NCT01304186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

1.4 years

First QC Date

February 18, 2011

Last Update Submit

February 28, 2013

Conditions

Human Immunodeficiency Virus I Infection

Keywords

Health literacyHIVMedication AdherenceIMB Model

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

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

  • Intervention acceptability and usability

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

Study Arms (1)

Tailored Information

EXPERIMENTAL

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

Interventions

Tailored InformationBEHAVIORAL

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

Also known as: Health literacy
Tailored Information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziff Health Clinics, Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

Related Publications (3)

  • 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.

    PMID: 23293544RESULT

  • 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.

    PMID: 22961499RESULT

  • 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.

    PMID: 23446180DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Health Literacy

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Consumer Health InformationHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Raymond L Ownby, MD, PhD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 25, 2011

Study Start

June 1, 2010

Primary Completion

November 1, 2011

Study Completion

June 1, 2012

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

US(1)