Adherence Intervention for People With Low-literacy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Seth Kalichman, University of Connecticut
ClinicalTrials.gov Identifier:
NCT01061762
First received: February 1, 2010
Last updated: June 14, 2013
Last verified: June 2013

February 1, 2010
June 14, 2013
February 2008
February 2013   (final data collection date for primary outcome measure)
Unannounced Phone Based Pill Counts for Medication Adherence [ Time Frame: Baseline, monthly for 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01061762 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adherence Intervention for People With Low-literacy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Stick To It
    3-counseling session adherence intervention tailored for people with poor literacy skills
  • Behavioral: Standard medication adherence counseling
    3 counseling sessions for adherence improvement derived from standard behavioral approaches.
  • Behavioral: Health Counseling
    3-session of health improvement counseling to serve as an attention control.
  • Experimental: Low Literacy Adherence Counseling
    3-counseling sessions for medication adherence improvement tailored for people with poor literacy
    Intervention: Behavioral: Stick To It
  • Active Comparator: Standard Adherence Counseling
    3 counseling sessions for adherence improvement derived from standard behavioral approaches.
    Intervention: Behavioral: Standard medication adherence counseling
  • Active Comparator: Health Counseling Comparison
    3-sessions of health improvement counseling.
    Intervention: Behavioral: Health Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older,
  • HIV positive,
  • receiving antiretroviral medications, and
  • score below cut-off on a standard health literacy test.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061762
H07-266, R01MH082633-01
No
Seth Kalichman, University of Connecticut
University of Connecticut
National Institute of Mental Health (NIMH)
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
University of Connecticut
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP