Rapid Home Test to Reduce Sexual Risk Behavior in MSM and Transgender Women

描述（由申请人提供）：艾滋病流行30多年来，男男性行为者（MSM）继续在存在艾滋病毒传播风险的情况下进行无保护的肛交（UAI）。男男性行为者是美国唯一一个由疾病控制与预防中心定义的风险群体，自上世纪90年代以来，美国新增艾滋病病毒感染人数一直在稳步上升。关于男变女跨性别女性（TGW）中艾滋病毒的统计数据通常无法获得，但众所周知，这一人群的艾滋病毒患病率很高，2011年医学研究所共识报告呼吁对跨性别人群进行急需的研究。对于不能或不愿使用避孕套的人，需要使用避孕套的替代品。使用hiv家庭快速检测（HT）来筛选潜在的性伴侣可能是这类人群降低风险的重要工具。我们研究的主要目的是确定高风险的MSM和TGW是否比不使用HT的MSM和TGW从事更少的性风险行为，这些MSM和TGW可以获得HT并学习如何与潜在的性伴侣一起使用HT。该研究的第二个目的是确定是否容易获得高温疗法影响其使用，以减少UAI的发生。这项为期5年的随机对照试验将主要（但不限于）针对少数民族男性和与男性发生性行为的TGW，他们未感染艾滋病毒，非一夫一妻制，从未或很少使用安全套，并且有血清不一致的UAI史。我们将在纽约、纽约和圣胡安这两个HIV高流行城市招募约600名参与者并对其进行预筛选。考虑到这项研究的严格资格标准，我们预计在第一次访问时进行筛选后，只有300名参与者有资格参加试验。在第2次访问中，他们将被随机分为两组：A组参与者将接受HT干预，使他们了解使用HT筛查性伴侣的有效方法，并将获得HT试剂盒，用于6个月以上的性伴侣；B组参与者既不接受HT干预，也不提供试剂盒，我们将监测他们是否通过购买或其他方式利用HT试剂盒。两组都将接受降低风险的咨询。所有参与者的行为将通过每日简短的短信报告进行监测，为期6个月。在第三次访问（6个月评估），我们将检验我们的主要假设；另外，我们将停止向A集团提供HT。A集团将被额外监测三个月。在第4次访问（9个月评估），我们将检验我们的次要假设。证明使用HT是一种有效的降低风险的工具，可以在艾滋病毒预防领域产生重大的变革性影响。此外，证明易于获得高温疗法对于实现高温疗法作为降低风险工具的潜力至关重要，可能会促使采取行动，使最有可能从使用高温疗法中受益的人群更容易获得高温疗法。它将提供证据，证明使用一种现有的、比其他生物技术（如预防PrEP）成本更低的生物技术，有可能减少新感染并减少公共卫生支出。

DESCRIPTION (provided by applicant): More than 30 years into the AIDS epidemic, men who have sex with men (MSM) continue to engage in unprotected anal intercourse (UAI) in circumstances in which there is risk of HIV transmission. MSM are the only CDC-defined risk group in the US in which new HIV infections have been increasing steadily since the 1990s. Statistics about HIV among male-to-female transgender women (TGW) are often unavailable but it is known that HIV prevalence in this population is high, and the 2011 Institute of Medicine Consensus Report called for much needed research among transgender populations. Alternatives to condom use are needed for individuals who cannot or will not use condoms. Use of a rapid HIV-home test (HT) to screen potential sexual partners could be an important risk-reduction tool for such population. The primary aim of our study is to determine if high-risk MSM and TGW who have access to HT and learn how to use it with potential sexual partners engage in less sexual risk behavior than MSM and TGW who do not use HT. The secondary aim of the study is to determine if ease of access to HT affects its use to reduce occasions of UAI. This 5-year randomized controlled trial will target mainly, but not exclusively, ethnic minority men and TGW who have sex with men, are HIV-uninfected and non-monogamous, never or seldom use condoms, and have a history of serodiscordant UAI. We will recruit and pre-screen approximately 600 participants in two cities with high HIV prevalence: New York, NY, and San Juan, PR. Given the stringent eligibility criteria of the study, we expect that only 300 participans will be eligible to enroll in the trial after screening at Visit 1. At Visit 2, they will be randomzed in equal numbers to one of two groups: Group A participants will receive an HT intervention orientating them to effective ways of using HT to screen sexual partners and will be supplied with HT kits to use with sexual partners over 6 months; Group B participants will receive neither the HT intervention nor supply of kits, and we will monitor whether they avail themselves of HT kits through purchase or other means. Both groups will receive risk-reduction counseling. All participants' behavior will be monitored for 6 months through daily brief SMS reports. At Visit 3 (6-month evaluation), we will test our primary hypothesis; also, we will discontinue the provision of HT to Group A. Group A will be monitored for three additional months. At Visit 4 (9-month evaluation), we will test our secondary hypothesis. Demonstrating that use of HT is an effective risk-reduction tool can have a high, transformative impact in the HIV prevention field. Additionally, demonstrating the crucial nature of easy access to HT to realizing the potential of HT as a risk-reduction tool may spur action to make HT more accessible to populations most likely to benefit from its use. It will give evidence that use of a biotechnology that is already available and less costly than others (e.g., PrEP) can potentially result in fewer new infections and reduce public health expenditures.