Trial Outcomes & Findings for Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs (NCT NCT03127358)
NCT ID: NCT03127358
Last Updated: 2021-09-14
Results Overview
The amount of medication taken by each patient during the treatment period is expressed as a percentage (range 0-100%). Subjects will be classified as "adherent" if they receive at least 80% of the total dose of Zepatier. The numbers below denotes the mean percent of the medication the participants in each arm took.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-09-14
Participant Flow
Recruitment dates were from 11/14/17 to 7/20/18, during which 11 participants were recruited and enrolled into the study. Participants were recruited from a Montefiore Medical Center opioid treatment program in the Bronx. Participants were identified through chart review and provider referral, and through participant self-referral.
Participant milestones
| Measure |
AiCure App
Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.
AiCure: Smartphone App
|
Treatment As Usual
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
|
AiCure With Gamification
Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.
AiCure with gamification: Smartphone App with gaming.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
Baseline characteristics by cohort
| Measure |
AiCure App
n=3 Participants
Direct Observed Therapy via the AiCure app (a-DOT)
|
Treatment As Usual
n=3 Participants
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
|
AiCure With Gamification
n=5 Participants
Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.
AiCure with gamification: Smartphone App with gaming.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
60 years
n=7 Participants
|
58 years
n=5 Participants
|
57 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe amount of medication taken by each patient during the treatment period is expressed as a percentage (range 0-100%). Subjects will be classified as "adherent" if they receive at least 80% of the total dose of Zepatier. The numbers below denotes the mean percent of the medication the participants in each arm took.
Outcome measures
| Measure |
AiCure With Gamification
n=5 Participants
Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.
AiCure with gamification: Smartphone App with gaming.
5 out 5 patients completed HCV treatment.
|
AiCure App
n=3 Participants
Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.
AiCure: Smartphone App
3 out 3 patients achieved SVR.
|
Treatment As Usual
n=3 Participants
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
3 out 3 patients achieved SVR.
|
|---|---|---|---|
|
HCV Treatment Adherence
|
88 percent of medication taken
Interval 0.0 to 100.0
|
83 percent of medication taken
Interval 0.0 to 100.0
|
100 percent of medication taken
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 weeksParticipants will be considered to have completed treatment if they have completed at least 80% of the planned treatment course (e.g. at least 10 week of 12-week course).
Outcome measures
| Measure |
AiCure With Gamification
n=5 Participants
Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.
AiCure with gamification: Smartphone App with gaming.
5 out 5 patients completed HCV treatment.
|
AiCure App
n=3 Participants
Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.
AiCure: Smartphone App
3 out 3 patients achieved SVR.
|
Treatment As Usual
n=3 Participants
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
3 out 3 patients achieved SVR.
|
|---|---|---|---|
|
Number of Participants With HCV Treatment Completion
|
5 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatmentHCV viral load undectable 12 weeks after treatment completion. Undetectable HCV viral load is defined as \<15 IU/ml and "target not detected". IU refers to "international units".One of the main outcomes looked for was the amount of patients who achieved Sustained Virologic Response (SVR) at 12 weeks post treatment, which denotes a cure of Hepatitis C.
Outcome measures
| Measure |
AiCure With Gamification
n=5 Participants
Sub-group of participants will use a-DOT technology called AiCure (a Smartphone app) with gaming to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks. The gaming feature is to test whether competition encourages engagement and helps to increase adherence to the HCV medication.
AiCure with gamification: Smartphone App with gaming.
5 out 5 patients completed HCV treatment.
|
AiCure App
n=3 Participants
Participants will use a-DOT technology called AiCure (a Smartphone App) to track ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks.
AiCure: Smartphone App
3 out 3 patients achieved SVR.
|
Treatment As Usual
n=3 Participants
Participants will receive treatment for ingestion of fixed-dose Elbasvir and Grazoprevir, 1 tablet, 50mg-100mg of each drug, respectively, daily for 12 weeks without using the AiCure app.
3 out 3 patients achieved SVR.
|
|---|---|---|---|
|
Number of Participants With Sustained Viral Response (SVR)
|
100 percent of patients with SVR
|
100 percent of patients with SVR
|
100 percent of patients with SVR
|
Adverse Events
AiCure App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment As Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AiCure With Gamification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place