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: 10327065
• 负责人: Andrea Norcini Pala
• 金额: $ 17.75万
• 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/10327065
• 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; Testing; 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; men; men who have sex with men; mortality; mortality risk; news; primary outcome; remote delivery; secondary outcome; skills; social; social stigma; social structure; substance use; therapy adherence; transmission process; virology

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、性取向和艾滋病毒状况的交叉污名减少了抗逆转录病毒治疗（ART） 与男性发生性关系的黑人男性（BMSM）和艾滋病毒感染者（LWH）之间的依从性， 艾滋病在美国的流行。抗逆转录病毒治疗依从性低也与病毒学失败的风险较高相关 发病率、死亡率和艾滋病毒向艾滋病毒阴性伴侣的传播。循证干预（EBI） BMSM/LWH仍然缺乏解决由于交叉污名而导致的抗逆转录病毒治疗依从性障碍的能力。基于手机 像ARemind这样的提醒系统可以以中等/高的效应量增加ART依从性，但是它们对 病毒抑制仍然知之甚少。基于提醒的干预措施解决了偶发的不依从问题 或由于健忘而错过的单次ART剂量，对病毒抑制的影响最小。他们不 解决由于社会和结构性因素，包括跨部门的污名化，造成的持续不遵守。 持续不依从是病毒学失败的风险因素。零星和持续的不依从性 HIV诱导的慢性炎症（例如，高白细胞介素[IL]-6水平），从而增加发病率和死亡率 风险候选人寻求培训和研究经验， GN和试点测试技术增强， BMSM/LWH的文化敏感性EBI，以解决零星和持续的不遵守。 通过这个K 01 奖励，他将完成以下培训目标（TGs）：TG 1。发展行为干预的技能 研究; TG 2.获得定性研究方法的技能; TG 3。要熟练掌握评估， 以及ART依从性和慢性炎症的生物标志物的解释。这些TG与 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 接受抗逆转录病毒治疗面临的障碍 由于交叉的耻辱和战略，以消除这些障碍， RA2。设计一个技术增强的、文化敏感的EBI， BMSM/LWH坚持抗逆转录病毒治疗的耻辱相关障碍; 使他能够实现以下研究目标（RA）：RA 1。识别 BMSM/LWH深度访谈 BMSM/LWH约30例; RA3。评估可行性、可接受性和效果 通过60例BMSM/LWH的试点RCT对EBI（RA 2）的大小估计。 EBI （RA2） 将联合收割机 与 有效的技能赋予有效的男人（ESTEEM）干预战略。因为这些策略 关注性取向的耻辱，候选人将适应他们的BMSM/LWH，以解决交叉 坚持抗逆转录病毒治疗的耻辱相关障碍。随机分配至实验组的受试者将接受 EBI （RA2）。对照组的参与者将仅接受ARemind。主要结局是基于ART依从性 自我报告、药物事件监测系统设备和头发ART水平。次要结局为 病毒抑制和慢性炎症。试点RCT结果将告知R 01提案，候选人 将在本奖项的第四年提交。K 01将为候选人提供一条明确的独立研究道路。