Hepatitis CNCT02740556
Evaluation of HepCure Toolkit to Improve Harvoni Adherence
A study testing HepCure ToolKit, AdhereTech Active Features and AdhereTech Passive Monitoring in people with Hepatitis C and Medication Adherence, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Hepatitis C, Medication Adherence
- What is being tested?
- HepCure ToolKit, AdhereTech Active Features and AdhereTech Passive Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age18 years and older
- Being prescribed Harvoni for treatment of HCV and not yet started treatment
- Speak and read English
- Possessing a smartphone device
- Ability to use a smartphone device
- Registered with a physician currently using the HepCure Provider Dashboard.
- Speak and read English
Who cannot join
- Individuals with diminished mental capacity who are unable to give informed consent
- Prisoners
- Participants who do not speak or write in English as a primary language
- Participants who are unable to speak and read English
- Participants who are expected to have difficult with regular access to smart phone device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal of this study is to evaluate the baseline level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to the level of adherence in patients provided with additional adherence support. Medication adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the form of a dashboard for medical providers (MDs and NPs) and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to set medication reminders, record doses taken, and communicate their adherence to their medical provider using the provider dashboard.
Read the detailed description
Primary Objectives:
The study will be conducted in two phases with the following aims: (1) To passively assess the adherence to hepatitis C virus (HCV) treatment with ledipasvir/sofosbuvir using a wireless pill monitoring device in 33 patients (Phase 1, months 1-3). (2) To test the impact on adherence of using the active wireless pill monitoring device in conjunction with the HepCure web-based tool kit in 66 patients (Phase 2, months 4-9). Participants in phase 2 will be randomized 1:1 to one of two conditions: (a) Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard; AdhereTech passively monitoring adherence. (b) Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard; AdhereTech actively monitoring adherence (chimes and reminders enabled).
Secondary Objectives:
The study design allows us to compare the additive effect on adherence of the HepCure provider toolkit and the HepCure provider toolkit + active AdhereTech reminder system.
Primary Endpoints:
The primary study endpoints are taking and timing adherence as assessed by electronic monitoring. There are numerous methods of assessing adherence to medication. They each have their strengths and weaknesses, and some are only feasible in the research but not clinical setting. The most commonly used methods of assessing adherence are (1) provider assessment, (2) structured self-report (3) pharmacy refill data (4) electronic monitoring (5) pill counts and (6) directly observed therapy. Electronic monitoring technology has been widely used in research studies of HIV medication adherence and is regarded by many as the most accurate method of assessing medication adherence (Weiss et al. 2009). In this method, the medication bottle cap has a microchip which records all openings and closings of the bottle. This microchip provides the researcher with a precise record of the date and time of each bottle opening. This method has been shown to be closely associated with random home pill count (Bangsberg et al., 2001a), viral suppression (Bangsberg et al., 2000; Paterson et al., 2000; Arnsten et al., 2001; Walsh et al., 2002b; Moss et al., 2004), and drug resistance (Walsh et al., 2002b). Studies have consistently found that provider assessment of adherence is poor (Bangsberg et al., 2001b; Gross et al., 2002; and Miller et al., 2002). Self-reported adherence tends to provide an over-estimate of actual adherence (Weiss et al. 2009). Pharmacy refill data is best employed when patients use one pharmacy for all prescriptions, pharmacy data are easily accessible to the clinician by computer, and prescriptions are not automatically delivered without the patient needing to request them or pick them up. Patients in clinical research studies are often asked to bring their medication to study visits so that the change in the number of pills (accounting for refills) since the last visit can be used to assess adherence. Potential problems associated with these announced pill counts are that patients may forget to bring their medication to study visits, and nonadherent patients may throw out pills prior to the visit ("pill dumps") to avoid being labeled nonadherent. While directly observed therapy (DOT) provides a highly accurate assessment of adherence, the cost and intrusiveness of observing all doses of medication ingestion make it an impractical method of ARV adherence assessment, except in very specific settings (e.g., prisons or nursing homes).
- Conditions
- Hepatitis C, Medication Adherence
- Being tested
- HepCure ToolKit, AdhereTech Active Features, AdhereTech Passive Monitoring
- Keywords
- Hepatitis C, Adherence, Adheretech, HepCure, Telehealth, Health apps
- Medical subject headings
- Hepatitis C, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepCure ToolKitOther
HepCure is a web-based tool kit in the form of a dashboard for providers and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to enter prescribed treatment, add medications to "Pill Box," log doses, visualize adherence, and includes several additional resources.
