Trial Outcomes & Findings for Linkage to Care for Persons With Hep C Infection (NCT NCT05397067)
NCT ID: NCT05397067
Last Updated: 2026-07-07
Results Overview
Number of participants who attended their first hepatitis C treatment appointment following diagnosis. Results are reported by study phase (time-based arms)
COMPLETED
NA
60 participants
Through study completion, within 6 months of diagnosis
2026-07-07
Participant Flow
Participants with hepatitis C virus (HCV) infection and substance use disorders were enrolled from a community-based program in Appalachia. A total of 60 participants were sequentially assigned to one of four cohorts (control or three intervention groups) as part of an iterative implementation study design.
This study included a qualitative phase consisting of semi-structured interviews with patients and healthcare providers to explore barriers and facilitators to care. Participants in the qualitative phase were not part of the interventional study population and were not included in the quantitative outcome analyses. Therefore, only participants enrolled in the quantitative phase (N=60) are included in the participant flow, baseline characteristics, ou
Participant milestones
| Measure |
Arm 1- Standard of Care
Participants received usual care prior to implementation of any interventions.
|
Arm 2 - Transition Period- Intervention 1
Participants received peer support plus incentive vouchers.
|
Arm 3- Intervention 2 (Incentives + Telehealth)
Participants received peer support, incentive vouchers, and access to telehealth visits.
|
Arm 4 - Intervention 3 (Incentives + Telehealth + Phone Access)
Participants received peer support, incentive vouchers, telehealth access, and prepaid mobile phones to facilitate communication and care engagement.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Linkage to Care for Persons With Hep C Infection
Baseline characteristics by cohort
| Measure |
Arm 4
n=15 Participants
PRS support +incentive+telehealth+ phone access
|
Total
n=60 Participants
Total of all reporting groups
|
Arm 1
n=15 Participants
patients receive standard of care
|
Arm 2
n=15 Participants
PRS support + incentive
|
Arm 3
n=15 Participants
PRS support +incentive+telehealth
|
|---|---|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
15 Participants
n=5 Participants
|
60 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
26 Participants
n=9 Participants
|
9 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
34 Participants
n=9 Participants
|
6 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
55 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Through study completion, within 6 months of diagnosisNumber of participants who attended their first hepatitis C treatment appointment following diagnosis. Results are reported by study phase (time-based arms)
Outcome measures
| Measure |
Arm 1
n=15 Participants
Standard of care
|
Arm 2
n=15 Participants
PRS support + incentive
|
Arm 3
n=15 Participants
PRS support+ incentive+teleheath visit
|
Arm 4
n=15 Participants
PRS support+Incentives+telehealth+ telephone
|
|---|---|---|---|---|
|
Number of Participants With Attendance at First Appointment
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
Adverse Events
Arm 1
Arm 2
Arm 3
Arm 4
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place