Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users

项目总结/摘要： 这一综合研究和培训计划将准备柴博士，执业急诊医学医师 为了成为一个独立的，NIH资助的医生研究人员在智能手机药物方面的专业知识， 针对药物使用者的基于依从性干预的艾滋病毒预防策略 紊乱尽管在艾滋病毒预防、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，与男性发生性关系的男性（MSM）受影响的比例更大。之间 MSM，伴随使用兴奋剂的人（MSM+S）经历更大的无安全套性行为的风险， 脱离护理，额外的物质使用和药物不依从性。干预措施的目标 MSM+S中的这些风险因素具有随着时间的推移而减少的适度影响。2010年，iPrEX研究 在坚持暴露前治疗的男男性行为者中， 预防（PrEP）与替诺福韦/恩曲他滨（TDF/FTC）。iPrEX研究的数据表明， 坚持使用，MSM可以达到90%以上的艾滋病毒保护。因此，PrEP是一种 有吸引力的选择，并接受男男性行为者，但坚持仍然很困难，特别是男男性行为者， 使用兴奋剂。整合实时PrEP依从性数据和行为的艾滋病毒预防策略 干预措施，以解决兴奋剂的使用和药物依从性的MSM+S可能会提高依从性， 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，柴博士将实现三个培训目标， 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 特别关注艾滋病毒和PrEP，（2）获得设计，实施和评估临床 在MSM中进行PrEP试验;（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，这将有助于他获得 他的新技能的实际经验。在一个分层的方法中，柴博士将首先告知一个 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PrEP步骤对PrEP的影响的可行性，可接受性和潜力 在MSM+S的PrEP初步随机对照试验（N=60）中，与常规治疗相比的依从性。 最后，Chai医生将评估PrEPsteps干预组件（和数字药丸）的可接受性 通过对那些随机分配到PrEP步骤条件的人进行定性离职访谈。创新的K23 指导病人导向的职业发展奖响应国家卫生研究院在艾滋病毒/艾滋病的高优先级主题（不- OD-15-137）通过开发一种新颖的依从性干预， 从数字药丸中反馈PrEP依从性，从而降低MSM+S中艾滋病毒/艾滋病的发病率。

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.