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 多年以来，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)。 MSM 是美国疾病预防控制中心 (CDC) 定义的唯一一个自 20 世纪 90 年代以来新发 HIV 感染人数稳步增加的高危人群。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，该人群中的艾滋病毒感染率很高，2011 年医学研究所共识报告呼吁在跨性别人群中开展急需的研究。对于不能或不愿使用安全套的人来说，需要使用安全套的替代品。使用快速艾滋病毒家庭检测（HT）来筛查潜在的性伴侣可能是此类人群的重要降低风险工具。我们研究的主要目的是确定能够获得 HT 并学习如何与潜在性伴侣一起使用 HT 的高风险 MSM 和 TGW 是否比不使用 HT 的 MSM 和 TGW 从事更少的性危险行为。该研究的第二个目的是确定接受 HT 的便利性是否会影响其使用以减少 UAI 的发生。这项为期 5 年的随机对照试验将主要（但不限于）针对与男性发生性行为、未感染 HIV、非一夫一妻制、从不或很少使用安全套、有血清不一致 UAI 病史的少数族裔男性和 TGW。我们将在纽约州纽约市和波多黎各州圣胡安这两个艾滋病毒高发城市招募并预筛选大约 600 名参与者。鉴于该研究严格的资格标准，我们预计在第 1 次访视筛选后，只有 300 名参与者有资格参加试验。在第 2 次访视时，他们将被随机分配到两组中的一组：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，并将获得 HT 套件，供性伴侣在 6 个月以上使用； B组参与者既不会接受HT干预，也不会获得试剂盒供应，我们将监测他们是否通过购买或其他方式使用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为期 6 个月的监控。在第 3 次访视（6 个月评估）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 组将被额外监控三个月。在第 4 次访问（9 个月评估）时，我们将检验我们的次要假设。证明 HT 的使用是一种有效的降低风险工具，可以对艾滋病毒预防领域产生巨大的变革性影响。此外，证明轻松获得HT对于实现HT作为降低风险工具的潜力的关键性质可能会刺激采取行动，使最有可能从HT的使用中受益的人群更容易获得HT。它将提供证据表明，使用现有的且比其他技术（例如 PrEP）成本更低的生物技术可能会减少新感染并减少公共卫生支出。