Adherence, Improvement Measure (AIM) System (AIM)
This study has been completed.
Sponsor:
University of California, San Francisco
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: November 18, 2013
Last verified: November 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patient Compliance AIDS |
Behavioral: SMS medication adherence Behavioral: No SMS adherence reminder |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Adherence, Improvement Measure (AIM) System; Challenge Topic: 10-MH-101 |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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].
Secondary Outcome Measures:
- 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.
| Enrollment: | 99 |
| Study Start Date: | August 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: SMS medication adherence
SMS messages to cell phones.
Other Name: mobile health messages for health conditions and medications
|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252212
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252212
Locations
| United States, California | |
| Ward 86, San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
Sponsors and Collaborators
University of California, San Francisco
The Commonwealth Fund
National Institute of Mental Health (NIMH)
Agency for Healthcare Research and Quality (AHRQ)
Investigators
| Principal Investigator: | James Kahn, MD | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01252212 History of Changes |
| Other Study ID Numbers: | 10-00019 1RC1MH088341 |
| Study First Received: | November 30, 2010 |
| Last Updated: | November 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
HIV, antiretroviral, adherence, SMS, cell phone |
ClinicalTrials.gov processed this record on September 23, 2016