Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 8, 2024
Open Peer Review Period: Nov 4, 2024 - Dec 30, 2024
Date Accepted: Jun 5, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Harm reduction contingency management for stimulant use reduction and ART adherence in HIV primary care: an implementation-effectiveness study protocol
ABSTRACT
Background:
Amongst people living with HIV, stimulant use disorder (StUD) has been linked with medication non-adherence and mortality. Contingency management (CM) is a strategy incentivizing measurable behavior change that is recommended as first-line treatment for StUD and can support antiretroviral therapy (ART) adherence. However, CM is not widely implemented, in part due to feasibility concerns. While reductions in substance use short of abstinence improve health outcomes, CM programs typically target stimulant use abstinence rather than reduction. To optimize care for safety-net populations living with comorbid StUD and HIV, we designed a novel CM program incentivizing both stimulant use reduction and ART adherence in the HIV ambulatory setting.
Objective:
1. Evaluate the feasibility of once weekly CM in safety-net HIV ambulatory care. 2. Assess the acceptability of CM among participants and providers.
Methods:
We conduct a single-arm, pilot hybrid implementation-effectiveness trial offering a novel CM intervention in two low-barrier, ambulatory HIV clinics. Patients with frequent stimulant use and suboptimal ART adherence are offered 12 weeks of once-weekly CM involving incentives for positive tenofovir and negative stimulants on urine point-of-care assays. We assess stimulant use once-weekly using tests with a four-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 assess feasibility and acceptability using quantitative process methods and qualitative in-depth interviews, guided by the RE-AIM (reach, effectiveness, acceptability, implementation, maintenance)¬ evaluation framework. We define preliminary effectiveness by proportion of stimulant-negative and TFV-positive urine tests, as well as changes in HIV viral suppression before and after participation.
Results:
As of September 2024, recruitment and CM visits have concluded. Quantitative and qualitative evaluation is underway, expected to continue through January 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 towards wider utilization of stimulant-reduction CM in the safety-net setting. Clinical Trial: Clinicaltrials.gov identifier: NCT06564792
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