Development and Pilot RCT of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Uptake and Adherence in Young Black Men who Have Sex with Men

远程医疗提供的同伴导航和应对技能干预的开发和试点随机对照试验，以提高男男性行为的年轻黑人男性对 PrEP 的采用和依从性

• 批准号: 10403173
• 负责人: Calvin John Fitch
• 金额: $ 19.63万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10403173
• 关键词: AIDS prevention; Address; Adherence; Affect; Age; Arousal; Award; Behavioral; Black race; Boston; Caring; Case Management; Cellular Phone; Color; Communities; Community Health; Consultations; Coping Skills; Development; Disclosure; Dose; Economics; Emotions; Enrollment; Event; Face; Feedback; Frequencies; Funding; Future; General Hospitals; Goals; Grant; HIV; HIV diagnosis; HIV risk; Health; Homelessness; Incidence; Intervention; Interview; Knowledge; Latino; Manuals; Massachusetts; Medical; Mental Health; Mentorship; Moods; Motivation; NIH Office of AIDS Research; National Institute of Child Health and Human Development; Newly Diagnosed; Office Visits; Outcome; Persons; Prevention; Problem Solving; Procedures; Process; Protocols documentation; Public Health; Qualitative Methods; Questionnaires; Race; Randomized Controlled Trials; Research; Research Personnel; Risk; Role; Running; Science; Site; Social Interaction; Specific qualifier value; Structure; Technology; Testing; Time; Training; Training Support; Underrepresented Minority; United States National Institutes of Health; Youth; acceptability and feasibility; adolescent health; age group; aged; base; behavior measurement; biobehavior; black men who have sex with men; career development; comorbidity; contextual factors; demographics; effective intervention; efficacy trial; experience; interest; meetings; men who have sex with men; peer; pre-exposure prophylaxis; prevent; preventive intervention; primary outcome; recruit; sexually active; skills; social; stressor; success; telehealth; theories; therapy development; tool; transmission process; treatment as usual; uptake; virtual; young men who have sex with men

ABSTRACT Young Black men who have sex with men (YBMSM) ages 15-24 are heavily affected by HIV transmission such that, at current rates, it is estimated that about half of Black MSM in the US will be infected with HIV in their lifetime. Pre-exposure prophylaxis (PrEP) for HIV is a highly effective biomedical treatment which is up to 99% effective at preventing HIV when adhered to in a prevention-effective manner. This involves daily or event-based dosing of PrEP specifically during periods of risk of HIV exposure (i.e., prevention-effective (P-E) adherence). Despite interest, both uptake and adherence have been low among Young Black men who have sex with men (YBMSM) compared to other age and racial groups. The barriers to PrEP uptake and adherence among YBMSM are multifactorial and an effective intervention must be multilevel addressing both contextual and self-change processes to promote PrEP uptake and P-E adherence. An NICHD-funded study conducted in Boston found that peer navigation was highly acceptable for newly diagnosed HIV-infected youth; however, this study excluded youth without HIV and only focused on contextual structural barriers and did not address self-change processes. Notably, factors like medical mistrust and disclosure concerns among YBSM may affect self-change processes and impede PrEP use. Limited knowledge exists on how these factors may impede PrEP use; however, it is clear these barriers may be amenable to intervention using problem/emotion-focused coping strategies to facilitate PrEP uptake and P-E adherence for YBMSM. Unfortunately, interventions often limit participation to those willing and able to present to a research office. Despite prevalent economic stressors, more than 90% of YMSM of color in various studies have smartphones, thus telehealth and remote study procedures may facilitate participation by YBMSM at highest HIV risk. This proposal will adapt the NICHD peer navigation (adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting PrEP uptake and P-E adherence for YBMSM ages 15-24. YBMSM will be recruited online and from the Sydney Borum Jr. Health Center in Boston, which provides care to 1200 YMSM aged 12-29 annually, half of whom are Black or Latino. Over a proposed 5-year award period, in partnership with Massachusetts General Hospital and Fenway Community Health this project will: (1) Obtain qualitative knowledge on experiences of YBMSM and specify role of peer navigator in promoting PrEP uptake and P-E adherence, (2) Develop and iteratively refine the intervention, in consultation with a Community Advisory Board (CAB), and (3) Evaluate the technology-based peer navigation/coping skills intervention for feasibility and acceptability. This will be supported by training in adolescent health, qualitative methods, behavior measurement, and intervention science as well as general and underrepresented minority-focused career development. This approach is consistent with the NIH Office of AIDS Research goal of addressing mental health and structural comorbidities to facilitate biomedical prevention.

摘要 15-24岁的男男性行为者（YBMSM）受到艾滋病毒传播的严重影响， 以目前的速度，据估计，美国大约一半的黑人男男性行为者将在他们的 辈子暴露前预防（PrEP）是一种非常有效的生物医学治疗方法， 如果以有效预防的方式坚持，就能有效预防艾滋病毒。这涉及日常或基于事件的 特别是在HIV暴露风险期间给予PrEP（即，预防有效（P-E）坚持）。 尽管有兴趣，但在与男性发生性关系的年轻黑人男性中， （YBMSM）与其他年龄和种族群体相比。YBMSM中PrEP吸收和坚持的障碍 是多因素的，有效的干预措施必须是多层次的，同时解决背景变化和自我变化 促进PrEP吸收和P-E依从性的过程。NICHD资助的一项在波士顿进行的研究发现， 同伴导航对于新诊断的HIV感染青年是高度可接受的;然而，这项研究排除了 该报告指出，艾滋病毒/艾滋病问题是一个关于未感染艾滋病毒的青年的问题，只侧重于背景结构性障碍，而不涉及自我改变进程。 值得注意的是，YBSM中的医疗不信任和披露担忧等因素可能会影响自我改变过程 并阻碍PrEP的使用。关于这些因素如何阻碍PrEP使用的知识有限;然而， 清除这些障碍可能适合使用问题/情绪为重点的应对策略进行干预， 促进YBMSM的PrEP摄取和P-E依从性。不幸的是，干预措施往往将参与限制在 那些愿意并能够向研究办公室提交报告的人。尽管存在普遍的经济压力，但超过90%的 YMSM的颜色在各种研究中有智能手机，因此远程医疗和远程研究程序可能有助于 YBMSM在最高艾滋病毒风险中的参与。该提案将调整NICHD同行导航（增加应对 技能和使用远程医疗）是可行的，可接受的，并能够支持PrEP吸收和P-E坚持 15-24岁的YBMSM。YBMSM将在网上招募，并从悉尼博勒姆小。波士顿的健康中心， 每年为1200名12-29岁的青年男同性恋者提供护理，其中一半是黑人或拉丁美洲人。 在拟议的5年奖励期内，与马萨诸塞州总医院和芬威合作 社区卫生本项目将：（1）获得YBMSM经验的定性知识，并明确角色 同伴导航器在促进PrEP吸收和P-E坚持，（2）开发和迭代完善 干预，与社区咨询委员会（CAB）协商，（3）评估基于技术的 同伴导航/应对技能干预的可行性和可接受性。这将得到以下培训的支持： 青少年健康，定性方法，行为测量和干预科学以及一般和 以少数群体为重点的职业发展。这种方法与美国国立卫生研究院艾滋病办公室一致 研究目标是解决心理健康和结构性共病，以促进生物医学预防。