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NIATx Coaching for HIV, Hepatitis C, and Opioid Use Disorder Management (BIRCH Trial)
N/A
Waitlist Available
Led By Frederick L Altice, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months for 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate an intervention to introduce screening, evaluation and treatment of HIV/hep C/opioid use disorder in WV primary care clinics to improve health outcomes.
Who is the study for?
This trial is for Federally Qualified Health Centers and similar primary care clinics in West Virginia that provide adult care. It's not open to private or specialty clinics, or any clinic outside of West Virginia.
What is being tested?
The study tests a strategy called NIATx Coaching to integrate screening, evaluation, and treatment procedures for HIV, hepatitis C, and Opioid Use Disorder into primary care. Clinics will receive training and coaching to adopt these practices.
What are the potential side effects?
Since this trial focuses on integrating treatment strategies rather than testing new medications, it does not directly involve medication side effects. However, the process may uncover challenges in managing patients' conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 months for 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months for 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Integration of services
Number of patients initiated on antiretroviral medication (ART) for HIV
Number of patients initiated on medication for HCV
+6 moreSecondary study objectives
Number of patients on PrEP to prevent HIV
Number of patients retained on medication (ART) for HIV
Number of patients retained on medication for OUD for at least 6 months
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention - Nominal Group Technique, Training, CoachingExperimental Treatment1 Intervention
Each group of clinics will receive the same intervention in a step-wedge design, starting every 6-months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIATx Coaching
2020
N/A
~270
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,927 Previous Clinical Trials
3,031,712 Total Patients Enrolled
7 Trials studying Hepatitis C
1,534 Patients Enrolled for Hepatitis C
National Institute on Drug Abuse (NIDA)NIH
2,593 Previous Clinical Trials
3,328,676 Total Patients Enrolled
46 Trials studying Hepatitis C
22,521 Patients Enrolled for Hepatitis C
West Virginia UniversityOTHER
185 Previous Clinical Trials
64,753 Total Patients Enrolled
3 Trials studying Hepatitis C
1,360 Patients Enrolled for Hepatitis C
Natalie Kil, MPHStudy DirectorYale University
Frederick L Altice, MDPrincipal InvestigatorYale University
9 Previous Clinical Trials
3,278 Total Patients Enrolled
2 Trials studying Hepatitis C
1,044 Patients Enrolled for Hepatitis C
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Intervention - Nominal Group Technique, Training, Coaching
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.