- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304186
An Automated, Tailored Information Application for Medication Health Literacy
February 28, 2013 updated by: Nova Southeastern University
The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection.
The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Health literacy is a critically important problem in improving the effectiveness of health care interventions.
Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects.
An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model.
The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model.
The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application.
Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills.
Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics.
This computer-based program will provide training, test understanding, and if necessary reteach and retest.
It will also provide printed information for participants to take home to provide ongoing prompts.
This study will comprise two phases.
In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials.
In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Fort Lauderdale, Florida, United States, 33328
- Ziff Health Clinics, Nova Southeastern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years or older
- Currently treated with at least one medication for HIV infection
- No change in target medication anticipated in the next two months
- Able to participate in the study intervention in English
Exclusion Criteria:
- Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
- Not able to participate in the intervention using English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored Information
Participants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection.
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The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence
Time Frame: Four weeks after intervention
|
Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.
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Four weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant self-efficacy
Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
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Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
|
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Mood
Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
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Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
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Elements of the Information, Motivation, and Behavioral Skills Model
Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
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A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.
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Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
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Intervention acceptability and usability
Time Frame: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention
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A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.
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Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ownby RL, Waldrop-Valverde D, Caballero J, Jacobs RJ. Baseline medication adherence and response to an electronically delivered health literacy intervention targeting adherence. Neurobehav HIV Med. 2012 Oct 18;4:113-121. doi: 10.2147/NBHIV.S36549.
- Ownby RL, Waldrop-Valverde D, Hardigan P, Caballero J, Jacobs R, Acevedo A. Development and validation of a brief computer-administered HIV-Related Health Literacy Scale (HIV-HL). AIDS Behav. 2013 Feb;17(2):710-8. doi: 10.1007/s10461-012-0301-3.
- Ownby RL, Waldrop-Valverde D, Jacobs RJ, Acevedo A, Caballero J. Cost effectiveness of a computer-delivered intervention to improve HIV medication adherence. BMC Med Inform Decis Mak. 2013 Feb 28;13:29. doi: 10.1186/1472-6947-13-29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
February 18, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (Estimate)
February 25, 2011
Study Record Updates
Last Update Posted (Estimate)
March 1, 2013
Last Update Submitted That Met QC Criteria
February 28, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- R21MH086491 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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