Innovative strategies to increase ART Initiation and viral suppression among HIV+ men in Malawi

提高马拉维艾滋病毒男性的抗逆转录病毒治疗启动和病毒抑制的创新策略

• 批准号: 10018124
• 负责人: Kathryn L Dovel
• 金额: $ 14.24万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018124
• 关键词: Address; Adopted; Adverse event; Africa South of the Sahara; Area; Baseline Surveys; Biometry; Caring; Characteristics; Client; Clinical Trials; Counseling; Country; Data; Development; Development Plans; Disclosure; Effectiveness; Effectiveness of Interventions; Enrollment; Ensure; Epidemic; Ethics; Female; Focus Groups; Fright; Goals; HIV; HIV Seropositivity; Health Personnel; Health Services Accessibility; Health care facility; Home environment; Home visitation; Human immunodeficiency virus test; Individual; Intervention; Interview; Knowledge; Location; Maintenance; Malawi; Mentored Research Scientist Development Award; Mentors; Mentorship; Modeling; Newly Diagnosed; Outcome; Population; Privacy; Public Health; Randomized Controlled Trials; Research; Research Activity; Research Personnel; Research Training; Resources; Respondent; Risk; Sample Size; Scientist; Service delivery model; Services; Sexual Partners; Social Sciences; Statistical Methods; Testing; Therapeutic Intervention; Time; Training; Viral; Woman; antiretroviral therapy; arm; barrier to care; base; career development; clinical practice; coping; cost; evidence base; experience; improved; indexing; informant; innovation; male; men; multidisciplinary; novel strategies; pilot trial; primary outcome; randomized trial; retention rate; secondary outcome; seroconversion; service delivery; skills; social; social observations; social stigma; standard care; standard of care; success; testing services; theories; treatment services

Project Summary Men continue to be missed by HIV testing and treatment services. Index partner testing is a critical strategy for reaching men. Index HIV self-testing (HIVST), whereby ART clients take HIVST kits home to their sexual partners for testing, is a new strategy that dramatically increases index testing among men, and is being taken to scale across Malawi. However, only 25% of men identified as HIV-positive through Index HIVST initiate ART after 6- months. Innovative strategies to increase ART initiation and retention among men are urgently needed. The overarching goal of the proposed K01 is to develop and pilot a home-based ART intervention (ART initiation + 3-months ART care) to increase ART initiation (primary outcome) and 6-month viral suppression (secondary outcome) among men who test HIV-positive through Index HIVST in Malawi. Candidate: I am a social scientist with a background in HIV research in sub-Saharan Africa. My long-term goal is to transition from observational social science to clinical trials research in innovative HIV service delivery models among hard-to-reach populations, such as men. I am applying for a five-year K01 award to obtain training, mentorship, and research experience. Mentoring: I have an exceptional multi-disciplinary mentoring team with extensive experience in HIV care and management and clinical trials in the region. The team has complementary expertise in social science and clinical trials in HIV service delivery models (Dr. Thomas Coates – Primary Mentor), best practices in HIV care and management and differentiated models of care in Malawi (Drs. Judith Currier and Risa Hoffman), scalability and sustainability of interventions (Dr. Sundeep Gupta – Malawi-based), and advanced biostatistics (Dr. Ron Brookmyer). Career Development: To achieve my long-term goals, we have developed a detail plan to build skills in four additional areas: (1) best clinical practices for ART care and maintenance; (2) clinical trials in novel approaches to HIV service delivery; (3) advanced statistical methods; and (4) ethics in clinical trials research in low-resource settings. Research Activities: The specific aims accompanying the career development plan are to: (1) Develop a home-based ART intervention for male partners tested through Index HIVST, using in-depth interviews with male Index HIVST users (n=15-20) and their partners (n=15-20), and focus group discussions with key informants (n=18-30). (2) Determine the potential effectiveness of home-based ART versus standard facility-based ART (on ART initiation (primary outcome) and 6-month viral suppression (secondary outcome) among male Index HIVST users in a pilot trial with 200 HIV-positive men. Expected Outcomes: Results from this study will inform definitive trial to test home-based ART services for men identified as HIV-positive through index HIVST strategies. The project will also give me the additional skillsets needed to become an independent investigator in clinical trials.

项目摘要 男子仍然得不到艾滋病毒检测和治疗服务。索引合作伙伴测试是 到达男人。索引艾滋病毒自我检测（HIVST），即抗逆转录病毒疗法的客户将HIVST试剂盒带回家给他们的性伴侣 是一项新的战略，它大大增加了男性的指数测试，并正在扩大规模。 穿越马拉维然而，只有25%的通过指数HIVST确定为艾滋病毒阳性的男性在6- 10岁后开始抗逆转录病毒治疗。 个月迫切需要采取创新战略，增加男性接受抗逆转录病毒疗法的人数和保留率。的 拟议的K 01的总体目标是开发和试验一种以家庭为基础的抗逆转录病毒疗法干预（抗逆转录病毒疗法启动+ 3-月ART护理），以增加ART启动（主要结局）和6个月病毒抑制（次要结局） 在马拉维，通过艾滋病毒/艾滋病监测指数，对艾滋病毒检测呈阳性的男性进行了监测。我是一名社会科学家 有撒哈拉以南非洲艾滋病研究的背景。我的长期目标是从观察型转变为 社会科学到临床试验研究在难以接触的人群中创新的艾滋病毒服务提供模式 人口，如男性。我正在申请一个为期五年的K 01奖，以获得培训，指导和研究 体验.指导：我有一个出色的多学科指导团队，在以下方面拥有丰富的经验： 本区域的艾滋病毒护理和管理以及临床试验。该团队在社会领域拥有互补的专业知识， 艾滋病毒服务提供模式的科学和临床试验（托马斯科茨博士-初级导师），最佳做法 在马拉维的艾滋病毒护理和管理以及不同的护理模式中（朱迪思·柯里尔博士和里萨·霍夫曼博士）， 干预措施的可扩展性和可持续性（Sundeep Gupta博士-马拉维），以及先进的生物统计学 (Dr.罗恩布鲁克迈尔）。职业发展：为了实现我的长期目标，我们制定了详细的计划 培养另外四个领域的技能：（1）ART护理和维持的最佳临床实践;（2）临床试验 艾滋病毒服务提供的新方法;（3）先进的统计方法;（4）临床试验中的伦理 低资源环境下的研究。研究活动：伴随职业生涯的具体目标 发展计划是：（1）为通过指数测试的男性伴侣制定以家庭为基础的抗逆转录病毒治疗干预措施 HIVST，使用对男性指数HIVST使用者（n=15-20）及其伴侣（n=15-20）的深入访谈， 与关键信息提供者进行小组讨论（n=18-30）。(2)确定家庭ART的潜在有效性 与基于标准设施的ART（开始ART（主要结局）和6个月病毒抑制）相比 （次要结果）在男性指数HIVST用户在一个试点试验与200艾滋病毒阳性男性。预计 结果：这项研究的结果将为确定的男性家庭ART服务的测试提供信息。 通过艾滋病毒感染者防治战略，该项目还将为我提供所需的额外技能， 成为临床试验的独立研究者。