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减少伤害应急管理对降低艾滋病毒初级护理中兴奋剂使用及提高抗逆转录病毒疗法依从性的作用:一项实施效果研究方案

Harm Reduction Contingency Management for Stimulant Use Reduction and Antiretroviral Therapy Adherence in HIV Primary Care: Protocol for an Implementation Effectiveness Study.

作者信息

Steiner Gabriela, Baral Stefan, Riley Elise D, Shoptaw Steven, Chamie Gabriel, Roberts Kate, Suchman Lauren, Knight Kelly, Gandhi Monica, Coffin Phillip, Appa Ayesha

机构信息

University of California, San Francisco, San Francisco, CA, United States.

Johns Hopkins University, Baltimore, MD, United States.

出版信息

JMIR Res Protoc. 2025 Aug 18;14:e67292. doi: 10.2196/67292.

Abstract

BACKGROUND

Stimulant use disorder has been linked with medication nonadherence and mortality among people living with HIV. Contingency management (CM) is a strategy incentivizing measurable behavior change that is recommended as the first-line treatment for stimulant use disorder and can support antiretroviral therapy (ART) adherence. However, CM is not widely implemented, in part due to feasibility concerns. Although reductions in substance use short of full abstinence can improve health outcomes, CM programs typically target complete abstinence from stimulant use rather than reduction. To optimize care for safety-net populations living with comorbid stimulant use disorder and HIV, we designed a novel CM program incentivizing both stimulant use reduction and ART adherence in the HIV ambulatory setting.

OBJECTIVE

We aimed to (1) evaluate the feasibility of once-weekly CM in safety-net HIV ambulatory care and (2) assess the acceptability of CM among participants and care providers.

METHODS

We will conduct a pilot, single-arm, hybrid implementation effectiveness trial offering a novel CM intervention in 2 low-barrier, ambulatory HIV clinics. Patients with stimulant use disorder and suboptimal ART adherence will be offered 12 weeks of once-weekly CM including incentives for positive-tenofovir and negative-stimulant results on urine point-of-care assays. We will assess stimulant use once weekly using tests with a 4-day detection window, allowing participants to use stimulants during select days of the week but earn incentives by reducing their frequency of use from near-daily use. We will assess feasibility and acceptability using quantitative process methods and qualitative in-depth interviews, guided by the RE-AIM (reach, effectiveness, acceptability, implementation, and maintenance) evaluation framework. We will define preliminary effectiveness by proportion of stimulant-negative and tenofovir-positive urine tests, as well as changes in HIV viral suppression before and after participation.

RESULTS

Recruitment and CM visits have concluded as of September 2024. Quantitative and qualitative evaluation is underway and is expected to continue through October 2025.

CONCLUSIONS

This novel CM program offers dual incentives targeting stimulant use reduction and ART adherence. We hypothesize that incentivizing stimulant use reduction is acceptable to our target safety-net population. Demonstration of a feasible, acceptable model may serve as a first step toward wider use of stimulant-reduction CM in the safety-net setting.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06564792; https://clinicaltrials.gov/study/NCT06564792.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67292.

摘要

背景

兴奋剂使用障碍与艾滋病毒感染者的药物治疗不依从和死亡率有关。应急管理(CM)是一种激励可测量行为改变的策略,被推荐作为兴奋剂使用障碍的一线治疗方法,并且可以支持抗逆转录病毒疗法(ART)的依从性。然而,CM并未得到广泛实施,部分原因是对可行性的担忧。虽然在未完全戒断的情况下减少物质使用也可以改善健康结果,但CM项目通常以完全戒除兴奋剂使用为目标,而非减少使用。为了优化对同时患有兴奋剂使用障碍和艾滋病毒的安全网人群的护理,我们设计了一种新型的CM项目,在艾滋病毒门诊环境中激励减少兴奋剂使用和提高ART依从性。

目的

我们旨在(1)评估在安全网艾滋病毒门诊护理中每周进行一次CM的可行性,以及(2)评估参与者和护理提供者对CM的可接受性。

方法

我们将进行一项试点、单臂、混合实施效果试验,在2家低门槛的艾滋病毒门诊诊所提供一种新型的CM干预措施。患有兴奋剂使用障碍且ART依从性欠佳的患者将接受为期12周的每周一次的CM,包括对即时尿液检测中替诺福韦呈阳性和兴奋剂呈阴性结果的激励措施。我们将使用具有4天检测窗口期的测试每周评估一次兴奋剂使用情况,允许参与者在一周中的特定几天使用兴奋剂,但通过减少使用频率(从近乎每日使用减少)来获得激励。我们将使用定量过程方法和定性深入访谈,在RE-AIM(覆盖范围、有效性、可接受性、实施和维持)评估框架的指导下评估可行性和可接受性。我们将通过兴奋剂阴性和替诺福韦阳性尿液检测的比例,以及参与前后艾滋病毒病毒抑制情况的变化来定义初步有效性。

结果

截至2024年9月,招募和CM访视已结束。定量和定性评估正在进行中,预计将持续到2025年10月。

结论

这种新型的CM项目提供了针对减少兴奋剂使用和提高ART依从性的双重激励措施。我们假设激励减少兴奋剂使用对于我们的目标安全网人群是可接受的。证明一个可行、可接受的模式可能是在安全网环境中更广泛地使用减少兴奋剂的CM的第一步。

试验注册

ClinicalTrials.gov NCT06564792;https://clinicaltrials.gov/study/NCT06564792。

国际注册报告识别码(IRRID):DERR1-10.2196/67292。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95a6/12402737/222aa8e049da/resprot_v14i1e67292_fig1.jpg

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