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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05493475
Other study ID # Nationwide Children's Hospital
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2022
Est. completion date September 2025

Study information

Verified date April 2024
Source Nationwide Children's Hospital
Contact Nichole Michaels, PhD
Phone 614-355-5870
Email nichole.michaels@nationwidechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select courts in rural and urban communities in Ohio.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fentanyl Test Strips
A brief fentanyl test strip (FTS) education intervention will be given to participants at court sites in the intervention arm after enrollment and collecting baseline data. It will be offered one-on-one with participants and will include the purpose, benefits, and limitations of FTS testing, and information on how to use FTS, interpret the results, what to do if the FTS is positive, and how to use FTS for different drug delivery methods. Participants will practice and demonstrate use of the FTS, and the short video on how to interpret the FTS will include an on-camera statement on the importance of testing for fentanyl. The video will be accessible to participants after study enrollment. Participants will be advised of the possibility of both false positive/negative results, and that the drugs may be mixed with other substances not detectable with FTS. Participants will be encouraged to practice other harm reduction strategies.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Key informant interviews Key informant interviews will be conducted with court personnel and peer recovery mentors who are affiliated with the court sites to discuss and obtain feedback on the intervention design and research protocols. Key informants will be asked to provide feedback on participant recruitment strategies, discuss potential barriers to the program's success, and describe any concerns with the implementation plan.
Quantitative Data/Process Measures:
# interested court sites
# Court sites enrolled
# potential participants who request to enroll
# participants successfully enrolled
# people who receive FTSED and OEND at baseline
# replacement FTS and Naloxone kits requested/distributed
total # FTS and Naloxone kits distributed
proportion of participants in the intervention arm who complete the biweekly surveys
proportion of participants who complete the 6-month follow-up questionnaire
Quarter 2 of Year 1
Primary Follow-up questionnaire A follow-up questionnaire will occur with intervention arm site personnel to gauge satisfaction with the program and identify any concerns.
Quantitative Data/Process Measures:
# interested court sites
# Court sites enrolled
# potential participants who request to enroll
# participants successfully enrolled
# people who receive FTSED and OEND at baseline
# replacement FTS and Naloxone kits requested/distributed
total # FTS and Naloxone kits distributed
proportion of participants in the intervention arm who complete the biweekly surveys
proportion of participants who complete the 6-month follow-up questionnaire
Quarter 3 of Year 3
Primary Interview Intervention arm site personnel will be interviewed to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites.
Quantitative Data/Process Measures:
# interested court sites
# Court sites enrolled
# potential participants who request to enroll
# participants successfully enrolled
# people who receive FTSED and OEND at baseline
# replacement FTS and Naloxone kits requested/distributed
total # FTS and Naloxone kits distributed
proportion of participants in the intervention arm who complete the biweekly surveys
proportion of participants who complete the 6-month follow-up questionnaire
Quarter 2 of Year 3
Primary Interview Intervention arm sites will be interviewed about the acceptability of the program.
Quantitative Data/Process Measures:
# interested court sites
# Court sites enrolled
# potential participants who request to enroll
# participants successfully enrolled
# people who receive FTSED and OEND at baseline
# replacement FTS and Naloxone kits requested/distributed
total # FTS and Naloxone kits distributed
proportion of participants in the intervention arm who complete the biweekly surveys
proportion of participants who complete the 6-month follow-up questionnaire
6-month follow-up
Primary Questionnaire All participants (in both the intervention and non-intervention arms) will complete a questionnaire at enrollment (for the intervention group, prior to the intervention) and again at 6 months. Both questionnaires (baseline and 6 months) will include the same questions about the participant's knowledge of and self-efficacy in reducing their risk of an opioid overdose by using FTS. 6-month follow-up
Primary Questionnaire Participants in the intervention arm will be contacted biweekly for 2 years and asked if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Intervention arm participants will be asked to notify the study team when they receive a positive FTS result. Participants in the non-intervention arm will be contacted biweekly up to a maximum of 2 years after enrollment to ask if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Fatal overdoses among participants in the intervention and non-intervention arms of the study will be identified by reviewing death certificates issued by the Ohio Department of Health quarterly starting in Year 2. Quarter 3 of Year 3
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