Health TrialsbyHealthPanel

The ENHANCE Project Toolkit

ConditionsSubstance Related DisorderDrug OverdoseeHealth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Are under the age of 18

Have impaired decision making capacity at the time of screening

Traveling to their nearest participating Vivent Health health center

Coordinating a visit with the Vivent Health harm reduction mobile unit

Trial design

Design model

Single group

Treatments tested in this trial

  • Connections mHealth Application

    Device

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Pilot ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 6 months
2

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.

Time frame
up to 6 months
3

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.

Time frame
up to 6 months

Secondary outcomes

1

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.

Time frame
baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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