Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users

项目摘要/摘要： 这一综合研究和培训计划将为实习急诊内科医生柴医生做好准备 成为一名独立的，由NIH资助的具有智能手机药物专业知识的医生兼研究人员 针对吸毒者的依从性干预HIV预防策略 精神错乱。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 与异性恋相比，影响男男性行为者(MSM)的比例更大。其中 男男性接触者，同时使用兴奋剂者(男男性接触者+S)发生无避孕套性行为的风险更大， 脱离护理，额外使用药物和药物不依从。干预靶向 这些风险因素在男男性接触者+S中的影响不大，随着时间的推移会逐渐减弱。2010年，iPrEX的研究 在坚持接触前的男男性接触者中，HIV传播减少了40% 替诺福韦/恩曲他滨(TDF/FTC)预防(PrEP)。来自iPrEX研究的数据表明， 始终如一的坚持，男男性接触者可以达到90%以上的艾滋病毒保护率。因此，预科是一种 有吸引力的选择，并在MSM中被接受，但坚持下去仍然困难，特别是在 兴奋剂的使用。整合实时PrEP遵守数据和行为的HIV预防策略 针对MSM+S使用兴奋剂和服药依从性的干预措施可能会提高依从性和服药依从性 预防后续的艾滋病毒感染。 在NIH资助的一支强大的研究团队的指导下，柴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)积累制定行为干预的经验 特别关注HIV和PrEP，(2)获得设计、实施和评估临床的经验 在MSM中进行PrEP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得到一个创新的研究计划的补充，该计划将帮助他获得 对他的新技能的实践经验。在分级方法中，柴博士将首先通知规范一个 基于智能手机的遵从性干预(PrEPSteps)，参与者生成的内容通过征求 焦点小组。接下来，他将测试PrEP步骤对PrEP的可行性、可接受性和潜在影响 MSM+S在PrEP上的试验性随机对照试验(N=60)的依从性与通常治疗的比较。 最后，柴博士将评估PrEPSteps干预组件(和数字避孕药)的可接受性 通过对那些随机进入PrEPSteps条件的人进行定性的离职访谈。这款创新的K23 以患者为导向的导师职业发展奖回应了NIH在艾滋病毒/艾滋病方面的高度优先主题(不是- OD-15-137)，通过开发一种创新地响应生动、实时的坚持干预 从数字药片中反馈PrEP遵守情况，从而降低MSM+S人群中艾滋病毒/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.