A behavioral intervention for Black men who have sex with men and live with HIV to address intersectional stigma and improve antiretroviral therapy adherence

针对男男性行为且感染艾滋病毒的黑人男性进行行为干预，以解决交叉耻辱并提高抗逆转录病毒治疗的依从性

• 批准号: 10432133
• 负责人: Andrea Norcini Pala
• 金额: $ 17.52万
• 依托单位: COLUMBIA UNIV NEW YORK MORNINGSIDE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10432133
• 关键词: Address; Adherence; Affect; Affective; Award; Behavior Therapy; Belief; Biological Markers; COVID-19 pandemic; Chronic; Clinical Psychology; Cognitive; Cognitive Therapy; Computers; Coupled; Custom; Data; Devices; Dimensions; Disclosure; Discrimination; Dose; Enhancement Technology; Epidemic; Event; Evidence based intervention; Face; Failure; Goals; HIV; HIV Seronegativity; Hair; Humor; Immunocompromised Host; Individual; Inflammation; Interleukin-6; Intervention; Intervention Studies; Interview; Measures; Medical; Memory; Mental Health; Mentored Research Scientist Development Award; Mentorship; Methods; Modeling; Monitor; Morbidity - disease rate; Outcome; Participant; Pathway interactions; Patient Self-Report; Pharmaceutical Preparations; Qualitative Research; Race; Randomized; Randomized Controlled Trials; Reminder Systems; Research; Research Methodology; Risk; Risk Factors; Sex Orientation; Sexual Partners; Social Environment; Social Processes; Social isolation; Stigmatization; System; Techniques; Telephone; Text Messaging; Training; Transportation; United States National Institutes of Health; Viral; Viral Load result; antiretroviral therapy; arm; base; behavioral adherence; biopsychosocial; black men who have sex with men; design; distrust; expectation; experience; experimental arm; handheld mobile device; high risk; improved; innovation; internalized stigma; men; men who have sex with men; mortality; mortality risk; news; perceived discrimination; pilot test; primary outcome; remote delivery; secondary outcome; skills; social; social stigma; social structure; substance use; therapy adherence; transmission process

7. Project Summary/Abstract Intersectional stigma based on race, sexual orientation, and HIV-status reduces antiretroviral therapy (ART) adherence among Black men who have sex with men (BMSM) and live with HIV (LWH), a group heavily affected by the HIV epidemic in the US. Low ART adherence is associated with a higher risk of virological failure as well as morbidity, mortality, and HIV transmission to HIV-negative partners. Evidence-based interventions (EBIs) for BMSM/LWH to address the ART adherence barriers due to intersectional stigma are still lacking. Phone-based reminder systems like ARemind can increase ART adherence with a medium/high effect size, but their effect on viral suppression remains poorly understood. Reminder-based interventions address sporadic non-adherence or single missed ART doses due to forgetfulness that has minimal impact on viral suppression. They do not address sustained non-adherence resulting from social and structural factors including intersectional stigma. Sustained non-adherence is a risk factor for virological failure. Sporadic and sustained non-adherence worsens HIV-induced chronic inflammation (e.g., high interleukin[IL]-6 levels), thereby increasing morbidity and mortality risk. The candidate seeks training and research experience to desi gn and pilot test a technology-enhanced, culturally-sensitive EBI for BMSM/LWH to address sporadic and sustained non-adherence. Through this K01 Award, he will accomplish the following Training Goals (TGs): TG1. To develop skills in behavioral intervention research; TG2. To gain skills in qualitative research methods; TG3. To acquire proficiency in the assessment and interpretation of biomarkers of ART adherence and chronic inflammation. These TGs coupled with the candidate’s expertise in quantitative methods, biopsychosocial stigma models, and clinical psychology will barriers to ART adherence faced by due to intersectional stigma and strategies to counter these barriers through RA2. Design a technology-enhanced, culturally-sensitive EBI addressing intersectional stigma-related barriers to ART adherence for BMSM/LWH; enable him to achieve the following Research Aims (RAs): RA1. Identify BMSM/LWH in-depth interviews with ~30 BMSM/LWH; RA3. Evaluate the feasibility, acceptability, and effect size estimates of the EBI (RA2) through a pilot RCT with 60 BMSM/LWH. The EBI (RA2) will combine ARemind with the Effective Skills to Empower Effective Men (ESTEEM) intervention’s strategies. Because these strategies focus on sexual orientation stigma, the candidate will adapt them for BMSM/LWH to address intersectional stigma-related barriers to ART adherence. Participants randomized to the experimental arm will receive the EBI (RA2). Participants in the control arm will receive ARemind only. The primary outcome is ART adherence based on self-report, Medication Event Monitoring System devices, and hair ART levels. The secondary outcomes are viral suppression and chronic inflammation. The pilot RCT findings will inform an R01 proposal that the candidate will submit in Year 4 of this Award. This K01 will set the candidate on a clear path to research independence.

