Delivering PrEP in Pregnancy

妊娠期提供 PrEP

• 批准号: 9161128
• 负责人: Jared Baeten
• 金额: $ 66.65万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9161128
• 关键词: AIDS prevention; Adherence; Adverse effects; Advocate; Africa South of the Sahara; Anti-Retroviral Agents; Birth; Centers for Disease Control and Prevention (U.S.); Child; Clinic; Clinic Visits; Cluster randomized trial; Couples; Data; Diagnosis; Economics; Effectiveness; Enrollment; Ensure; Equilibrium; Female; Growth; HIV; HIV Infections; HIV risk; Health system; High Risk Woman; Human immunodeficiency virus test; Incidence; Individual; Infant; Kenya; Life; Maternal and Child Health; Mediation; Meta-Analysis; Modeling; Mother-to-child HIV transmission; Mothers; Oral; Outcome; Outcome Study; 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' s Health; arm; base; cofactor; condoms; cost; cost effective; cost effectiveness; disability-adjusted life years; emtricitabine; health economics; high risk; infant outcome; male; medication compliance; men who have sex with men; pregnant; programs; public health relevance; randomized trial; sex; trial comparing; uptake

 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） 生活在艾滋病毒高流行地区的妇女在怀孕和产后感染艾滋病毒的风险很高，因为她们很少使用安全套，不知道伴侣的艾滋病毒感染状况，并且伴侣的性伙伴关系发生了生物学变化，从而增加了易感性。 - 考虑到临床医生和妇女在怀孕期间使用 PrEP 的有效性和安全性，暴露抗逆转录病毒预防 (PrEP) 是一种有吸引力的妊娠/产后艾滋病毒预防策略；研究表明，妇女、卫生工作者和政策制定者支持在怀孕期间使用 PrEP，但提倡 PrEP 实施模式，确保高危妇女接受 PrEP，同时最大限度地减少非高危妇女不必要的 PrEP 使用。 HIV 可以最大限度地提高效益、最大限度地降低潜在风险并优化成本效益。我们建议在肯尼亚西部 20 个妇幼保健 (MCH) 诊所（每组 10 家诊所，每组 200 名妇女）进行整群随机临床试验 (RCT)。诊所，总共 4000 名女性）来比较怀孕期间的 2 种 PrEP 分娩模式。诊所将利用现有的 MCH 诊所就诊时间表提供普遍的 PrEP（女性自行选择）或针对性的 PrEP（为高风险评分的女性提供）。能够对 PrEP 的吸收、使用和 HIV 发病率进行有计划的相关评估。该研究的结果将是一个优化妊娠期 PrEP 交付的模型，该模型可以优化有效性、安全性和成本效益。我们的团队拥有母婴方面的专业知识。 HIV（John-Stewart，Kinuthia），PrEP 试验（Baeten，Richardson）合作伙伴自我测试（Thirumurthy），经济学和定性研究（Barnabas，O'Malley）我们追求有针对性的 PrEP 模型将降低 HIV 发病率，接受 PrEP 的女性数量更少，使用 PrEP 更“适当”，依从性更好，ART 合作伙伴更多，并且将更具成本效益。集群随机对照试验，比较通用 PrEP（向所有人提供；女性自行选择 PrEP）与针对性 PrEP（向高风险评分的女性提供，结合伴侣 HIV 自检数据），以获得反映 PrEP 有效性和安全性平衡的结果：所有女性（包括接受和未接受 PrEP 的女性）产后 9 个月的 HIV 发病率以及接触 PrEP 的女性比例 比较试验组中“适当”接受 PrEP 的女性比例（风险）。目标 2. 与避免的 HIV 感染和伤残调整生命年 (DALY) 相比，针对怀孕和产后妇女，评估针对性 PrEP 与普遍 PrEP 的增量成本效益 AIM 3. 定性评估依从性的障碍和促进因素。组织中通用和有针对性的 PrEP 模型的可接受性和可行性，优化妊娠期 PrEP 实施将有助于根除 HIV，因为高度可及的 MCH 系统可以在规定的有限风险期内有效地向女性提供 PrEP，并加快男性诊断和治疗。