Adherence, Improvement Measure (AIM) System

This study is ongoing, but not recruiting participants.

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

ClinicalTrials.gov Identifier:

NCT01252212

First received: November 30, 2010

Last updated: September 15, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2010

Last Updated Date

September 15, 2011

Start Date ^ICMJE

August 2010

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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].

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01252212 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Adherence, Improvement Measure (AIM) System

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Patient Compliance
AIDS

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

November 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01252212

Other Study ID Numbers ^ICMJE

10-00019, 1RC1MH088341

Has Data Monitoring Committee

Responsible Party

University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

The Commonwealth Fund
National Institute of Mental Health (NIMH)
Agency for Healthcare Research and Quality (AHRQ)

Investigators ^ICMJE

Principal Investigator:

James Kahn, MD

University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

September 2011

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

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