PrEP and Risk Compensation: Assessing Effect and Preparing for Rollout

PrEP 和风险补偿：评估效果并为推出做准备

• 批准号: 8324196
• 负责人: Amy Lynn Corneli
• 金额: $ 48.57万
• 依托单位: FAMILY HEALTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-25 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8324196
• 关键词: AIDS prevention; Address; Africa South of the Sahara; Anti-Retroviral Agents; Behavior; Behavioral; Clinical Trials; Clinical Trials Design; Consultations; Counseling; Data; Data Sources; Effectiveness; Environment; Exhibits; Financial compensation; Future; Guidelines; HIV; HIV Infections; Health Benefit; Hearing; High Risk Woman; Individual; Interview; Kenya; Link; Local Microbicides; Measures; Methodology; Methods; Motivation; Oral; Outcome Study; Participant; Pharmaceutical Preparations; Phase; Placebos; Population Study; Process; Professional counselor; Prophylactic treatment; Public Health; Randomized; Reporting; Research; Risk; Risk Behaviors; Risk Reduction; Risk Reduction Behavior; Safety; Sampling; Site; South Africa; Surveys; Testing; Variant; Woman; arm; base; condoms; information model; innovation; meetings; prevent; response; risk perception; sex; sex risk; sexual encounter; skills

DESCRIPTION (provided by applicant): New HIV prevention methods such as oral pre-exposure prophylaxis (PrEP) may soon be approved for HIV prevention if current clinical trials confirm their effectiveness and safety. Risk compensation among future users is a major concern, as it could seriously undermine the potential public health impact of PrEP once rolled out. Currently risk compensation has only been assessed in clinical trials designed to evaluate the effectiveness of PrEP. But clinical trial data on risk compensation alone is not sufficient to guide PrEP planning given those data are collected in situations of optimal counseling, and where the potential for socially desirable answers is enhanced. The unknown effectiveness of the study drug and the presence of a placebo arm are also substantial threats to data validity. Research outside the clinical trial environment is needed to adequately prepare for PrEP rollout. Conducting the proposed research now, before PrEP is approved for HIV prevention, allows for a quick response to PrEP rollout if current trials demonstrate the effectiveness and safety of PrEP. The proposed research includes three aims and is investigated in two phases. Each phase uses a different methodology but is linked together by an underlying conceptual model - the Information, Motivation, and Behavioral (IMB) Framework. In Phase 1, after hearing messages about PrEP, 600 women from two sites in sub-Saharan Africa - Bondo, Kenya and Pretoria, South Africa - will be randomized to receive one of two factorial-type surveys. Each survey will use the same realistic vignettes, but will vary by PrEP context based on study arm - the participant in vignette taking PrEP or participant in vignette not taking PrEP. Survey data will be used to address Aims 1 and 2 of the research: 1) to assess the effect that the availability of PrEP will have on sexual risk decisions among women at higher risk for HIV infection, and 2) to identify demographic and behavioral correlates of women who are most likely to increase their sexual risk behavior when using PrEP. Phase 2 of the proposed research will address Aim 3, which is to develop risk-reduction counseling guidelines for women who are most likely to increase their sexual risk behavior when using PrEP. In-depth interviews (IDIs) will be conducted with 30 women per site who meet this criterion (as identified from survey data) as well as up to 3 counselors per site. Data from these interviews, as well as survey data, will be used to create risk-reduction counseling guidelines within an IMB framework. Guidelines will include key messages, questions to stimulate discussion on perception of risk, questions to identify those mostly likely to exhibit risk compensation, and behavior skills needed to minimize risk compensation.

描述（由申请人提供）：新的艾滋病毒预防方法，如口服暴露前预防（PrEP）可能很快被批准用于艾滋病毒预防，如果目前的临床试验证实其有效性和安全性。未来用户的风险补偿是一个主要问题，因为一旦推出，它可能会严重破坏PrEP的潜在公共卫生影响。目前，风险补偿仅在旨在评估PrEP有效性的临床试验中进行了评估。但是，仅关于风险补偿的临床试验数据不足以指导PrEP计划，因为这些数据是在最佳咨询情况下收集的，并且提高了社会期望答案的潜力。研究药物的未知有效性和安慰剂组的存在也是对数据有效性的实质性威胁。需要在临床试验环境之外进行研究，以便为PrEP的推出做好充分准备。在PrEP被批准用于艾滋病毒预防之前，现在进行拟议的研究，如果目前的试验证明了PrEP的有效性和安全性，则可以对PrEP的推出做出快速反应。拟议的研究包括三个目标，并分两个阶段进行调查。每个阶段使用不同的方法，但通过一个基本的概念模型-信息，动机和行为（IMB）框架联系在一起。在第一阶段，在听取了有关PrEP的信息后，来自撒哈拉以南非洲两个地点--肯尼亚邦多和南非比勒陀利亚--的600名妇女将被随机接受两项因素型调查之一。每次调查将使用相同的真实小插曲，但将根据研究组的PrEP背景而有所不同-小插曲中的参与者服用PrEP或小插曲中的参与者不服用PrEP。调查数据将用于解决研究的目标1和2：1）评估PrEP的可用性对艾滋病毒感染风险较高的妇女的性风险决定的影响，和2）确定使用PrEP时最有可能增加其性风险行为的女性的人口统计学和行为相关性。拟议研究的第2阶段将解决目标3，这是为那些在使用PrEP时最有可能增加性风险行为的女性制定降低风险咨询指南。每个研究中心将有30名符合这一标准的妇女（根据调查数据确定）以及每个研究中心最多3名顾问。这些访谈的数据以及调查数据将用于在IMB框架内制定降低风险的咨询指南。指南将包括关键信息、激发风险感知讨论的问题、识别最有可能表现出风险补偿的问题以及最大限度减少风险补偿所需的行为技能。