7. 项目总结/摘要 基于种族、性取向和艾滋病毒感染状况的交叉耻辱会减少抗逆转录病毒治疗 (ART) 男男性行为者 (BMSM) 和艾滋病病毒感染者 (LWH) 的黑人男性的依从性，这是一个受到严重影响的群体 美国艾滋病毒流行导致 ART 依从性低也与病毒学失败的风险较高有关。 艾滋病毒阴性伴侣的发病率、死亡率和艾滋病毒传播情况。 仍然缺乏 BMSM/LWH 来解决由于交叉耻辱而导致的 ART 依从障碍。 像 ARemind 这样的提醒系统可以以中/高效果大小提高 ART 依从性，但它们的影响 病毒抑制仍然知之甚少，基于提醒的干预措施可解决零星的不依从问题。 或由于健忘而错过一次 ART 剂量，对病毒抑制的影响微乎其微。 解决由于社会和结构因素（包括交叉耻辱）导致的持续不遵守的问题。 持续不依从是病毒学失败的危险因素，零星和持续不依从会恶化。 HIV 引起的慢性炎症（例如，高白细胞介素 [IL]-6 水平），从而增加发病率和死亡率 候选人寻求培训和研究经验来设计。 gn 并进行了一项技术增强型试点测试， BMSM/LWH 具有文化敏感性的 EBI，以解决偶发和持续的不依从问题。 通过这个K01 获奖后，他将完成以下培训目标 (TG)： TG1。 研究；TG2. 获得定性研究方法的技能；TG3。 以及对 ART 依从性和慢性炎症的生物标志物的解释。 候选人在定量方法、生物心理社会耻辱模型和临床心理学方面的专业知识将 坚持 ART 面临的障碍 由于交叉污名和应对这些障碍的战略 RA2. 设计一个技术增强、文化敏感的 EBI，解决跨部门问题 BMSM/LWH 的 ART 依从性耻辱相关障碍； 使他能够实现以下研究目标 (RA)： RA1。 BMSM/LWH 深度访谈 BMSM/LWH 约为 30； RA3. 评估可行性、可接受性和效果 通过 60 BMSM/LWH 的试点 RCT 估算 EBI (RA2) 的大小。 息税前利润 (RA2) 将结合ARemind 与 赋予高效男性的有效技能（ESTEEM）干预策略 因为这些策略。 关注性取向耻辱，候选人将针对 BMSM/LWH 进行调整，以解决交叉问题 接受 ART 治疗的耻辱相关障碍将被随机分配到实验组。 息税前利润 (RA2) 对照组的参与者将仅收到 ARemind，主要结果是基于 ART 依从性。 次要结果是自我报告、药物事件监测系统设备和头发 ART 水平。 试验性随机对照试验结果将为 R01 提案提供信息，即候选者。 该 K01 将在该奖项的第 4 年提交，将为候选人指明一条通往独立研究的道路。