PrEP uptake/adherence to reduce periconception HIV risk for South African women

采取/坚持 PrEP 可降低南非妇女围孕期 HIV 风险

• 批准号: 9336963
• 负责人: Lynn T Matthews
• 金额: $ 57.74万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-25 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9336963
• 关键词: AIDS prevention; Adherence; Affect; Age; Anti-Retroviral Agents; Caring; Centers for Disease Control and Prevention (U.S.); Child; Communities; Conceptions; Counseling; Couples; Data; Development; Drug Kinetics; Family; Female; Fertility; Future; Goals; Guidelines; HIV; HIV Infections; HIV risk; HIV therapy; High Risk Woman; Human immunodeficiency virus test; Incidence; Intervention; Interview; Live Birth; Measures; Motivation; Oral; Participant; Pattern; Perinatal; Pharmaceutical Preparations; Placebos; Planned Pregnancy; Plasma; Population; Pregnancy; Pregnant Women; Prevalence; Prevention; Prevention strategy; Qualitative Methods; Recruitment Activity; Reporting; Research Personnel; Resources; Risk; Risk Reduction; Safety; Sampling; Sex Behavior; Sexual Partners; Social support; South Africa; South African; Tenofovir; Testing; Time; Visit; Woman; arm; base; condoms; cost; emtricitabine; experience; follow-up; high risk; men; novel; pandemic disease; pill; placebo controlled study; pre-exposure prophylaxis; pregnant; prevent; primary outcome; promoter; public health relevance; risk perception; sex; transmission process; uptake

 DESCRIPTION (provided by applicant): In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown- serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing her risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children. We propose a single-arm study to offer daily, oral PrEP for periconception use to 350 HIV-uninfected women in KwaZulu-Natal, South Africa who report personal or partner plans for pregnancy with an infected or unknown serostatus partner. Women who become pregnant on PrEP will have the option to continue PrEP during pregnancy. PrEP will be offered as part of a safer conception package inclusive of couples-based HIV counseling and testing. In Aim 1, we will evaluate the proportion of women initiating PrEP and determine factors associated with uptake. In Aim 2, we will evaluate objectively-measured PrEP adherence during periconception and pregnancy follow-up. Level, patterns, and correlates of adherence will be evaluated using plasma drug concentrations and electronic pill caps. Our primary outcome is prevalence of protective plasma tenofovir concentrations (> 40 ng/ml). We will also evaluate median adherence to dispensed pills with electronic pill caps. From formative studies in South Africa, we hypothesize that adherence to a proven intervention (TDF/FTC PrEP) for a defined risk period (periconception, pregnancy) with a clear end point (live birth) will be high (protective tenofovir concentrations at 80% of visits, adherence to >80% of prescribed pills). In Aim 3, longitudinal quantitative data and in-depth interviews with initially high- and low-adhering participants will inform our conceptual framework for periconception PrEP uptake and adherence. Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. Consistent with PA11-275 "Discovery, Development, & Testing of Novel Interventions to Advance HIV Prevention and Care", this application advances combination approaches to HIV- prevention and targets a population highly affected by the pandemic. This project will determine whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.

 描述（由适用提供）：在艾滋病毒领域的环境中，许多艾滋病毒未感染的妇女选择与感染了HIV感染或未知的血清伴侣一起带来。对于一个不能依靠伴侣进行测试，启动和遵守艺术的妇女来说，没有避孕套的性行为会使她的高风险获取艾滋病毒，并增加了向孩子传播围产期的风险。每天，口服TDF/FTC准备大大降低了妇女患HIV的风险，并且是唯一降低围绕围绕艾滋病毒艾滋病毒的风险的女性控制的选择。了解每天的口服准备是否对于未感染怀孕的妇女来说是否可行，对于降低妇女及其子女的艾滋病毒发病率至关重要。我们提出了一项单臂研究，为南非夸祖鲁 - 纳塔尔省的350名艾滋病毒未感染的妇女提供每天的口服准备，以与感染或未知的血清伴侣报告妊娠的个人或伴侣计划。怀孕期间怀孕的妇女可以在怀孕期间继续准备。 PREP将作为安全概念包的一部分，包括基于夫妻的艾滋病毒咨询和测试。在AIM 1中，我们将评估妇女启动PREP的比例并确定与摄取相关的因素。在AIM 2中，我们将评估在周期感受和妊娠随访期间客观测量的准备依从性。将使用血浆药物浓度和电子药帽评估依从性的水平，模式和相关性。我们的主要结果是受保护的血浆替诺福韦浓度（> 40 ng/ml）的患病率。我们还将评估中位数依从性，以分配带有电子药盖的药丸。从南非的形成性研究中，我们假设在确定的风险时期（Periconception，怀孕）中，遵守良好的干预措施（TDF/FTC准备）具有明显的终点（活产）（活产）很高（保护性替诺福韦浓度在80％的访问中，对处方药的80％依靠）。在AIM 3中，纵向定量数据和对最初高和低辅助参与者的深入访谈将为我们的概念框架提供概念性框架，以吸收和依从性。安慰剂对照试验将遵守性确定为长期准备使用的主要挑战。但是，妇女渴望预防允许概念的预防策略，我们假设遵守验证的预防策略的依从性，在有限的时间内，有有限的动机，将会会召集预防艾滋病毒传播所需的药物水平。与PA11-275一致，“发现，开发和测试新的干预措施，以推动艾滋病毒预防和护理”，该应用程序进一步发展了预防HIV的组合方法，并针对受大流行影响的人群。该项目将确定每日口服准备是否是对有风险伴侣怀孕的南非妇女的可行预防策略。鉴于在受孕和怀孕期间获得艾滋病毒的影响，这是为妇女及其子女提供关键预防策略的重要一步。