Rapid HIV Home Test and Decision-Making Among HIV-Negative Men

HIV 阴性男性的快速 HIV 家庭检测和决策

• 批准号: 7684539
• 负责人: Alex CARBALLO-DIEGUEZ
• 金额: $ 52.95万
• 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: 2009
• 资助国家: 美国
• 起止时间: 2009-04-15 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7684539
• 关键词: AIDS prevention; Address; Anal Sex; Antibodies; Anus; Appearance; Area; Behavioral; Clinic; Coitus; Contracts; Data; Data Analyses; Decision Making; Development; Devices; Eligibility Determination; Enrollment; Epidemic; Evaluation; Frequencies; Future; Genetic Transcription; Goals; HIV; HIV therapy; HIV vaccine; Harm Reduction; Health; Home environment; Human immunodeficiency virus test; Incentives; Indigenous; Individual; Internet; Intervention; Interview; Knowledge; Liquid substance; Modeling; Motivation; Oral cavity; Participant; Phase; Population; Positioning Attribute; Prevention; Privacy; Procedures; Provider; Public Health; Reader; Recommendation; Research; Research Design; Risk; Risk Reduction; Sales; Screening procedure; Self-Administered; Sex Behavior; Sexual Abstinence; Sexual Partners; Sexually Transmitted Diseases; Stress; Swab; Target Populations; Technology; Telephone; Test Result; Testing; Time; United States Food and Drug Administration; Vial device; Visit; Work; base; condoms; cost; experience; heuristics; high risk; innovation; interest; meetings; men; men who have sex with men; microbicide; new technology; newspaper article; prevent; public health relevance; research study; sex; sex risk; sexual encounter; skills; tool; transmission process

DESCRIPTION (provided by applicant): The FDA is considering allowing the over-the counter sale of a rapid HIV test, the OraQuick(R) In-Home HIV Test (HT). Newspaper articles already discuss the possibility that this new technology could be used by individuals who are HIV uninfected to screen potential sexual partners. Our preliminary studies show that a sizable proportion of men who engage intentional unprotected intercourse are highly interested in using a HT to screen casual sexual partners. Focusing on English- or Spanish-speaking HIV-uninfected men who have unprotected intercourse in circumstances in which there is risk of HIV transmission, the goal of this project is to study the possible use of the HT as a tool for decision-making about sexual behavior. It has two Specific Aims (SA). SA1 is to elicit men's (a) motivation (or lack of motivation) to use OraQuick as a screening tool prior to intercourse; (b) anticipated strategies (or hindrances) to use and have a partner use OraQuick for testing prior to intercourse; and (c) anticipated ways (or problems) to handle test results. SA2 is to assess (a) men's frequency of use of a set number of OraQuick kits with sexual partners over 3 months; (b) factors associated with OraQuick use or lack of use; (c) condom use (following our recommendation to use them) with OraQuick unscreened partners vs. screened HIV-negative partners; (d) factors associated with changes in sexual risk behavior over 3 months; and (e) feasibility of conducting a larger and longer trial of HT use to develop a HT- based harm-reduction intervention. This 3-year study will consist of two phases. Phase 1 is hypothetical ("Would you use HT to screen sexual partners for HIV if you had the chance?"). In this phase, 60 MSM will undergo a quantitative, qualitative, and skill-demonstration assessment during a single study visit. Phase 2 moves from the hypothetical realm to the actual evaluation of HT use ("With what proportion of your sexual partners and how frequently did you use HT as a screening tool in the past three months?"). This phase is divided in two: Phase 2A, in which we will conduct a baseline CASI and skill-demonstration of about 60 new study candidates; and Phase 2B in which 30 MSM from Phase 2A who meet eligibility criteria will be invited to enroll in a 3-month study. These 30 men will be provided a set of HT kits and will have the choice to use them to screen sexual partners. During the three months, they will be asked to keep a phone tally of their sexual behavior and HT use (receiving incentives per call). At the end of the 3-month study, participants will undergo a quantitative and qualitative interview on experiences using (or not using) HT with partners. Data analysis of Phase 2 data will determine whether an intervention centered around the use of HT is feasible, practical, and worth pursuing. PUBLIC HEALTH RELEVANCE: More than a quarter of a century into the HIV epidemic, it is evident that many individuals at high risk of contracting HIV cannot or will not use condoms with their partners. Given the documented emergence of serosorting as a risk-reduction strategy (often based on faulty heuristics), this study seeks to examine possible uses and misuses of a rapid HIV home test as a partner-screening device among HIV-uninfected men with knowledge about HIV and how to prevent its transmission who choose not to use condoms in circumstances in which there is risk of HIV transmission. This study will provide urgently needed information to harness the harm-reduction potential of this technology, develop interventions that may include it among an array of non- condom prevention tools, and anticipate rather than remediate possible problems.

