An Automated, Tailored Information Application for Medication Health Literacy - Full Text View

Purpose

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.

Condition	Intervention
Human Immunodeficiency Virus I Infection	Behavioral: Tailored Information

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Automated, Tailored Information Application for Medication Health Literacy

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Health Literacy

U.S. FDA Resources

Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:

Medication adherence [ Time Frame: Four weeks after intervention ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Participant self-efficacy [ Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
Mood [ Time Frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.
Intervention acceptability and usability [ Time Frame: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention ] [ Designated as safety issue: No ]
A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.

Enrollment:	124
Study Start Date:	June 2010
Study Completion Date:	June 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: Tailored Information The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion. Other Name: Health literacy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304186

Locations

United States, Florida
Ziff Health Clinics, Nova Southeastern University
Fort Lauderdale, Florida, United States, 33328

Sponsors and Collaborators

Nova Southeastern University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Raymond L Ownby, MD, PhD

Nova Southeastern University

More Information

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Nova Southeastern University
ClinicalTrials.gov Identifier:	NCT01304186 History of Changes
Other Study ID Numbers:	R21MH086491, R21MH086491
Study First Received:	February 18, 2011
Last Updated:	February 28, 2013
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Nova Southeastern University:

Health literacy
HIV
Medication Adherence
IMB Model

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013