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Using HIV Surveillance Data to Evaluate Outcomes of Site Randomized
Interventions in the TLC-Plus Study
Deborah Donnell*, Irene Hall, Y Jia, Angelique Griffin, Kathleen Brady, Becky Grigg, Aaron Sayegh, Lucia Torian, Wafaa El Sadr
*Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA
2011 National HIV Surveillance Conference: Atlanta, GA
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The TLC-Plus Trial (HPTN 065)
• Feasibility study of implementing “Test and Treat” for HIV Prevention in the US
• Five study components with feasibility outcomes
• Two study components testing financial incentives(FI) vs. Standard of care (SOC) – Site randomized outcomes in two intervention
cities (Bronx NY, Washington DC)
(Session E07, Wednesday 8 am)
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Test
Linkage to Care
Initiate Art per current
guidelines
Viral suppression
Viral Suppression: Randomization of HIV Care Sites
FI for viral suppression
SOC for viral suppression
Prevention for Positives: Individual randomization of HIV+
CARE plus SOC SOC alone
HPTN 065: Study Design Linkage-to-Care:
Randomization of HIV Test Sites
FI to link to care
SOC to link to care
Expanded HIV Testing • Social mobilization • Universal offer of testing in ED/hospital
admission
Provider & Patient Surveys
• Knowledge and attitudes regarding ART and FIs
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Test
Linkage to Care
Initiate Art per current
guidelines
Viral suppression
Viral Suppression: Randomization of HIV Care Sites
FI for viral suppression
SOC for viral suppression
Prevention for Positives: Individual randomization of HIV+
CARE plus SOC SOC alone
HPTN 065: Study Design Linkage-to-Care:
Randomization of HIV Test Sites
FI to link to care
SOC to link to care
Expanded HIV Testing • Social mobilization • Universal offer of testing in ED/hospital
admission
Provider & Patient Surveys
• Knowledge and attitudes regarding ART and FIs
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Two site randomized components testing efficacy of financial incentives
Linkage to Care • 20 testing sites in Bronx, NY and
Washington DC (40 total)
• 10 sites randomly selected to use FI coupons
• Data from HIV Surveillance for linkage of newly tested HIV cases – Number of newly tested cases in
the previous year
– Among newly tested cases, proportion linked to care in 3 months
Viral load suppression • 20 care sites in Bronx, NY and
Washington DC (40 total)
• 10 sites randomly selected to use FI for achieving low VL
• Data from HIV Surveillance for viral load of PHWH – Number of PLWH in care
– Among HIV-infected people in care, proportion with last viral load < 400 copies/mL
– Cannot assess whether on antiretroviral therapy
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HIV Surveillance used to assess site aggregate data
• Baseline data – Site selection
– Inform randomization (to achieve balance between arms)
– Conduct power calculations for site-randomized trial
• Follow-up data – Study outcomes
– Monitoring of unintended effects (e.g. site migration)
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HIV Surveillance Information Flow TLC-Plus
Sources of Reports
Hospital Practitioners Private Practitioners Public Clinics Laboratories
CDC
74,353
HPTN Statistical Center Aggregate surveillance data Also receives: Aggregate testing data Aggregate behavioral data
Active Case Finding
Local and/or State Health Department
People with HIV
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To assess site aggregate outcomes
Sources of Reports
Hospital Practitioners Private Practitioners Public Clinics Laboratories
CDC
74,353
HPTN Statistical Center Aggregate surveillance data Also receives: Aggregate testing data Aggregate behavioral data
Active Case Finding
Local and/or State Health Department
People with HIV
Depends on mandatory name based reporting of viral load and CD4 laboratory data
HIV case identified as accessing care within
jurisdiction
Testing/Care site identified in laboratory requisition
Linkage of lab result to case
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Use of surveillance data for site aggregate measures
• HIV Prevention Trials Network (HPTN) study conducted using HIV surveillance data to measure outcomes
• Only aggregate site data are released from DoH and CDC as HPTN 065 data – Study conducted under a waiver of informed consent
– Strict confidentiality laws for surveillance data
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Issues in compiling aggregate data
• Health systems with multiple sites – Not able to separate data unless lab requisitions can be
identified by location or provider
– Varied completeness of required information
• Completeness and consistency of lab data reporting – Mandatory in New York City since 2005
• Mature QC systems between laboratories, state and city
– Electronic reporting in Washington DC began 2008 • QC process under development
• Data exchange with surrounding states under development
• Not all laboratory data reported electronically
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Results: Site selection
• Site identification began in 2008, randomization occurred in 2010/11 – Linkage to care – newly diagnosed cases
• Bronx NY: 2007 data for selection, 2008 for randomization
• Washington DC: 2008 data for selection, 2009 for randomization
– Viral load suppression – most recent viral load at site • Bronx: 2008 data for selection and randomization
• Washington DC: 2008 data for selection, 2009 for randomization
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HPTN 065: Test Site Selection
1 Combined
3 Did not respond
Total number of test sites identified by DOH: 27
Number of sites approached: 27
Number of sites that signed LoI: 19
Number of sites selected for study participation: 18
Randomized to FI: 9
Randomized to SOC: 9
Total number of test sites identified by DOH: 31
Number of sites that signed LoI: 25
Number of sites selected for study participation: 19
Randomized to FI: 10
Randomized to SOC: 9
Number of sites approached: 28
2 Not seeing HIV-infected 3 Declined 3 Did not respond
2 Combined 4 Test volume too low
Bronx NY Washington D.C.
