MedPath

The Effect of Teaching HIV-Infected Patients About HIV and Treatment

Phase 3
Completed
Conditions
HIV Infections
Registration Number
NCT00002409
Lead Sponsor
Glaxo Wellcome
Brief Summary

The purpose of this study is to see if an HIV-education course can help under-represented, HIV-infected patients. This study examines the areas of faithfulness to drug regimen, level of HIV in the blood, and health status.

Detailed Description

Following initial screening, eligible patients are treated with open-label Combivir plus abacavir for 24 weeks. Patients are randomized to undergo the education intervention, Tools for Health and Empowerment (T.H.E.) course plus counseling, or routine counseling only (control group). Measurements and evaluations for assessment of immunologic effects, adherence, and health outcomes are performed at entry (Day 1) and at Weeks 2, 5, 8, 12, 16, and 24.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (25)

Specialty Med Care Ctrs of South Florida Inc

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Miami, Florida, United States

Rush Med College / Dept of Infectious Diseases

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Chicago, Illinois, United States

Santa Rosa Med Ctr / Baptist Med Ctr

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San Antonio, Texas, United States

Allegheny Univ of the Hlth Sciences / Div of Infect Diseases

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Philadelphia, Pennsylvania, United States

Southeast Dallas Health Ctr

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Dallas, Texas, United States

Oasis Clinic / King Drew Med Ctr

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Los Angeles, California, United States

Holmes Hosp / Univ of Cincinnati Med Ctr

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Cincinnati, Ohio, United States

AIDS Research Consortium of Atlanta

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Atlanta, Georgia, United States

Therapeutic Concepts

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Houston, Texas, United States

Univ of Miami School of Medicine

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Miami, Florida, United States

Saint Josephs Comprehensive Research Institute

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Tampa, Florida, United States

Whitman Walker Clinic/Elizabeth Taylor Med Ctr

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Washington, District of Columbia, United States

Robert Scott MD

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Oakland, California, United States

Encounter Med Group

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Oak Park, Illinois, United States

Bentley-Salick Med Practice

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New York, New York, United States

Addiction Research and Treatment Corp

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Brooklyn, New York, United States

Carolina Family Care/Denmark Med Ctr / P O Box 278

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Denmark, South Carolina, United States

Newark Community Health Ctr

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Newark, New Jersey, United States

Univ of Tennessee / Div of Infect Dis / Dept of Med

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Memphis, Tennessee, United States

Univ of Tennessee

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Memphis, Tennessee, United States

New England Med Ctr / Div of Geo Med & Infect Disease

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Boston, Massachusetts, United States

UMDNJ / Dept of Ob/Gyn

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Newark, New Jersey, United States

Jeffrey Bomser Clinic / NJCR

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Newark, New Jersey, United States

Georgetown Univ Med Ctr

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Washington, District of Columbia, United States

AIDS Healthcare Foundation

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Los Angeles, California, United States

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