Integrating Trauma-Informed Research in Assessment of Young Women Engaged in HIV Cure Research (Post-Intervention Control) Trial with Analytical Treatment Interruption in Durban, South Africa

将创伤知情研究纳入南非德班参与艾滋病毒治疗研究（干预后控制）试验的年轻女性与分析治疗中断的评估中

• 批准号: 10761531
• 负责人: Karine Dube
• 金额: $ 42.18万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10761531
• 关键词: AIDS prevention; Acute; Address; Affect; Africa; Africa South of the Sahara; Anxiety; Area; Basic Science; Behavioral Research; Biological; CD4 Lymphocyte Count; Caring; Clinical Research; Communities; Complex; Data; Decision Making; Development; Diagnosis; Disclosure; Dose; Early treatment; Economics; Education; Emotional; Enrollment; Ensure; Equity; Ethics; Female; Fright; Future; Gender; Goals; HIV; HIV Infections; Health; Impact evaluation; Inequality; Inequity; Informed Consent; Interruption; Interview; Measures; Mediation; Mental Depression; Mental Health; Outcome; Participant; Perception; Population; Populations at Risk; Prevalence; Process; Protocols documentation; Psychosocial Assessment and Care; Psychosocial Influences; Recommendation; Research; Research Priority; Risk; Risk Reduction; Safe Sex; Safety; Sexual Partners; Social Behavior; Social Environment; South Africa; South African; Surveys; Therapeutic; Time; Trauma; Viral reservoir; Visit; Woman; Women' s Health; clinical research site; cohort; design; economic need; experience; follow-up; healing; high risk population; holistic approach; implementation barriers; innovation; insight; intimate partner violence; low and middle-income countries; marginalized population; men; multidisciplinary; novel; post intervention; psychologic; psychosocial; recruit; research study; resilience; risk mitigation; scale up; self esteem; seroconversion; social; social stigma; socioeconomics; standard of care; systemic barrier; trauma exposure; trial design; trial enrollment; violence exposure; viral rebound; young man; young woman

7. PROJECT SUMMARY/ABSTRACT Significance: HIV cure has emerged as a global research priority requiring the field to look beyond trials conducted primarily in the US enrolling white men. Participation in cure research that includes prolonged complex visit requirements and analytical treatment interruptions (ATIs) pose not only biological risk, but also social, emotional, and ethical challenges. Understanding barriers to inclusion of key populations in high-HIV burden low- and middle-income countries (LMICs), particularly challenges facing marginalized groups, is critical to designing protocols that promote equitable enrollment of those in greatest need of innovations in HIV cure and treatment. Women remain critically underrepresented in cure research globally. Despite representing 53% of HIV infections worldwide, women represent only 12% of HIV cure research participants. Opportunity: To conduct a socio-behavioral research (SBR) study to assess the experiences of young women enrolled in a first-in-Africa all-female HIV cure trial that includes an ATI, in KwaZulu-Natal, South Africa. The trial will recruit from FRESH, a clinical research site established in 2012 to enroll young women in HIV prevention, early treatment, and HIV cure-related (post-intervention control) research. High intimate partner violence (IPV) is endemic in the region, underscoring the need for trauma-informed research (TIR) and healing-centered design (HCD). Proposal: A SBR study that includes a TIR framework and robust psychosocial support, with study interactions that take place at key points during the trial, including at enrollment, prior to the first dose of study product, before pausing ART during ATI, and after viral rebound. Longitudinal assessments will allow insight into decision making related to trial participation, as well as potential worries around viral rebound, partner protections and disclosure. Inclusion of open-ended discussions will allow sharing of challenges and give social context beyond triggers related to trial participation. The study will also engage non-trial participants and clinical research staff contributing perceptions about HIV cure and trial implementation challenges. Specific Aims: 1) Develop strategies to reduce risks related to enrollment in an HIV cure trial, by characterizing the experiences of 25 trial participants, focusing on their decision-making processes, trial-related concerns (e.g., disclosure, partner protections) and lived experience at key points during the trial. 2) Gain an understanding of the social context and challenges of women enrolled in an HIV cure trial, by quantifying trauma and IPV exposure, self-esteem, resilience, and mental health (anxiety, depression) outcomes in 25 trial participants and 25 non-trial participants living with HIV, and 50 women without HIV. 3) Develop recommendations for safe and ethical enrollment of women in future HIV cure trials in Africa, based on input from 20 clinical research staff about trial implementation, trauma-informed and healing- centered strategies. Expected Outcomes: To achieve an HIV cure globally, research must include key at-risk groups from high-HIV burden LIMCs (e.g., young women in sub-Saharan Africa), underscoring the importance of developing concrete recommendations on trial design, recruitment, informed consent, and retention.

7。项目摘要/摘要 意义：HIV治疗已成为全球研究的优先级，需要该领域超越试验 主要在美国注册白人。参与包括长期复合物在内的治疗研究 访问需求和分析治疗中断（ATI）不仅构成生物学风险，而且会带来社会风险 情感和道德挑战。了解将关键人群纳入高HIV负担的障碍 低收入和中等收入国家（LMIC），特别是边缘化群体面临的挑战，对 设计协议，以促进对艾滋病毒治愈和最需要创新的人的公平入学 治疗。在全球治疗研究中，妇女的人数仍然不足。尽管代表了53％ 全世界的艾滋病毒感染，女性仅占艾滋病毒治愈研究参与者的12％。机会：进行 一项社会行为研究（SBR）研究，以评估年轻女性的经历 全女性艾滋病毒治疗试验，其中包括南非夸祖鲁 - 纳塔尔省的ATI。审判将从新鲜的 一个临床研究地点于2012年成立，旨在让年轻女性预防艾滋病毒，早期治疗和艾滋病毒 治疗相关（干预后控制）研究。高亲密的伴侣暴力（IPV）在该地区是地方性的， 强调了对创伤信息研究（TIR）和以治疗为中心的设计（HCD）的需求。提案：SBR 研究包括TIR框架和强大的社会心理支持，并进行了研究互动 试验期间的要点，包括入学率，在第一次剂量研究产品之前，在暂停艺术之前 在ATI期间和病毒反弹之后。纵向评估将使您深入了解与 试用参与以及对病毒反弹，合作伙伴保护和披露的潜在担忧。包容 开放式讨论将允许分享挑战，并为与触发器有关 审判参与。该研究还将吸引非试验参与者和临床研究人员贡献 对HIV治疗和试验实施挑战的看法。具体目的：1）制定策略来减少 通过表征25个试验参与者的经验，重点是与艾滋病毒治疗试验的入学风险 关于他们的决策过程，与试用有关的问题（例如，披露，合作伙伴保护）并生活 试用期间的要点经验。 2）了解妇女的社会背景和挑战 通过量化创伤和IPV暴露，自尊，韧性和心理健康，参加了HIV治疗试验 （焦虑，抑郁）25个试验参与者和25名非试验参与者的结果，50名女性 没有艾滋病毒。 3）为未来的艾滋病毒治疗试验制定了对妇女安全和道德入学的建议 非洲，基于20名临床研究人员的意见，有关试验实施，创伤和治愈 - 集中策略。预期的结果：为了在全球范围内实现艾滋病毒治疗，研究必须包括关键的高风险 来自高HIV负担LIMC的团体（例如，撒哈拉以南非洲的年轻妇女），强调了这一重要性 关于试验设计，招聘，知情同意和保留的具体建议。