Adherence, Improvement Measure (AIM) System

NCT ID: NCT01252212

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Patient Compliance AIDS

Keywords

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HIV, antiretroviral, adherence, SMS, cell phone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMS medication adherence

Intervention Type BEHAVIORAL

SMS messages to cell phones.

No SMS messages

The patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions.

Group Type ACTIVE_COMPARATOR

No SMS adherence reminder

Intervention Type BEHAVIORAL

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.

Interventions

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SMS medication adherence

SMS messages to cell phones.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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mobile health messages for health conditions and medications No medication adherence or disease specific messages.

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


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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Commonwealth Fund

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Kahn, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Ward 86, San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1RC1MH088341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-00019

Identifier Type: -

Identifier Source: org_study_id