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NCT Number: NCT01252212

Adherence, Improvement Measure (AIM) System

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ward 86, San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

SMS medication adherence

Behavioral

SMS messages to cell phones.

Other names: mobile health messages for health conditions and medications

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.

Other names: No medication adherence or disease specific messages.

Primary outcomes

  1. HIV viral load

    Time frame: 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 outcomes

  1. Level of antiretroviral medication in hair

    Time frame: 12 month

    We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Acronym: AIM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2010
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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