Reducing Overdose and Substance Use-related Stigma by Training Non-substance-using Friends and Family Members of People Who Use Opioids to Be Harm Reduction Champions

NCT06823453 | Recruiting DMC

• 1 other identifier: R01CE003666
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Fatal opioid overdoses are more frequent among populations with low access to harm reduction (HR) services and with high substance use-related stigma (which is a major barrier to accessing HR services). One such population is older adults who use drugs (PWUD) on the West side of Chicago. Over 34% of Chicago's opioid-related EMS responses in 2023 were located in communities on the West side, but older adults in these communities access HR services at low rates, likely due to stigma and other barriers. To help address these barriers and increase HR service access among this population, the proposed clinical trial will evaluate a novel intervention that will recruit non-substance-using friends and family members of people who use opioids and live on the West side of Chicago, educate them on HR tools and services, and train them to become peer HR support champions. They will be asked to recruit one friend or family member who uses opioids to the study, who will also be provided with an educational training on overdose risk reduction and available HR tools and services. The intervention will then facilitate a counselor-led initial conversation between peer HR support champions and their friend or family member who uses opioids to help establish HR support, and provide all participants with naloxone and fentanyl test strip kits. This intervention will not only provide another mechanism through which PWUD can access HR tools and services, thereby reducing logistical barriers, but should also reduce stigma and increase social support by facilitating and normalizing open conversations about HR between PWUD and their non-PWUD HR support champions. Participants of a previous focus group conducted by the Investigators among West side PWUD thought this intervention would be helpful, said they would be willing to participate in it, and said they knew someone who could participate as their non-PWUD peer HR support champion. To facilitate recruitment of older adults, the Investigative Team will work with local faith-based and service organizations and educate them about the importance of HR. The intervention's efficacy will be evaluated for a) increasing uptake/use of HR services, b) decreasing overdose frequency, and c) decreasing stigma and other barriers to accessing HR services, both i) by examining change over time among intervention participants, and ii) by using propensity-score matching methods to compare outcomes between intervention participants and a comparison group of PWUD who have recently accessed HR services from one of the study's community partners (Community Outreach Intervention Projects or West Side Heroin and Opioid Task Force).

Conditions

Opioid Overdose Prevention; People Who Use Opioids/People With Opioid Use Disorder (OUD); Reduction of Substance Use-related Stigma; Non-substance-using People With a Friend or Family Member Who Uses Opioids; Peer Harm Reduction Support Champions

Keywords

opioid overdose prevention; drug overdose prevention; overdose prevention

Outcome Measures

Primary Outcomes (3)

• Overdose Frequency and Experiences

  Overdose frequency and experiences will be measured using participant self-report on items used by the Investigators in previous studies of PWUD. Items will ask about the number of overdoses participants experienced in the last three months (at baseline) and since the last interview (for follow-up). For each overdose reported, items will ask whether the participant was alone, whether naloxone was used, whether first responders were called, and whether an emergency room visit occurred. Participants will also be asked to report on whether they were present while someone else overdosed, and if so, whether they or someone else used naloxone.

  baseline, 1 month, 3 months, 6 months

• Number of Types of Harm Reduction Services Accessed

  This will be measured using participant self-report. Participants will be asked about their harm reduction service access and use in the last three months (at baseline) and since the last interview (for follow-up). Specifically, participants will be asked to report on how many times they accessed or received naloxone and fentanyl test strip kits, used fentanyl test strip kits, used "never use alone" hotlines, used "safe spaces" to use drugs or to experience withdrawal, used syringe service programs, tested for HIV or HCV, accessed medication for opioid use disorder, and accessed other types of drug treatment. A composite score will be computed reflecting the number of types of harm reduction tools and services accessed, which will be a count of all service/tool types accessed or used.

  baseline, 1 month, 3 months, 6 months

• Frequency of Access to Harm Reduction Tools and Services

  This will be measured using participant self-report. Participants will be asked about their harm reduction service access and use in the last three months (at baseline) and since the last interview (for follow-up). Specifically, participants will be asked to report on how many times they accessed or received naloxone and fentanyl test strip kits, used fentanyl test strip kits, used "never use alone" hotlines, used "safe spaces" to use drugs or to experience withdrawal, used syringe service programs, tested for HIV or HCV, accessed medication for opioid use disorder, and accessed other types of drug treatment. A composite score will be computed reflecting frequency of access to these tools and services, which will be a sum of the total number of times each participant used any of the harm reduction tools and services above.

  baseline, 1 month, 3 months, 6 months

Secondary Outcomes (7)

• Barriers to Harm Reduction Services (Number of Types of Barriers)

  baseline, 1 month, 3 months, 6 months

• Barriers to Harm Reduction Services (Frequency of Experiencing Barriers)

  baseline, 1 month, 3 months, 6 months

• Substance Use-related Stigma (Individual Experiences of Stigma)

  baseline, 1 month, 3 months, 6 months

• Substance Use-related Stigma (Perception of Community-Level Stigma)

  baseline, 1 month, 3 months, 6 months

• Peer Facilitation of Harm Reduction Service Access (Discussions about Harm Reduction)

  baseline, 1 month, 3 months, 6 months

Study Arms (2)

Peer Harm Reduction Support Champion Intervention

ACTIVE COMPARATOR

This intervention will recruit non-substance-using friends and family members of people who use opioids and live on the West side of Chicago, educate them on harm reduction (HR) tools and services, and train them to become peer HR support champions. They will be asked to recruit one friend or family member who uses opioids to the study, who will also be provided with an educational training on overdose risk reduction and available HR tools and services. The intervention will then facilitate a counselor-led initial conversation between peer HR support champions and their friend or family member who uses opioids, to help establish HR-related support, and will provide all participants with naloxone and fentanyl test strip kits. This intervention will not only provide another mechanism through which people who use opioids can access HR tools and services, thereby reducing logistical barriers to access and preventing overdose, but it should also reduce stigma and increase social support.