AdhereTech Active FeaturesDevice
AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. It is a HIPAA-compliant, FDA-registered Class I medical device. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication.
AdhereTech Passive MonitoringOther
AdhereTech passively monitors adherence (no chimes or reminders)
| Study group | Role | What they receive |
|---|---|---|
| AdhereTech Passive Monitoring | Placebo comparator | Patients not using the HepCure patient app while AdhereTech passively monitors adherence (no chimes or reminders). Receives: Other: AdhereTech Passive Monitoring |
| HepCure Toolkit | Experimental | Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard with AdhereTech passively monitoring adherence (no chimes or reminders). Receives: Other: HepCure ToolKit; Other: AdhereTech Passive Monitoring |
| HepCure Toolkit and AdhereTech Active Features | Experimental | Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard and with AdhereTech actively monitoring adherence (chimes and reminders enabled). Receives: Other: HepCure ToolKit; Device: AdhereTech Active Features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
AdhereTech bottles use sensors to provide a timestamp of when the bottle cap was open and closed.
Measured: up to 9 months
Secondary outcomes (1)
HCV RNA
The Sustained Viral Response (SVR) outcome will be monitored until the patient attains sustained virologic response post-treatment measured by HCV RNA from medical record.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Jeffrey J Weiss, PhD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740556
- Sponsor's protocol ID
- GCO 15-1273
- Other IDs
- GS-IN-US-337-3933
- Status last verified
- Mar 2020
- First submitted
- 12 Apr 2016
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang CJ, Buono D, Eckholdt H, Howard AA, Schoenbaum EE. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001 Oct 15;33(8):1417-23. doi: 10.1086/323201. Epub 2001 Sep 5.
PubMed 11550118Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, Bamberger JD, Chesney MA, Moss A. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000 Mar 10;14(4):357-66. doi: 10.1097/00002030-200003100-00008.
PubMed 10770537Bangsberg DR, Hecht FM, Charlebois E, Chesney M, and Moss AR (2001a). Comparing objective methods of adherence assessment: electronic medication monitoring and unannounced pill count. AIDS Behav 5:275-281.
Bangsberg DR, Perry S, Charlebois ED, Clark RA, Roberston M, Zolopa AR, Moss A. Non-adherence to highly active antiretroviral therapy predicts progression to AIDS. AIDS. 2001 Jun 15;15(9):1181-3. doi: 10.1097/00002030-200106150-00015. No abstract available.
PubMed 11416722Fennie KP, Bova CA, Williams AB. Adjusting and censoring electronic monitoring device data. Implications for study outcomes. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S88-95. doi: 10.1097/01.qai.0000248336.97814.2f.
PubMed 17133208Gross R, Bilker WB, Friedman HM, Coyne JC, Strom BL. Provider inaccuracy in assessing adherence and outcomes with newly initiated antiretroviral therapy. AIDS. 2002 Sep 6;16(13):1835-7. doi: 10.1097/00002030-200209060-00021.
PubMed 12218400Miller LG, Liu H, Hays RD, Golin CE, Beck CK, Asch SM, Ma Y, Kaplan AH, Wenger NS. How well do clinicians estimate patients' adherence to combination antiretroviral therapy? J Gen Intern Med. 2002 Jan;17(1):1-11. doi: 10.1046/j.1525-1497.2002.09004.x.
PubMed 11903770Moss AR, Hahn JA, Perry S, Charlebois ED, Guzman D, Clark RA, Bangsberg DR. Adherence to highly active antiretroviral therapy in the homeless population in San Francisco: a prospective study. Clin Infect Dis. 2004 Oct 15;39(8):1190-8. doi: 10.1086/424008. Epub 2004 Sep 27.
PubMed 15486844Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.
PubMed 10877736Walsh JC, Pozniak AL, Nelson MR, Mandalia S, Gazzard BG. Virologic rebound on HAART in the context of low treatment adherence is associated with a low prevalence of antiretroviral drug resistance. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):278-87. doi: 10.1097/00126334-200207010-00003.
PubMed 12131564Weiss JJ, Brau N, Stivala A, Swan T, Fishbein D. Review article: adherence to medication for chronic hepatitis C - building on the model of human immunodeficiency virus antiretroviral adherence research. Aliment Pharmacol Ther. 2009 Jul;30(1):14-27. doi: 10.1111/j.1365-2036.2009.04004.x. Epub 2009 Mar 26.
