.63万
• 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/8657624
• 关键词: AIDS prevention; AIDS/HIV problem; Accounting; Anus; Behavior Therapy; Bisexual; Centers for Disease Control and Prevention (U.S.); Clinical; Cognitive; Collaborations; 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; public health relevance; 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）：尽管艾滋病毒检测和高效抗逆转录病毒疗法（ART）改善了艾滋病毒感染者的生存，但相对较低的抗逆转录病毒疗法依从性在传播艾滋病毒的可能性方面构成了重大的公共卫生挑战。2011年，美国男男性行为者（MSM）占新感染人数的65%。更令人担忧的是，60%的艾滋病毒阳性男男性行为者没有坚持抗逆转录病毒治疗。预防病毒未受抑制的艾滋病毒阳性男男性行为者与血清不一致的伴侣进行无保护肛交（UAI）的传播可产生重大的公共卫生影响。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计划的目标，旨在减少新的艾滋病毒感染。由于男男性接触者中新的艾滋病毒感染在一定程度上归因于网上性伴侣的增加，因此，对在线艾滋病毒阳性男男性接触者进行行为干预至关重要，以相对较低的成本接触到许多高风险男性，让艾滋病毒阳性男男性接触他们与性伴侣见面的地方，并使男性能够按照自己的时间表在电脑、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。我们的三个基于理论的艾滋病毒预防视频中的第一个，关于UAI，艾滋病毒披露和MSM检测，在网上招募的MSM中进行了严格的评估。在我们对971名男男性行为者进行的单次在线视频试点中，我们发现，与基线相比，最近一次遭遇的UAI显著减少，3个月随访时艾滋病毒状况披露显著增加。在我们随后对3092名男男性接触者进行的在线单期随机对照试验（RCT）中，我们发现在60天的随访中，与基线相比，视频组男男性接触者的UAI显著降低；与基线相比，视频组的HIV+ MSM降低了UAI，包括60天随访时血清不一致的UAI （SDUAI）。根据我们对HIV+ MSM的随机对照试验结果，我们测试了我们招募不同种族的HIV+ MSM的能力。我们与最大的艾滋病毒感染者网站POZ.com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