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: 9464057
• 负责人: Lynn T Matthews
• 金额: $ 4.41万
• 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/9464057
• 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（由申请人证明）：在艾滋病毒的环境中，许多艾滋病毒未感染的妇女选择与艾滋病毒感染或不知名的伴侣构想。安德里亚（Andreas）向孩子传播的风险。每天提供对周围感受的口服准备，以对350名艾滋病毒未受的妇女在南非的夸祖鲁 - 纳塔尔省，她们与感染或未知的血清伴侣报告了个人或怀孕。在AIM 2中，概念包含夫妻的艾滋病毒咨询和测试。药物浓度和电子帽。具有清晰终点（活产）的SK期（围绕妊娠）将在80％的访问中占高（保护性的）替诺福韦浓度，在AIM 3中的80％）。遗产参与者将向我们的概念提供我们的概念，以吸收和遵守安慰剂对照试验，以此作为长期准备的主要挑战，我们假设有限的动机，以实现良好的预期策略。为了有一个健康的孩子，将使药物水平用于艾滋病毒传播。可行的可行的他的可行的他可行的他的fricanigy frican fricanw with有风险的伴侣。