Attitudes and Beliefs and the Steps of HIV Care
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| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Human Immunodeficiency Virus Infections |
| Purpose: |
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Through a prospective observational cohort study enrolling patients newly diagnosed with
Human immunodeficiency virus (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.
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| Study Summary: |
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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 Centers for Disease Control and
Prevention's (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.
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| Criteria: |
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Inclusion Criteria:
- A new diagnosis of HIV infection, defined as diagnosed with HIV less than 3 months
before the current diagnosis AND not yet having completed a regularly scheduled
outpatient primary medical care visit for HIV.
- Ability to speak English or Spanish. Ability to provide informed consent (or have a
representative able to do so). Age greater than or equal to 18 years.
- Adherence Sub-Study. Persons in the Steps of HIV Care Cohort Study and prescribed
HAART at either Thomas Street Health Center, the Northwest Health Center, or the
Michael E. DeBakey VA HIV Clinic. Using or planning on using the Thomas Street Health
Center, Northwest Health Center or the Michael E. DeBakey VA pharmacy to fill their
prescriptions for HAART. On HAART for less than 6 months at the time of enrollment
into the sub-study.
- Qualitative Sub-Study Persons in Steps of HIV Care Cohort. Willing and cognitively
able to complete the interview, in the eyes of the investigator or the research team.
Exclusion Criteria:
- Persons diagnosed with HIV more than 3 months before the current diagnosis will be
excluded, as will persons diagnosed with HIV less than 3 months before the current
diagnosis who have seen an outpatient provider for HIV care at a regularly scheduled
visit.
- Patients with dementia, active psychosis, or other conditions that will not allow
them to accurately complete the interview will be followed separately from the main
cohort, provided informed consent can be obtained from their representative.
- Since the instruments are interviewer-administered, illiterate patients will not be
excluded; in that circumstance, the research staff will read the informed consent
documents to the potential participant.
- Patients who speak neither English nor Spanish will be excluded, since the informed
consent and survey instruments will be available in only those languages. Pregnant
women will not be excluded, as the study poses no risk to the fetus.
- Adherence Sub-Study. As for the Steps of HIV Care Cohort Study. In addition: Patients
will be excluded if they are not willing to forego use of a pill organizer for the
medication to be monitored with the computerized caps. Pill organizers for the
unmonitored medications will be allowed. Patients will be excluded if they are not
themselves responsible for taking their own medication, i.e., if they are
institutionalized or incarcerated (though neither Thomas Street Health Center,
Northwest Health Center, nor the VA HIV Clinic cares for incarcerated person).
- Or, if a person other than the patient takes primary responsibility for ensuring
medication is taken by the patient. We will also exclude patients who cannot agree to
not pocket doses on a routine basis, that is, remove extra pills from the bottle for
later ingestion. This behavior will likely be infrequently practiced, since almost
all HAART regimens currently are once or twice daily rather than thrice daily.
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| NCT ID: |
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NCT00749840 |
| Primary Contact: |
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Principal Investigator
Michael A. Kallen, PhD
M.D. Anderson Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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