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: 10676833
• 负责人: Rebecca Marie Zash
• 金额: $ 58.64万
• 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/10676833
• 关键词: AIDS prevention; Address; Adherence; Admission activity; Adult; Adverse effects; Africa; Africa South of the Sahara; Appointment; Award; Birth Rate; Botswana; Breast Feeding; Breastfed infant; Caring; 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; 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; Recommendation; Reporting; Reproductive Health; Resistance; 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：预防年轻女性感染艾滋病是终结艾滋病的关键