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Virus Therapy
Simplified HCV care within a mobile medical unit for Hepatitis C
N/A
Waitlist Available
Research Sponsored by Family Health Centers of San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months of follow-up
Awards & highlights
Study Summary
This trial will test a simplified approach to delivering HCV care in a street-based mobile medical clinic to see if it is more effective than the current practice of usual care in community clinics.
Eligible Conditions
- Hepatitis C
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months of follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months of follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who initiate HCV treatment
Secondary outcome measures
Initiation rates for medication-assisted treatment (MAT) for Opioid Use Disorder
Number of patients who complete HCV treatment
Number of patients who receive abscess care
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Simplified Care within a Mobile Medical UnitExperimental Treatment1 Intervention
Simplified Care treatment is the same as for Usual Care with the exception that it is taking place within a mobile medical clinic that is scheduled to deliver treatment in alignment with regular syringe exchange services.
Group II: Usual Care within Community ClinicsActive Control1 Intervention
Complete blood count, comprehensive metabolic panel, international normalized ratio, HCV RNA, hepatitis B virus (HBV) serologies, point of care HIV test, and point of care liver fibrosis measurement. HCV genotype if required by patient's insurance for prior authorization. Care for opioid use disorder and skin infection is offered. Completion of the initial visit workup is sufficient to initiate a prior authorization request for DAAs from payers and an appointment for MAT follow-up in a community clinic if indicated. Patient coordination; authorization with insurance companies; scheduling appointments, follow-up, and ancillary support services will be conducted by a Patient Navigator. Patients are seen every 2-4 weeks for monitoring and adherence support. HCV treatment regimens are at the discretion of the treating provider in accordance with AASLD/IDSA guidelines and insurance requirements. Twelve weeks after HCV therapy completion, SVR12 HCV RNA and SVR12 CMP tests will be obtained.
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Who is running the clinical trial?
Family Health Centers of San DiegoLead Sponsor
6 Previous Clinical Trials
14,373 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Usual Care within Community Clinics
- Group 2: Simplified Care within a Mobile Medical Unit
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical experiment currently recruiting participants?
"As per information presented on clinicaltrials.gov, this medical trial is not currently recruiting participants; however, the initial posting was made February 2nd 2021 and it underwent its last update March 14th 2022. Although no candidates are sought now, 281 other trials have open enrollment at present."
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