Attitudes and Beliefs and the Steps of HIV Care

Human Immunodeficiency Virus Infections Clinical Trial

Official title:

Attitudes and Beliefs and the Steps of HIV Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749840
• Other study ID #: 2008-0011
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: February 12, 2013
• Start date: April 2008
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Infections
• Immunologic Deficiency Syndromes
• Virus Diseases

Intervention

Behavioral:
• Questionnaire
Questionnaire taking 60-90 minutes.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survey to Assess Attitudes + Beliefs about Steps of HIV Disease Care		Interviewer-administered at time of enrollment and every 3 months for 18 months	No

External Links

•   UT MD Anderson Cancer Center website