Adherence, Improvement Measure (AIM) System

This study has been completed.
Sponsor:
Collaborators:
The Commonwealth Fund
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01252212
First received: November 30, 2010
Last updated: November 18, 2013
Last verified: November 2013

November 30, 2010
November 18, 2013
August 2010
February 2012   (final data collection date for primary outcome measure)
HIV viral load [ Time Frame: 12 month ] [ Designated as safety issue: No ]
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].
Same as current
Complete list of historical versions of study NCT01252212 on ClinicalTrials.gov Archive Site
Level of antiretroviral medication in hair [ Time Frame: 12 month ] [ Designated as safety issue: No ]
We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.
Same as current
Not Provided
Not Provided
 
Adherence, Improvement Measure (AIM) System
Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Patient Compliance
  • AIDS
  • Behavioral: SMS medication adherence
    SMS messages to cell phones.
    Other Name: mobile health messages for health conditions and medications
  • 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.
  • 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.
    Intervention: Behavioral: SMS medication adherence
  • 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.
    Intervention: Behavioral: No SMS adherence reminder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
December 2012
February 2012   (final data collection date for primary outcome measure)

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

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01252212
10-00019, 1RC1MH088341
No
University of California, San Francisco
University of California, San Francisco
  • The Commonwealth Fund
  • National Institute of Mental Health (NIMH)
  • Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: James Kahn, MD University of California, San Francisco
University of California, San Francisco
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP