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.项目总结/摘要 意义：艾滋病毒治愈已成为全球研究的重点，要求该领域超越试验 主要在美国招募白色男性。参与治疗研究，包括长期复杂的 访视要求和分析治疗中断（ATI）不仅会造成生物风险，还会造成社会风险， 情感和道德上的挑战了解将艾滋病毒高负担的重点人群纳入的障碍 低收入和中等收入国家，特别是边缘化群体面临的挑战， 制定协议，促进最需要艾滋病毒治疗创新的人的公平入学， 治疗在全球范围内，妇女在治疗研究中的代表性仍然严重不足。尽管代表了53%的 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，评估参加非洲第一个 在南非的夸祖鲁-纳塔尔进行的一项包括ATI在内的全女性艾滋病毒治愈试验。试验将从FRESH招募人员， 2012年成立的一个临床研究中心，招收年轻女性参加艾滋病毒预防，早期治疗和艾滋病毒 治疗相关（干预后控制）研究。亲密伴侣暴力行为在该区域很普遍， 强调需要创伤知情研究（TIR）和以愈合为中心的设计（HCD）。建议：SBR 一项研究，包括TIR框架和强大的心理社会支持，研究互动发生在 试验期间的关键点，包括入组时、研究药物首次给药前、暂停ART前 在ATI期间和病毒反弹后。纵向评估将有助于深入了解与以下方面有关的决策 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 不限成员名额的讨论将允许分享挑战，并提供社会背景，而不仅仅是与 试验参与。本研究还将邀请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，减少 与HIV治愈试验入组相关的风险，通过描述25名试验参与者的经历， 关于他们的决策过程，与审判有关的问题（例如，披露，合作伙伴保护）和生活 在审判过程中的关键点上的经验。2)了解社会背景和妇女面临的挑战 通过量化创伤和IPV暴露、自尊、复原力和心理健康， 25名试验参与者、25名非试验参与者和50名女性艾滋病毒感染者的（焦虑、抑郁）结局 没有艾滋病毒。3)为妇女在未来的艾滋病毒治疗试验中的安全和道德招募提出建议， 非洲，基于20名临床研究人员关于试验实施、创伤知情和愈合的投入， 中心战略。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高危人群， 来自高艾滋病毒负担的limc的群体（例如，撒哈拉以南非洲的青年妇女），强调 制定关于试验设计、招募、知情同意和保留的具体建议。