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.

项目概要/摘要： 这项综合研究和培训计划将为执业急诊医学医师柴博士做好准备 成为一名独立的、由 NIH 资助的医生兼研究员，拥有智能手机药物治疗方面的专业知识 针对药物滥用个体的基于依从性干预的艾滋病毒预防策略 失调。尽管艾滋病毒预防、检测和行为健康方面取得了进展，但艾滋病毒的流行仍在继续 与异性恋者相比，对男男性行为者 (MSM) 的影响更大。之中 MSM，那些同时使用兴奋剂（MSM+S）的人经历无套性行为的风险更大， 小心脱离、额外使用药物和不依从药物治疗。干预措施目标 这些风险因素对 MSM+S 的影响不大，随着时间的推移会逐渐减弱。 2010年，iPrEX研究 研究表明，坚持预先暴露的 MSM 个体的 HIV 传播减少了 40% 使用替诺福韦/恩曲他滨 (TDF/FTC) 进行预防 (PrEP)。 iPrEX 研究的数据表明， 坚持坚持，MSM 可以实现 90% 以上的 HIV 防护。因此，PrEP 是一种 有吸引力的选择并被 MSM 接受，但坚持仍然很困难，特别是在 MSM 中 兴奋剂的使用。整合实时 PrEP 依从性数据和行为的 HIV 预防策略 解决 MSM+S 中兴奋剂使用和药物依从性的干预措施可能会提高依从性和 预防随后的艾滋病毒感染。 在 NIH 资助的强大研究团队的指导下，Chai 博士将实现三个培训目标： 融入他的研究计划的具体目标。 (1) 获得制定行为干预措施的经验 特别关注 HIV 和 PrEP，(2) 获得设计、实施和评估临床的经验 MSM 对 PrEP 的试验，以及 (3) 学习定性研究方法和分析技术。 柴博士的培训活动将辅之以创新的研究计划，这将帮助他获得 他的新技能的实践经验。在分层方法中，Chai 博士将首先告知 基于智能手机的依从性干预 (PrEPsteps)，通过参与者生成的内容 焦点小组。接下来，他将测试PrEPsteps对PrEP效果的可行性、可接受性和潜力 在一项 MSM+S PrEP 试验随机对照试验 (N=60) 中，与常规治疗相比的依从性。 最后，Chai 博士将评估 PrEPsteps 干预组件（和数字药丸）的可接受性 通过对随机分配到 PrEPsteps 条件的人员进行定性退出访谈。这款创新的 K23 以患者为导向的指导职业发展奖响应了 NIH 在艾滋病毒/艾滋病方面的高度优先主题（非 OD-15-137）通过开发一种新颖的依从性干预措施，创新地响应生动、实时的 通过数字药丸反馈 PrEP 依从性，从而降低 MSM+S 中艾滋病毒/艾滋病的发病率。