PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women

PrEP My Way：满足非洲年轻女性需求的新型 PrEP 交付系统

• 批准号: 10364655
• 负责人: Jessica Elizabeth Haberer
• 金额: $ 18.61万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-06 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10364655
• 关键词: AIDS prevention; Address; Adherence; Africa South of the Sahara; African; Age; Behavioral Sciences; Blood; Businesses; Caring; Cellular Phone; Characteristics; Chlamydia; Client; Clinic; Communication; Communities; Contraceptive methods; Diagnostic Reagent Kits; Education; Ensure; Environment; Face; Focus Groups; Future; General Hospitals; Gonorrhea; Grant; HIV; Health Services; Home; Hour; Human immunodeficiency virus test; Individual; Infection; Infrastructure; Intervention; Interview; Kenya; Location; Massachusetts; Mediating; Medical Research; Methods; Modeling; Oral; Phase III Clinical Trials; Plasma; Population; Pregnancy Tests; Protocols documentation; Questionnaires; Randomized; Research Institute; Research Personnel; Sampling; Self Efficacy; Services; Sexual Health; Sexually Transmitted Diseases; Social Behavior; South Africa; Southern Africa; Spottings; Swab; System; Technology; Telephone; Tenofovir; Test Result; Testing; Training; Uganda; Universities; Vagina; Vulnerable Populations; Washington; Woman; Work; Youth; Zambia; base; cost; design; early experience; empowerment; experience; female sex worker; follow-up; health care delivery; innovation; interest; learning materials; men who have sex with men; novel; oral HIV; peer; peer support; pre-exposure prophylaxis; primary outcome; programs; remote delivery; remote monitoring; self testing; service uptake; social cognitive theory; social stigma; standard of care; success; uptake; young woman

PROJECT SUMMARY - Significance: Young women (16-24 years old) in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention. Proposed intervention: PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. Innovation: This study is the first, to our knowledge, to develop a peer-delivered kit for PrEP use, sexually transmitted infection (STI) testing, and contraception. The intervention leverages smart use of readily available technology (e.g., SMS, WhatsApp, Vimeo) to support use of the kit and peer-based empowerment. Approach: We will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). We will use a client-centered, iterative approach, involving ~15 individual interviews and two focus group discussions (with ~5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). We will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). We will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic- based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at baseline and 6 months. Investigators/environment: Our team has extensive relevant experience to ensure the success of this proposal, including PrEP adherence and behavioral science (PI: Dr. Haberer at Massachusetts General Hospital), sexual health service delivery (Dr. Bukusi at the Kenyan Medical Research Institute, Dr. Baeten at the University of Washington), and remote delivery and monitoring for PrEP and STIs (Dr. Siegler at Emory), as well as product design (ARK in Nairobi). Future directions: PrEP My Way is designed with limited infrastructure needs, thus creating potential for real world implementation at scale that can be tested in a future R01 grant.

项目摘要 - 意义：撒哈拉以南非洲的年轻妇女（16-24岁）是 在收购艾滋病毒方面，脆弱的人群每周发生约7,000个新感染。每天口服 预防前预防（PREP）是定期服用的一种高效预防HIV的手段。早期的 在该人群中全球PROP推出的经验表明了对准备的热情，也表明了 依从性和计划保留。建议的干预措施：准备我的方式是一种新颖的准备递送系统 由基于诊所的Prep启动组成，然后是用于艾滋病毒自我测试，预先补充的同伴分配套件， 淋病和衣原体自我采样，妊娠试验和避孕补助的阴道拭子，如果 需要。基于社会认知理论，我们的总体假设是准备我的方式将克服关键 目前限制PREP使用，从而使年轻女性促进其促进她们的污名和结构性障碍 性健康。创新：据我们所知，这项研究是开发同行提供的套件进行准备的第一项 使用，性传播感染（STI）测试和避孕。干预利用明智的使用 随时可用的技术（例如SMS，WhatsApp，Vimeo）支持套件和基于同行的使用 授权。方法：我们将首先开发，量身定制和完善与年轻女性一起使用的方式 肯尼亚基苏木（目标1）。我们将使用以客户为中心的迭代方法，涉及约15个个人访谈 以及两个焦点小组讨论（每个女性约有5个），以最佳设计我的套件（使用 教学材料）和同行交付系统（包括通信和套件交付计划）。我们将 然后测试干预措施是否可行性，可接受性和对准备依从性和计划的初步影响 保留（目标2）。我们将随机将100名肯尼亚妇女与我的护理标准进行准备（即诊所 - 基于准备和性健康服务的提供），并关注它们6个月。可行性将被评估 通过在1、3和6个月的时间内收到套件，并通过协议使用其组件的能力。可接受性将是 通过6个月的混合方法采访确定。初步影响将通过干燥 血点替诺福韦水平（依从性）和套件使用/诊所在6个月（保留）作为主要 结果。可能会通过问卷调查来探讨潜在的影响和调解社会行为因素 基线和6个月。调查人员/环境：我们的团队拥有丰富的相关经验以确保 该提案的成功，包括准备依从性和行为科学（PI：Haberer博士在 马萨诸塞州综合医院），性保健服务（Bukusi博士，肯尼亚医学研究 研究所，华盛顿大学的Baeten博士，以及远程交付和监控Prep和ETIS （Emory的Siegler博士）以及产品设计（内罗毕的方舟）。未来的指示：准备我的方式是 设计有有限的基础设施需求，因此为现实世界实施的潜力而言， 可以在未来的R01赠款中进行测试。