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Outcomes and Effectiveness Research in HIV/AIDS

Outcomes and Effectiveness Research in HIV/AIDS. William Cunningham, MD, MPH Professor UCLA Schools of Medicine/Public Health Monday, February 24, 2014 HPM214. Lecture Overview. Brief tour of 3 different HRQL studies in HIV HRQL is an outcome in observational study;

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Outcomes and Effectiveness Research in HIV/AIDS

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  1. Outcomes and Effectiveness Research in HIV/AIDS William Cunningham, MD, MPH Professor UCLA Schools of Medicine/Public Health Monday, February 24, 2014 HPM214

  2. Lecture Overview • Brief tour of 3 different HRQL studies in HIV • HRQL is an outcome in observational study; • HRQL is predictor of survival/mortality outcomes; then • HRQL is an outcome in RCT study, including analysis evaluating reliability and validity of the SF-12

  3. Study #1: The Effect of Case-management on HRQL Outcomes in HIV • To examine the use of case-management services in a nationally representative cohort of persons with HIV infection • To examine the effect of case-management use on physical and mental HRQL outcomes in HIV Cunningham et al. (2008) J Natl Med Assoc

  4. Background • Case-management has been advocated for improving HIV care, quality of life and decreasing costs • $225 M of Title I Ryan white funding for case-management 2010 • It is unknown whether case-management affects HRQL outcomes

  5. Ability to engage in daily functions: Physical Role Social Perceived well-being versus distress Multi-dimensional Conceptualization of Health-Related Quality of Life (HRQL) HRQL PhysicalHealth MentalHealth

  6. Design Overview • Nationally representative sample of people with HIV in care in early 1996 • 3 stage probability sampling (areas, providers, and patients) • 2864 (71%) were enrolled and followed from 1996-1999 (base-line and 2 FU interviews) • Followed through 2002 for mortality outcomes • Collected data on sociodemographics, clinical, treatment, and mortality variables

  7. HCSUS Was the First Nationally Representative Sample of Persons with HIV/AIDS Stage 1: Random areas (n = 53) Stage 2: Random providers (n = 177) Stage 3: Random patients seen by providers (n = 4042)

  8. HRQL Measures for HIV Research(Number of Items in Each Domain) - Wu, QLR 1997 HS 214, Winter 02·27·12

  9. Example Disease-Targeted (symptom) HRQL Items from HCSUS • In the last 6 months, have you had fever, sweats, or chills? • In the last 6 months, have you had nausea or loss of appetite? • Yes or No • If yes, how much were you bothered by it? • Extremely, quite a bit, moderately, very little

  10. Case-Management Definition “A social worker, nurse, AIDS service organization staff member, staff in other service organizations, or anyone else who is assigned to help you get and coordinate care.”

  11. Other Independent Variables

  12. Other Outcomes Measures • Ambulatory visits • Emergency room visits • Hospitalization • Antiretroviral medications

  13. HCSUS HRQL Measure

  14. Formulas for Transforming Scores

  15. Construction of Physical and Mental Health Composites HRQL PhysicalHealth MentalHealth

  16. HRQL for HIV Compared to OtherChronic Illnesses and General Population Hays et al. (2000), American Journal of Medicine

  17. Construct Validity Analysis: HRQL Scores by Disability Days

  18. Construct Validity Analysis: HRQL Scores by Severity of Illness

  19. Patient Characteristics by Use of Case Manager (n=2864)

  20. Bivariate Effect of Case-Management on HRQOL Outcomes in HIV

  21. Multivariate Effect of Case-Management on HRQOL Outcomes in HCSUS

  22. Handling loss to follow-up, death • N=238 died before FU2 interview • Options: • Imputation • Propensity score weighting • Assign an HRQOL value to death • Assigned HRQOL value of zero to dead, conducted sensitivity analysis • Varied T-Scores for dead from 0-30 • For PH, case-management loses effect with scores >20 • For MH, case-management loses effect with scores >5

  23. Study #2: The Effect of HRQOL on Survival Outcomes in HIV • To examine the association of HRQOL with relative risk of death over time in a nationally representative cohort of persons with HIV infection • To examine the relationship between physical and mental HRQOL in relation to survival outcomes

  24. Main Outcome Variable • Mortality was reported by providers, supplemented by a national index search • 17% died by December 1999 • Risk of death computed from survival time • Relative risk (RR) of death compared between groups

