Adherence, Improvement Measure (AIM) System

AIDS Clinical Trial

— AIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252212
• Other study ID #: 10-00019
• Secondary ID: 1RC1MH088341
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2010
• Last updated: November 18, 2013
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• AIDS
• Patient Compliance

Intervention

Behavioral:
• SMS medication adherence
SMS messages to cell phones.
• 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.

Locations

Country	Name	City	State
United States	Ward 86, San Francisco General Hospital	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Agency for Healthcare Research and Quality (AHRQ), National Institute of Mental Health (NIMH), The Commonwealth Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Level of antiretroviral medication in hair	We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.	12 month	No