Adherence, Improvement Measure (AIM) System

Study Overview
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Brief Summary
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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.

Official Title
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Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101

Conditions
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Patient Compliance, AIDS

Intervention / Treatment
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* Behavioral: SMS medication adherence
* Behavioral: No SMS adherence reminder


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving SMS alerts<br>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<br>* SMS messages to cell phones.<br>* Other names: mobile health messages for health conditions and medications;|
| Active Comparator: No SMS messages<br>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<br>* 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.<br>* Other names: No medication adherence or disease specific messages.;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, antiretroviral, adherence, SMS, cell phone