Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
completion around
Principal Investigator
by Steffanie Strathdee (ucsd)
Headshot of Steffanie Strathdee
Steffanie Strathdee

Description

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

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

Details

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)

Keywords

Overdose, Drug Overdose, MI-CHANCE, TS + FTIR + COVID-19 and Hepatitis A Education

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

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

Lead Scientist at University of California Health

  • Steffanie Strathdee (ucsd)
    Steffanie A. Strathdee is the Harold Simon Distinguished Professor in the Department of Medicine at the University of California San Diego School of Medicine. She co-directs UCSD’s center for Innovative Phage Applications and Therapeutics (IPATH) and the International Core of UCSD’s Center for AIDS Research.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06855836
Study Type
Interventional
Participants
Expecting 588 study participants
Last Updated