Hepatitis C
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERTelemedicine
Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
Sponsors
Patient-Centered Outcomes Research Institute
Andrew Talal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HCV antibody detected 2. Ability and willingness of subject or legal representative to provide written informed consent. 3. 18 years of age 4. A minimum of 12-month enrollment in the opiate agonist treatment program 5. Likely to be adherent to the therapeutic regimen 6. Covered by medical insurance
Exclusion criteria
1. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain. 2. \<18 years of age 3. \< 12 months enrolled in an opiate agonist treatment program. 4. Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI. 5. Lack of medical insurance coverage 6. Ineligibility for HCV treatment 7. Active treatment for HCV at the time of the study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication | 12 weeks post treatment cessation | Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Treatment Initiation Percentages | Up to 160 weeks | Comparison of treatment initiation percentages between the two arms, as measured by the percentage of patients that take an initial medication dose. |
| Comparison of Treatment Completion Rates | Up to 210 weeks | Comparison of treatment completion percentages between the two arms. |
| Comparison of Patient Satisfaction | Baseline (initial time point) and at time HCV is cured, i.e., sustained virological response (up to 210 weeks). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 312 |
| 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 | 290 |
| Total | 602 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 47.12 years STANDARD_DEVIATION 13.1 | 48.06 years STANDARD_DEVIATION 12.97 | 48.94 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 89 Participants | 185 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 201 Participants | 417 Participants | 216 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/AA & Other | 135 Participants | 296 Participants | 161 Participants |
| Race/Ethnicity, Customized White | 155 Participants | 306 Participants | 151 Participants |
| Region of Enrollment United States | 290 participants | 602 participants | 312 participants |
| Sex: Female, Male Female | 115 Participants | 233 Participants | 118 Participants |
| Sex: Female, Male Male | 175 Participants | 369 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 312 | 9 / 290 |
| other Total, other adverse events | 0 / 312 | 0 / 290 |
| serious Total, serious adverse events | 0 / 312 | 0 / 290 |
Outcome results
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)
Time frame: 12 weeks post treatment cessation
Population: Participants enrolled from 12 opioid treatment programs throughout New York State
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication | 106 Participants |
| Intervention | Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication | 246 Participants |
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). 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Comparison of Patient Satisfaction | Initial Time point | 91.5 % participants satisfied or high satisfy |
| Control | Comparison of Patient Satisfaction | HCV cure time point | 91.5 % participants satisfied or high satisfy |
| Intervention | Comparison of Patient Satisfaction | Initial Time point | 98.3 % participants satisfied or high satisfy |
| Intervention | Comparison of Patient Satisfaction | HCV cure time point | 98.7 % participants satisfied or high satisfy |
Secondary
Comparison of Treatment Completion Rates
Comparison of treatment completion percentages between the two arms.
Time frame: Up to 210 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Comparison of Treatment Completion Rates | 116 Participants |
| Intervention | Comparison of Treatment Completion Rates | 261 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.
Time frame: Up to 160 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Comparison of Treatment Initiation Percentages | 126 Participants |
| Intervention | Comparison of Treatment Initiation Percentages | 268 Participants |