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Adherence Intervention for People With Low-literacy

HIV Treatment Adherence Intervention for People With Poor Literacy Skills

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01061762
Enrollment
450
Registered
2010-02-03
Start date
2008-02-29
Completion date
2013-02-28
Last updated
2013-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Treatment adherence, Low literacy skills, HIV treatment

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.

Interventions

BEHAVIORALStick To It

3-counseling session adherence intervention tailored for people with poor literacy skills

BEHAVIORALStandard medication adherence counseling

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

3-session of health improvement counseling to serve as an attention control.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Unannounced Phone Based Pill Counts for Medication AdherenceBaseline, monthly for 12 months

Secondary

MeasureTime frame
Theoretical Constructs derived from the Information-Motivation-Behavioral Skills Model assessed by psychometric scales of AIDS knowledge, behavioral intentions, adherence self-efficacy, adherence strategies/skillsBaseline, 3, 6, and 9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026