Trial Outcomes & Findings for TeleHepC Treatment Trial (NCT NCT04798521)
NCT ID: NCT04798521
Last Updated: 2024-10-08
Results Overview
Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
12 weeks post treatment
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Tele-HCV Treatment
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
103
|
|
Overall Study
COMPLETED
|
63
|
16
|
|
Overall Study
NOT COMPLETED
|
37
|
87
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TeleHepC Treatment Trial
Baseline characteristics by cohort
| Measure |
Tele-HCV Treatment
n=100 Participants
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=103 Participants
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
103 participants
n=7 Participants
|
203 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentNumber of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.
Outcome measures
| Measure |
Tele-HCV Treatment
n=63 Participants
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=16 Participants
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Viral Response
|
63 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 4 weeksNumber of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment.
Outcome measures
| Measure |
Tele-HCV Treatment
n=100 Participants
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=103 Participants
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Treatment Initiation
|
85 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 36 weeks post treatmentHCV treatment completion, filled final prescription. 90% of HCV pills taken
Outcome measures
| Measure |
Tele-HCV Treatment
n=100 Participants
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=103 Participants
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Treatment Completion
|
46 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 36 WeeksParticipants complete surveys to assess whether or not they are regularly engaging in substance use and harm reduction resources in the community. Surveys conducted a Baseline, 12 weeks, and 36 weeks.
Outcome measures
| Measure |
Tele-HCV Treatment
n=100 Participants
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=103 Participants
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Engagement in Harm Reduction Resources
Baseline
|
100 Participants
|
103 Participants
|
|
Engagement in Harm Reduction Resources
12 Weeks
|
88 Participants
|
83 Participants
|
|
Engagement in Harm Reduction Resources
36 Weeks
|
61 Participants
|
68 Participants
|
Adverse Events
Tele-HCV Treatment
Serious events: 1 serious events
Other events: 2 other events
Deaths: 3 deaths
Community Linkage to Care
Serious events: 4 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Tele-HCV Treatment
n=100 participants at risk
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=103 participants at risk
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Cardiac disorders
Cardiac event
|
0.00%
0/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
0.97%
1/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
|
Gastrointestinal disorders
Gastrointestinal event
|
1.0%
1/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
0.00%
0/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
|
Immune system disorders
AIDS-related event
|
0.00%
0/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
0.97%
1/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
|
Social circumstances
Overdose, non-fatal
|
0.00%
0/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
1.9%
2/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
Other adverse events
| Measure |
Tele-HCV Treatment
n=100 participants at risk
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Tele-HCV: Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
|
Community Linkage to Care
n=103 participants at risk
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.
Community Linkage to Care: Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Unintentional injury
|
0.00%
0/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
0.97%
1/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
|
Psychiatric disorders
Psychological event
|
1.0%
1/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
0.97%
1/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
|
Gastrointestinal disorders
Gastrointestinal event
|
1.0%
1/100 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
0.00%
0/103 • Adverse events were collected over the 1 year a participant was enrolled in the study.
|
Additional Information
Dr. P. Todd Korthuis
Oregon Health & Science University
Phone: 503-494-8044
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place