Care4Today v2.0 Application for Improving Adherence to HIV Medications

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT02001064
• Collaborator: Janssen Research & Development, LLC (Industry)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV; AIDS	Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 Medication Event Monitoring System (MEMS) cap.	Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence; 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.
No Intervention: Electronic monitoring of adherence Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap.

Outcome Measures

Primary Outcome Measures

1. Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings [Completion of 30-day intervention]

   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.

2. Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings [Completion of 30-day intervention]

   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

3. Percentage of Doses Taken in Dose Time Window [Completion of 30-day intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to provide informed consent

• 18 years or older at the time of enrollment

• HIV-infected

• Taking at least one medication to treat HIV illness

• Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence

• Willingness to use electronic monitoring caps to track ART medication

• Willingness to respond to application alert messages

Exclusion Criteria:

• Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features

• Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke)

• Unwillingness or inability to use electronic medication monitoring technology

• Unwillingness or inability to use daily alert messages

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hnrc-Tmarc	San Diego	California	United States	92103

Sponsors and Collaborators

• University of California, San Diego
• Janssen Research & Development, LLC

Investigators

• Principal Investigator: David J. Moore, Ph.D., University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David J. Moore, Ph.D., Professor of Psychiatry, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT02001064
• Other Study ID Numbers: Care4Today-13
• First Posted: Dec 4, 2013
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by David J. Moore, Ph.D., Professor of Psychiatry, University of California, San Diego: interventions; technology; adherence; ARV

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence	Electronic Monitoring of Adherence
Arm/Group Description	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.	Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
Period Title: Overall Study
STARTED	30	30
COMPLETED	28	29
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence	Electronic Monitoring of Adherence	Total
Arm/Group Description	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.	Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.	Total of all reporting groups
Overall Participants	28	29	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (9.6)	48.5 (9.5)	49.2 (9.4)
Sex: Female, Male (Count of Participants)
Female	4 14.3%	2 6.9%	6 10.5%
Male	24 85.7%	27 93.1%	51 89.5%
Race/Ethnicity, Customized (participants) [Number]
Non-Hispanic White	14 50%	15 51.7%	29 50.9%
Non-Hispanic Black	12 42.9%	8 27.6%	20 35.1%
Hispanic	1 3.6%	5 17.2%	6 10.5%
Other	1 3.6%	1 3.4%	2 3.5%
Region of Enrollment (participants) [Number]
United States	28 100%	29 100%	57 100%
Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.9 (2.2)	12.9 (2.9)	13.4 (2.6)

Outcome Measures

1. Primary Outcome

Title	Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
Description	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.
Time Frame	Completion of 30-day intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence	Electronic Monitoring of Adherence
Arm/Group Description	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.	Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
Measure Participants	28	29
Count of Participants [Participants]	9 32.1%	5 17.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence, Electronic Monitoring of Adherence
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
Description	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
Time Frame	Completion of 30-day intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence	Electronic Monitoring of Adherence
Arm/Group Description	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.	Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
Measure Participants	28	29
Mean (Standard Deviation) [minutes from target dose time]	112.0 (112.0)	146.7 (101.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence, Electronic Monitoring of Adherence
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.073
	Comments	Cohen's d (ranks) = -.049
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Percentage of Doses Taken in Dose Time Window
Time Frame	Completion of 30-day intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence	Electronic Monitoring of Adherence
Arm/Group Description	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.	Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
Measure Participants	28	29
Mean (Standard Deviation) [Percentage of doses taken in window]	66.8 (27.0)	57.5 (32.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence, Electronic Monitoring of Adherence
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments	Cohen's d=0.31
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse event data were collected while participants were on study (i.e., 30 days)
Arm/Group Title	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence		Electronic Monitoring of Adherence
Arm/Group Description	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.		Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
All Cause Mortality
	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence		Electronic Monitoring of Adherence
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)
Serious Adverse Events
	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence		Electronic Monitoring of Adherence
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence		Electronic Monitoring of Adherence
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.