Clinical trial NCT06823453: 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
Official title: Reducing Overdose and Substance Use-related Stigma on Chicago's West Side by Training Non-substance-using Friends and Family Members of People Who Use Opioids to Be Harm Reduction Champions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: Study Overview. The goal of the proposed study is to conduct a clinical trial to a) evaluate the feasibility and acceptability of and b) evaluate the efficacy of a peer harm reduction support champion intervention that is designed to increase access to harm reduction tools and services and prevent opioid overdose by increasing social support, decreasing substance use-related stigma, and addressing barriers to accessing harm reduction tools and services. This novel intervention will recruit non-substance-using friends and family members (i.e., "peers") of people who use opioids and live on the West side of Chicago, educate them on harm reduction tools and services, and train them to become peer harm reduction 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 harm reduction tools and services. The intervention will then facilitate a counselor-led initial conversation between peer harm reduction support champions and their friend or family member who uses opioids, to help establish harm reduction-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 drugs (PWUD) can access harm reduction tools and services, thereby reducing logistical barriers to access and preventing overdose, but it should also reduce stigma and increase social support by facilitating and normalizing open conversations about harm reduction between PWUD and their non-PWUD harm reduction support champions.

Intervention participants will be recruited to the study using two strategies: 1) non-PWUD peers will be directly recruited to be trained as harm reduction support champions, and then asked to recruit their peer who uses drugs (i.e., PWUD partner) who they will provide with support; and 2) PWUD will be directly recruited - with an emphasis on trying to recruit PWUD who have not recently accessed harm reduction services (though this will not be an eligibility requirement) - to the intervention, and then asked to recruit a non-PWUD peer who is willing to offer them harm reduction-related support. Separate recruitment will be conducted of comparison group participants (specifically, a comparison group of PWUD who have recently accessed harm reduction services from one of the study's community partners). Participants will either be recruited to the intervention to participate with their peer partners, as described above, or they will be recruited to the non-equivalent comparison group of people who use opioids who have recently accessed harm reduction services from one of the study's community partners (i.e., there will be no random assignment). To facilitate recruitment of older adults to the intervention, the Investigative Team will work with local faith-based organizations and service-providing organizations in the Austin and Garfield Park communities. This effort will be led by two faith-based consultants (the Director of Community Relations from Breakthrough Urban Ministries; and a local pastor who is also Director of the West Side Heroin and Opioid Task Force) who will help the study team build relationships with faith-based organizations and service-providing organizations and educate them about the importance of HR. Study recruitment fliers will be disseminated through these organizations. All participants will be interviewed and assessed at baseline, and will also be asked to complete 1-month, 3-month, and 6-month follow-up interviews. The intervention's efficacy will be evavluated for a) increasing uptake/use of harm reduction 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 quasi-experimental methods to compare outcomes between intervention participants and comparison group participants.

Recruitment Coupons. All recruitment of participants' peer partners in the intervention condition will occur via the distribution of recruitment coupons by participants. Coupons will contain unique, confidential alpha-numeric codes which will not contain any identifying information about the participant, but which will be used to link participants' peer partners to them for analytic purposes. To protect participants' privacy, coupons will state only that the study is about "community health." Coupon design and language will be reviewed and approved by UIC's IRB.

Number and Characteristics of Participants to Be Enrolled. A planned total of 600 human subjects will be involved in the proposed research. Of these, 300 will be intervention participants, and 300 will be non-equivalent comparison group participants. Of the 300 intervention participants, 150 will be people who use opioids, and 150 will be non-substance-using friends and family members (i.e., "peers") of the 150 participants who use opioids, who will be trained to become peer harm reduction support champions. The 300 non-equivalent comparison group participants will be people who use drugs (PWUD) - specifically, opioids - who have recently accessed harm reduction services from one of the study's community partners: Community Outreach Intervention Projects (COIP) or West Side Heroin and Opioid Task Force (WSHOTF). The purpose of recruiting a comparison group of 300 PWUD to compare to the 150 intervention participants who are PWUD is to ensure adequate matching of intervention group and comparison group participants on socioeconomic and demographic characteristics for propensity-score matching analysis.