  25. Analysis Overview • Kaplan-Meier bivariate analysis • Multivariate Cox Proportional Hazard models • Higher relative risk (RR) reflects increased likelihood of dying • Controlled for age, gender, race, income, education, insurance status, region, CD4 count, HIV exposure, HAART

  26. Kaplan-Meier Survival Estimates, by Physical HRQOL Quartile 1.0 100th 75th 50th 0.75 25th 0.50 0.25 500 1000 1500 0 Days of observation

  27. Kaplan-Meier Survival Estimates, by Mental HRQOL Quartile 1.0 100th 75th 25th 0.75 50th 0.50 0.25 500 1000 1500 0 Time in days

  28. Multivariate: HRQOL Predicts Survival, Physical > Mental Health

  29. Multivariate: Comparing Effect of HRQOL and HAART on Survival

  30. Significance • Assessment of HRQOL for risk stratification • Adds prognostic information above CD4 count • Useful in clinical care • PH>MH in predicting death • Effect of HRQOL comparable to effect of HAART

  31. Handling Loss to Follow-up, Death • N=238 died before FU2 interview • Options: • Imputation • Propensity score weighting • Assign an HRQL value to death • Assigned HRQL value of zero to dead, conducted sensitivity analysis • Varied T-Scores for dead from 0-30 • For PH, case-management loses effect with scores >20 • For MH, case-management loses effect with scores >5

  32. Study #2: The Effect of HRQL on Survival Outcomes in HIV • To examine the association of HRQL with relative risk of death over time in a nationally representative cohort of persons with HIV infection • To examine the relationship between physical and mental HRQL in relation to survival outcomes

  33. Main Outcome Variable • Mortality was reported by providers, supplemented by a national index search • 17% died by December 1999 • Risk of death computed from survival time • Relative risk (RR) of death compared between groups

  34. Analysis Overview • Kaplan-Meier bivariate analysis • Multivariate Cox Proportional Hazard models • Higher relative risk (RR) reflects increased likelihood of dying • Controlled for age, gender, race, income, education, insurance status, region, CD4 count, HIV exposure, HAART

  35. Kaplan-Meier Survival Estimates, by Physical HRQL Quartile 1.0 100th 75th 50th 0.75 25th 0.50 0.25 500 1000 1500 0 Days of observation

  36. Kaplan-Meier Survival Estimates, by Mental HRQL Quartile 1.0 100th 75th 25th 0.75 50th 0.50 0.25 500 1000 1500 0 Time in days

  37. Multivariate: HRQL Predicts Survival, Physical > Mental Health

  38. Multivariate: Comparing Effect of HRQL and HAART on Survival

  39. Significance • Assessment of HRQL for risk stratification • Adds prognostic information above CD4 count • Useful in clinical care • PH>MH in predicting death • Effect of HRQL comparable to effect of HAART

  40. Study # 3: The Effect of Culturally Sensitive Peer Navigation Intervention on HRQL Outcomes in HIV • To examine the reliability and validity of the SF-12 in a RCT among HIV+ MSM • To examine, in a randomized controlled trial peer navigation intervention among persons with HIV infection on: • HRQL outcomes • Other PRO measures Cunningham et al. (2008) J Natl Med Assoc

  41. Background • Latinos HIV prevalence high and increasing • Latinos with HIV less likely to receive care and have worse survival outcomes • Peer navigation (PN) a promising intervention to improve care for HIV+ Latino MSM • Unknown whether PN will improve HRQL as well as other intermediate PROs

  42. HRSA Continuum of Engagement Not in Care Fully engaged Cheever. Clin Infect Dis 2007;44:1500-1502

  43. PODER Addresses Retention in HIV Care for Latino MSM Suppressed Viral Load High risk MSM Linkage to initial care Engaged in care Re-engaged care Retained in HIV care Adherence to ART medications PODER Intervention Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. (2011). "The Spectrum of Engagement in HIV Care and its Relevance to Test-and-Treat Strategies for Prevention of HIV Infection." Clin Infect Dis 52(6): 793-800.

  44. Study Design • Phase 1 (Complete): • Key informant interviews to inform adaptation of PN intervention for HIV+ Latino MSM (n=20) • Phase 2 (in progress): • RCT of PN intervention vs. usual care (60 participants in each arm) • PN intervention delivered over 4 months; follow up evaluation for 8 months total

  45. The SF-36 # items per Scale

  46. The SF-12 # Items per Scale

  47. SF-12 Abbreviated Item Content

  48. Sociodemographic Characteristics

  49. Clinical Characteristics

  50. Substance Use and Service Utilization Characteristics

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