Implementing Low-Barrier HCV Treatment in a Jail Setting
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifespan
About this trial
The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial.
The study asks:
* Can a simplified, low-barrier HCV treatment program work in a jail setting? * Do participants finish treatment and get cured using this approach?
All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work.
Researchers will measure:
* Whether participants are cured of HCV * Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity) * Whether the program could be used in other jails or expanded in the future
This study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Incarcerated individual at RIDOC
Age ≥ 18 years
Awaiting trial (i.e., not sentenced)
English speaking
Disqualifiers
Cirrhosis (FIB-4 Score >3.25 within 90 days prior to study entry and/or clinical signs of cirrhosis)
Positive for Hepatitis B surface antigen
Actively pregnant or breastfeeding
Known allergy/sensitivity to study drug components
Trial design
Design model
Single group
Treatments tested in this trial
Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
DrugIndividuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.
Community Health Worker
Other interventionParticipants will receive support from a Community Health Worker which may include assistance with basic needs (transportation, housing, employment, vital documents, insurance re-activation) as well as medication adherence, patient navigation, and peer recovery support.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MINMON-JExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
HCV Cure Rate
HCV Cure Rate will be defined as achieving a Sustained Virological Response at 12 weeks after treatment completion (SVR12), assessed by an undetectable HCV RNA viral load measured via standard laboratory assay. An undetectable result indicates that the virus is no longer present in the blood and is considered the clinical definition of virologic cure.
Time frame
Between 12 and 24 weeks after completion of HCV treatmentSecondary outcomes
1
Implementation: Feasibility of Implementation Measure
The Feasibility of Implementation Measure (FIM) is a validated 4-item Likert-scale tool assessing provider perceptions of the feasibility of implementing a specific intervention. Each item is scored from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived feasibility. The total score ranges from 4 to 20. Mean FIM scores will be reported across participants. This will be administered to participating stakeholders.
Time frame
Between 4 to 12 weeks post-implementation2
Fidelity: In-facility Treatment Adherence
Fidelity will be assessed by calculating the percentage of prescribed doses taken during the treatment period, based on in-facility medication dispensation data from the Rhode Island Department of Corrections (RIDOC) electronic medical record (EMR), Adherence will be reported both as a continuous variable (% of doses taken) and as a binary indicator (≥80% of prescribed daily doses taken during treatment). Missing doses will be quantified to assess treatment fidelity across care settings.
Time frame
From enrollment to the end of treatment at 12 weeks3
Fidelity: Community Treatment Adherence
Fidelity will be assessed by calculating the percentage of prescribed doses taken during the treatment period, based on community adherence data collected by community health workers (CHWs) using the Brief Adherence Rating Scale (BARS). Adherence will be reported both as a continuous variable (% of doses taken) and as a binary indicator (≥80% of prescribed daily doses taken during treatment). Missing doses will be quantified to assess treatment fidelity across care settings.
Time frame
From enrollment to the end of treatment at 12 weeks4
Implementation: Acceptability of Implementation Measure
Acceptability will be assessed using the validated 4-item Acceptability of Intervention Measure (AIM), which evaluates provider perceptions of how acceptable the intervention is. Each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater acceptability.
Time frame
Between 4 to 12 weeks post-implementationSponsors and contacts
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Lifespan
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov