The ENHANCE Project Toolkit

Mobile Health Strategies to Support Longitudinal Engagement in Comprehensive, Community-based Prevention Services for People Who Use Drugs (Aim 3)

This study will examine the feasibility, appropriateness, and acceptability of a bundle of smartphone-based tools for lowering overdose risk. 40 participants will be enrolled and can expect to be on study for up to 9 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Overdose; eHealth; Substance Related Disorder
• Intervention / Treatment: Device: Connections mHealth Application

Detailed Description

As a pilot study, this study is not designed to rigorously evaluate the effect of the intervention (i.e., health-related biomedical or behavioral outcome) on participants. Rather, the sample size will allow determination of feasibility, acceptability, appropriateness, and secondarily, will allow quantification of preliminary effect size to aid in future trial planning. After enrolling in the study, participants will receive a mobile phone with an unlimited data plan. After receiving the phone, participants will receive a brief orientation to a bundle of phone and internet-based overdose prevention tools. This includes overdose crisis hotlines, mail-order overdose prevention supplies, and a mobile health app that has been adapted for people who use drugs to support self-determined motivation for reaching goals through educational content, social engagement, and peer-to-peer support. Each month for 6 months, participants will also complete a 20-30 minute survey evaluating the primary and secondary outcomes (described below) and use of each phone and internet-based tool that is part of the enhanced harm reduction bundle. 25 participants will also be invited to complete a 45-60 minute semi-structured in-depth interview about their experience participating in the study and use of the phone- and internet-based tools. Primary analyses will seek to describe the feasibility, acceptability, and appropriateness of the overdose prevention service model. Secondarily, changes in overdose risk behaviors and experiences over the 6-month study period relative to baseline will be analyzed.

Primary Objective: to evaluate feasibility, appropriateness, and acceptability of an enhanced harm reduction service model incorporating internet and/or mobile health tools to reduce overdose risk for people who use opioid and/or stimulant drugs.

Secondary Objective: to understand overdose risk behaviors before and after the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Team; Phone Number: (608) 572-3514; Email: enhance@medicine.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Pilot Participant):

• Be at least 18 years old
• Be able to read and write in English

• Report drug use in the past 30 days, defined as

  • Any use of illicit stimulants, opioids, OR
  • Use of prescription opioids by a route other than "by mouth/swallowed"
• Additionally report recent drug use of at least twice in the past 7 days

• Have NOT used any of the following harm reduction services in the past 6 months:

  • In-person community-based prevention services for people who use drugs
  • Overdose crisis hotlines
  • Online mail-order prevention supply delivery
  • Apps for supporting addiction treatment or recovery

Inclusion Criteria (Peer Mentor Participant):

• Be at least 18 years old
• Be able to read and write in English
• Have served as a member of the existing Community Leadership Team.

Exclusion Criteria:

• Are under the age of 18
• Have impaired decision making capacity at the time of screening

• Do not have the ability to participate in screening and enrollment activities in any one of the following ways:

  • Traveling to their nearest participating Vivent Health health center
  • Coordinating a visit with the Vivent Health harm reduction mobile unit
  • Accessing and completing the online screening survey on a personal wifi/internet enabled device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot Participants; People who use opioid and/or stimulant drugs and are disconnected from harm reduction services.	Device: Connections mHealth Application; Mobile health app, bundled with other harm reduction internet and phone resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale. Participants will be asked the 4-item questionnaire for each tool offered in the bundle (3). Scores are averaged across the measure for each tool and subsequently scores for individual tools will be summed to generate a composite acceptability score of the program. Scores can range from 3-15, with higher scores meaning higher acceptability of the intervention	up to 6 months
Intervention Appropriateness Measure (IAM)	The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale. Participants will be asked the 4-item questionnaire for each tool offered in the bundle (3). Scores are averaged across the measure for each tool and subsequently scores for individual tools will be summed to generate a composite appropriateness score of the program. Scores can range from 3-15, with higher scores meaning higher appropriateness of the intervention.	up to 6 months
Feasibility of Intervention Measure (FIM)	The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale. Participants will be asked the 4-item questionnaire for each tool offered in the bundle (3). Scores are averaged across the measure for each tool and subsequently scores for individual tools will be summed to generate a composite feasibility score of the program. Scores can range from 3-15, with higher scores meaning higher feasibility of the intervention.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Number of Risk Days from baseline to 6 months	This data will be collected using the Overdose Risk Behavior Scale (ORBS) instrument which provides a comprehensive index of proximal opioid-related overdose risks. At baseline and study completion, participants will complete the ORBS assessment. The ORBS assessment will be administered to assess the potential effect of the intervention on the frequency of overdose risk behaviors. The average change in the self reported risk days on this instrument from baseline to six months will be reported as the outcome.	baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ryan Westergaard, MD, PhD, MPH, UW School of Medicine and Public Health; Principal Investigator: Rachel Gicquelais, PhD, MPH, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Substance Use Disorder
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Drug Misuse; Mental Disorders; Chemically-Induced Disorders; Prescription Drug Misuse; Opioid-Related Disorders; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: 2026-0408; Protocol Version 3/13/26 (Other Identifier: UW Madison); R01DA057645-02 (U.S. NIH Grant/Contract); SMPH | Population Health (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As part of a NIH-funded study which requires data sharing and open access commitments, data from this project will be shared with a national coordinating center and in an open-access data repository. Data shared with external research partners may contain limited identifiable information but will remain confidential and under the direction of an approved Data Use and Transfer Agreement (e.g. not public). Any data shared on public data repositories will be stripped of any potential identifiers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No