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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.
The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled "Care4Today v2.0" versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.
The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV-infected participants assigned standard of care.
The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care4Today v2.0 mobile application + electronic monitoring of adherence | Experimental | Care4Today v2.0 mobile application Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual. Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. |
|
| Electronic monitoring of adherence | No Intervention | Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care4Today v2.0 mobile application + electronic monitoring of adherence | Behavioral | Care4Today mobile application will send automated medication alert messages to HIV-infected persons. The alert messages are customizable and automated, and real-time results are viewable within the application. The Care4Today intervention is designed to improve adherence to ART medications among HIV-infected persons who experience adherence difficulties over standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings | Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: <90% and ≥90% using MEMS caps. | Completion of 30-day intervention |
| Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings | The absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap | Completion of 30-day intervention |
| Percentage of Doses Taken in Dose Time Window | Completion of 30-day intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Moore, Ph.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hnrc-Tmarc | San Diego | California | 92103 | United States |
We enrolled 60 participants for the study cohort. 58 participants completed the initial assessment, 2 decided to discontinue after randomization (both did not wish to use the mobile application and phone for the duration of the study). Additionally, 1 participant decided to no longer participate in research studies between visits one and two.
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| ID | Title | Description |
|---|---|---|
| FG000 | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Care4Today v2.0 mobile application Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual. Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. |
| FG001 | Electronic Monitoring of Adherence | Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Care4Today v2.0 mobile application Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual. Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings | Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: <90% and ≥90% using MEMS caps. | Posted | Count of Participants | Participants | Completion of 30-day intervention |
|
Adverse event data were collected while participants were on study (i.e., 30 days)
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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 | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Care4Today v2.0 mobile application Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual. Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. |
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1) Small sample size; 2) Short time period; 3) MEMS adherence data based on # of cap openings, not directly whether the medication was ingested; 4) No group without psychoeducation component
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David J Moore, Professor of Psychiatry | UCSD HIV Neurobehavioral Research Program (HNRP) | 619-543-5093 | djmoore@ucsd.edu |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| BG001 | Electronic Monitoring of Adherence | Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Mean | Standard Deviation | years |
|
| OG001 | Electronic Monitoring of Adherence | Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. |
|
|
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| Primary | Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings | The absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap | Posted | Mean | Standard Deviation | minutes from target dose time | Completion of 30-day intervention |
|
|
|
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| Primary | Percentage of Doses Taken in Dose Time Window | Posted | Mean | Standard Deviation | Percentage of doses taken in window | Completion of 30-day intervention |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Electronic Monitoring of Adherence | Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. | 0 | 29 | 0 | 29 | 0 | 28 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |