Clinical trial NCT04798521: TeleHepC Treatment Trial
Official title: Oregon HIV/Hepatitis and Opioid Prevention and Engagement (OR-HOPE) Study: Tele-HCV Treatment Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Comagine Health
name: HIV Alliance
name: Oregon Health Authority
First posted: 2021-03-15
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).

Detailed description: Non-blinded, randomized controlled trial. In-depth qualitative interviews assess attitudes and barriers to treatment.

In Phase 1, potential participants will be pulled from a convenience sample at a Portland clinic providing care for the urban area. An initial target sample of 100 Hepatitis C positive participants will be enrolled for DBS validation. Power will be reassessed based on feedback from receiver operating curve model and additional participants enrolled up to a total of 100 Hepatitis C Positive participants, if necessary. A total of 500 potential participants can be screened expecting 1 in every 4 participants will be positive HCV.

In Phase 2, rural peer care coordinators (PCCs) and research assistants recruit up to 200 PWUD participants from high-needs rural Oregon counties. Study staff specifically target untreated populations recruited from local syringe exchange programs and direct community outreach (e.g. community barbeques, parks, homeless shelters, food pantries, etc.). Participants are encouraged to refer others for study screening.

A subset of up to 40 study participants will complete in-depth qualitative interviews regarding their experiences of hepatitis C treatment.

Eligibility criteria: Inclusion Criteria:

1. live in the study area
2. have injected drugs or report recreational opioid use without injection in the last 90 days
3. are age 18 or greater
4. have chronic active, untreated hepatitis C (defined as positive HCV RNA)
5. are seeking treatment for hepatitis C infection.
6. are able to communicate in English (this is due to the fact that less than 5% of the population in which we are targeting will be non-English speaking; see "Non-English Speaking Subjects" for additional information).
7. are enrolled in health insurance

Exclusion Criteria:

1. Have decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score of 7 or greater, or CTP B cirrhosis. CTP scoring is a composite of laboratory metrics (bilirubin, albumin, PT/INR) and clinical findings, including:

   1. increased abdominal or lower extremity swelling
   2. confusion consistent with hepatic encephalopathy
2. Are pregnant or breastfeeding

Primary outcomes:
measure: Viral Response
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Treatment Initiation
timeFrame: 4 weeks
measure: Treatment Completion
timeFrame: 36 weeks post treatment
measure: Engagement in Harm Reduction Resources
timeFrame: Baseline, 12 weeks, and 36 Weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Central City Concern
state: Oregon
city: Portland
country: United States
facility: Comagine Health
state: Oregon
city: Roseburg
country: United States
facility: HIV Alliance
state: Oregon
Study officials:
References: