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

快速家庭测试可减少 MSM 和跨性别女性的性危险行为

• 批准号: 8877576
• 负责人: Alex CARBALLO-DIEGUEZ
• 金额: $ 62.27万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8877576
• 关键词: AIDS prevention; Abbreviations; Acquaintances; Acquired Immunodeficiency Syndrome; Address; Affect; Antibodies; Anus; Behavior; Biotechnology; Centers for Disease Control and Prevention (U.S.); Cities; Consensus; Control Groups; Counseling; Decision Making; Eligibility Determination; Enrollment; Epidemic; Evaluation; Female; HIV; HIV Antibodies; HIV Infections; HIV risk; Health; Health Care Costs; Health Expenditures; Home environment; Human immunodeficiency virus test; Individual; Infection; Institute of Medicine (U.S.); Intervention; Learning; Liquid substance; Monitor; Multiple Partners; Nature; New York; Oral; Participant; Persons; Population; Prevalence; Prevention; Prevention approach; Price; Procedures; Prophylactic treatment; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Reporting; Research; Risk; Risk Reduction; Sampling; Sex Behavior; Sexual Partners; Staging; Technology; Test Result; Testing; United States Food and Drug Administration; Virus; Visit; acronyms; condoms; cost effective; design; ethnic minority population; follow-up; group intervention; heuristics; high risk; high risk behavior; high risk sexual behavior; male; mathematical model; men; men who have sex with men; novel strategies; peer; screening; sex; sex risk; statistics; tool; transgender; transgender women; transmission process

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.

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是美国唯一一个CDC定义的风险群体，自20世纪90年代以来，新的HIV感染一直在稳步增加。关于从男性到女性的跨性别妇女（TGW）中艾滋病毒的统计数据往往是不可用的，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。使用艾滋病毒快速家庭检测（HT）来筛查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谁可以获得HT，并学习如何使用它与潜在的性伴侣从事性风险行为比MSM和TGW谁不使用HT。该研究的第二个目的是确定是否容易获得HT影响其使用，以减少UAI的机会。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，他们与男性发生性关系，未感染HIV，非一夫一妻制，从不或很少使用避孕套，并且有血清不一致的UAI病史。我们将在两个HIV流行率较高的城市（纽约州纽约和PR州圣胡安）招募和预筛选约600名受试者。鉴于研究的严格合格标准，我们预计在访视1筛选后，只有300名哥伦比亚人有资格入组试验。在第2次访视时，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筛选性伴侣的有效方法，并将提供HT套件，供性伴侣使用6个月; B组受试者既不接受HT干预，也不提供试剂盒，我们会监察他们是否透过购买或其他途径使用HT套件。这两个群体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。在访视3（6个月评价）时，我们将检验我们的主要假设;此外，我们将停止向A组提供HT。A组将再监测三个月。在访视4（9个月评价）时，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巨大的变革性影响。此外，证明容易获得HT的关键性质，以实现HT作为减少风险工具的潜力，可能会刺激采取行动，使HT更容易获得最有可能受益于其使用的人群。它将提供证据，证明使用一种已经存在且成本低于其他生物技术的生物技术（例如，PrEP）可能会减少新感染并减少公共卫生支出。