Delivering PrEP in Pregnancy

妊娠期提供 PrEP

基本信息

批准号：
9912703
负责人：
Grace John-Stewart
金额：
$ 65.31万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-05-01 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9912703
关键词：
AIDS prevention Acute Adherence Adverse effects Advocate Africa South of the Sahara Anti-Retroviral Agents Biological Biological Models Birth Centers for Disease Control and Prevention (U.S.)Child Clinic Clinic Visits Cluster randomized trial Couples Data Diagnosis Economics Effectiveness Enrollment Ensure Equilibrium Exposure to Female Growth HIV HIV Infections HIV risk Health system High Risk Woman Human immunodeficiency virus test Incidence Individual Infant Kenya Maternal and Child Health Mediation Meta-Analysis Modeling Mother-to-child HIV transmission Mothers Oral Outcome Outcome Study Pharmaceutical Preparations Policy Maker Postpartum Period Postpartum Women Predisposition Pregnancy Pregnant Women Premature Birth Prevalence Preventive Intervention Prophylactic treatment Provider Qualitative Research Randomized Randomized Clinical Trials Research Risk Risk Factors Safety Saliva Schedule Sexual Partners Sexually Transmitted Diseases Specificity Tenofovir Testing Viral Woman Women&apos s Health arm base cofactor condoms cost effective cost effectiveness cost estimate disability-adjusted life years emtricitabine health economics high risk high risk population incremental cost-effectiveness infant outcome male men who have sex with men pre-exposure prophylaxis pregnant programs public health relevance randomized trial risk minimization sex trial comparing uptake

项目摘要

DESCRIPTION (provided by applicant) Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner's HIV status, and have biologic changes or changes in their partner's sexual partnerships that increase susceptibility. Oral pre-exposure antiretroviral prophylaxis (PrEP) is an attractive strategy for HIV prevention in pregnancy/postpartum, given its effectiveness and safety. Clinicians and women are using PrEP in pregnancy; in qualitative studies, women, health workers and policy-makers support use of PrEP in pregnancy, but advocate for models of PrEP delivery that ensure women at risk receive PrEP while minimizing unnecessary PrEP use in women not at risk. Targeting PrEP to women at greatest risk of HIV may maximize benefits, minimize potential risks, and optimize cost-effectiveness. We propose a cluster-randomized clinical trial (RCT) in 20 Maternal Child Health (MCH) clinics in western Kenya (10 clinics per arm, 200 women per clinic, 4000 women overall) to compare 2 models of PrEP delivery in pregnancy. Clinics will offer universal PrEP (women self-select) or targeted PrEP (offer to women with high risk score). Leveraging the pre-existing MCH clinic visit schedule will enable programmatically relevant assessment of PrEP uptake, use, and HIV incidence. The outcome of the study will be a model of PrEP delivery in pregnancy that optimizes effectiveness, safety, and cost- effectiveness. Our team has expertise in maternal-child HIV (John-Stewart, Kinuthia), PrEP trials (Baeten, Richardson) partner self-testing (Thirumurthy), economics and qualitative research (Barnabas, O'Malley). We hypothesize that a targeted PrEP model will result in lower HIV incidence, fewer women on PrEP, more 'appropriate' PrEP use, better adherence, more partners on ART, and will be more cost-effective. Our AIMS: AIM 1a. In a cluster-RCT, to compare universal PrEP (offer to all; women self-select PrEP) to targeted PrEP (offer to women with a high risk score incorporating partner HIV self-test data) for outcomes reflecting the balance of PrEP effectiveness and safety: HIV incidence at 9 months postpartum among all women (including those who did and did not receive PrEP) and proportion of women exposed to PrEP. AIM 1b. To compare trial arms for proportion of women 'appropriately' on PrEP (risk factors), PrEP adherence (drug levels) and duration, partners with known HIV status, partners on ART; infant outcomes (growth, birth outcomes). AIM 2. To estimate the incremental cost-effectiveness of targeted PrEP compared to universal PrEP for women during pregnancy and postpartum, per HIV infection and disability-adjusted life-year (DALY) averted. AIM 3. To qualitatively assess barriers and facilitators to adherence, acceptability, and feasibility in universal and targeted PrEP models at the organizational, provider, and individual woman level. Optimized PrEP delivery in pregnancy will contribute to HIV eradication as highly accessed MCH systems can efficiently deliver PrEP to women in a defined limited risk period and expedite male diagnosis and treatment.

描述（由申请人提供）居住在艾滋病毒率高的地区的妇女因不经常使用避孕套，不知道其伴侣的艾滋病毒状况，并改变了伴侣的性伙伴关系，以增加敏感性，因此怀孕和产后艾滋病毒的艾滋病毒感染风险很高。鉴于其有效性和安全性，口服抗逆转录病毒预防（PREP）是妊娠/产后预防HIV的有吸引力的策略。临床医生和妇女在怀孕中使用准备；在定性研究中，妇女，卫生工作者和决策者支持在怀孕中使用PREP，但倡导PREP交付模型，以确保处于危险中的女性获得PREP，同时最大程度地减少了不必要的PREP使用，而在不风险的妇女中使用。针对妇女以艾滋病毒的最大风险做好准备可能会最大程度地利用福利，最大程度地减少潜在风险并优化成本效益。我们在肯尼亚西部的20个产妇儿童健康（MCH）诊所（每只手臂10个诊所，每名诊所200名诊所，总计4000名妇女）中提出了一项簇伴有临床试验（RCT），以比较2种妊娠期预备术模型。诊所将提供普遍的预备（女性自我选择）或有针对性的准备（为具有高风险评分的女性提供）。利用预先存在的MCH诊所访问时间表将对预先摄取，使用和HIV事件进行编程相关的评估。该研究的结果将是一种在怀孕期间的预付款模型，可优化有效性，安全性和成本效益。我们的团队在母婴艾滋病毒（John-Stewart，Kinuthia），预科试验（Baeten，Richardson）伴侣自我测试（Thirumurthy），经济学和定性研究（Barnabas，O'Malley）方面拥有专业知识。我们假设有针对性的PREP模型将导致较低的HIV事件，较少的女性使用PREP，更多的“适当” PREP使用，更好的依从性，更多的ART合作伙伴，并且会更具成本效益。我们的目标：目标1a。在群集RCT中，将通用准备（提供给所有妇女的自我选择准备）与有针对性的预备（向具有高风险分数的女性提供伴侣自我测试数据的高风险分数的妇女），以反映了预期有效性和安全性的平衡：艾滋病毒在所有女性中（包括那些曾经和没有接受预备的女性）和女性成分为女性的女性的HIV发病率。目标1B。要比较妇女在PREP（风险因素），依从性（药物水平）和持续时间的妇女比例的审判武器，具有已知艾滋病毒状况的伴侣，ART的伴侣；婴儿结局（成长，出生结果）。目的2。与怀孕期间和产后妇女的普遍预备相比，估算有针对性准备的逐渐成本效益，避免了艾滋病毒感染和残疾调整的生命年（DALY）。目的3。定性评估障碍和促进者，以遵守组织，提供者和个人女性层面的普遍和有针对性的PREP模型的遵守，可接受性和可行性。在怀孕期间，优化的预备分娩将有助于消除HIV，因为高度可访问的MCH系统可以在有限的风险时期有效地向女性提供准备，并加快男性诊断和治疗。