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(申请人提供)：虽然艾滋病毒检测和高效抗逆转录病毒疗法(ART)提高了艾滋病毒的存活率，但相对较低的ART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，男男性行为者(MSM)占美国新感染病例的65%。更令人担忧的是，60%的HIV+MSM不遵守抗逆转录病毒治疗。在病毒未抑制的HIV+MSM中预防传播，这些人与血清不一致的伴侣进行无保护的肛交(UAI)，可能会对公共卫生产生重大影响。拟议的研究有可能具有成本效益和可扩充性，这是国家艾滋病毒/艾滋病战略和2013年跨国立卫生研究院减少新的艾滋病毒感染计划的目标。由于MSM中新的HIV感染在一定程度上是由于在线接触性伴侣的机会增加，因此至关重要的是在网上向HIV+MSM提供行为干预，以相对较低的成本接触到许多高危男性，让HIV+MSM在他们遇到性伴侣的地方参与进来，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参与。我们关于UAI、HIV披露和MSM检测的3个理论上有根据的HIV预防视频中的第一个在网上招募的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，在最近一次接触中，UAI显著降低，而在3个月的随访中，HIV状况披露显著增加。在我们随后对3,092名MSM进行的在线单期随机对照试验(RCT)中，我们发现，与基线相比，视频组MSM在60天的随访中UAI显著降低；与基线相比，视频组的HIV+MSM降低了UAI，包括60天随访时的血清不一致UAI(SDUAI)。基于我们关于HIV+MSM的随机对照研究结果，我们随后测试了我们招募不同种族的HIV+MSM的能力。我们与最大的HIV+个人网站POZ.com(POZ)的合作非常成功。通过我们之前的工作，我们已经确定了一种潜在的高度有效和可行的 针对HIV+MSM的降低风险干预方法。我们还展示了在吸引目标人群方面取得的成功。在POZ和一支强大的专家团队的承诺下，我们建议通过编辑我们的3个艾滋病毒预防视频到10个在线课程(包括加强疫苗)的短剂量来完善我们的干预措施；针对未被抑制的艾滋病毒/男男性接触者；监测自我报告的临床指标(即病毒载量)；针对RAE和种族的在线招募以招募同等数量的HIV+白人、黑人和西班牙裔MSM以均衡代表性；通过激励和一个成熟的在线平台提高保留率；包括关于遵守抗逆转录病毒药物的教育信息；以及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。在网上，我们将招募并跟踪全国1500名高危、未经病毒抑制的HIV+MSM样本，为期12个月。