Clinical trial NCT01304186: An Automated, Tailored Information Application for Medication Health Literacy
Official title: An Automated, Tailored Information Application for Medication Health Literacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus I Infection
Keywords: Health literacy
HIV
Medication Adherence
IMB Model
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-02-25
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Medication adherence
timeFrame: Four weeks after intervention
Secondary outcomes:
measure: Participant self-efficacy
timeFrame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
measure: Mood
timeFrame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
measure: Elements of the Information, Motivation, and Behavioral Skills Model
timeFrame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
measure: Intervention acceptability and usability
timeFrame: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Ziff Health Clinics, Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Raymond L Ownby, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.