The ENHANCE Project Toolkit

NCT07649278 | Recruiting FDA Device

• 4 other identifiers: 2026-0408R01DA057645-02SMPH | Population HealthProtocol Version 3/13/26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Related Disorder; Drug Overdose; eHealth

Keywords

Substance Use Disorder; Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in the Number of Risk Days from baseline to 6 months

  baseline, 6 months

Study Arms (1)

Pilot Participants

EXPERIMENTAL

People who use opioid and/or stimulant drugs and are disconnected from harm reduction services.

Device: Connections mHealth Application

Interventions

Connections mHealth Application DEVICE

Mobile health app, bundled with other harm reduction internet and phone resources

Pilot Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Drug Overdose; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse; Narcotic-Related Disorders

Study Officials

• Rachel Gicquelais, PhD, MPH

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

• Ryan Westergaard, MD, PhD, MPH

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Team

CONTACT

(608) 572-3514; enhance@medicine.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive intervention, up to N=10 are Peer Mentor Participants who have additional responsibility for generating content on discussion boards in the Connections App.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)