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Attitudes and Beliefs and the Steps of HIV Care

18 Years
Not Enrolling
Human Immunodeficiency Virus Infections

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Trial Information

Attitudes and Beliefs and the Steps of HIV Care

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

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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Survey to Assess Attitudes + Beliefs about Steps of HIV Disease Care

Outcome Time Frame:

Interviewer-administered at time of enrollment and every 3 months for 18 months

Safety Issue:


Principal Investigator

Michael A. Kallen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

November 2012

Related Keywords:

  • Human Immunodeficiency Virus Infections
  • Acquired Immune Deficiency Syndrome
  • Human Immunodeficiency Virus
  • Questionnaire
  • AIDS
  • HIV
  • Highly Active Antiretroviral Therapy
  • Steps of HIV Care
  • CDC
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Virus Diseases



Baylor College of MedicineHouston, Texas  77030