A randomized clinical trial of client-centered care coordination to improve pre-exposure prophylaxis use for Black men who have sex with men

一项以客户为中心的护理协调的随机临床试验，以改善男男性行为黑人的暴露前预防使用

• 批准号: 10762186
• 负责人: Manya Magnus
• 金额: $ 82.94万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10762186
• 关键词: AIDS prevention; Address; Adherence; Area; Biological Assay; Black race; Case Management; Client; Clinic; Clinical; Collaborations; Communities; Data; Data Collection; District of Columbia; Dose; Elements; Enrollment; Epidemic; Evaluation; Exposure to; Frequencies; Funding; Gays; Goals; HIV; HIV Infections; HIV prevention trials network; Health Insurance; Health Personnel; Health care facility; Healthcare; Incidence; Individual; Inequity; Institutionalization; Intervention; Interview; Job loss; Laboratories; Learning; Length; Life; Methodology; Methods; Modeling; New York City; Participant; Pharmaceutical Preparations; Population; Provider; Psychosocial Factor; Public Health; Racial Equity; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Reporting; Research; Risk; Risk Reduction; Sampling; Science; Secure; Self Determination; Serum; Service delivery model; Services; Specific qualifier value; Statistical Methods; Supportive care; Surveys; Testing; Time; Transportation; United States; United States National Institutes of Health; Visit; Waiting Lists; Washington; Work; acceptability and feasibility; arm; barrier to care; black men who have sex with men; care coordination; care systems; clinical research site; community setting; cost; dosage; efficacy evaluation; efficacy trial; experience; follow-up; health care disparity; health training; implementation science; improved; innovation; men who have sex with men; multi-component intervention; novel; pre-exposure prophylaxis; prevention service; psychosocial; racial disparity; racism; randomized, clinical trials; recruit; scale up; service providers; social stigma; staff intervention; standard of care; theories; trial design

Project Abstract In view of the continued disproportionate rates of HIV infection among Black men who have sex with men (MSM), there is an urgent public health need to identify scalable interventions to support Black MSM at risk of HIV to decide to take pre-exposure prophylaxis (PrEP), help access PrEP, and adhere to PrEP. Currently, Black MSM have the highest rates of HIV acquisition in the United States yet have the lowest rates of PrEP utilization. Innovative methods to support use of this lifesaving medication are few and those that are available are seldom rigorously tested. One intervention demonstrated in early studies to have potential for positive impact a client-centered care coordination (C4) intervention model. C4 was piloted in the NIH-funded HIV Prevention Trials Network (HPTN) 073 study and showed promise, yet more evaluation is required to assess and leverage this intervention. The aims of this study are to further the work done in HPTN 073 with regard to C4 in real-world clinical settings in Washington, DC and in New York City. Aim 1 will determine the efficacy of C4 for increasing PrEP adherence among Black MSM, Aim 2 will identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence, and Aim 3 will d Describe the acceptability and feasibility of C4 implementation in community settings. Findings from this study will contribute to the NIH priorities to reduce HIV incidence as well as cross-cutting areas of using implementation science to contribute to our understanding of structural and psychosocial barriers to care and reduction of healthcare disparities.

项目摘要 鉴于与男性发生性关系的黑人艾滋病毒感染率持续不成比例 （MSM），紧急公共卫生需要确定可扩展的干预措施，以支持黑人MSM的风险 艾滋病毒决定采取暴露前预防（PREP），帮助访问准备并遵守准备。现在， 黑色MSM在美国的艾滋病毒收购率最高，但预备率最低 利用率。支持使用这种救生药物的创新方法很少，而且可用的方法很少 很少经过严格测试。早期研究表明的一项干预措施具有阳性的潜力 影响以客户为中心的护理协调（C4）干预模型。 C4在NIH资助的艾滋病毒中被驾驶 预防试验网络（HPTN）073研究并表现出希望，需要进行更多评估以评估 并利用这种干预措施。这项研究的目的是进一步在HPTN 073中完成的工作 C4在华盛顿特区和纽约市的现实世界临床环境中。 AIM 1将决定 C4以提高黑色MSM的准备依从性，AIM 2将确定C4的最佳剂量 实施以最大化其对准备依从性的影响，而目标3将描述可接受性和 C4实施在社区环境中的可行性。这项研究的发现将有助于NIH 减少艾滋病毒发病率以及使用实施科学贡献的跨切割领域的优先事项 我们了解护理和减少医疗保健差异的结构和社会心理障碍。