An Automated, Tailored Information Application for Medication Health Literacy

NCT ID: NCT01304186

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus I Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tailored Information

Intervention Type BEHAVIORAL

The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.

Interventions

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Tailored Information

The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.

Intervention Type BEHAVIORAL

Other Intervention Names

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Health literacy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond L Ownby, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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Ziff Health Clinics, Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23293544 (View on PubMed)

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.

Reference Type RESULT
PMID: 22961499 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23446180 (View on PubMed)

Other Identifiers

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R21MH086491

Identifier Type: NIH

Identifier Source: secondary_id

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R21MH086491

Identifier Type: NIH

Identifier Source: org_study_id

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