Clinical Trials


Adherence Intervention for People With Low-literacy

This study has been completed
University of Connecticut

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
Seth Kalichman, University of Connecticut Identifier

First received: February 1, 2010
Last updated: June 14, 2013
Last Verified: June 2013
History of Changes


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
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Treatment Adherence Intervention for People With Poor Literacy Skills

Further study details as provided by Seth Kalichman, University of Connecticut:

Primary Outcome Measures

  • Unannounced Phone Based Pill Counts for Medication Adherence [ Time Frame: Baseline, monthly for 12 months ]
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 ]

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.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

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 identifier: NCT01061762


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

Sponsors and Collaborators

University of Connecticut
National Institute of Mental Health (NIMH)


Principal Investigator: Seth C Kalichman, PhD University of Connecticut
More Information

More Information

Responsible Party: Seth Kalichman, Professor, University of Connecticut Identifier: NCT01061762   History of Changes  
Other Study ID Numbers: H07-266  
Study First Received: February 1, 2010  
Last Updated: June 14, 2013  

Keywords provided by Seth Kalichman, University of Connecticut:

Treatment adherence
Low literacy skills
HIV treatment

Additional relevant MeSH terms:
HIV Infections processed this data on July 19, 2018
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