An interventional study of Telemedicine in Hepatitis C, sponsored by Andrew Talal. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Andrew Talal · Not applicable, Interventional, and Health services research
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.
The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 602 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →This is the only study on the registry with Andrew Talal as lead sponsor.
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Exclusion Criteria:
Referral-HCV seropositive subjects enrolled for at least 12 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist
Telemedicine - HCV seropositive subjects enrolled for at least 12 months in an OAT program will be treated on site by a liver specialist via two-way video conferencing. (telemedicine)
Other: Telemedicine
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
Also known as: Two way video conferencing
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
Time frame: 12 weeks post treatment cessation
Comparison of Treatment Initiation Percentages
Comparison of treatment initiation percentages between the two arms, as measured by the percentage of patients that take an initial medication dose.
Time frame: Up to 160 weeks
Comparison of Treatment Completion Rates
Comparison of treatment completion percentages between the two arms.
Time frame: Up to 210 weeks
Comparison of Patient Satisfaction
We assessed patient satisfaction with healthcare delivery between the two arms through the Patient Satisfaction Questionnaire (PSQ) (1). The instrument is comprised of 18 questions from 7 subscales with responses on a 5-point Likert scale ranging from "1=Strongly Agree" to "5=Strongly Disagree". We administered the PSQ-18 at baseline and at the SVR time point. The higher the scored value, the higher the satisfaction. We calculated the score per participant, per time point, as the average of the scored values of all questions answered out of 18, and subsequently rounded the average score to the nearest integer (2). 1. Marshall GN, Hays RD. The patient satisfaction questionnaire short-form (PSQ-18). Santa Monica, CA: RAND, 1994. 2. Talal AH, Sofikitou EM, Wang K, Dickerson SS, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E-Health, 2023; 29: 395-407.
Time frame: Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks).
| Milestone | Sequence 1: 27 Month Usual Care, 9 Months Telemedicine | Sequence 2: 18 Month Usual Care, 18 Months Telemedicine | Sequence 3: 9 Months of Usual Care Followed by 27 Months Telemedicine |
|---|---|---|---|
| Started | 52 | 52 | 52 |
| Completed | 52 | 52 | 52 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: 27 Month Usual Care, 9 Months Telemedicine | Sequence 2: 18 Month Usual Care, 18 Months Telemedicine | Sequence 3: 9 Months of Usual Care Followed by 27 Months Telemedicine |
|---|---|---|---|
| Started | 52 | 52 | 52 |
| Completed | 52 | 52 | 52 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: 27 Month Usual Care, 9 Months Telemedicine | Sequence 2: 18 Month Usual Care, 18 Months Telemedicine | Sequence 3: 9 Months of Usual Care Followed by 27 Months Telemedicine |
|---|---|---|---|
| Started | 52 | 48 | 52 |
| Completed | 52 | 48 | 52 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: 27 Month Usual Care, 9 Months Telemedicine | Sequence 2: 18 Month Usual Care, 18 Months Telemedicine | Sequence 3: 9 Months of Usual Care Followed by 27 Months Telemedicine |
|---|---|---|---|
| Started | 51 | 35 | 52 |
| Completed | 51 | 25 | 51 |
| Not completed | 0 | 10 | 1 |
Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)
| Participants | Control | Intervention |
|---|---|---|
| Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication | 106 | 246 |
Comparison of treatment initiation percentages between the two arms, as measured by the percentage of patients that take an initial medication dose.
| Participants | Control | Intervention |
|---|---|---|
| Comparison of Treatment Initiation Percentages | 126 | 268 |
Comparison of treatment completion percentages between the two arms.
| Participants | Control | Intervention |
|---|---|---|
| Comparison of Treatment Completion Rates | 116 | 261 |
We assessed patient satisfaction with healthcare delivery between the two arms through the Patient Satisfaction Questionnaire (PSQ) (1). The instrument is comprised of 18 questions from 7 subscales with responses on a 5-point Likert scale ranging from "1=Strongly Agree" to "5=Strongly Disagree". We administered the PSQ-18 at baseline and at the SVR time point. The higher the scored value, the higher the satisfaction. We calculated the score per participant, per time point, as the average of the scored values of all questions answered out of 18, and subsequently rounded the average score to the nearest integer (2). 1. Marshall GN, Hays RD. The patient satisfaction questionnaire short-form (PSQ-18). Santa Monica, CA: RAND, 1994. 2. Talal AH, Sofikitou EM, Wang K, Dickerson SS, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E-Health, 2023; 29: 395-407.
| % participants satisfied or high satisfy | Control | Intervention |
|---|---|---|
| Initial Time point | 91.5 | 98.3 |
| HCV cure time point | 91.5 | 98.7 |
Collected over Adverse event data were collected over the entire study period from screening through the two year post-treatment follow up perod.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 3/312 (1%) | 0/312 (0%) | 0/312 (0%) |
| Intervention | 9/290 (3.1%) | 0/290 (0%) | 0/290 (0%) |
| Age, Continuous(years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 48.94 ± 12.8 | 47.12 ± 13.1 | 48.06 ± 12.97 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 118 | 115 | 233 |
| Male | 194 | 175 | 369 |
| Ethnicity (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 96 | 89 | 185 |
| Not Hispanic or Latino | 216 | 201 | 417 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Control | Intervention | Total |
|---|---|---|---|
| White | 151 | 155 | 306 |
| Black/AA & Other | 161 | 135 | 296 |
| Region of Enrollment(participants) | Control | Intervention | Total |
|---|---|---|---|
| United States | 312 | 290 | 602 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — At the completion of the study, the data will be filed with the Patient-Centered Outcomes Research Institute and will be publicly availability.
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