An Automated, Tailored Information Application for Medication Health Literacy

Human Immunodeficiency Virus I Infection Clinical Trial

Official title:

An Automated, Tailored Information Application for Medication Health Literacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304186
• Other study ID #: R21MH086491
• Secondary ID: R21MH086491
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: February 28, 2013
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus I Infection
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Ziff Health Clinics, Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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.	Four weeks after intervention	No
Secondary	Participant self-efficacy		Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention	No
Secondary	Mood		Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention	No
Secondary	Elements of the Information, Motivation, and Behavioral Skills Model	A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.	Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention	No
Secondary	Intervention acceptability and usability	A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.	Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention	No