Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care

阶梯式护理、同伴提供的干预措施可提高初级护理中的 ART 依从性和 SUD

• 批准号: 10462094
• 负责人: Jessica F Magidson
• 金额: $ 68.46万
• 依托单位: UNIV OF MARYLAND, COLLEGE PARK
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10462094
• 关键词: Address; Adherence; Adoption; Affect; Aftercare; Attitude; Behavior Therapy; Behavioral; Biological Markers; Blood; Caring; Clinic; Clinical; Continuity of Patient Care; Counseling; Data; Dose; Effectiveness; Epidemic; Evidence based intervention; Feedback; HIV; Health; Health Care Sector; Home; Hybrids; Hypertension; Individual; Intervention; Interview; Life; Low income; Measures; Mental Depression; Mental Health Services; Mentored Patient-Oriented Research Career Development Award; Methods; Modeling; Monitor; National Institute of Drug Abuse; Outcome; Participant; Patient Participation; Patient Self-Report; Patients; Persons; Pilot Projects; Population; Primary Health Care; Problem Solving; Provider; Qualitative Research; Randomized; Reach Effectiveness Adoption Implementation and Maintenance; Recovery; Resource-limited setting; Resources; Services; Site; South Africa; Spottings; Substance Use Disorder; Supervision; Testing; Time; Training; Treatment outcome; Urinalysis; Viral Load result; Work; antiretroviral therapy; base; cost effective; cost estimate; disorder later incidence prevention; economic impact; economic value; effectiveness implementation study; effectiveness implementation trial; effectiveness outcome; effectiveness testing; effectiveness-implementation randomized trial; ethnic minority population; high risk; implementation measures; implementation outcomes; implementation strategy; improved; low and middle-income countries; medication compliance; mindfulness; model design; motivational enhancement therapy; motivational intervention; peer; phosphatidylethanol; preference; primary care services; primary care setting; primary outcome; racial and ethnic; recruit; reduced substance use; response; skills; standard of care; substance use; substance use treatment; success; therapy adherence; transmission process; treatment adherence; treatment program; uptake; willingness to pay

Significance: This proposal is for a type 2 hybrid effectiveness-implementation trial to test an intervention and implementation strategy of a peer-delivered, stepped care approach for integrating HIV and substance use (SU) services in a resource-limited primary care setting. Globally, a SU treatment gap exists, with only 1-4% of individuals who need treatment in the most resource-limited contexts receiving minimally adequate treatment. Given the impact of untreated SU on poor HIV outcomes along the care continuum, efforts are needed to sustainably integrate behavioral interventions into primary care settings to reach individuals at highest risk for poor ART adherence and SU outcomes. This gap in care in resource-limited settings will be met through implementing a peer-delivered, stepped care intervention, which has been successfully piloted in Cape Town, South Africa in the PI’s K23 award (“Khanya”). Preliminary work: Our team has developed and adapted the Khanya peer-delivered intervention based on key stakeholder feedback to improve ART adherence among PLWH with SU in primary care in South Africa. Khanya integrates Life-Steps, a single-session problem solving and motivational intervention for ART adherence, with brief behavioral skills to reduce SU (i.e., behavioral activation, mindfulness, relapse prevention). The PI’s K23 award included a pilot Type 1 hybrid effectiveness- implementation trial that demonstrated initial feasibility, acceptability, and preliminary effectiveness of Khanya for improving ART adherence compared to enhanced standard of care (ESOC). At post-treatment, adherence in Khanya was M=60.3% days vs. M=26.5% in ESOC. Methods: Guided by RE-AIM, the current study aims to test in a Type 2 hybrid effectiveness-implementation trial the effectiveness and implementation of a stepped- care Khanya intervention for PLWH at highest risk for ongoing ART nonadherence and HIV transmission. A stepped care approach is appealing in a resource-limited context, as the least resource intensive part of an intervention is delivered first, and only individuals who do not respond receive the more resource intensive part of the intervention. 150 PLWH with SU will be recruited from an integrated primary care site and randomized to ESOC (i.e., facilitated referral to public SU treatment) or Khanya. Khanya begins with Life-Steps + ESOC, and only those who continue to demonstrate ART nonadherence (i.e., detected using real-time electronic adherence monitoring; ≥3 missed doses in a 2-week period) will step up to receive the full intervention. Based on our pilot data, we anticipate Life-Steps + ESOC alone will be sufficient for ~44% of patients to overcome barriers to ART adherence, but the other ~56%, particularly those with more severe SU, will require the full intervention. Participants will be followed for 12 months on: ART adherence (Wisepill, DBS concentrations, and self-report), SU (urinalysis, PEth, and self-report), implementation (reach and uptake, fidelity, adoption), and economic impact. The overall aim is to test a feasible, sustainable, and effective peer-delivered approach to improve ART adherence among PLWH with SU in resource-constrained primary care settings.

意义：这项建议是一项第二类混合有效性-实施试验，以测试干预和 将艾滋病毒和药物使用相结合的同行递送、分步护理方法的实施战略 (SU)资源有限的初级保健环境中的服务。在全球范围内，存在SU治疗缺口，仅有1%-4%的 在资源最有限的情况下需要治疗的个人只能得到最低限度的适当治疗。 考虑到未经治疗的SU对整个护理过程中不良的艾滋病毒结果的影响，需要努力 可持续地将行为干预措施整合到初级保健环境中，以接触到患病风险最高的个人 不良的艺术坚持和SU结果。在资源有限的情况下，这一护理缺口将通过以下方式弥补 实施由同行提供的分步护理干预，该干预已在开普敦成功试行， 南非荣获少年派的K23奖(“Khanya”)。前期工作：我们的团队已经开发并适应了 Khanya同行根据关键利益相关者的反馈进行干预，以提高 与苏一起在南非进行初级保健的PLWH。Khanya整合了Life-Steps，一种单会话问题解决方案 以及对艺术坚持的动机干预，通过简短的行为技能来减少SU(即行为 激活、正念、预防复发)。PI的K23奖包括Pilot Type 1混合动力效能- 实施试验，证明了Khanya的初步可行性、可接受性和初步有效性 与增强型护理标准(ESOC)相比，可提高ART的依从性。在治疗后，坚持 Khanya的M=60.3%，而ESOC的M=26.5%。方法：在RE-AIM的指导下，本研究旨在 在类型2混合有效性-实施试验中的测试阶梯式的有效性和实施- 对PLWH的持续ART不依从性和HIV传播风险最高的患者进行Khanya干预。一个 分步护理方法在资源有限的情况下很有吸引力，因为它是 首先提供干预，只有没有回应的个人才会收到更多的资源密集型部分 干预的结果。将从一个综合初级保健地点招募150名具有SU的PLWH，并随机分配到 ESOC(即，促进转诊到公共SU治疗)或Khanya。Khanya从Life-Steps+ESOC开始，以及 只有那些继续证明ART不坚持的人(即，使用实时电子检测 依从性监测；≥3在2周内错过剂量)将加强接受全面干预。基座 根据我们的试点数据，我们预计仅Life-Steps+ESOC一项就足以让约44%的患者克服 ART坚持的障碍，但其他~56%，特别是那些SU更严重的人，将需要完全 干预。参与者将接受为期12个月的跟踪：ART依从性(Wisepill、DBS浓度和 自我报告)、SU(尿检、佩思和自我报告)、实施(达到和吸收、保真度、收养)，以及 对经济的影响。总体目标是测试一种可行、可持续和有效的同行交付方法，以 在资源有限的初级保健环境中，提高PLWH与SU之间的抗逆转录病毒治疗依从性。