Adherence Intervention for People With Low-literacy
HIV Treatment Adherence Intervention for People With Poor Literacy Skills
2 other identifiers
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Feb 2008
Longer than P75 for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJune 17, 2013
June 1, 2013
5 years
February 1, 2010
June 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unannounced Phone Based Pill Counts for Medication Adherence
Baseline, monthly for 12 months
Secondary Outcomes (1)
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
Study Arms (3)
Low Literacy Adherence Counseling
EXPERIMENTAL3-counseling sessions for medication adherence improvement tailored for people with poor literacy
Standard Adherence Counseling
ACTIVE COMPARATOR3 counseling sessions for adherence improvement derived from standard behavioral approaches.
Health Counseling Comparison
ACTIVE COMPARATOR3-sessions of health improvement counseling.
Interventions
3-counseling session adherence intervention tailored for people with poor literacy skills
3 counseling sessions for adherence improvement derived from standard behavioral approaches.
3-session of health improvement counseling to serve as an attention control.
Eligibility Criteria
You may qualify if:
- years or older,
- HIV positive,
- receiving antiretroviral medications, and
- score below cut-off on a standard health literacy test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southeast HIV/AIDS Research and Evaluation Project
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth C Kalichman, PhD
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 3, 2010
Study Start
February 1, 2008
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 17, 2013
Record last verified: 2013-06