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

描述(申请人提供)：艾滋病流行30多年后，男男性行为者(MSM)继续在有艾滋病毒传播风险的情况下进行无保护的肛交(UAI)。MSM是美国疾病控制与预防中心定义的唯一风险群体，自20世纪90年代以来，新的艾滋病毒感染一直在稳步增加。关于男性变性人女性(TGW)中艾滋病毒的统计数据往往无法获得，但众所周知，艾滋病毒在这一人群中的流行率很高，2011年医学研究所的共识报告呼吁在变性人中进行亟需的研究。对于不能或不愿使用避孕套的人来说，需要使用避孕套的替代品。对这类人群来说，使用快速艾滋病毒家庭检测(HT)来筛选潜在的性伴侣可能是一个重要的降低风险的工具。我们研究的主要目的是确定有机会接触HT的高危MSM和TGW是否比没有使用HT的MSM和TGW从事更少的性危险行为，并了解如何与潜在的性伴侣使用它。这项研究的次要目的是确定是否容易获得HT影响其使用以减少UAI的次数。这项为期5年的随机对照试验将主要针对但不限于少数民族男性和TGW，他们与男性发生性行为，未感染艾滋病毒，不是一夫一妻制，从不或很少使用避孕套，有血清不一致UAI病史。我们将在两个艾滋病毒流行率较高的城市招募约600名参与者并进行预筛选：纽约和PR的圣胡安。鉴于这项研究的严格资格标准，我们预计只有300名参与者在访问1进行筛查后有资格参加试验。在访问2中，他们将被随机分为两组：A组参与者将接受HT干预，指导他们使用HT筛查性伴侣的有效方法，并将获得HT试剂盒，以便在6个月内与性伴侣一起使用；B组参与者将既不接受HT干预，也不供应试剂盒，我们将监测他们是否通过购买或其他方式获得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为期6个月的监测。在访问3(6个月评估)时，我们将检验我们的主要假设；同时，我们将停止向A组提供羟色胺治疗。A组将再监测3个月。在访问4(9个月评估)时，我们将检验我们的第二个假设。证明使用羟色胺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高度的、变革性的影响。此外，证明容易获得羟色胺的关键性质，以实现羟色胺作为一种降低风险的工具的潜力，可能会刺激行动，使最有可能从使用中受益的人群更容易获得羟色胺。它将证明，使用现有的、成本低于其他生物技术(例如PrEP)的生物技术可能会导致较少的新感染，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.