Adherence Intervention for People With Low-literacy
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Purpose
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | HIV Treatment Adherence Intervention for People With Poor Literacy Skills |
- Unannounced Phone Based Pill Counts for Medication Adherence [ Time Frame: Baseline, monthly for 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2013 |
| Estimated 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Georgia | |
| Southeast HIV/AIDS Research and Evaluation Project | |
| Atlanta, Georgia, United States, 30308 | |
| Principal Investigator: | Seth C Kalichman, PhD | University of Connecticut |
More Information
No publications provided
| Responsible Party: | Seth Kalichman, Professor, University of Connecticut |
| ClinicalTrials.gov Identifier: | NCT01061762 History of Changes |
| Other Study ID Numbers: | H07-266, R01MH082633-01 |
| Study First Received: | February 1, 2010 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Connecticut:
|
Treatment adherence Low literacy skills HIV treatment |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 19, 2013