PubMed 19416131
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HepCure Toolkit to Improve Harvoni Adherence
- ClinicalTrials.gov ID
- NCT02740556
- Acronym / sponsor ID
- GCO 15-1273
- Conditions
- Hepatitis C, Medication Adherence
- Keywords
- Hepatitis C, Adherence, Adheretech, HepCure, Telehealth, Health apps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Feb 2016
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal of this study is to evaluate the baseline level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to the level of adherence in patients provided with additional adherence support. Medication adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the form of a dashboard for medical providers (MDs and NPs) and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to set medication reminders, record doses taken, and communicate their adherence to their medical provider using the provider dashboard.
Detailed description
Primary Objectives:
The study will be conducted in two phases with the following aims: (1) To passively assess the adherence to hepatitis C virus (HCV) treatment with ledipasvir/sofosbuvir using a wireless pill monitoring device in 33 patients (Phase 1, months 1-3). (2) To test the impact on adherence of using the active wireless pill monitoring device in conjunction with the HepCure web-based tool kit in 66 patients (Phase 2, months 4-9). Participants in phase 2 will be randomized 1:1 to one of two conditions: (a) Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard; AdhereTech passively monitoring adherence. (b) Patients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard; AdhereTech actively monitoring adherence (chimes and reminders enabled).
Secondary Objectives:
The study design allows us to compare the additive effect on adherence of the HepCure provider toolkit and the HepCure provider toolkit + active AdhereTech reminder system.
Primary Endpoints:
The primary study endpoints are taking and timing adherence as assessed by electronic monitoring. There are numerous methods of assessing adherence to medication. They each have their strengths and weaknesses, and some are only feasible in the research but not clinical setting. The most commonly used methods of assessing adherence are (1) provider assessment, (2) structured self-report (3) pharmacy refill data (4) electronic monitoring (5) pill counts and (6) directly observed therapy. Electronic monitoring technology has been widely used in research studies of HIV medication adherence and is regarded by many as the most accurate method of assessing medication adherence (Weiss et al. 2009). In this method, the medication bottle cap has a microchip which records all openings and closings of the bottle. This microchip provides the researcher with a precise record of the date and time of each bottle opening. This method has been shown to be closely associated with random home pill count (Bangsberg et al., 2001a), viral suppression (Bangsberg et al., 2000; Paterson et al., 2000; Arnsten et al., 2001; Walsh et al., 2002b; Moss et al., 2004), and drug resistance (Walsh et al., 2002b). Studies have consistently found that provider assessment of adherence is poor (Bangsberg et al., 2001b; Gross et al., 2002; and Miller et al., 2002). Self-reported adherence tends to provide an over-estimate of actual adherence (Weiss et al. 2009). Pharmacy refill data is best employed when patients use one pharmacy for all prescriptions, pharmacy data are easily accessible to the clinician by computer, and prescriptions are not automatically delivered without the patient needing to request them or pick them up. Patients in clinical research studies are often asked to bring their medication to study visits so that the change in the number of pills (accounting for refills) since the last visit can be used to assess adherence. Potential problems associated with these announced pill counts are that patients may forget to bring their medication to study visits, and nonadherent patients may throw out pills prior to the visit ("pill dumps") to avoid being labeled nonadherent. While directly observed therapy (DOT) provides a highly accurate assessment of adherence, the cost and intrusiveness of observing all doses of medication ingestion make it an impractical method of ARV adherence assessment, except in very specific settings (e.g., prisons or nursing homes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AdhereTech Passive Monitoring | Placebo comparator | Other: AdhereTech Passive MonitoringPatients not using the HepCure patient app while AdhereTech passively monitors adherence (no chimes or reminders). |
| HepCure Toolkit | Experimental | Other: HepCure ToolKit, Other: AdhereTech Passive MonitoringPatients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard with AdhereTech passively monitoring adherence (no chimes or reminders). |
| HepCure Toolkit and AdhereTech Active Features | Experimental | Other: HepCure ToolKit, Device: AdhereTech Active FeaturesPatients using the HepCure patient app linked to a provider using the HepCure Provider Dashboard and with AdhereTech actively monitoring adherence (chimes and reminders enabled). |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age18 years and older
- Being prescribed Harvoni for treatment of HCV and not yet started treatment
- Speak and read English
- Possessing a smartphone device
- Ability to use a smartphone device
Key exclusion criteria (5 listed)
- Individuals with diminished mental capacity who are unable to give informed consent
- Prisoners
- Participants who do not speak or write in English as a primary language
- Participants who are unable to speak and read English
- Participants who are expected to have difficult with regular access to smart phone device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepCure ToolKitHepCure is a web-based tool kit in the form of a dashboard for providers and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to enter prescribed treatment, add medications to "Pill Box," log doses, visualize adherence, and includes several additional resources. | Other | HepCure Toolkit, HepCure Toolkit and AdhereTech Active Features |
| AdhereTech Active FeaturesAdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. It is a HIPAA-compliant, FDA-registered Class I medical device. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication. | Device | HepCure Toolkit and AdhereTech Active Features |
| AdhereTech Passive MonitoringAdhereTech passively monitors adherence (no chimes or reminders) | Other | AdhereTech Passive Monitoring, HepCure Toolkit |
Primary outcome
Medication Adherence
Time frame: up to 9 months
AdhereTech bottles use sensors to provide a timestamp of when the bottle cap was open and closed.
