Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose (MI-CHANCE)

University of California San Diego

Status: Not yet enrolling

Conditions: Overdose

Treatments: Behavioral: MI-CHANCE; Behavioral: TS + FTIR + COVID-19 and Hepatitis A Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06855836

1R33DA061260-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Along with ~50 other syringe services programs (SSPs) in the US, the Harm Reduction Coalition San Diego (HRCSD), a local SSP, recently launched CheckSD (San Diego), a DCS using test strips (TS) and Fourier Transform Infrared Spectrometry (FTIR) that allows people to submit drug samples with non-nominal identifiers and obtain personalized results. While most existing DCS using FTIR offer some counseling, no theory-based interventions to increase DCS uptake and promote post-DCS adoption of safer drug use behaviors have been rigorously evaluated

Full description

588 PWUD who have not yet used CheckSD 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 CheckSD'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 HRCSD's peer counselors who will be trained in motivational interviewing (MI) to encourage CheckSD uptake and safer drug use behaviors. Those in the attention-control SOC arm will receive COVID-19 (coronavirus infection) and Hepatitis A education. All will undergo semi-annual follow-up for 30 months.

Primary Objective: To test the efficacy of MI-CHANCE on 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)

Enrollment: 588 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 CheckSD drug checking service
7. Enrolled into ongoing prospective cohort study La Frontera (the border) (existing or new participants)

Enrollment will be capped so that <25% 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. It is anticipated that enrollment will include 65% men. 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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588 participants in 2 patient groups, including a placebo group

Standard of Care Control (SOC; Group 1) -TS + FTIR + COVID-19 and Hepatitis A education.

Placebo Comparator group

Description:

Participants will receive overdose prevention pamphlets and be shown videos (English or Spanish) on how naloxone works. Participants will be offered to have their drug sample tested by CheckSD's technician at HRCSD after their study session. The training videos will be on COVID-19 and Hepatitis A education. Overall, the session for Group 1 as the attention control participants will last 30 minutes.

Treatment:

Behavioral: TS + FTIR + COVID-19 and Hepatitis A Education

MI-CHANCE Intervention (Group 2) - TS+FTIR+MI.

Experimental group

Description:

Participants will receive naloxone, overdose prevention pamphlets and MI in 30 minute counseling session. Trained counselors will engage participants in discussion on drug supply, ask to rate personal control perceptions over drugs' content and OD risk and active role playing using a dummy sample containing fentanyl to see how TS/FTIR machine work, highlighting results on drug potency and purity. Using "decisional balance" approach, participants will identify pros and cons of regularly using DCS prior to drug use and modifying drug use behaviors based on results. Participants will propose potential safer alternatives to using drugs and their advantages and disadvantages. Once the balance shifts towards positive change, participants will be offered to test their own drug. Participants will develop an individualized action plan with harm reduction principles to problem-solve specific challenges, identify their current OD risk status on a 'risk ladder' and their goals.

Treatment:

Behavioral: MI-CHANCE