描述（由申请人提供）： FDA 正在考虑允许在柜台销售一种快速 HIV 检测试剂，即 OraQuick(R) 家用 HIV 检测试剂盒 (HT)。报纸文章已经讨论了这种新技术可以被未感染艾滋病毒的人用来筛查潜在性伴侣的可能性。我们的初步研究表明，相当大比例的有意进行无保护性交的男性对使用 HT 筛选临时性伴侣非常感兴趣。该项目的目标是在存在艾滋病毒传播风险的情况下进行无保护性交的讲英语或西班牙语的未感染艾滋病毒的男性，其目标是研究使用 HT 作为性行为决策工具的可能性。它有两个具体目标 (SA)。 SA1 是为了引出男性 (a) 在性交前使用 OraQuick 作为筛查工具的动机（或缺乏动机）； (b) 使用 OraQuick 的预期策略（或障碍），并让伴侣在性交前使用 OraQuick 进行测试； (c) 处理测试结果的预期方法（或问题）。 SA2 旨在评估 (a) 男性在 3 个月内与性伴侣使用一定数量 OraQuick 套件的频率； (b) 与 OraQuick 使用或不使用相关的因素； (c) 与 OraQuick 未经筛查的性伴侣和已筛查的 HIV 阴性伴侣使用安全套（按照我们的建议使用）； (d) 与 3 个月内危险性行为变化相关的因素； (e) 进行更大规模、更长时间的 HT 使用试验以开发基于 HT 的减害干预措施的可行性。这项为期3年的研究将分为两个阶段。第一阶段是假设的（“如果有机会，您会使用 HT 来筛查性伴侣是否感染 HIV？”）。在此阶段，60 名 MSM 将在单次研究访问期间接受定量、定性和技能展示评估。第二阶段从假设领域转向对 HT 使用的实际评估（“过去三个月内，您的性伴侣比例是多少，以及您使用 HT 作为筛查工具的频率如何？”）。此阶段分为两个阶段：第 2A 阶段，我们将对约 60 名新研究候选人进行基线 CASI 和技能演示； 2B 阶段将邀请 2A 阶段符合资格标准的 30 名 MSM 参加为期 3 个月的研究。这 30 名男性将获得一套 HT 试剂盒，并可以选择使用它们来筛查性伴侣。在这三个月内，他们将被要求记录他们的性行为和 HT 使用情况（每次通话获得奖励）。在为期 3 个月的研究结束时，参与者将接受定量和定性访谈，了解与合作伙伴使用（或不使用）HT 的经历。对第二阶段数据的数据分析将确定以 HT 的使用为中心的干预措施是否可行、实用且值得追求。公共卫生相关性：艾滋病毒流行已超过四分之一个世纪，很明显，许多感染艾滋病毒的高风险个人不能或不会与其性伴侣使用安全套。鉴于血清分类已被证明是一种降低风险的策略（通常基于错误的启发法），本研究旨在探讨快速艾滋病毒家庭测试作为性伴侣筛查工具的可能用途和误用，这些艾滋病毒感染者了解艾滋病毒以及如何预防其传播，但在存在艾滋病毒传播风险的情况下选择不使用安全套。这项研究将提供迫切需要的信息，以利用该技术的减害潜力，制定干预措施，将其纳入一系列非安全套预防工具中，并预测而不是补救可能的问题。