Linking HIV Prevention and post-partum care: Safety, efficacy and feasibility of cabotegravir-LA PrEP in high-risk breastfeeding population in Botswana

将艾滋病毒预防与产后护理联系起来：卡博特韦-LA PrEP 在博茨瓦纳高危母乳喂养人群中的安全性、有效性和可行性

• 批准号: 10494175
• 负责人: Rebecca Marie Zash
• 金额: $ 60.84万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10494175
• 关键词: AIDS prevention; Address; Adherence; Adult; Adverse effects; Africa; Africa South of the Sahara; Appointment; Award; Birth Rate; Botswana; Breast Feeding; Breastfed infant; Caring; Centers for Disease Control and Prevention (U.S.); Child; Childhood; Clinical; Communities; Country; Data; Development; Drug Kinetics; Drug resistance; Effectiveness; Enrollment; Epidemic; Epidemiology; Evaluation; Female Adolescents; Fertility; Formulation; Growth; Guidelines; HIV; HIV Infections; HIV resistance; Healthcare; Healthcare Systems; High Prevalence; High Risk Woman; Human Milk; Hybrids; Incidence; Income; Infant; Infant Care; Infrastructure; Injectable; Injections; Integrase Inhibitors; Lactation; Link; Location; Male Adolescents; Measures; Mothers; Motivation; Observational Study; Oral; Outcome; Outpatients; Persons; Pharmaceutical Preparations; Plasma; Population; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy; Prevalence; Prevention Guidelines; Prevention strategy; Public Health; Race; Reporting; Reproductive Health; Resistance to infection; Risk; Safety; Sampling; Scientist; Services; Sexual Health; Site; Tenofovir; Testing; Time; Weight Gain; Woman; cardiometabolism; child bearing; emtricitabine; follow-up; health organization; high risk; implementation barriers; implementation study; innovation; maternal serum; maternal weight; novel; pediatric human immunodeficiency virus infection; postpartum care; pre-exposure prophylaxis; pregnant; prevent; primary caregiver; programs; reproductive; safety study; success; treatment guidelines; uptake; ward; young woman

Project Summary/Abstract: Preventing HIV among young women is key to ending the HIV epidemic. However, prevention strategies have been hampered by poor adherence to oral pre- exposure prophylaxis (PrEP) in women and difficult implementing PrEP for young healthy women who have limited interaction with the healthcare system. The recent announcement that injectable long-acting cabotegravir (CAB-LA) is associated with a 9-fold decrease in the incidence of HIV infection in women compared with oral PrEP has the potential to transform the course of the HIV epidemic if CAB-LA can be effectively implemented. In addition to identifying strategies to efficiently reach young women at risk for HIV, breastfeeding safety data for CAB- LA are needed to achieve widespread use in women. Countries with high HIV prevalence also have high fertility and women spend up to 1/3 of their reproductive years pregnant and breastfeeding. Additionally, HIV acquisition risk is 2-4 times higher during the post-partum period, and preventing HIV during breastfeeding also prevents pediatric HIV infection. We propose to address both implementation challenges and lack of breastfeeding safety data by evaluating a strategy of starting CAB-LA PrEP in high risk women who are admitted to the post- partum ward after delivery, and co-locating follow up PrEP services with post-partum and pediatric care, in a primarily breastfeeding population in Botswana. The immediate post-partum period is a unique time to reach young women with PrEP because they are engaged in regular healthcare and highly motivated to stay healthy. In addition to assessing feasibility, uptake, acceptability and retention of this approach, we will also measure HIV incidence with CAB-LA PrEP in a real-world, high HIV prevalence setting. This will be the first large study to evaluate the pharmacokinetics of CAB-LA in breastfeeding women without HIV (and their infants), and this study will perform additional important safety evaluations related to use of integrase inhibitors, including the impact of CAB on maternal weight and cardiometabolic outcomes, post- partum depression and infant growth. We expect this innovative strategy will be easily scalable, influence HIV prevention guidelines and result in the advancement of HIV prevention strategies for women around the world.

项目摘要/摘要：预防年轻女性的艾滋病毒是结束艾滋病毒的关键 流行性。但是，预防策略因口头前的依从性而受到阻碍 女性的暴露预防（PREP），并难以实施年轻健康的准备 与医疗保健系统互动有限的妇女。最近的公告 可注射的长效Cabotegravir（Cab-la）与降低9倍有关 与口服PREP相比，女性艾滋病毒感染的发病率有可能改变 艾滋病毒流行的过程是否可以有效地实施。除了确定 有效地接触有艾滋病毒风险的年轻女性的策略，为驾驶室提供母乳喂养的安全数据 - 需要洛杉矶以实现女性的广泛使用。艾滋病毒患病率高的国家 生育力高，妇女在怀孕的生殖年中最多花费1/3 哺乳。此外，在产后，艾滋病毒收购风险高2-4倍 时期，在母乳喂养期间预防HIV也可以防止小儿艾滋病毒感染。我们 建议通过 评估一项在高风险妇女中开始使用Cab-la Prep的策略，这些妇女被接纳为 分娩后的围栏，并通过后产后共同列出后续准备服务， 小儿护理，主要是博茨瓦纳的母乳喂养人群。立即的产后 时期是吸引年轻女性的独特时间，因为她们有常规 医疗保健和高度动力保持健康。除了评估可行性，吸收， 这种方法的可接受性和保留性，我们还将用CAB-LA测量艾滋病毒的发病率 在现实世界中的高HIV患病率设置中进行准备。这将是第一项评估的大型研究 在没有艾滋病毒（及其婴儿）和 这项研究将执行与使用集成酶有关的其他重要安全评估 抑制剂，包括CAB对孕妇体重和心脏代谢结果的影响，后 组成抑郁和婴儿的生长。我们预计这种创新策略将很容易扩展， 影响艾滋病毒预防准则，并导致艾滋病毒预防策略的发展 适用于世界各地的妇女。