Attitudes and Beliefs and the Steps of HIV Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749840
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Infections Behavioral: Questionnaire

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Attitudes and Beliefs and the Steps of HIV Care
Study Start Date : April 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV Care Questionnaire
Patients with a new diagnosis of HIV infection.
Behavioral: Questionnaire
Questionnaire taking 60-90 minutes.
Other Name: Survey

Primary Outcome Measures :
  1. Survey to Assess Attitudes + Beliefs about Steps of HIV Disease Care [ Time Frame: Interviewer-administered at time of enrollment and every 3 months for 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a new diagnosis of HIV infection.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749840

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Michael A. Kallen, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00749840     History of Changes
Other Study ID Numbers: 2008-0011
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by M.D. Anderson Cancer Center:
Acquired Immune Deficiency Syndrome
Human Immunodeficiency Virus
Highly Active Antiretroviral Therapy
Steps of HIV Care

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases