Adherence, Improvement Measure (AIM) System

NCT01252212 | Completed Phase 3

• 2 other identifiers: 10-000191RC1MH088341
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Compliance; AIDS

Keywords

HIV, antiretroviral, adherence, SMS, cell phone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of antiretroviral medication in hair

  12 month

Study Arms (2)

Receiving SMS alerts

EXPERIMENTAL

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

No SMS messages

ACTIVE COMPARATOR

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

Interventions

SMS medication adherence BEHAVIORAL

SMS messages to cell phones.

Also known as: mobile health messages for health conditions and medications

Receiving SMS alerts

No SMS adherence reminder 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.

Also known as: No medication adherence or disease specific messages.

No SMS messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• The Commonwealth Fund: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Ward 86, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Patient Compliance; Acquired Immunodeficiency Syndrome

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• James Kahn, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

US (1)