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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

TypeNameDescription
BEHAVIORALMI-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.
BEHAVIORALTS + FTIR + Flu and Hepatitis A EducationNaloxone 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.