Clinical trial NCT00385632: Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants
Official title: Quality of Life and Healthcare Utilization Substudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Community Programs for Clinical Research on AIDS
First posted: 2006-10-11
Enrollment: 1224
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants using conservation and viral suppression ART treatment regimens

Brief summary: The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.

Detailed description: Advances in antiretroviral therapy (ART) have dramatically reduced mortality and morbidity rates for HIV infected people. However, HIV infection is a costly disease to treat. With improvement in survival, quality of life and the long-term cost of HIV treatment have become increasingly important to the majority of individuals infected with HIV. Different HIV treatment regimens may lead to variations in quality of life and health care costs over the course of treatment. In the SMART study, participants were randomly assigned to one of two treatment groups:

* Group 1 participants followed a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count.
* Group 2 participants followed a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count.

The purpose of this study is to compare how the DC and VS regimens affect quality of life, symptom severity, health care utilization, and resulting costs among SMART study participants.

At baseline, participants will complete questionnaires regarding quality of life, symptoms, health care utilization, current insurance, and socioeconomic status. Body appearance and signs of HIV disease progression will also be assessed at this time. Follow-up evaluations on quality of life and symptoms will be repeated at Months 4, 8, and 12 and annually thereafter. Follow-up evaluations of all other baseline measures will occur once a year.

Eligibility criteria: Inclusion Criteria:

* Coenrollment in the SMART study
* Parent or guardian willing to provide informed consent, if applicable

