JMIR research protocols · 2025
Harm Reduction Contingency Management for Stimulant Use Reduction and Antiretroviral Therapy Adherence in HIV Primary Care: Protocol for an Implementation Effectiveness Study.
СтатьяПротокол клинического исследованияПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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Steiner Gabriela, Baral Stefan, Riley Elise D, Shoptaw Steven, Chamie Gabriel, Roberts Kate, Suchman Lauren, Knight Kelly, Gandhi Monica, Coffin Phillip, Appa Ayesha
Аннотация
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.
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.