Trials / Active Not Recruiting
Active Not RecruitingNCT06855836
Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose
Efficacy and Implementation Considerations for a Peer-led Motivational Interviewing Intervention to Promote Uptake of Drug Checking Services and Safe Drug Use Behaviors to Reduce Overdose
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 588 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A hybrid type 1 study will be conducted to evaluate efficacy and preliminary implementation considerations for a novel intervention to promote uptake of drug checking services (DCS) and safer drug use behaviors among people who use drugs (PWUD) to reduce incidence of overdose (OD) and HIV and Hepatitis C virus (HCV) infections in San Diego County. Approximately 50 syringe services programs (SSPs) in the US now offer advanced drug checking services using test strips (TS) and Fourier Transform Infrared Spectrometry (FTIR), allowing people to submit drug samples with non-nominal identifiers and obtain personalized results. While most existing FTIRs offer some counseling, no theory-based interventions to increase FTIR uptake and promote post-FTIR adoption of safer drug use behaviors have been rigorously evaluated.
Detailed description
588 PWUD who have not yet used FTIR will be recruited into a two-arm randomized controlled trial (RCT) (N=294 per group). Recruitment sources will be the community and La Frontera study. Both arms will have access to FTIR's standard of care (SOC) already available at SSP sites (i.e., FTIR, and overdose education and naloxone distribution (OEND)). PWUD randomized to receive MI-CHANCE will receive it from peer support specialists who will be trained in motivational interviewing (MI) to encourage FTIR uptake and safer drug use behaviors. Those in the attention-control SOC arm will receive Flu and Hepatitis A education. All will undergo semi-annual follow-up for 30 months. Primary Objective: To test the efficacy of MI-CHANCE on reducing rates of combined fatal and non-fatal OD over 30 months and examine social cognitive theory (SCT)-informed mediators and moderators of intervention effects (i.e., knowledge, outcome expectancies, self-efficacy)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | MI-CHANCE (TS + FTIR + MI) | MI-CHANCE was built following key principles of MI (partnership, acceptance, compassion and evocation) to empower PWUD, help them identify potential benefits of DCS and strategies to integrate these into their daily lives. The manual follows three key stages: 1) introducing DCS, 2) generating change talk, and 3) verbalizing commitment, using open questions, affirmations, reflections and summaries. Pros and cons for regularly using FTIR and changing drug use behaviors accordingly were identified in the literature and through discussions with PWUD and peer support specialists. Peer support specialists are urged to mirror participants' own language (e.g., oxy or M30s=oxycontin; carga= heroin; malilla=withdrawal, fetty=fentanyl). Challenges were categorized into 8 key areas: legal, financial, scheduling, transportation, ability to change drug use behaviors, communication with SSP staff, managing mood and substance use. |
| BEHAVIORAL | TS + FTIR + Flu and Hepatitis A Education | Naloxone and educational materials (i.e. pamphlets) on overdose prevention, videos (English or Spanish) on naloxone, flu and Hepatitis A education. |
Timeline
- Start date
- 2025-03-03
- Primary completion
- 2029-02-01
- Completion
- 2029-05-01
- First posted
- 2025-03-04
- Last updated
- 2026-04-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06855836. Inclusion in this directory is not an endorsement.