Adherence Intervention for People With Low-literacy

June 14, 2013 updated by: Seth Kalichman, University of Connecticut

HIV Treatment Adherence Intervention for People With Poor Literacy Skills

Consistent adherence to antiretroviral therapy is necessary for treatment success. People with poor health literacy skills experience considerable difficulty adhering to their medications. Effective strategies for improving adherence in patients with poor health literacy must be tailored to achieve optimal adherence and therefore viral suppression. This proposal requests support to conduct a randomized clinical trial of a theory-based HIV treatment adherence intervention tailored for people with low-literacy skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adherence to antiretroviral medications is necessary to achieve sufficient HIV suppression and nonadherence can lead to the development of treatment resistant genetic variants of HIV. Research has demonstrated that people living with HIV/AIDS who have low-levels of health literacy experience greater treatment non-adherence than their higher-literacy counterparts. Interventions are urgently needed to improve treatment adherence in people with poor literacy skills. This application proposes to test a theory based behavioral intervention for improving HIV treatment adherence in people living with HIV/AIDS who have low-literacy skills. Grounded in the Information - Motivation - Behavioral Skills (IMB) model of health behavior change, the experimental intervention has been tailored for people with low-levels of health literacy and has been pilot tested in preliminary intervention development research. The intervention is delivered in three one-on-one counseling sessions and one maintenance-focused booster session. The intervention will be conducted in a community care setting in Atlanta. Men and women will be recruited from a AIDS services and infectious disease clinics throughout the Atlanta metropolitan area. Following screening, informed consent and baseline assessments participants will be randomly assigned to receive one of three conditions: (a) Theory-based literacy tailored treatment adherence intervention; (b) standard of care non-tailored time-matched adherence counseling intervention; (c) noncontaminating time-matched attention control intervention. Participants will be followed for 12-months observation. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence, self-report and objective medication adherence, and viral load. The study will test the hypothesis that a theory-based HIV treatment adherence intervention that is tailored for people with low-literacy will improve HIV treatment adherence and health relative to the standard and attention control conditions. The study will also examine the influence of IMB theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to address treatment adherence among people with poor literacy skills. If shown effective, the intervention model will be ready for immediate dissemination to clinical and community adherence enhancement services for people living with HIV-AIDS.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Southeast HIV/AIDS Research and Evaluation Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older,
  • HIV positive,
  • receiving antiretroviral medications, and
  • score below cut-off on a standard health literacy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Literacy Adherence Counseling
3-counseling sessions for medication adherence improvement tailored for people with poor literacy
Behavioral: Stick To It
3-counseling session adherence intervention tailored for people with poor literacy skills
Active Comparator: Standard Adherence Counseling
3 counseling sessions for adherence improvement derived from standard behavioral approaches.
Behavioral: Standard medication adherence counseling
3 counseling sessions for adherence improvement derived from standard behavioral approaches.
Active Comparator: Health Counseling Comparison
3-sessions of health improvement counseling.
Behavioral: Health Counseling
3-session of health improvement counseling to serve as an attention control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unannounced Phone Based Pill Counts for Medication Adherence
Time Frame: Baseline, monthly for 12 months
Baseline, monthly for 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Theoretical Constructs derived from the Information-Motivation-Behavioral Skills Model assessed by psychometric scales of AIDS knowledge, behavioral intentions, adherence self-efficacy, adherence strategies/skills
Time Frame: Baseline, 3, 6, and 9 months
Baseline, 3, 6, and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Seth C Kalichman, PhD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H07-266
  • R01MH082633-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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