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Adherence Intervention for People With Low-literacy

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stick To It
Standard medication adherence counseling
Health Counseling
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Treatment adherence, Low literacy skills, HIV treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Southeast HIV/AIDS Research and Evaluation Project

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Low Literacy Adherence Counseling

Standard Adherence Counseling

Health Counseling Comparison

Arm Description

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

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

3-sessions of health improvement counseling.

Outcomes

Primary Outcome Measures

Unannounced Phone Based Pill Counts for Medication Adherence

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

Full Information

First Posted
February 1, 2010
Last Updated
June 14, 2013
Sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01061762
Brief Title
Adherence Intervention for People With Low-literacy
Official Title
HIV Treatment Adherence Intervention for People With Poor Literacy Skills
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment adherence, Low literacy skills, HIV treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Literacy Adherence Counseling
Arm Type
Experimental
Arm Description
3-counseling sessions for medication adherence improvement tailored for people with poor literacy
Arm Title
Standard Adherence Counseling
Arm Type
Active Comparator
Arm Description
3 counseling sessions for adherence improvement derived from standard behavioral approaches.
Arm Title
Health Counseling Comparison
Arm Type
Active Comparator
Arm Description
3-sessions of health improvement counseling.
Intervention Type
Behavioral
Intervention Name(s)
Stick To It
Intervention Description
3-counseling session adherence intervention tailored for people with poor literacy skills
Intervention Type
Behavioral
Intervention Name(s)
Standard medication adherence counseling
Intervention Description
3 counseling sessions for adherence improvement derived from standard behavioral approaches.
Intervention Type
Behavioral
Intervention Name(s)
Health Counseling
Intervention Description
3-session of health improvement counseling to serve as an attention control.
Primary Outcome Measure Information:
Title
Unannounced Phone Based Pill Counts for Medication Adherence
Time Frame
Baseline, monthly for 12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older, HIV positive, receiving antiretroviral medications, and score below cut-off on a standard health literacy test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth C Kalichman, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast HIV/AIDS Research and Evaluation Project
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

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Adherence Intervention for People With Low-literacy

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