Adherence Intervention for People With Low-literacy

Sponsor

University of Connecticut (Other)

Overall Status

Completed

CT.gov ID

NCT01061762

Collaborator

National Institute of Mental Health (NIMH) (NIH)

450

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

450 participants

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Unannounced Phone Based Pill Counts for Medication Adherence [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 [Baseline, 3, 6, and 9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Southeast HIV/AIDS Research and Evaluation Project	Atlanta	Georgia	United States	30308

Sponsors and Collaborators

University of Connecticut
National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seth Kalichman, Professor, University of Connecticut

ClinicalTrials.gov Identifier:

NCT01061762

Other Study ID Numbers:

H07-266
R01MH082633-01

First Posted:

Feb 3, 2010

Last Update Posted:

Jun 17, 2013

Last Verified:

Jun 1, 2013

Keywords provided by Seth Kalichman, Professor, University of Connecticut

Treatment adherence

Low literacy skills

HIV treatment

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Jun 17, 2013