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: 10600014
• 负责人: Calvin John Fitch
• 金额: $ 19.41万
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10600014
• 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; Exclusion; 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; Randomized, Controlled Trials; Research; Research Personnel; Risk; Role; Running; Science; Site; Social Interaction; Specific qualifier value; Structure; Technology; Testing; Training; Training Support; Underrepresented Minority; United States National Institutes of Health; Youth; acceptability and feasibility; adolescent health; age group; aged; behavior measurement; biobehavior; black men who have sex with men; career development; comorbidity; contextual factors; demographics; effective intervention; efficacy trial; experience; interest; intervention refinement; meetings; men who have sex with men; peer; pre-exposure prophylaxis; prevent; preventive intervention; primary outcome; racial population; recruit; sexually active; skills; social; stressor; structural determinants; 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.

抽象的 与男性发生性关系（YBMSM）15-24岁的年轻黑人受艾滋病毒传播的影响很大 据目前，据估计，美国约有一半的黑色MSM将在其中感染HIV 寿命。暴露前预防（PREP）HIV是一种高效的生物医学治疗，高达99％ 以预防有效的方式遵守时有效预防艾滋病毒。这涉及日常或基于事件的 在艾滋病毒暴露风险期间（即预防有效（P-e）依从性）的PREP剂量。 尽管有兴趣，但与男人发生性关系的年轻黑人的吸收和依从性均较低 （YBMSM）与其他年龄和种族群体相比。 YBMSM之间的准备吸收和遵守的障碍 是多因素和有效的干预措施，必须是多层次来解决上下文和自我改变 促进摄取和P-E依从性的过程。在波士顿进行的一项NICHD资助的研究发现 同伴导航对于新诊断的HIV感染的青年是高度可接受的；但是，这项研究排除了 没有艾滋病毒的年轻人，只专注于上下文结构障碍，没有解决自我改变过程。 值得注意的是，YBS中医学不信任和披露问题等因素可能会影响自我改变过程 并阻碍准备使用。关于这些因素如何阻碍预备使用的知识有限；但是，是 清除这些障碍可能可以使用问题/以情感为中心的应对策略进行干预 促进YBMSM的预备摄取和P-E依从性。不幸的是，干预措施通常将参与限制为 那些愿意并且能够介绍研究办公室的人。尽管经济压力很普遍，但超过90％ 各种研究中的YMMM具有智能手机，因此远程医疗和远程学习程序可能有助于 YBMSM以最高的艾滋病毒风险参与。该建议将调整NICHD同行导航（添加应对 技能和使用远程医疗）是可行的，可接受的，并且能够支持摄取和P-E遵守 对于15-24岁的YBMSM。 YBMSM将在线招募，并从波士顿的悉尼Borum Jr. Jr. Health Center招募 这为每年12-29岁的1200 YMSM提供护理，其中一半是黑人或拉丁裔。 在拟议的5年奖励期内，与马萨诸塞州综合医院和Fenway合作 社区健康该项目将：（1）获得有关YBMSM经验的定性知识并指定角色 同伴导航器在促进摄取和p-e依从性方面的发展，（2）迭代并改进 干预，与社区顾问委员会（CAB）协商，（3）评估基于技术的 同行导航/应对技能干预措施，以实现可行性和可接受性。这将通过培训来支持 青少年健康，定性方法，行为衡量和干预科学以及一般以及 代表性不足的少数族裔职业发展。这种方法与NIH艾滋病办公室一致 解决心理健康和结构合并症以促进生物医学预防的研究目标。