Trial Outcomes & Findings for Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals (NCT NCT02933970)

Last Updated: 2024-12-20

Results Overview

Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)

Recruitment status

COMPLETED

Study phase

Target enrollment

602 participants

Primary outcome timeframe

12 weeks post treatment cessation

Results posted on

2024-12-20

Participant Flow

Unit of analysis: Opioid Treatment Programs

Participant milestones

Participant milestones
Measure	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.	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.	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.
Step 1: Months 0-9 STARTED	52 4	52 4	52 4
Step 1: Months 0-9 COMPLETED	52 4	52 4	52 4
Step 1: Months 0-9 NOT COMPLETED	0 0	0 0	0 0
Step 2: Months 10-18 STARTED	52 4	52 4	52 4
Step 2: Months 10-18 COMPLETED	52 4	52 4	52 4
Step 2: Months 10-18 NOT COMPLETED	0 0	0 0	0 0
Step 3: Months 19-27 STARTED	52 4	48 4	52 4
Step 3: Months 19-27 COMPLETED	52 4	48 4	52 4
Step 3: Months 19-27 NOT COMPLETED	0 0	0 0	0 0
Period 4: Mos 28-36 STARTED	51 4	35 4	52 4
Period 4: Mos 28-36 COMPLETED	51 4	25 4	51 4
Period 4: Mos 28-36 NOT COMPLETED	0 0	10 0	1 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=312 Participants 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 n=290 Participants 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	Total n=602 Participants Total of all reporting groups
Age, Continuous	48.94 years STANDARD_DEVIATION 12.8 • n=5 Participants	47.12 years STANDARD_DEVIATION 13.1 • n=7 Participants	48.06 years STANDARD_DEVIATION 12.97 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants	115 Participants n=7 Participants	233 Participants n=5 Participants
Sex: Female, Male Male	194 Participants n=5 Participants	175 Participants n=7 Participants	369 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	96 Participants n=5 Participants	89 Participants n=7 Participants	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	216 Participants n=5 Participants	201 Participants n=7 Participants	417 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/Ethnicity, Customized White	151 Participants n=5 Participants	155 Participants n=7 Participants	306 Participants n=5 Participants
Race/Ethnicity, Customized Black/AA & Other	161 Participants n=5 Participants	135 Participants n=7 Participants	296 Participants n=5 Participants
Region of Enrollment United States	312 participants n=5 Participants	290 participants n=7 Participants	602 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment cessation

Population: Participants enrolled from 12 opioid treatment programs throughout New York State

Percentage of patients who achieve viral eradication (defined as undetectable HCV RNA for 12 weeks post treatment cessation)

Outcome measures

Outcome measures
Measure	Control n=312 Participants 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 n=290 Participants 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
Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication	106 Participants	246 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=312 Participants 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 n=290 Participants 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
Comparison of Treatment Initiation Percentages	126 Participants	268 Participants

SECONDARY outcome

Timeframe: Up to 210 weeks

Comparison of treatment completion percentages between the two arms.

Outcome measures

Outcome measures
Measure	Control n=312 Participants 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 n=290 Participants 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
Comparison of Treatment Completion Rates	116 Participants	261 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=106 Participants 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 n=238 Participants 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
Comparison of Patient Satisfaction Initial Time point	91.5 % participants satisfied or high satisfy	98.3 % participants satisfied or high satisfy
Comparison of Patient Satisfaction HCV cure time point	91.5 % participants satisfied or high satisfy	98.7 % participants satisfied or high satisfy

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Talal

University at Buffalo

Phone: 7168884737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place