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: 8043509
• 负责人: Alex CARBALLO-DIEGUEZ
• 金额: $ 54.21万
• 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 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8043509
• 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; HIV-1; 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; 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正在考虑允许一种快速艾滋病毒检测--OraQuick(R)家庭艾滋病毒检测(HT)--在柜台上销售。报纸文章已经讨论了这项新技术可以被未感染艾滋病毒的人用来筛选潜在的性伴侣的可能性。我们的初步研究表明，相当大比例的男性故意进行无保护的性行为，对使用HT筛查随意性伴侣非常感兴趣。该项目的重点是那些在有艾滋病毒传播风险的情况下进行无保护性行为的讲英语或西班牙语的未感染艾滋病毒的男性，该项目的目标是研究将HT作为性行为决策工具的可能性。它有两个特定的目标(SA)。SA1旨在引出男性在性交前使用OraQuick作为筛查工具的动机(或缺乏动机)；(B)预期的策略(或障碍)，以及在性交前让伴侣使用OraQuick进行测试；以及(C)处理测试结果的预期方法(或问题)。SA2的目的是评估(A)男性在3个月内与性伴侣使用一定数量的OraQuick药盒的频率；(B)与OraQuick使用或不使用OraQuick相关的因素；(C)与未筛查的性伴侣和筛查的HIV阴性伴侣使用避孕套的情况(按照我们的建议使用)；(D)与3个月以上性行为变化相关的因素；以及(E)进行更大规模和更长时间的羟色胺使用试验以开发基于羟色胺的减少伤害干预的可行性。这项为期3年的研究将分为两个阶段。第一阶段是假设的(“如果你有机会，你会使用羟色胺来筛查性伴侣的艾滋病毒吗？”)在这一阶段，60名男男性接触者将在一次学习访问中接受定量、定性和技能展示评估。第二阶段从假设的领域进入对羟色胺使用的实际评估(“在过去的三个月里，你的性伴侣的比例是多少，你使用羟色胺作为筛查工具的频率是多少？”)。这一阶段分为两个阶段：阶段2A，我们将对大约60名新考生进行基线CASI和技能示范；阶段2B，将邀请来自阶段2A的30名符合资格标准的MSM参加为期3个月的学习。这30名男性将被提供一套HT试剂盒，并可以选择使用它们来筛查性伴侣。在这三个月里，他们将被要求记录他们的性行为和使用HT的电话记录(每次通话都会收到奖励)。在为期3个月的研究结束时，参与者将就与合作伙伴使用(或不使用)羟色胺的经历进行定量和定性的访谈。对第二阶段数据的数据分析将确定以使用羟色胺为中心的干预是否可行、实用和值得继续进行。与公共卫生相关：艾滋病毒流行已超过四分之一个世纪，显然，许多感染艾滋病毒的高风险个人不能或不愿与其伴侣一起使用避孕套。鉴于血清滴定作为一种降低风险的策略(通常基于错误的启发式方法)的记录出现，这项研究试图在了解艾滋病毒的未感染艾滋病毒的男性中检查作为伴侣筛查设备的快速艾滋病毒家庭检测的可能使用和误用，以及如何防止在存在艾滋病毒传播风险的情况下选择不使用避孕套的艾滋病毒传播。这项研究将提供迫切需要的信息，以利用这项技术的减害潜力，开发干预措施，将其纳入一系列非避孕套预防工具，并预测而不是补救可能出现的问题。