Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users

开发可摄入生物传感器以增强药物使用者的 PrEP 依从性

• 批准号: 9924467
• 负责人: Peter R Chai
• 金额: $ 19.56万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9924467
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Affect; Alcohol or Other Drugs use; Architecture; Behavior Therapy; Biosensor; Caring; Cellular Phone; Clinical Trials; Cocaine; Cognitive Therapy; Collaborations; Complement; Data; Development; Drug usage; Emergency Medicine; Enrollment; Epidemic; Evaluation; Feedback; Focus Groups; Funding; Future; Goals; Grant; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; Heterosexuals; Incidence; Individual; Ingestion; Intervention; Interview; Investigation; K-Series Research Career Programs; Learning; Measurement; Measures; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Oral; Participant; Patients; Pattern; Pharmaceutical Preparations; Physicians; Population; Preparation; Prevention strategy; Prophylactic treatment; Psychological reinforcement; Qualitative Research; Randomized; Randomized Controlled Trials; Research; Research Methodology; Research Personnel; Research Training; Risk; Risk Factors; Substance Use Disorder; Substance abuse problem; Support System; Techniques; Technology; Tenofovir; Testing; Therapeutic Intervention; Time; Training; Training Activity; United States National Institutes of Health; Unsafe Sex; Work; base; behavioral health; career development; design; digital; emtricitabine; evidence base; experience; high risk; high risk population; improved; innovation; mHealth; medication compliance; medication nonadherence; men who have sex with men; methamphetamine use; multidisciplinary; new technology; novel; patient oriented; pill; pre-exposure prophylaxis; prevent; response; screening, brief intervention, referral, and treatment; skills; stimulant use; success; therapy development; transmission process; treatment as usual; usability

PROJECT SUMMARY/ABSTRACT: This integrated research and training plan will prepare Dr. Chai, a practicing emergency medicine physician to become an independent, NIH funded physician-researcher with expertise in smartphone medication adherence intervention-based HIV prevention strategies directed toward individuals with substance use disorders. Despite advances in HIV prevention, testing and behavioral health, the epidemic of HIV continues to affect men who have sex with men (MSM) in greater proportion compared to heterosexual individuals. Among MSM, those with concomitant stimulant use (MSM+S) experience greater risk of condomless sex, disengagement with care, additional substance use and medication nonadherence. Interventions targeting these risk factors among MSM+S have modest effects that diminish over time. In 2010, the iPrEX study demonstrated a 40% reduction in HIV transmission in MSM individuals who adhered to pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC). Data from the iPrEX study demonstrates that with consistent adherence, MSM can achieve a greater than 90% protection from HIV. PrEP, therefore is an attractive option and accepted among MSM, but adherence remains difficult, especially among MSM with stimulant use. HIV prevention strategies integrating real-time PrEP adherence data and behavioral interventions to address stimulant use and medication adherence among MSM+S may improve adherence and prevent subsequent HIV infection. Under guidance of a strong team of NIH-funded researchers, Dr. Chai will achieve three training goals that integrate into the specific aims of his research plan. (1) Gain experience in crafting behavioral interventions with a particular focus on HIV and PrEP, (2) Gain experience designing, conducting and evaluating clinical trials in MSM on PrEP, and (3) Learn qualitative research methods and analysis techniques. Dr. Chai’s training activities will be complemented by an innovative research plan that will help him gain practical experience of his new skills. In a tiered approach, Dr. Chai will first inform the specification of a smartphone-based adherence intervention (PrEPsteps) with participant-generated content solicited through focus groups. Next, he will test the feasibility, acceptability and potential for an effect of PrEPsteps on PrEP adherence compared to treatment as usual in a pilot randomized controlled trial (N=60) of MSM+S on PrEP. Finally, Dr. Chai will assess the acceptability of the PrEPsteps intervention components (and the digital pill) through qualitative exit interviews with those randomized to the PrEPsteps condition. This innovative K23 Mentored Patient Oriented Career Development Award responds to NIH high priority topics in HIV/AIDS (NOT- OD-15-137) by developing a novel adherence intervention that innovatively responds to vivid, real-time feedback of PrEP adherence from a digital pill, thereby reducing the incidence of HIV/AIDS among MSM+S.

项目摘要/摘要： 该综合研究和培训计划将为Chai博士做好准备，这是一名实用急诊医生 成为一名具有NIH资助的独立物理研究者，具有智能手机药物专业知识 依从性干预的预防艾滋病毒预防策略针对具有物质使用的人 疾病。尽管艾滋病毒预防，测试和行为健康方面取得了进步，但艾滋病毒的流行仍在继续 与异性恋者相比，与男性发生性关系（MSM）的男性比例更大。之中 MSM，那些伴随兴奋剂使用（MSM+S）的人会经历更大的无避孕套性别风险， 谨慎的脱离接触，额外的药物使用和药物不遵守。干预措施针对性 MSM+S之间的这些危险因素随着时间的流逝而减少了适度的影响。 2010年，IPREX研究 在遵守前暴露的MSM个体中，艾滋病毒传播的艾滋病毒传播降低了40％ 用替诺福韦/Emtricerabine（TDF/FTC）进行预防（PREP）。 IPREX研究的数据表明， 一致的依从性，MSM可以获得超过90％的艾滋病毒保护。准备，因此是一个 有吸引力的选择并在MSM中接受，但依从性仍然很困难，尤其是在MSM中 兴奋剂的使用。艾滋病毒预防策略整合了实时准备依从性数据和行为 在MSM+S中解决兴奋剂使用和药物遵守的干预措施可能会提高依从性和 防止随后的HIV感染。 在由NIH资助的研究人员组成的强大团队的指导下，Chai博士将实现三个培训目标， 集成到他的研究计划的具体目标中。 （1）获得制定行为干预的经验 特别关注艾滋病毒和准备，（2）获得经验设计，进行和评估临床 在MSM中进行PREP的试验，（3）学习定性研究方法和分析技术。 Chai博士的培训活动将由创新的研究计划完成，这将帮助他获得 他的新技能的实践经验。在分层的方法中，Chai博士将首先告知 基于智能手机的依从性干预（PrepSteps），参与者生成的内容通过 焦点小组。接下来，他将测试预科对准备的可行性，可接受性和潜力 在PREP上的MSM+S的试验随机对照试验（n = 60）中，与往常一样的依从性。 最后，Chai博士将评估预科干预组件（和数字药）的可接受性 通过定性退出访谈，与随机的预科条件进行了访谈。这个创新的K23 指导了以患者为导向的职业发展奖对NIH高优先级主题的回应（不 - OD-15-137）通过开发一种新颖的依从性干预措施，该干预措施是对生动，实时的响应 从数字药丸中依从性的反馈，从而减少了MSM+s之间的艾滋病毒/艾滋病事件。