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Completed

NCT Number: NCT01304186

An Automated, Tailored Information Application for Medication Health Literacy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziff Health Clinics, Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tailored Information

Behavioral

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

Other names: Health literacy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Participant self-efficacy

    Time frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention

  2. Mood

    Time frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention

  3. 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

    A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.

  4. Intervention acceptability and usability

    Time frame: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention

    A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 25, 2011
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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