Contingency Management in HIV Care for Both Stimulant Use & ART Adherence
- Conditions
- Stimulant Use (Diagnosis)Hiv
- Interventions
- Behavioral: Contingency management
- Registration Number
- NCT06564792
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
Methamphetamine use and associated sequelae have been rising, and represent a major barrier to successful control of the HIV epidemic. Methamphetamine use is associated with poor adherence to antiretroviral therapy for HIV, and we propose a trial of contingency management (providing incentives for behavioral change) targeting both reduced methamphetamine use and improved adherence to HIV medications. We will utilize a real-time, point-of-care urine assay for both outcomes, aiming to evaluate feasibility, acceptability and preliminary effectiveness of HIV care-based contingency management. We will also study hair levels as a quantitative outcome for reduction in methamphetamine use.
- Detailed Description
Methamphetamine (MA) use is increasing in the United States, along with a sharp rise in overdose deaths. MA use is particularly prevalent among people with HIV (PWH), which can contribute to non-adherence to antiretroviral therapy (ART) and progression to AIDS. Contingency management (CM) is an evidence-based intervention that has repeatedly demonstrated efficacy in stimulant use disorder treatment and has also proved efficacious in improving ART adherence for those in care. Since uptake of CM outside of formal drug treatment programs has been limited, incorporating CM into HIV primary care is an important opportunity to expand access to treatment for MA use disorder while also supporting ART adherence.
This study addresses two barriers that have each limited outward expansion of CM into HIV primary care: 1) feasibility challenges for CM in clinical practice settings; as CM is traditionally delivered 2-3x weekly, this study explores a de-intensified CM schedule (e.g., once weekly visits) in HIV primary care; and 2) CM for ART adherence has been previously limited by the inaccuracy of indirect or non-timely measures of adherence.
The study utilizes a novel point-of-care urine tenofovir assay to perform POC testing on the same urine specimen for both ART use and MA non-use, enabling a truly paired CM intervention that addresses the following aims: 1) a pilot RCT evaluating feasibility of de-intensified (once weekly) combined contingency management for reducing MA use and increasing ART adherence in HIV primary care, compared to conventional twice weekly CM; 2) in-depth interviews following RCT completion to qualitatively explore the acceptability of this intervention to participants and their primary care providers; and 3) given incomplete ability to detect cumulative MA use with only once weekly urine testing, we will study the correlation between monthly MA hair levels with monthly Timeline Followback interviews to validate use of hair MA levels to be able to quantitatively detect reduced use (in addition to abstinence) as a future study outcome.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 37
- Stimulant use disorder
- Living with HIV or risk for HIV
- Suboptimal ART adherence (treatment or prevention)
- Unable to provide urine testing weekly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Contingency management arm Contingency management Participants are offered once weekly contingency management in clinic to support reduced stimulant use and HIV medication adherence.
- Primary Outcome Measures
Name Time Method Feasibility: proportion of CM visits attended Measured during intervention participation. We will report multiple process measures as feasibility outcomes, though primary outcome is the number and proportion of contingency management visits attended (of 12). We expect that 50% of participants will attend at least 6 or more CM visits, which we will define as minimum engagement suggesting feasibility of this HIV primary care-based CM intervention.
Acceptability: in-depth interviews with participants, staff Interviews performed within 6 months of intervention participation. We will conduct in-depth qualitative interviews to understand factors and circumstances that influence CM engagement among PWH with stimulant use disorder and suboptimal ART adherence. These findings will also help elucidate mechanisms contributing to stimulant use reduction and ART adherence when once weekly CM is delivered to PWH in a designated primary care setting.
- Secondary Outcome Measures
Name Time Method Effectiveness (Hair) Analyzed within 1 year following hair collection We will correlate within-person changes in cumulative stimulant hair levels with the days free of stimulant use performed pre- vs. post-intervention using mixed effects Poisson regression with random effects for individual.
Effectiveness (Urine) Measured during intervention participation. We will report proportion of urine tests negative for stimulants; proportion positive for tenofovir.
Trial Locations
- Locations (1)
UCSF at San Francisco General Hospital
🇺🇸San Francisco, California, United States