Clinical trial NCT03411265: RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing
Official title: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing Through Active Patients Sharing Experiences and the Provision of Information About Infections -an electroNic-health Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Opioid-use Disorder
Drug Addiction
Substance Use Disorders
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to:

1. assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
3. assess treatment retention rates in patients completing the RETAIN intervention.
4. test the impact of RETAIN on knowledge about HCV/HIV
5. test the impact of RETAIN on interest in being tested for HCV/HIV

Detailed description: The pre-post study of RETAIN will: 1) assess the acceptability of RETAIN as measured by participant feedback about the intervention; 2) test the impact of RETAIN on knowledge about MAT, as measured by the MAT Knowledge Assessment; 3) assess MAT retention rates in patients completing the RETAIN intervention; 4) test the impact of RETAIN on knowledge about HCV/ HIV; 5) test the impact of RETAIN on interest in being tested for HCV/HIV.

The acceptability of RETAIN will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about MAT and HCV/HIV) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The 3- and 6-month retention rates for RETAIN participants will be compared, using Fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the UC Health MAT clinics as determined by the retrospective chart review.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;

   Exclusion Criteria:
3. Does not sign the "short form" consent form

Primary outcomes:
measure: treatment retention status after 3 months
timeFrame: 3 months
Secondary outcomes:
measure: treatment retention status after 6 months
timeFrame: 6 months
measure: MAT Knowledge Assessment
timeFrame: Pre and Post Tests in E-Health App Day 1
measure: The Injection-Related Infection and Treatment Survey (I-RITS)
timeFrame: Pre and Post Tests in E-Health App Day 1
measure: Feedback on the RETAIN e-health application
timeFrame: Day 1
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Addiction Sciences Division
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References: