Attitudes and Beliefs and the Steps of HIV Care

NCT00749840 | Completed

• 1 other identifier: 2008-0011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus Infections

Keywords

Acquired Immune Deficiency Syndrome; Human Immunodeficiency Virus; Questionnaire; AIDS; HIV; Highly Active Antiretroviral Therapy; HAART; Steps of HIV Care; CDC

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

HIV Care Questionnaire

Patients with a new diagnosis of HIV infection.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire taking 60-90 minutes.

Also known as: Survey

HIV Care Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a new diagnosis of HIV infection.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael A. Kallen, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

US (1)