An intervention to improve HIV pre-exposure prophylaxis initiation, adherence and linkage to care for recently incarcerated men who inject drugs.

旨在改善艾滋病毒暴露前预防的启动、坚持以及与最近被监禁的注射吸毒男性护理的联系的干预措施。

• 批准号: 10614643
• 负责人: Matthew Murphy
• 金额: $ 19.54万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10614643
• 关键词: AIDS prevention; Address; Adherence; Adult; Area; Attitude; Awareness; Behavior Therapy; Behavioral; Biometry; Caring; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Research; Clinical Trials Design; Cognitive Therapy; Communities; Continuity of Patient Care; Criminal Justice; Data; Disease Management; Disease Outbreaks; Enrollment; Ensure; Environment; Evaluation; Future; Goals; HIV; HIV Infections; Health Personnel; Health Priorities; Health behavior; Imprisonment; Individual; Injecting drug user; Intervention; Interview; Knowledge; Life; Link; Measures; Medicine; Mentors; Mentorship; Methodology; Modeling; Morbidity - disease rate; Outcome; Participant; Pharmaceutical Preparations; Physicians; Play; Population; Population Intervention; Prevention approach; Problem Solving; Public Health; Public Health Schools; Qualitative Research; Randomized; Recommendation; Recording of previous events; Reporting; Research; Research Methodology; Research Personnel; Rhode Island; Risk; Role; Scientist; Self Efficacy; Services; Structure; Substance Use Disorder; System; Time; Training; Training Activity; United States; Universities; Vulnerable Populations; Work; acceptability and feasibility; community reentry; correctional system; design; expectation; experience; health determinants; health inequalities; high risk; improved; infection risk; injection drug use; interest; male; men; men who have sex with men; mortality; motivational enhancement therapy; novel; open label; opioid use disorder; patient oriented; pre-exposure prophylaxis; prevent; prevention service; preventive intervention; primary outcome; public health research; responsible research conduct; skill acquisition; skills; social cognitive theory; social stigma; standard of care; substance use; therapy development; transmission process

PROJECT SUMMARY This K23 application outlines a novel area of clinical research that meets a growing public health need as people who inject drugs (PWID) represent a disproportionate number of new HIV cases with limited knowledge about the programming and linkage to care needed to support pre-exposure prophylaxis (PrEP) usage among this population. The research aims are designed to ensure Dr. Matthew Murphy's (PI) future research independence in HIV prevention and PrEP use for those with substance use disorders (SUD) at the greatest risk of HIV infection by providing preliminary data for a future R01 application. The specific aims of the K23 proposal are to 1) conduct qualitative interviews with 20 CJ-involved male PWID to evaluate barriers and facilitators to PrEP initiation, adherence, and linkage to care after release from incarceration; 2) develop a “PrEPare-for-Release” intervention and conduct an open label pilot intervention with 15 male PWID who are being released from incarceration and 3) conduct an RCT of the “PrEPare-for-Release” intervention among 100 male PWID who are being released from incarceration. In order to both achieve those aims and attain research independence, Dr. Murphy will receive training in HIV prevention approaches for those with SUD within the criminal justice (CJ) system, qualitative research methodology used to identify barriers and facilitators to HIV prevention care, approaches to behavioral intervention development and evaluation as well as training in the responsible conduct of research. The mentorship team, made up of leading experts in related fields of clinical and public health research from both Brown University and nearby Yale University, are incredibly well suited to ensure both successful attainment of the research aims as well as future research independence for the PI. Dr. Philip A Chan (primary mentor), as a leader in the field of PrEP clinical research, will be a key expert on the successful implementation of the PrEP care continuum for this population and conducting trials evaluating interventions to improve its use. Additional mentorship for this proposal includes Dr. Josiah Rich (co-mentor), a global leader on intervention development to improve SUD management and HIV infection risk during the period of transition from incarceration to the community, Dr. Amy Nunn (co- mentor), a leading expert on qualitative methodology related to PrEP care and health inequalities with significant prior experience working with CJ-involved populations, Dr. Trace Kershaw (co-mentor), a global leader on behavioral intervention development to reduce HIV infection risk in populations with SUDs, and Dr. Christopher Schmid (co-mentor), former chair of biostatistics at Brown's School of Public Health with significant experience in clinical trial design and an expert in quantitative methodology.

项目概要 该 K23 申请概述了一个新的临床研究领域，可以满足日益增长的公共卫生需求 因为注射吸毒者 (PWID) 在新发艾滋病毒病例中所占比例不成比例，但其感染率有限 有关支持暴露前预防 (PrEP) 所需护理的规划和联系的知识 该研究的目的是为了确保 Matthew Murphy 博士 (PI) 的未来。 艾滋病毒预防和药物滥用障碍 (SUD) 患者使用 PrEP 方面的研究独立性 通过为未来 R01 应用提供初步数据来确定 HIV 感染的最大风险。 K23 提案是 1) 对 20 名涉及 CJ 的男性注射吸毒者进行定性访谈，以评估障碍和 PrEP 启动、坚持以及出狱后与护理的联系的促进者 2) 制定 “PrEPare-for-Release”干预并对 15 名男性注射吸毒者进行开放标签试点干预 从监禁中释放，以及 3) 在其中进行“PrEPare-for-Release”干预的随机对照试验 100 名男性注射吸毒者正在刑满释放，以实现这些目标。 研究，独立的墨菲博士将接受针对 SUD 患者的艾滋病毒预防方法培训 在刑事司法（CJ）系统中，用于识别障碍和障碍的定性研究方法 艾滋病毒预防护理的促进者、行为干预开发和评估的方法 作为负责任的研究行为的培训 导师团队由相关领域的领先专家组成。 布朗大学和附近的耶鲁大学的临床和公共卫生研究领域是 非常适合确保成功实现研究目标以及未来的研究 PI 的独立性。 Philip A Chan 博士（主要导师），作为 PrEP 临床研究领域的领导者， 将成为针对该人群成功实施 PrEP 连续护理的关键专家，并且 进行试验评估干预措施以改进其使用。对此提案的额外指导包括。 Josiah Rich 博士（联合导师）是改善 SUD 管理和干预开发的全球领导者 从监禁到社区过渡期间的艾滋病毒感染风险，Amy Nunn 博士（共同 导师），PrEP 护理和健康不平等相关定性方法的领先专家 Trace Kershaw 博士（共同导师）是一位全球性的专家，拥有与 CJ 相关人群合作的丰富经验。 行为干预开发的领导者，以降低 SUD 人群的艾滋病毒感染风险，博士。 克里斯托弗·施密德（Christopher Schmid）（联合导师），布朗大学公共卫生学院生物统计学前系主任，在 临床试验设计经验和定量方法学专家。