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. 项目概要/摘要 意义：艾滋病毒治疗已成为全球研究重点，要求该领域超越试验 主要在美国招募白人男性进行。参与治疗研究，包括长期复杂的治疗研究 就诊要求和分析治疗中断 (ATI) 不仅会带来生物风险，还会带来社会风险、 情感和道德挑战。了解将重点人群纳入艾滋病毒高负担的障碍 低收入和中等收入国家（LMIC），特别是边缘化群体面临的挑战，对于 设计促进最需要艾滋病毒治疗创新的人群公平入学的方案 治疗。女性在全球治疗研究中的代表性仍然严重不足。尽管占53% 在全球艾滋病毒感染者中，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)，旨在评估参加非洲首个项目的年轻女性的经历 在南非夸祖鲁-纳塔尔省进行的全女性艾滋病毒治愈试验，其中包括 ATI。该试验将从 FRESH 招募， 2012 年成立的临床研究中心，旨在招募年轻女性参与艾滋病毒预防、早期治疗和艾滋病毒治疗 治疗相关（干预后控制）研究。亲密伴侣暴力（IPV）在该地区十分普遍， 强调创伤知情研究（TIR）和以康复为中心的设计（HCD）的必要性。建议：SBR 研究包括 TIR 框架和强大的社会心理支持，研究互动发生在 试验期间的关键点，包括入组时、第一剂研究产品之前、暂停 ART 之前 ATI 期间以及病毒反弹后。纵向评估将有助于深入了解与以下方面相关的决策： 试验参与，以及对病毒反弹、合作伙伴保护和披露的潜在担忧。包容性 开放式讨论将允许分享挑战并提供超越相关触发因素的社会背景 试用参与。该研究还将吸引非试验参与者和临床研究人员参与 对艾滋病毒治疗和试验实施挑战的看法。具体目标： 1) 制定战略以减少 通过描述 25 名试验参与者的经历，重点关注与参加 HIV 治疗试验相关的风险 关于他们的决策过程、与试验相关的问题（例如披露、合作伙伴保护）和生活 试用期间的关键点经验。 2) 了解女性的社会背景和挑战 通过量化创伤和 IPV 暴露、自尊、复原力和心理健康，参加了 HIV 治愈试验 25 名试验参与者和 25 名感染艾滋病毒的非试验参与者以及 50 名女性的（焦虑、抑郁）结果 没有艾滋病毒。 3) 制定关于妇女安全和合乎道德地参与未来艾滋病毒治疗试验的建议 非洲，基于 20 名临床研究人员关于试验实施、创伤知情和治疗的意见—— 以中心为中心的策略。预期成果：为了在全球范围内实现艾滋病毒治愈，研究必须包括关键的风险 来自艾滋病毒高负担低收入国家的群体（例如撒哈拉以南非洲的年轻妇女），强调了这一点的重要性 制定有关试验设计、招募、知情同意和保留的具体建议。