An Automated, Tailored Information Application for Medication Health Literacy

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
An Automated, Tailored Information Application for Medication Health Literacy

Conditions
-----------------
Human Immunodeficiency Virus I Infection

Intervention / Treatment
-----------------
* Behavioral: Tailored Information


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Information<br>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<br>* The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.<br>* Other names: Health literacy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant self-efficacy |  | Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention | 
| Mood |  | Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health literacy, HIV, Medication Adherence, IMB Model