Adherence Intervention for People With Low-literacy

NCT ID: NCT01061762

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-02-28

Brief Summary

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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Low Literacy Adherence Counseling

3-counseling sessions for medication adherence improvement tailored for people with poor literacy

Group Type: EXPERIMENTAL

Stick To It

Intervention Type: BEHAVIORAL

3-counseling session adherence intervention tailored for people with poor literacy skills

Standard Adherence Counseling

3 counseling sessions for adherence improvement derived from standard behavioral approaches.

Group Type: ACTIVE_COMPARATOR

Standard medication adherence counseling

Intervention Type: BEHAVIORAL

3 counseling sessions for adherence improvement derived from standard behavioral approaches.

Health Counseling Comparison

3-sessions of health improvement counseling.

Group Type: ACTIVE_COMPARATOR

Health Counseling

Intervention Type: BEHAVIORAL

3-session of health improvement counseling to serve as an attention control.

Interventions

Stick To It

3-counseling session adherence intervention tailored for people with poor literacy skills

Intervention Type: BEHAVIORAL

Standard medication adherence counseling

3 counseling sessions for adherence improvement derived from standard behavioral approaches.

Intervention Type: BEHAVIORAL

Health Counseling

3-session of health improvement counseling to serve as an attention control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Seth Kalichman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth C Kalichman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

Southeast HIV/AIDS Research and Evaluation Project

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

R01MH082633-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H07-266

Identifier Type: -

Identifier Source: org_study_id