Adherence, Improvement Measure (AIM) System

Phase 3

Completed

• Conditions: Patient Compliance; AIDS
• Interventions: Behavioral: SMS medication adherence; Behavioral: No SMS adherence reminder

• Registration Number: NCT01252212
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-02
• Primary Completion: 2012-02
• Study Completion: 2012-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

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Exclusion Criteria

Failure to meet inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receiving SMS alerts	SMS medication adherence	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.
No SMS messages	No SMS adherence reminder	The patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions.

Primary Outcome Measures

Name	Time	Method
HIV viral load	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

Name	Time	Method
Level of antiretroviral medication in hair	12 month	We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.

Trial Locations

Locations (1)

Ward 86, San Francisco General Hospital; 🇺🇸 San Francisco, California, United States