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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: Stick To It
Behavioral: Standard medication adherence counseling
Behavioral: Health Counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Treatment Adherence Intervention for People With Poor Literacy Skills

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Unannounced Phone Based Pill Counts for Medication Adherence [ Time Frame: Baseline, monthly for 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 450
Study Start Date: February 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older,
  • HIV positive,
  • receiving antiretroviral medications, and
  • score below cut-off on a standard health literacy test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061762

Locations
United States, Georgia
Southeast HIV/AIDS Research and Evaluation Project
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
  More Information

No publications provided

Responsible Party: Seth Kalichman, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT01061762     History of Changes
Other Study ID Numbers: H07-266, R01MH082633-01
Study First Received: February 1, 2010
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
Treatment adherence
Low literacy skills
HIV treatment

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014