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: 10675089
• 负责人: Jessica F Magidson
• 金额: $ 58.88万
• 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/10675089
• 关键词: Address; Adherence; Adoption; Affect; Aftercare; Attitude; Behavior Therapy; Behavioral; Biological Markers; Blood; Caring; Clinic; Clinical; Continuity of Patient Care; Counseling; Data; Diabetes Mellitus; Dose; Dryness; 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; National Institute of Drug Abuse; Outcome; Participant; Patient Participation; Patient Self-Report; Patients; Persons; Pilot Projects; Policy Maker; Population; Primary Care; Problem Solving; Provider; Qualitative Research; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Resource Allocation; Resource-limited setting; Resources; Services; Site; South Africa; Spottings; Substance Use Disorder; Testing; Time; Training; Treatment outcome; Urinalysis; Viral Load result; Work; antiretroviral therapy; cost effective; cost estimate; design; economic impact; economic value; effectiveness outcome; effectiveness testing; effectiveness trial; effectiveness-implementation randomized trial; effectiveness/implementation hybrid; effectiveness/implementation trial; electronic adherence monitoring; ethnic minority population; high risk; high risk population; implementation measures; implementation outcomes; implementation strategy; improved; low and middle-income countries; medication compliance; mindfulness; motivational enhancement therapy; motivational intervention; patient retention; peer; peer recovery; phosphatidylethanol; preference; primary care services; primary care setting; primary outcome; racial minority; recruit; reduced substance use; relapse prevention; response; skills; standard of care; substance use; substance use treatment; success; therapy adherence; transmission process; 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：该建议是针对2型混合有效性实施试验来测试干预措施和 同行提供的，阶梯护理方法的实施策略，用于整合艾滋病毒和药物的使用 （SU）在资源有限的初级保健环境中的服务。在全球范围内，存在SU治疗差距，只有1-4％ 在最有限的环境中需要治疗的个人接受最低限度的治疗。 鉴于未经治疗的SU对沿护理连续体的艾滋病毒不良结果的影响，需要精力 可持续整合的行为干预措施与初级保健环境，以达到最高风险的个人 不良的艺术依从性和SU成果。在资源有限的设置中的护理差距将通过 实施了在开普敦成功驾驶的同行提供的阶梯护理干预措施 南非在PI的K23奖（“ Khanya”）中。初步工作：我们的团队已经发展并改编了 Khanya同行提供的干预措施基于关键利益相关者的反馈，以提高艺术依从性 PLWH与SU在南非的初级保健中。 Khanya整合了生命步骤，这是一个解决问题的问题 以及对艺术依从性的动机干预，并具有简短的行为技巧来减少SU（即行为 激活，正念，预防救济）。 PI的K23奖包括一个试点1型混合有效性 - 实施试验表明，khanya的最初可行性，可接受性和初步有效性 与增强的护理标准（ESOC）相比，改善艺术依从性。治疗后，遵守 在Khanya中，M = 60.3％的天数，而M = 26.5％的ESOC。方法：在Re-Aim的指导下，当前的研究旨在 在2型混合有效性试验中测试的有效性和实施 护理Khanya干预PLWH的持续不遵守和HIV传播的最高风险。一个 阶梯护理方法正在以资源有限的环境中出现，这是资源最少的一部分 干预措施是首先提供的，只有不响应的人才能获得更多资源密集的部分 干预。 150 plwh with su将从集成的初级保健站点招募，并随机分配给 ESOC（即准备转介到公共SU治疗）或Khanya。 Khanya从生命步骤 + ESOC开始， 只有那些继续展示艺术不遵守的人（即使用实时电子检测到 依从性监测； ≥3次在2周内错过的剂量）将加强接受全面干预。基于 在我们的飞行员数据上，我们预计仅生命步骤 + ESOC就足以使约44％的患者克服 艺术依从性的障碍，但另一个〜56％，尤其是那些更严重的SU的障碍，将需要充分 干涉。参与者将被遵循12个月：艺术依从性（Wisepill，DBS浓度和 自我报告），SU（尿液分析，Peth和自我报告），实施（触及和吸收，忠诚，采用）和 经济影响。总体目的是测试可行，可持续和有效的同行分配方法 在资源受限的初级保健环境中，可以提高PLWH的艺术依从性。