Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR003015 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
Hepatitis C Virus (HCV) infection is an ongoing challenge in the United States, with an estimated 2.4 million individuals living with HCV in 2016. According to the Virginia Department of Health, over 11,500 people were living with HCV infection in 2017 with a rate of 170 reported cases/100,000 adults. This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.
This study evaluated whether community-based interventions, including peer support, incentives, telehealth, and phone access, improve linkage to care among individuals with hepatitis C and substance use disorders in Appalachia.
This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.
The primary component of the study was a prospective interventional evaluation in which participants (N=60) were sequentially assigned to one of four cohorts: a control group and three intervention groups. All participants received peer support, with additional interventions introduced iteratively across cohorts, including incentive vouchers (e.g., food, transportation, phone), telehealth access, and provision of prepaid mobile phones to facilitate communication and engagement in care.
The primary outcome was attendance at the first HCV treatment visit.
The study used a pragmatic, quasi-experimental approach to evaluate the impact of these interventions on linkage to care. The goal was to assess whether addressing structural barriers such as transportation, communication access, and care navigation would improve engagement in HCV treatment among a high-risk population.
A qualitative component was conducted to inform intervention development and better understand barriers and facilitators to care. This included semi-structured interviews with patients and healthcare providers. Findings from the qualitative phase were used to refine intervention strategies but were not part of the interventional study population or quantitative outcome analyses.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | No Intervention | patients receive standard of care | |
| Arm 2 | Experimental | Patients received PRS support + incentive |
|
| Arm 3 | Experimental | Patients received PRS support + incentive + Telehealth visits |
|
| Arm 4 | Experimental | Patients received PRS support + incentive + telehealth visit + phone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer specialist (PS) | Behavioral | These participants will receive PRS support |
|
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2026 | Apr 27, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D019966 | Substance-Related Disorders |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| D005298 | Fertility |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
Not provided
Not provided
This study used a quasi-experimental, sequential (interrupted time-series) design. Participants were assigned to one of four time-based cohorts based on when they were enrolled: (1) pre-implementation (standard of care), (2) arm 2 ntervention phase including peer specialist support and incentives (3) intervention phase including peer specialist support and incentives with telehealth, and (4) enhanced intervention phase including peer specialist support, incentives, telehealth, and phone access.
Not provided
Not provided
Not provided
Not provided
| Incentives | Behavioral | These participants will receive incentives |
|
| telehealth visits | Behavioral | These participants will receive telehealth visits |
|
| phone access | Behavioral | These participants will receive pre-paid phones |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |