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Adherence, Improvement Measure (AIM) System (AIM)

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ClinicalTrials.gov Identifier: NCT01252212
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : November 20, 2013
Sponsor:
Collaborators:
The Commonwealth Fund
National Institute of Mental Health (NIMH)
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Patient Compliance AIDS Behavioral: SMS medication adherence Behavioral: No SMS adherence reminder Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101
Study Start Date : August 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Receiving SMS alerts
The patients randomized to this arm will have a SMS message sent to them regarding medication adherence for antiretroviral medications, anti-hypertensive medications, anti-depressants, hyperglycemic controlling medications and hypercholesterolemia controlling medications as well as life style supportive suggestions.
 Behavioral: SMS medication adherence
SMS messages to cell phones.
Other Name: mobile health messages for health conditions and medications
Active Comparator: No SMS messages
The patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions.
 Behavioral: No SMS adherence reminder
In this arm, patients will be sent supportive lifestyle suggestions to their phone using SMS technology but will not be sent a reminder regarding their medication adherence.
Other Name: No medication adherence or disease specific messages.


Outcome Measures
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Primary Outcome Measures :
  1. HIV viral load [ Time Frame: 12 month ]
    The primary analyses of the 12-month trial data will compare the two study groups with respect to (i) change from baseline in CD4 T-cell count; and (ii) proportion of patients whose HIV viral load (VL) level is detectable. We will use repeated-measures analysis techniques to estimate longitudinal prevalence at the population level (via generalized estimating equations) and at the individual levels (via generalized linear mixed models)[25].


Secondary Outcome Measures :
  1. Level of antiretroviral medication in hair [ Time Frame: 12 month ]
    We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18
  • Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests
  • Detectable Viral Load, based on patient's medical record
  • Receiving primary medical care at the AIDS Program at SFGH
  • Able and willing to give informed consent to be randomized to study arms
  • Willing to use the patient portal
  • Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH

Exclusion Criteria:

Failure to meet inclusion criteria

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252212


Locations
United States, California
Ward 86, San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
The Commonwealth Fund
National Institute of Mental Health (NIMH)
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: James Kahn, MD University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01252212     History of Changes
Other Study ID Numbers: 10-00019
1RC1MH088341 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by University of California, San Francisco:
HIV, antiretroviral, adherence, SMS, cell phone