Primary outcomes:
measure: Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance
timeFrame: Throughout study
measure: Self-reported healthcare utilization
timeFrame: Throughout study
measure: Recorded medications used by participants
timeFrame: Throughout study
measure: Cost of treating HIV/AIDS
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
state: California
city: Mill Valley
country: United States
facility: Dr. M. Estes Med. Practice CRS
state: California
city: Oakland
country: United States
facility: Dr. Robert Scott Med. Practice CRS
state: California
city: Oakland
country: United States
facility: East Bay AIDS Ctr. CRS
state: California
city: San Francisco
country: United States
facility: Dr. Shawn Hassler Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
state: California
city: San Francisco
country: United States
facility: Dr. Virginia Cafaro Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Dr. William Owen Med. Practice CRS
state: California
city: San Francisco
country: United States
facility: Castro-Mission Health Ctr. CRS
state: California
city: San Francisco
country: United States
facility: San Francisco VAMC, Infectious Diseases Clinic CRS
state: California
city: San Francisco
country: United States
facility: UCSF PHP, Gen. Internal Medicine Practice CRS
state: California
city: Boulder
country: United States
facility: Beacon Clinic at Boulder CRS
state: Colorado
city: Denver
country: United States
facility: Denver Infectious Diseases Consultants CRS
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente of Denver CRS
state: Colorado
city: Denver
country: United States
facility: Univ. of Colorado Health Science Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS
state: Colorado
city: Denver
country: United States
facility: Eastside Family Health Ctr. CRS
state: Colorado
city: Denver
country: United States
facility: Denver VAMC CRS
state: Colorado
city: Denver
country: United States
facility: Denver Public Health CRS - INSIGHT
state: Colorado
city: Wheat Ridge
country: United States
facility: Western Infectious Disease Consultants CRS
state: Colorado
city: Farmington
country: United States
facility: Univ. of Connecticut Health Ctr. CRS
state: Connecticut
city: New Haven
country: United States
facility: Yale Univ. School of Medicine, NE ProACT - New Haven CRS
state: Connecticut
city: New Haven
country: United States
facility: Hosp. of St. Raphael CRS
state: Connecticut
city: West Haven
country: United States
facility: VAMC West Haven CRS
state: Connecticut
city: Georgetown
country: United States
facility: Georgetown Wellness Clinic
state: Delaware
city: Wilmington
country: United States
facility: Christiana Care Health Services HIV Program CRS
state: Delaware
city: Washington
country: United States
facility: Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
state: District of Columbia
city: Miami
country: United States
facility: Miami VAMC CRS
state: Florida
city: Decatur
country: United States
facility: Atlanta VAMC CRS
state: Georgia
city: Chicago
country: United States
facility: Klein & Slotten Medical Associates CRS
state: Illinois
city: Chicago
country: United States
facility: Cook County Hosp. CORE Ctr.
state: Illinois
city: Chicago
country: United States
facility: Univ. of Illinois Family Ctr. for Infectious Disease CRS
state: Illinois
city: Chicago
country: United States
facility: Univ. of Chicago Hosps. CRS
state: Illinois
city: Chicago
country: United States
facility: Lakeshore Infectious Disease Associates CRS
state: Illinois
city: Chicago
country: United States
facility: North Side Family Medicine CRS
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Physicians Group CRS
state: Illinois
city: Baton Rouge
country: United States
facility: Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
state: Louisiana
city: Baton Rouge
country: United States
facility: James Osterberger, MD (Private Med. Practice) CRS
state: Louisiana
city: New Orleans
country: United States
facility: Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans VAMC CRS
state: Louisiana
city: Boston
country: United States
facility: CRI-Boston CRS
state: Massachusetts
city: Springfield
country: United States
facility: CRI-Springfield CRS
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hosp. CRS
state: Michigan
city: Jackson
country: United States
facility: Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS
state: Michigan
city: Lansing
country: United States
facility: Michigan State Univ., Infectious Disease Clinic CRS
state: Michigan
city: Mount Clemens
country: United States
facility: Mt. Clemens Gen. Hosp. CRS
state: Michigan
city: Southfield
country: United States
facility: Providence Hosp,-Newland Med. Assoc Inc CRS
state: Michigan
city: Hillsborough
country: United States
facility: ID Care Inc. - Hillsborough CRS
state: New Jersey
city: Newark
country: United States
facility: Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
state: New Jersey
city: Newark
country: United States
facility: New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
state: New Jersey
city: Perth Amboy
country: United States
facility: Raritan Bay Med. Ctr., Perth Amboy Division CRS
state: New Jersey
city: Randolph
country: United States
facility: ID Care - Randolph CRS
state: New Jersey
city: Union,
country: United States
facility: Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
state: New Jersey
city: Bronx
country: United States
facility: Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
state: New York
city: New York
country: United States
facility: St. Vincent Hosp. & Med. Ctr. CRS
state: New York
city: New York
country: United States
facility: Metropolitan Hosp. Ctr. CRS
state: New York
city: New York
country: United States
facility: Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
state: New York
city: New York
country: United States
facility: Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS
state: New York
city: Houston
country: United States
facility: Legacy Community Health Services, Inc. CRS
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Thomas St. Clinic CRS
state: Texas
city: Houston
country: United States
facility: Houston AIDS Research Team CRS
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VAMC CRS
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic CRS
state: Texas
city: Houston
country: United States
facility: Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System, Immunosuppression Clinic CRS
state: Texas
Study officials:
affiliation: Harlem AIDS Treatment Group, Harlem Hospital Center
name: Wafaa El-Sadr, MD, MPH
role: STUDY_CHAIR
affiliation: CPCRA Statistical and Data Management Center/CCBR
name: James Neaton, PhD
role: STUDY_CHAIR
References:
citation: Anis AH, Guh D, Hogg RS, Wang XH, Yip B, Craib KJ, O'Shaughnessy MV, Schechter MT, Montaner JS. The cost effectiveness of antiretroviral regimens for the treatment of HIV/AIDS. Pharmacoeconomics. 2000 Oct;18(4):393-404. doi: 10.2165/00019053-200018040-00007.
citation: Byrne MW, Honig J. Health-related quality of life of HIV-infected children on complex antiretroviral therapy at home. J Assoc Nurses AIDS Care. 2006 Mar-Apr;17(2):27-35. doi: 10.1016/j.jana.2006.01.003.
citation: Liu C, Ostrow D, Detels R, Hu Z, Johnson L, Kingsley L, Jacobson LP. Impacts of HIV infection and HAART use on quality of life. Qual Life Res. 2006 Aug;15(6):941-9. doi: 10.1007/s11136-005-5913-x.
citation: Lowy A, Page J, Jaccard R, Ledergerber B, Somaini B, Weber R, Szucs T. Costs of treatment of Swiss patients with HIV on antiretroviral therapy in hospital-based and general practice-based care: a prospective cohort study. AIDS Care. 2005 Aug;17(6):698-710. doi: 10.1080/09540120412331336689.