Adherence, Improvement Measure (AIM) System (AIM)

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.

Study Overview

• Status: Completed
• Conditions: AIDS; Patient Compliance
• Intervention / Treatment: Behavioral: SMS medication adherence; Behavioral: No SMS adherence reminder

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Ward 86, San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: No medication adherence or disease specific messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV viral load	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].	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of antiretroviral medication in hair	We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.	12 month

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH); The Commonwealth Fund; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: James Kahn, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: HIV, antiretroviral, adherence, SMS, cell phone
• Other Study ID Numbers: 10-00019; 1RC1MH088341 (U.S. NIH Grant/Contract)