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.项目摘要/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) 黑人男男性行为者(BMSM)和艾滋病毒携带者(LWH)的依从性，这是一个受严重影响的群体 受美国艾滋病毒流行的影响。抗逆转录病毒治疗依从性低也与病毒学失败的风险较高有关。 作为发病率、死亡率和艾滋病毒传播给艾滋病毒阴性的伴侣。循证干预(EBI) BMSM/LWH仍然缺乏解决由于横截面柱头造成的ART附着障碍的问题。基于电话的 像Aremind这样的提醒系统可以增加中/高效果大小的艺术附着力，但它们对 病毒抑制仍然知之甚少。基于提醒的干预措施解决零星不遵守问题 或者由于健忘而错过了单一的ART剂量，对病毒抑制的影响最小。他们不会 解决由社会和结构性因素造成的持续不遵守问题，包括跨部门的耻辱。 持续的不遵守是病毒学失败的风险因素。零星和持续的不遵守恶化 艾滋病毒引起的慢性炎症(如高IL-6水平)，从而增加发病率和死亡率 风险。应聘者寻求培训和研究经验来设计 GN和Pilot测试了一项增强的技术， 针对BMSM/LWH的对文化敏感的EBI，以解决零星和持续的不遵守问题。 通过这个K01 获奖后，他将完成以下培训目标(TGS)：TG1。培养行为干预技能 研究；TG2。获得定性研究方法的技能；TG3。在评估中获得熟练程度 以及ART粘连和慢性炎症的生物标志物的解释。这些TG与 应聘者在量化方法、生物心理社会污名模型和临床心理学方面的专业知识将 艺术坚守面临的障碍 由于跨部门的耻辱和通过以下方式对抗这些障碍的战略 Ra2.设计技术增强的、对文化敏感的EBI，以解决跨部门 BMSM/LWH患者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(RAS)：RA1。识别 BMSM/LWH深入访谈 ~30 BMSM/LWH； Ra3.评估可行性、可接受性和效果 通过60个BMSM/LWH的试点RCT估计EBI(RA2)的规模。 EBI (RA2) 将结合阿莱明德 与 有效技能使有效男性(自尊)干预的策略。因为这些策略 专注于性取向污名，候选人将把它们改编成BMSM/LWH，以解决交叉问题 与污名有关的坚持艺术的障碍。被随机分配到试验组的参与者将收到 EBI (RA2)。控制臂的参与者将只获得AREMIND。主要结果是基于ART的坚持 关于自我报告、用药事件监测系统设备和头发艺术水平。次要结果是 病毒抑制和慢性炎症。试验性随机对照试验结果将通知R01提案，候选人 将在该奖项的第四年提交。这一K01将使候选人走上一条明确的研究独立之路。