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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00749840 |
Purpose
Through a prospective observational cohort study enrolling patients newly diagnosed with HIV:
Aim 1: Assess attitudes and beliefs about HIV disease and care over time and relate those attitudes and beliefs to success in following the Steps of HIV Care.
Aim 2: Validate a simple visual analogue scale for assessing adherence to highly active antiretroviral therapy (HAART) in patients newly starting HAART in routine care.
Aim 3: Implement latent growth curve analysis for modeling changes in attitudes and beliefs over time, and for assessing the impact of the components of the Steps of HIV Care model on health outcomes.
| Condition | Intervention |
|---|---|
|
Human Immunodeficiency Virus Infections |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Attitudes and Beliefs and the Steps of HIV Care |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
HIV Care Questionnaire
Patients with a new diagnosis of HIV infection.
|
Behavioral: Questionnaire
Questionnaire taking 60-90 minutes.
|
The introduction of highly active antiretroviral therapy (HAART) dramatically improved the survival of patients with HIV in the US. The effectiveness of HAART in routine care is determined by the success with which patients are able to follow certain crucial Steps of HIV Care. This 'Steps of HIV Care' framework is based on the CDC's "Serostatus Approach to Fighting the HIV Epidemic," which has been overlaid with patient and process of care factors. It includes 1) access outpatient care, 2) utilize care and treatment services, and 3) adhere to care, including medications and appointments.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with a new diagnosis of HIV infection.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael A. Kallen, PhD | 713-745-7670 |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Thomas P. Giordano, MD | |
| Principal Investigator: | Michael A. Kallen, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Michael A. Kallen, PhD/Assistant Professor ) |
| Study ID Numbers: | 2008-0011 |
| Study First Received: | September 5, 2008 |
| Last Updated: | September 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00749840 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Acquired Immune Deficiency Syndrome Human Immunodeficiency Virus Questionnaire AIDS HIV |
Highly Active Antiretroviral Therapy HAART Steps of HIV Care CDC |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |