Stepped care to optimize PrEP effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa

南非孕妇和产后妇女采用阶梯式护理优化 PrEP 效果 (SCOPE-PP)

• 批准号: 10663362
• 负责人: DVORA JOSEPH DAVEY
• 金额: $ 45.41万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663362
• 关键词: AIDS prevention; Address; Adherence; Africa South of the Sahara; Behavioral Sciences; Biofeedback; Biological Assay; Breast Feeding; California; Caring; Clinic Visits; Clinical; Collection; Consolidated Framework for Implementation Research; Counseling; Diagnostic Reagent Kits; Diphosphates; Drops; Effectiveness; Eligibility Determination; Enrollment; Epidemiology; Equity; Fertility; Frequencies; Guidelines; HIV; HIV Infections; Health Personnel; Health care facility; Healthcare; High Prevalence; High Risk Woman; Home; Human immunodeficiency virus test; Incidence; Infant; Intervention; Interview; Lead; Link; Los Angeles; Measures; Modeling; Monitor; Mothers; Participant; Partner Communications; Patient Self-Report; Pharmaceutical Preparations; Pilot Projects; Play; Policies; Postnatal Care; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Provider; Randomized, Controlled Trials; Research; Risk; Safety; Services; South Africa; Surveys; Tenofovir; Testing; Time; Translating; Universities; Urine; Vertical Transmission; Visit; Woman; Work; acceptability and feasibility; antenatal; antenatal care; arm; comparison intervention; cost effectiveness; cost-effectiveness evaluation; design; disability-adjusted life years; economic evaluation; efficacy evaluation; empowerment; health economics; high risk; improved; incremental cost-effectiveness; innovation; intervention participants; lateral flow assay; male; microcosting; novel; novel strategies; point of care; pre-exposure prophylaxis; pregnant; prevent; preventive intervention; primary outcome; programs; routine care; secondary outcome; self testing; standard of care; testing services; transmission process; treatment arm

PROJECT SUMMARY: HIV incidence doubles during pregnancy and postpartum period compared with non- pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 76,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drops precipitously in the postpartum period. Our team is made up of experts in epidemiology, behavioral science, health economics and HIV prevention in pregnant women from University of California Los Angeles and the University of Cape Town. Together we have implemented one of the first studies to integrate PrEP into antenatal care in South Africa (“PrEP-PP”; R01MH116771). We propose to test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including PrEP, HIV self-testing (HIVST) for the participant and her partner(s), and enhanced adherence counseling (with bio-feedback on adherence) combined with home PrEP delivery for women who want to take PrEP but have difficulties adhering. We developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by reducing clinic visit frequency and empowering women to adhere to PrEP. We will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. We will enroll 500 pregnant women in antenatal care and follow them through 12m postpartum. Women in the intervention will be offered: HIVST for participants & partners, rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP adherence will be offered a differentiated care model of home PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. We aim to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research; and 3) Estimate the incremental cost effectiveness of SCOPE-PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and transmission in South Africa and beyond.

项目总结：与非妊娠期相比，妊娠期和产后期间的艾滋病毒感染率增加一倍。 强调迫切需要针对高风险孕妇采取预防干预措施， 孕妇和哺乳期妇女。据估计，孕产妇艾滋病毒感染事件导致三分之一的 婴儿艾滋病毒感染。南非预计未来十年将有超过76，000例婴儿艾滋病毒病例;其中三分之一 可以通过消除孕产妇艾滋病毒感染来预防。妊娠期暴露前预防（PrEP）， 母乳喂养是安全和有效的预防艾滋病毒。然而，PrEP的使用在怀孕期间仍然很低， 在产后期间急剧增加。我们的团队由流行病学，行为科学， 来自加州大学洛杉矶和 开普敦大学。我们一起实施了第一项研究，将PrEP整合到 南非的产前保健（“PrEP-PP”; R 01 MH 116771）。我们建议测试一种新的策略来优化 南非孕妇和产后妇女的PrEP。我们的随机对照试验（RCT）设计为 解决孕产妇使用PrEP的主要障碍，并评估成本效益，为国家政策提供信息。 本试验建立在我们早期工作的基础上，证明了 一揽子干预措施，包括PrEP，参与者及其伴侣的艾滋病毒自我检测（HIVST），以及 加强依从性咨询（对依从性的生物反馈）结合家庭PrEP交付， 想要服用PrEP但难以坚持的女性。我们开发并试验了一种新的干预措施 标题为，分步护理，以优化PrEP在孕妇和产后妇女的有效性（SCOPE-PP） 通过减少诊所就诊频率和增强妇女权能， 坚持PrEP。我们将在一项务实的RCT中评估SCOPE-PP，该RCT针对有以下风险的孕妇和产后妇女： 艾滋病毒感染。我们将招募500名孕妇进行产前护理，并对她们进行12个月的随访。 产后将为参与干预的妇女提供：参与者和伴侣的HIVST，快速PrEP收集 强化的坚持咨询。PrEP依从性差的女性将获得差异化护理 家庭PrEP交付模式，将PrEP与临床访视脱钩。主要结局是PrEP持续 和产后妇女的依从性，通过二磷酸替诺福韦的药物水平来测量。我们的目标是：1） 评估SCOPE-PP干预对孕妇和产后妇女PrEP依从性的有效性 在RCT中; 2）评估将SCOPE-PP纳入产前和产后 使用实施研究的综合框架进行护理;以及3）估计增量成本 SCOPE-PP与标准治疗的有效性（每例HIV感染和避免的残疾调整生命年）。 这项研究对于告知孕产妇PrEP干预措施以消除艾滋病毒感染和传播至关重要， 南非及其他地区

项目成果

Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial.

• DOI: 10.1186/s12889-022-13652-5
• 发表时间: 2022-07-07
• 期刊: BMC PUBLIC HEALTH
• 影响因子: 4.5
• 作者: Davey, Dvora Leah Joseph;Dovel, Kathryn;Cleary, Susan;Khadka, Nehaa;Mashele, Nyiko;Silliman, Miriam;Mvududu, Rufaro;Nyemba, Dorothy C.;Coates, Thomas J.;Myer, Landon
• 通讯作者: Myer, Landon