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: 10403232
• 负责人: Rebecca Marie Zash
• 金额: $ 66.81万
• 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/10403232
• 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：在年轻女性中预防艾滋病毒是结束艾滋病毒的关键 疫情然而，预防战略受到了口服预防措施的阻碍， 暴露预防（PrEP）在妇女和难以实施的PrEP年轻健康 与医疗保健系统互动有限的妇女。最近宣布 可注射长效卡博特拉韦（CAB-LA）与9倍降低相关， 与口服PrEP相比，女性艾滋病毒感染的发病率有可能改变 如果CAB-LA能够得到有效实施，艾滋病毒流行的过程将更加艰难。除了识别 有效接触有艾滋病毒风险的年轻妇女的战略，CAB的母乳喂养安全数据， 需要LA来实现在女性中的广泛使用。艾滋病毒流行率高的国家也 生育率高，妇女在怀孕期间的时间占其生育年龄的三分之一， 母乳喂养。此外，产后感染艾滋病毒的风险要高出2-4倍。 母乳喂养期间预防艾滋病毒也可以预防儿科艾滋病毒感染。我们 建议通过以下方式解决实施挑战和缺乏母乳喂养安全数据的问题 评估在入院后的高风险女性中开始CAB-LA PrEP的策略， 分娩后的产房，并与产后和 儿童护理，在博茨瓦纳主要是母乳喂养的人口。产后期间因直接 时期是一个独特的时间，以达到年轻女性与PrEP，因为他们从事定期 医疗保健和高度积极性，以保持健康。除了评估可行性，吸收， 为了确保这种方法的可接受性和可保留性，我们还将用CAB-LA测量HIV发病率 PrEP在现实世界中，高艾滋病毒流行率设置。这将是第一个大型研究，以评估 CAB-LA在无HIV的哺乳期妇女（及其婴儿）中的药代动力学，以及 本研究将进行与使用整合酶相关的其他重要安全性评价， 抑制剂，包括CAB对母体体重和心脏代谢结果的影响， 产后抑郁症和婴儿生长。我们预计这一创新战略将很容易扩展， 影响艾滋病毒预防指导方针，推动艾滋病毒预防战略的发展 for women妇女around the world世界.