Baseline Quantitative Interviews. All participants will be interviewed about their sociodemographic and socioeconomic characteristics, knowledge of harm reduction tools and services, experiences of substance use-related stigma and social support, perception of the level of substance use-related stigma in their communities, and depression and anxiety in the last month. Intervention participants will be asked about their relationship (type, length, and closeness) to their peer partner that is enrolled in the intervention. All PWUD participants (in the intervention group and comparison group) will be asked about their drug use behaviors (including how often they use drugs alone) and overdose experiences during the last three months, their access to and use of harm reduction tools and services and/or drug treatment in the last three months, and any barriers they have experienced to accessing or using these services. Audio computer-assisted self-interviewing (ACASI) will be used to ask questions about sensitive topics such as drug use behaviors, such that participants will not have to answer these questions out loud.

Follow-Up Quantitative and Qualitative Interviews. Participants will be asked to return to complete follow-up interviews approximately 1 month, 3 months, and 6 months after they have completed intervention activities (for intervention participants), or after their baseline interviews (for comparison group participants). At each time point, follow-up interviews will ask all participants about their knowledge of harm reduction tools and services, experiences of substance use-related stigma and social support, perception of the level of substance use-related stigma in their communities, and depression and anxiety in the last month. Follow-up interviews for PWUD participants (in the intervention group and comparison group) will also ask about participants' drug use behaviors, overdose experiences, access to and use of harm reduction tools and services, and barriers to accessing or using such services during the period between the last interview and each follow-up interview. Follow-up interviews for intervention participants will also ask about how often participants discussed harm reduction with their peer partner, and what services they helped their partner access (for non-PWUD) or accessed with the help of their partner (for PWUD). This will include whether the non-PWUD partner was intentionally present or available while the PWUD partner was using drugs, in order to avoid the PWUD partner using drugs alone. Intervention participants will also be asked to rate the acceptability, appropriateness, and feasibility of the intervention during the 1-month and 6-month follow-up interviews, and will ask questions to monitor for any distress or relationship strain between peer pairs at every follow-up interview. Any negative experiences reported will be followed up and evaluated as potential Adverse Events (see DSMP).

Brief (30 minutes or less) qualitative interviews will be conducted with intervention participants at each follow-up time point, and immediately following the counselor-facilitated harm reduction support discussion between peer pairs (a component of the intervention), to obtain participant feedback on the intervention. These qualitative interviews will include the following topics: feasibility and acceptability of each component of the intervention (recruiting peers, educational training, counselor-facilitated conversations, and receipt of naloxone and fentanyl test strip kits); participants' reactions to being recruited by their peer, or the reactions of the peer(s) they tried to recruit; participant comfort with helping or being helped with access to specific different harm reduction tool, services, and overdose prevention strategies; perceptions of productiveness of counselor-facilitated conversation with peer; conversational ease or awkwardness during counselor-facilitated conversation; anticipated comfort with having future conversations about HR services with peers; and any distress or discomfort experienced during any intervention component.

Participant Locator Forms. All participants will be asked to complete a locator form at the time of their baseline interviews, in order to obtain information to use to contact participants for follow-up interviews. Participants will be informed during the consent process about this follow-up component, and consent forms will obtain permission to contact them again for their 1-month, 3-month, and 6-month follow-up interviews. Locator forms will include the participants' own contact information, as well as information about other individuals who might be able to help locate the participant if direct attempts are unsuccessful.

Outcomes to Be Compared between Study Arms to Evaluate Intervention Efficacy. Outcomes to be compared between intervention and comparison group arms to evaluate the efficacy of the peer harm reduction support champion intervention are: uptake/use of harm reduction tools and services, overdose frequency, substance use-related stigma, barriers to accessing harm reduction services, and perceptions of social support.

Eligibility criteria: 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.

Primary outcomes:
measure: Overdose Frequency and Experiences
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Number of Types of Harm Reduction Services Accessed
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Frequency of Access to Harm Reduction Tools and Services
timeFrame: baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Barriers to Harm Reduction Services (Number of Types of Barriers)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Barriers to Harm Reduction Services (Frequency of Experiencing Barriers)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Substance Use-related Stigma (Individual Experiences of Stigma)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Substance Use-related Stigma (Perception of Community-Level Stigma)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Peer Facilitation of Harm Reduction Service Access (Discussions about Harm Reduction)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Peer Facilitation of Harm Reduction Service Access (Frequency of Collaborative or Peer-Facilitated Access)
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Social Support
timeFrame: baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Community Outreach Intervention Projects (COIP)
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Leslie D. Williams, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: