Overdose
Conditions
Brief 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)
Interventions
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 Education
Naloxone and educational materials (i.e. pamphlets) on overdose prevention, videos (English or Spanish) on naloxone, flu and Hepatitis A education.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All recruited study participants will receive the Overdose Education and Naloxone Distribution (OEND) materials. The control group will receive additional Flu and Hepatitis A education as Group 1, and the experimental group will receive the MI-CHANCE intervention as Group 2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A total of 588 PWUD participants will be recruited for the proposed study (MI-CHANCE). To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Be aged ≥18 years at time of recruitment 4. Must have used illicit opiates (e.g., heroin, fentanyl) and/or methamphetamine ≤1 week prior to recruitment date 5. Live in San Diego County with no plans to permanently move over the next 30 months 6. Have not previously used the FTIR drug checking service 7. Enrolled into ongoing prospective cohort study La Frontera (the border) (existing or new participants) Enrollment will be capped so that \<50% of the sample reports only using methamphetamine to ensure that the sample is comprised primarily of people who use opiates who are at greatest risk of OD. Recruitment will be done through targeted sampling at hotspots as well as homeless encampments, shelters and outreach through social media.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Not being able to provide a signed and dated informed consent form 2. Not willing to comply with all study procedures and availability for the duration of the study 3. Currently enrolled in another randomized controlled trial 4. Not having used illicit opiates (e.g., heroin, fentanyl), methamphetamine ≤1 week prior to recruitment date 5. Having used CheckSD (i.e. drug testing with TS+FTIR) 6. Participated in the MI-CHANCE pilot
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk rates of fatal and non-fatal overdose over 30 months | Through study completion, an average of 30 months | Rate of fatal and non-fatal ODs over the course of the study (i.e., the total # of ODs that a participant experiences during the study offset by the natural log of the time spent at risk during the study). Self-reported and obtained through record linkage between MI-CHANCE and emergency medical services and the medical examiner's office to obtain data on ODs that received medical attention and OD deaths, respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of drug checking service utilization | At baseline and every 6 months for 30 months | Number of times one utilized FTIR over the past 6 months. Self-reported |
| Risk rates of HIV/HCV infection over 30 months | Through study completion, an average of 30 months | Rates of HIV and HCV infection determined through serology (biological sample collection) over the course of the study (i.e. between baseline and 30 months) |
Countries
United States
Outcome results
None listed