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 鉴于男男性行为黑人中艾滋病毒感染率持续不成比例 （MSM），迫切需要确定可扩展的干预措施来支持面临风险的黑人 MSM HIV 决定采取暴露前预防 (PrEP)、帮助获得 PrEP 并坚持 PrEP。现在， 美国黑人 MSM 的 HIV 感染率最高，但 PrEP 率最低 利用率。支持使用这种救命药物的创新方法很少，而且可用的方法也很少 很少经过严格的测试。早期研究表明，一项干预措施具有积极的潜力 影响以客户为中心的护理协调（C4）干预模式。 C4 在 NIH 资助的艾滋病毒研究中心进行了试点 预防试验网络 (HPTN) 073 研究并显示出希望，但需要更多评估来评估 并利用这种干预措施。本研究的目的是进一步推进 HPTN 073 在以下方面所做的工作： 华盛顿特区和纽约市的真实临床环境中的 C4。目标 1 将决定效果 C4 用于提高黑人 MSM 中的 PrEP 依从性，目标 2 将确定 C4 的最佳剂量 实施以最大限度地提高其对 PrEP 依从性的影响，目标 3 将描述可接受性和 C4 在社区环境中实施的可行性。这项研究的结果将有助于 NIH 减少艾滋病毒发病率的优先事项以及利用实施科学做出贡献的交叉领域 我们对护理和减少医疗保健差异的结构性和社会心理障碍的理解。