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NCT Number: NCT07649278

The ENHANCE Project Toolkit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Connections mHealth Application

Device

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

Primary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: up to 6 months

    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

  2. Intervention Appropriateness Measure (IAM)

    Time frame: up to 6 months

    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.

  3. Feasibility of Intervention Measure (FIM)

    Time frame: up to 6 months

    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.

Secondary outcomes

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

    Time frame: baseline, 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Team

CONTACT

[email protected]

(608) 572-3514

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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