Behavioral: Peer Harm Reduction Support Champion Intervention

Non-equivalent comparison group of PWUD with some recent access to harm reduction services

NO INTERVENTION

A non-equivalent comparison group will be recruited of people who use drugs (PWUD) who have recently (in the last six months) accessed harm reduction services from one of the study's community partners.

Interventions

Peer Harm Reduction Support Champion Intervention BEHAVIORAL

This intervention will recruit non-substance-using friends and family members of people who use opioids and live on the West side of Chicago, educate them on harm reduction (HR) tools and services, and train them to become peer HR support champions. They will be asked to recruit one friend or family member who uses opioids to the study, who will also be provided with an educational training on overdose risk reduction and available HR tools and services. The intervention will then facilitate a counselor-led initial conversation between peer HR support champions and their friend or family member who uses opioids, to help establish HR-related support, and will provide all participants with naloxone and fentanyl test strip kits. This intervention will not only provide another mechanism through which people who use opioids can access HR tools and services, thereby reducing logistical barriers to access and preventing overdose, but it should also reduce stigma and increase social support.

Peer Harm Reduction Support Champion Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility Criteria for Non-PWUD (i.e., people who do not use drugs) Peer Intervention Participants, to Be Trained as Harm Reduction Support Champions. 1) Non-PWUD peers recruited directly to the study (i.e., not by a PWUD peer partner) will be eligible to participate in the intervention arm of the study if they live in Chicago, know someone at least 18 years of age who lives on the West side of Chicago who currently uses opioids (to the best of their knowledge), state that they are interested in learning how to offer social support and practical support to that person, report that they have not used "hard" drugs (drugs other than alcohol or marijuana) recreationally in the last year, are at least 18 years of age, and state that they and the person they want to support are able to be interviewed in English and/or Spanish. 2) Non-PWUD peers recruited to the intervention arm of the study by a study participant they know who uses drugs will be eligible to participate in the intervention if they live in Chicago, report that they have not used "hard" drugs (drugs other than alcohol or marijuana) recreationally in the last year, state that they are willing to learn how to support their peer who uses drugs, are at least 18 years old, and are able to be interviewed in English and/or Spanish. Eligibility Criteria for PWUD Intervention Participants (i.e., intervention participants who use drugs). 1) People who use drugs (PWUD) recruited directly to the intervention arm of the study (i.e., not by a non-PWUD peer partner) by West Side Heroin and Opioid Task Force or snowball sampling will be eligible to participate in the intervention if they live on the West side of Chicago, report that they currently use opioids (i.e., in the last week), know at least one person living in Chicago who has not used opioids in the last year and who they are willing to try to recruit to the study as someone who might be willing to offer them harm reduction support, are at least 18 years old, and are able to be interviewed in English and/or Spanish. 2) PWUD recruited to the intervention arm of the study by their non-PWUD peers who are enrolled in the study will be eligible to participate in the intervention group if they live in Chicago, have a study recruitment coupon from a non-PWUD participant, report that they currently use opioids (i.e., in the last week), state that they are willing to learn how their peer might be able to support them, are at least 18 years of age, and are able to be interviewed in English and/or Spanish. Eligibility Criteria for Non-equivalent Comparison Group Participants. Comparison group participants will be eligible to participate in the comparison arm of the study if they report currently using opioids (i.e., in the last week), have accessed harm reduction services from one of the study's community partners (Community Outreach Intervention Projects; or West Side Heroin and Opioid Task Force) in the last six months, are at least 18 years old, and are able to speak English and/or Spanish. These individuals who are recruited to the comparison group will not be eligible to participate in the intervention unless they are given a recruitment coupon by a non-PWUD peer.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Community Outreach Intervention Projects (COIP)

Chicago, Illinois, 60644, United States

RECRUITING

Study Officials

• Leslie D. Williams, Ph.D.

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie D. Williams, Ph.D.

CONTACT

312-996-8820; lesliedw@uic.edu

Maggie Kaufmann, M.P.H.

CONTACT

312-996-3197; mkaufm4@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 12 months of the publication of the set of papers that address the main specific aims of this study, all data will be compiled in a standard statistical software and available for open access. The data will be available for a minimum of ten years.
• Access Criteria: OpenICPSR© is a secure repository for storing and sharing social and behavioral science research data. To ensure confidentiality and to protect sensitive data, openICPSR© reviews all data to assess disclosure risk and to determine the level of access (open or restricted). Additionally, openICPSR© requires that data users must be granted approval for access, and in cases of restricted data, allows access only via controlled virtual labs. Users of the public use data will be required to register with ICPSR and agree to its Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, by prohibiting attempts to identify study participants, and by requiring immediate reporting of any disclosure of study participant identity. Data users will also be required to agree not to share or redistribute any data downloads.

Locations

US (1)