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

描述（由申请人提供）：FDA正在考虑允许非处方销售一种快速HIV检测试剂盒，OraQuick(R)家庭HIV检测（HT）。报纸上的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选潜在性伴侣的可能性。我们的初步研究表明，相当一部分有意进行无保护性交的男性对使用HT筛查偶然性伴侣非常感兴趣。该项目的重点是讲英语或西班牙语的未感染艾滋病毒的男子，他们在有艾滋病毒传播风险的情况下进行无保护的性交，目的是研究将艾滋病毒检测作为性行为决策工具的可能性。它有两个特定目标（SA）。SA1是诱导男性(a)动机（或缺乏动机）在性交前使用OraQuick作为筛查工具；(b)性交前使用OraQuick进行测试的预期策略（或障碍），并让伴侣使用OraQuick进行测试；(c)预期的处理测试结果的方法（或问题）。SA2是评估(a)男性在3个月内与性伴侣使用一定数量的OraQuick试剂盒的频率；(b)与使用或不使用OraQuick相关的因素；(c)避孕套的使用（按照我们的建议使用）与OraQuick未筛查的伴侣和筛查的hiv阴性伴侣；(d) 3个月内与性危险行为改变相关的因素；(e)开展规模更大、时间更长的高温疗法试验，以开发基于高温疗法的减少危害干预措施的可行性。这项为期三年的研究将分为两个阶段。第一阶段是假设性的（“如果你有机会，你会用艾滋病毒筛查性伴侣吗？”）。在这个阶段，60名男男性行为者将在一次研究访问中接受定量、定性和技能演示评估。第二阶段将从假设的领域转移到对激素使用的实际评估（“在过去三个月里，你与性伴侣的比例是多少？你使用激素作为筛查工具的频率是多少？”）。该阶段分为两个阶段：2A阶段，我们将对大约60个新的研究候选人进行基线CASI和技能演示；在2B阶段，来自2A阶段的30名符合资格标准的MSM将被邀请参加为期3个月的研究。这30名男子将获得一套艾滋病毒检测试剂盒，并可以选择使用它们来筛查性伴侣。在三个月的时间里，他们将被要求记录他们的性行为和HT使用的电话记录（每打一次电话就会得到奖励）。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，了解与伴侣一起使用（或不使用）HT的经历。第二阶段数据的数据分析将决定以高温疗法为中心的干预是否可行、实用和值得进行。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，许多感染艾滋病毒高风险的人不能或不愿与伴侣使用避孕套。鉴于有文献记载的血清分选作为一种降低风险的策略（通常基于错误的启发式）的出现，本研究试图检查在艾滋病毒感染的未感染的男性中，快速艾滋病毒家庭检测作为一种伴侣筛查设备的可能使用和滥用，这些男性了解艾滋病毒以及如何预防其传播，并且在存在艾滋病毒传播风险的情况下选择不使用避孕套。这项研究将提供迫切需要的信息，以利用这种技术减少伤害的潜力，开发干预措施，可能包括它在一系列非避孕套预防工具中，并预测而不是补救可能出现的问题。

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.