1 secondary outcome
HCV RNA
Time frame: up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Background: PubMed 11550118Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang CJ, Buono D, Eckholdt H, Howard AA, Schoenbaum EE. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001 Oct 15;33(8):1417-23. doi: 10.1086/323201. Epub 2001 Sep 5.
- Background: PubMed 10770537Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, Bamberger JD, Chesney MA, Moss A. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000 Mar 10;14(4):357-66. doi: 10.1097/00002030-200003100-00008.
- BackgroundBangsberg DR, Hecht FM, Charlebois E, Chesney M, and Moss AR (2001a). Comparing objective methods of adherence assessment: electronic medication monitoring and unannounced pill count. AIDS Behav 5:275-281.
- Background: PubMed 11416722Bangsberg DR, Perry S, Charlebois ED, Clark RA, Roberston M, Zolopa AR, Moss A. Non-adherence to highly active antiretroviral therapy predicts progression to AIDS. AIDS. 2001 Jun 15;15(9):1181-3. doi: 10.1097/00002030-200106150-00015. No abstract available.
- Background: PubMed 17133208Fennie KP, Bova CA, Williams AB. Adjusting and censoring electronic monitoring device data. Implications for study outcomes. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S88-95. doi: 10.1097/01.qai.0000248336.97814.2f.
- Background: PubMed 12218400Gross R, Bilker WB, Friedman HM, Coyne JC, Strom BL. Provider inaccuracy in assessing adherence and outcomes with newly initiated antiretroviral therapy. AIDS. 2002 Sep 6;16(13):1835-7. doi: 10.1097/00002030-200209060-00021.
- Background: PubMed 11903770Miller LG, Liu H, Hays RD, Golin CE, Beck CK, Asch SM, Ma Y, Kaplan AH, Wenger NS. How well do clinicians estimate patients' adherence to combination antiretroviral therapy? J Gen Intern Med. 2002 Jan;17(1):1-11. doi: 10.1046/j.1525-1497.2002.09004.x.
- Background: PubMed 15486844Moss AR, Hahn JA, Perry S, Charlebois ED, Guzman D, Clark RA, Bangsberg DR. Adherence to highly active antiretroviral therapy in the homeless population in San Francisco: a prospective study. Clin Infect Dis. 2004 Oct 15;39(8):1190-8. doi: 10.1086/424008. Epub 2004 Sep 27.
- Background: PubMed 10877736Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.
- Background: PubMed 12131564Walsh JC, Pozniak AL, Nelson MR, Mandalia S, Gazzard BG. Virologic rebound on HAART in the context of low treatment adherence is associated with a low prevalence of antiretroviral drug resistance. J Acquir Immune Defic Syndr. 2002 Jul 1;30(3):278-87. doi: 10.1097/00126334-200207010-00003.
- Background: PubMed 19416131Weiss JJ, Brau N, Stivala A, Swan T, Fishbein D. Review article: adherence to medication for chronic hepatitis C - building on the model of human immunodeficiency virus antiretroviral adherence research. Aliment Pharmacol Ther. 2009 Jul;30(1):14-27. doi: 10.1111/j.1365-2036.2009.04004.x. Epub 2009 Mar 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Weiss, PhD, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HepCure ToolKit, AdhereTech Active Features and AdhereTech Passive Monitoring in people with Hepatitis C and Medication Adherence, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740556, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.