Hepatitis C
Conditions
Keywords
recently incarcerated, Hepatitis C, peer mentor
Brief summary
The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with Hepatitis C Virus (HCV) who were recently released from correctional settings to promote linkage to and retention in HCV care. The investigators will assess the existing barriers and facilitators of HCV treatment initiation, HCV treatment completion, and sustained virologic response among individuals recently released from a U.S. jail or prisons in a randomized control trial. This study will assess the feasibility and process measures of a peer-enhanced HCV care coordination intervention among recently incarcerated individuals.
Detailed description
The proposed 2-year study will be a block stratified, randomized controlled trial. Once consented and enrolled, participants will be randomly assigned to either the peer-enhanced intervention or referred to standard clinical care. The investigators will enroll 80 former inmates with chronic HCV who have been released from incarceration within the past 6 months. It is expected that enrollment will be completed by the fourth quarter of the first year. This will allow sufficient time for HCV treatment uptake, completion, determination of Sustained Virologic Response (SVR), and assessment of reinfection. Individual participant follow-up will be 3 months on average for treatment, 3 months for SVR, and 3 months to assess for reinfection. Elucidating the barriers and facilitators in the re-entry care cascade (as well as how they may be overcome) will be critical in designing sustainable models of care for HCV-infected former inmates. The investigators hypothesize that a peer-enhanced strategy will be more effective than standard referral in improving linkage to, and retention in, HCV care among individuals recently released from correctional settings.
Interventions
BEHAVIORALPeer mentor
Peer mentors will contact participants within 72 hours of enrollment to discuss the early release period, gauge their readiness for HCV treatment, and identify ancillary needs. They will also accompany the participant to their first medical appointment with an HCV provider and any future appointments if requested by the participant. Peer mentors will offer participants social support throughout the 6 months they are enrolled in the study.
BEHAVIORALStandard of care
Passive referral to a HCV provider
Sponsors
Montefiore Medical Center
Prisma Health-Upstate
National Institute on Drug Abuse (NIDA)
New York City Department of Homeless Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* currently incarcerated or recently released from a U.S. jail or prison (6 months) * Chronic HCV with documented detectable viral load * 18 years old * Fluent in English or Spanish * Resident of the Upstate area of South Carolina
Exclusion criteria
* Unable to sign informed consent * Life expectancy of less than 1 year * Plans to relocate from the Upstate area of South Carolina in the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Care | 6 months | Linkage to care is defined as having a visit with an HCV treatment provider after release. Electronic Medical record (EMR) data will be extrapolated to evaluate this outcome. Results will be summarized by study arm using descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to HCV Treatment Initiation | Up to 3 months after linkage to care | For participants who initiate HCV treatment, time to HCV treatment initiation will be determined by the number of days following release from the correctional setting to HCV treatment initiation. Results will be summarized by study arm using descriptive statistics. |
| Time to HCV Treatment completion | Up to 3 months after treatment initiation | Time to HCV treatment completion will be sourced from electronic medical record data and will be defined as the number of days following release from the correctional setting to completion of HCV treatment. Results will be summarized by study arm using descriptive statistics. |
| Number of Participants with Detectable Hepatitis C Virus (HCV) Reinfection | 12 months after treatment completion | HCV reinfection will be assessed based upon a review of electronic medical records. HCV reinfection will be defined as the return of detectable Hepatitis C virus in the blood at 12 weeks after a previously confirmed clearance. Results will be summarized by study arm. |
| Sustained Virologic Response (SVR) | 3 months after treatment completion | The number/percentage of participants who achieve HCV cure (i.e., the virus is undetectable in the blood at 12 weeks), as determined by electronic medical records, will be summarized by study arm using basic descriptive statistics. |
| Reincarceration Rate | Up to 24 weeks (~6 months) | Reincarceration rate will be determined using public correctional facility inmate lookup systems to confirm instances of re-incarceration. Results will be summarized by study arm. If a participant is reincarcerated after being enrolled, they will remain as part of the study throughout the study period. During the reincarceration period, the research team will not be in contact with the participant, nor will any research-related activities be conducted until the participant is released back into the community. |
| Emergency Department (ED) Utilization | Up to 24 weeks (~6 months) | ED utilization will be assessed by the number of documented health-care related visits to an ED facility. ED utilization will be sourced via REDCap participant interviews and electronic medical records. Results will be summarized by study arm. |
| Hospitalizations | Up to 24 weeks (~6 months) | Hospitalizations will be determined by the number of inpatient hospital admissions up to 24 weeks. Hospitalization data will be sourced via REDCap patient interviews and electronic medical records. The number/percentage of participants who are hospitalized will be summarized by study arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew Akiyama, MD
Montefiore Medical Center/Albert Einstein College of Medicine
PRINCIPAL_INVESTIGATORAlain Litwin, MD
Prisma Health-Upstate
Outcome results
None listed