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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | |
| Intervention | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Other | Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks post treatment cessation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 160 weeks |
| Comparison of Treatment Completion Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew H Talal, MD | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrew H Talal | Buffalo | New York | 14216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41094463 | Derived | Talal AH, Markatou M, Zeremski M, Liu A, Dharia A, George SG, Taylor M, Davis K, Silber A, Brown LS, Tobin JN. Opioid treatment program-integrated facilitated telemedicine for hepatitis C treatment: a hybrid effectiveness-implementation analysis. BMC Complement Med Ther. 2025 Oct 15;25(1):377. doi: 10.1186/s12906-025-05138-9. | |
| 38865703 |
| Label | URL |
|---|---|
| Related Info | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: 27 Month Usual Care, 9 Months Telemedicine | 27 months of usual care: referral-HCV seropositive subjects enrolled for at least 6 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist. Then, 9 months of telemedicine: patients will be linked with the provider via two-way videoconferencing facilitated by an onsite case manager. |
| FG001 | Sequence 2: 18 Month Usual Care, 18 Months Telemedicine | 18 months of usual care: referral-HCV seropositive subjects enrolled for at least 6 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist. Then, 18 months of telemedicine: patients will be linked with the provider via two-way videoconferencing facilitated by an onsite case manager. |
| FG002 | Sequence 3: 9 Months of Usual Care Followed by 27 Months Telemedicine | 9 months of usual care: referral-HCV seropositive subjects enrolled for at least 6 months in an opiate agonist treatment (OAT) program will be referred to an off-site liver specialist. Then, 27 months of telemedicine: patients will be linked with the provider via two-way videoconferencing facilitated by an onsite case manager. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Months 0-9 |
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| Step 2: Months 10-18 |
| |||||||||||||
| Step 3: Months 19-27 |
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| Period 4: Mos 28-36 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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 |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants enrolled from 12 opioid treatment programs throughout New York State | Posted | Count of Participants | Participants | 12 weeks post treatment cessation |
|
Adverse event data were collected over the entire study period from screening through the two year post-treatment follow up perod.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Talal | University at Buffalo | 7168884737 | AHTALAL@BUFFALO.EDU |
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| 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 | Oct 20, 2023 | Apr 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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Comparison of treatment completion percentages between the two arms. |
| 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).
| Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks). |
| Dickerson SS, George SJ, Ventuneac A, Dharia A, Talal AH. Care Integration for Hepatitis C Virus Treatment Through Facilitated Telemedicine Within Opioid Treatment Programs: Qualitative Study. J Med Internet Res. 2024 Jun 12;26:e53049. doi: 10.2196/53049. |
| 38568601 | Derived | Talal AH, Markatou M, Liu A, Perumalswami PV, Dinani AM, Tobin JN, Brown LS. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial. JAMA. 2024 Apr 23;331(16):1369-1378. doi: 10.1001/jama.2024.2452. |
| 37252770 | Derived | Ventuneac A, Dickerson SS, Dharia A, George SJ, Talal AH. Scaling and Sustaining Facilitated Telemedicine to Expand Treatment Access Among Underserved Populations: A Qualitative Study. Telemed J E Health. 2023 Dec;29(12):1862-1869. doi: 10.1089/tmj.2022.0534. Epub 2023 May 26. |
| 35925809 | Derived | Talal AH, Sofikitou EM, Wang K, Dickerson S, 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 Mar;29(3):395-407. doi: 10.1089/tmj.2022.0189. Epub 2022 Aug 4. |
| Related Info | View source |
| NOT COMPLETED |
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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)
Telemedicine: Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 160 weeks |
|
|
|
| Secondary | Comparison of Treatment Completion Rates | Comparison of treatment completion percentages between the two arms. | Posted | Count of Participants | Participants | Up to 210 weeks |
|
|
|
| Secondary | 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).
| Posted | Number | % participants satisfied or high satisfy | Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks). |
|
|
|
| 3 |
| 312 |
| 0 |
| 312 |
| 0 |
| 312 |
| EG001 | Intervention | 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) Telemedicine: Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member | 9 | 290 | 0 | 290 | 0 | 290 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |