HIV Testing and Counseling in STD Clinics: an Adaptation of CTN 0032

描述(申请人提供)：使艾滋病毒检测常规化是美国主要的艾滋病毒预防战略之一。疾病控制和预防中心最近建议，预防咨询不应作为医疗机构艾滋病毒筛查计划的一部分，除非作为对检测结果呈阳性的人进行后咨询的一部分。这一政策建议一直存在争议，政策制定者、研究人员和公共卫生官员对艾滋病毒检测的常规检测前咨询的必要性和效果存在分歧。自从在保健或非保健环境中实施艾滋病毒快速检测以来，没有任何前瞻性研究评估了在有和没有咨询的情况下，艾滋病毒快速检测对接受检测(即增加了解其艾滋病毒状况的人数)、减少危险行为和减少包括艾滋病毒在内的新的性传播感染的影响。在这一背景下，这项建议寻求调整我们目前在NIDA临床试验网络(CTN)的主持下进行的研究。CTN 0032是一项在药物滥用治疗计划中进行的随机对照多中心艾滋病毒检测和咨询试验，旨在确定最有效的艾滋病毒检测和咨询策略，以(1)增加知道自己艾滋病毒血清状态的人数，(2)减少他们的危险行为。我们提议的研究将使用CTN 0032中创建的基础设施来对艾滋病毒感染的极高风险人群进行研究：性病诊所的患者。在我们对CTN 0032的改编中，我们建议评估(1)现场艾滋病毒快速检测与(2)现场艾滋病毒快速检测(如疾控中心指南中所建议的)的相对有效性和成本效益。我们将评估咨询对两个主要结果的影响：性传播感染的发生率和6个月随访时HIV检测结果的接收。次要结果将是减少性危险行为，在性行为中使用药物，以及咨询和检测的成本和成本效益。我们将在美国的9家性病诊所招募5000名参与者。我们将在艾滋病毒最高风险人群中进行分组疗效分析，包括男男性接触者、18-25岁人群和非裔美国人。这项研究将在两年内完成，因为我们将使用为CTN 0032开发和实施的研究基础设施、已经到位的站点以及已经建立了良好和富有成效的工作关系的绩效指标和研究团队。这项研究在NIDA网站的临床试验网络：增加NIDA药物滥用治疗临床试验网络试验结果的影响下被指定为高度科学优先领域。为了与《美国复苏法案》的目标保持一致，这项研究将通过在多个州的公共卫生诊所雇佣多名工作人员来提供经济效益，其中包括许多受经济衰退影响最严重的州。 公共卫生相关性：将CTN 0032修改为包括性传播疾病诊所，将能够快速评估在向艾滋病毒高危患者提供医疗护理的环境中，咨询在性传播感染发病率和艾滋病毒检测率方面的作用。重要的是，我们将在这项研究中加入经济成分，使我们能够确定咨询和检测与单独检测相比是否具有成本效益。这项研究的结果将被用于制定美国未来的艾滋病毒检测和预防政策。

DESCRIPTION (provided by applicant): Making HIV testing routine is one of the major HIV prevention strategies in the United States. The Centers for Disease Control and Prevention recently recommended that prevention counseling not be required as part of HIV screening programs in medical care settings, except as part of post-counseling for persons who have a positive test result. This policy recommendation has been controversial, and there is disagreement among policy makers, researchers, and public health officials about the need for and effect of routine pre-test counseling with HIV testing. There have been no prospective studies since the implementation of rapid HIV testing in either health care or non-health care settings that have evaluated the effect of rapid HIV testing with and without counseling on acceptance of testing (i.e., increasing the number of persons who learn their HIV status), reduction of risk behaviors and decreasing new sexually transmitted infection including HIV. Within this context, this proposal seeks to adapt our current study that is being conducted under the auspices of the NIDA Clinical Trials Network (CTN). CTN 0032 is a randomized controlled multi-center HIV testing and counseling trial conducted in substance abuse treatment programs to determine the most effective HIV testing and counseling strategy to (1) increase the numbers of persons who know their HIV serostatus and (2) decrease their risk behaviors. Our proposed study will use the infrastructure created in CTN 0032 to conduct the study on a population that is at an extreme high risk for HIV infection: patients at STD clinics. In our adaptation of CTN 0032, we propose to assess the relative efficacy and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only (as recommended in the CDC guidelines). We will evaluate the effect of counseling on two primary outcomes: STI incidence and receipt of HIV test results at 6-month follow-up. Secondary outcomes will be reduction of sexual risk behaviors, substance use during sex, and cost and cost-effectiveness of counseling and testing. We will enroll 5,000 participants at 9 STD clinics in the US. We will conduct subgroup efficacy analyses among persons at highest risk for HIV, including MSM, persons 18-25, and African- Americans. This study will be completed in a 2 year period since we will be using the research infrastructure that has been developed and implemented for CTN 0032, the sites already in place, and the PIs and research teams that have established excellent and productive working relationships. This research was designated as an area of high scientific priority on the NIDA website under the Clinical Trials Network: Increasing the Impact of Trial Results from the NIDA Drug Abuse Treatment Clinical Trials Network. In keeping with the goals of the American Recovery Act, the study will provide economic benefits by employing multiple staff at public health clinics in multiple states, including many of those hit hardest by the recession. PUBLIC HEALTH RELEVANCE: The adaptation of CTN 0032 to include sexually transmitted disease clinics will enable the rapid evaluation of the role of counseling on STI incidence and HIV testing rates in settings that provide medical care to patients at high risk for HIV. Importantly, we will include an economic component of this study that will allow us to determine whether counseling and testing, compared to testing alone, is cost-effective. The results of this study will be used to shape future HIV testing and prevention policies in the United States.