Clinical trial NCT06855836: Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overdose
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Harm Reduction Coalition of San Diego (HRCSD)
First posted: 2025-03-04
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

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

Detailed 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 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)

Eligibility criteria: 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. 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

Primary outcomes:
measure: Risk rates of fatal and non-fatal overdose over 30 months
timeFrame: Through study completion, an average of 30 months
Secondary outcomes:
measure: Frequency of drug checking service utilization
timeFrame: At baseline and every 6 months for 30 months
measure: Risk rates of HIV/HCV infection over 30 months
timeFrame: Through study completion, an average of 30 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: MI CHANCE - Park Blvd
state: California
Study officials:
References:
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