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

基本信息

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
项目类别：
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

项目摘要

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）：在艾滋病流行病的30年以上，与男性发生性关系的男性（MSM）继续在存在HIV传播风险的情况下继续进行无保护的肛交（UAI）。 MSM是美国唯一自1990年代以来新艾滋病毒感染一直在稳步增加的CDC定义风险群体。关于男女跨性别妇女（TGW）中有关艾滋病毒的统计数据通常不可用，但众所周知，该人群中的艾滋病毒患病率很高，2011年医学研究所共识报告要求在跨性别人群中进行急需的研究。对于不能或不会使用避孕套的个人，需要使用避孕套的替代方法。使用快速的HIV家庭测试（HT）筛选潜在的性伴侣可能是此类人群的重要风险减少工具。我们研究的主要目的是确定可以使用HT并学习如何与潜在性伴侣使用它的高风险MSM和TGW，而不是使用不使用HT的MSM和TGW较少的性风险行为。该研究的次要目的是确定易于使用HT是否会影响其用于减少UAI场合的使用。这项为期5年的随机对照试验将主要是针对但不仅仅针对与男性发生性关系的少数民族男性和TGW的针对性，艾滋病毒未感染且非一夫一妻制，从不或很少使用避孕套，并且有塞赛司法的历史。我们将在两个高艾滋病毒患病率的两个城市中招募和屏幕前约600名参与者：纽约，纽约和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; B组参与者既不会获得HT干预也不会供应套件，我们将监视他们是否通过购买或其他方式来利用HT套件。两组将获得降低风险咨询。所有参与者的行为将通过每日简短的短信报告监视6个月。在访问3（6个月评估）中，我们将检验我们的主要假设；此外，我们将停止向A组的HT提供的A组提供三个月。在访问4（9个月评估）中，我们将测试次要假设。证明使用HT是一种有效的风险减少工具，可以对HIV预防领域产生巨大的变革性影响。此外，证明轻松访问HT以意识到HT作为降低风险的工具的潜力的关键性质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。它将提供证据表明，使用已经可用的生物技术，而比其他生物技术（例如PREP）可能会导致新的新感染并减少公共卫生支出。