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HPTN 065: Care Site Selection
2 Combined 3 Low volume of patients
1 Declined 3 Did not respond
Total number of care sites identified by DOH: 36
Number of sites approached: 36
Number of sites that signed LoI: 25
Number of sites selected for study participation: 20
Randomized to FI: 10
Randomized to SOC: 10
Total number of care sites identified by DOH: 32
Number of sites that signed LoI: 23
Number of sites selected for study participation: 19
Randomized to FI: 10
Randomized to SOC: 9
Number of sites approached: 27
2 Not seeing HIV-infected 3 Declined 4 Did not respond 2 Other reason
3 Combined 1 Declined
Bronx NY Washington D.C.
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Calculating power for a site randomized study
Linkage to Care (Outcome: Newly tested linked
w/i 3 months)
• Total number of sites
• Mean number of HIV positive cases per site
• Baseline probability of linkage to care
• Intracluster correlation coefficient for linkage
Viral suppression (Outcome: VL <400 copies/mL)
• Total number of sites
• Mean number of cases in care per site
• Baseline proportion of viral suppression
• Intracluster correlation coefficient for low viral load
Variability in
linkage probability across sites
Variability in VL < 400 copies/mL
across sites
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Study design: Linkage to Care
Bronx (2007)
Bronx (2008)
Washington DC (2008)
Washington DC (2009)
Number newly diagnosed cases
Median 13 13 24 20
(Q1, Q3) (9-41) (3-44) (13-60) (3-44)
Mean 22 28 40 38
Proportion linked to care in 3 months
Median 75% 69% 77% 54%
(Q1, Q3) (49%-86%) (50%-86%) (57%-87%) (33%-71%)
ICC* 0.27 0.42 0.31 0.64
*Intracluster correlation coefficient
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Study design: Viral load < 400 copies/mL
Bronx (2008)
Bronx (2008)
Washington DC (2008)
Washington DC (2009)
Number of cases assessed at care site
Median 174 251 100 153
(Q1, Q3) (121-310) (130-806) (48-229) (50-348)
Mean 692 625 245 311
Proportion with HIV viral load suppression
Median 57% 57% 37% 64%
(Q1, Q3) (39%-60%) (54%-61%) (27%-50%) (56%-72%)
ICC* 0.07 0.04 0.11 0.18
*Intracluster correlation coefficient
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Power of site randomized studies
Linkage to Care
• 40 sites (37 sites)
• 54 linkage cases per site (mean 33 per year)
• ICC of 0.27
• 80% power to detect increase from 67% to 80% linkage to care
Viral suppression
• 40 sites (39 sites)
• 180 cases in care per site (mean 481 per site)
• ICC of 0.11
• 80% power to detect increase from 60% to 66% VL <400 copies/mL
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Randomization Strategy
• Restricted randomization – Small number of sites
– Protect against imbalance in factors predicting outcome
– Volume of site; baseline outcome measure
• Randomization index: – Sites divided into R1, R2
t statistic for difference in site volume
t statistic for difference in
baseline outcomes
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Data for randomization
0
20
40
60
80
100
120
140
160
0% 20% 40% 60% 80% 100% 120%
Num
ber o
f new
dia
gnos
es
Proportion linked to care in 3 mos.
Baseline linkage to care
0
1000
2000
3000
4000
5000
6000
0% 20% 40% 60% 80% 100%
Num
ber o
f pat
ient
s
Proportion with VL < 400 cp/mL
Viral load suppression
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Issues in conducting randomization • Test sites could not start until care sites had initiated
study
• Additional restriction added to ensure balance for highest volume sites
• Randomization of sites after IRB approvals required different start times – added blocks – Washington DC
• Test: two blocks (Feb and March 2011)
• Care: three blocks (October 2010, Jan and March 2011)
– Bronx • Test: one block (Feb 2011)
• Care: one block (Jan 2011)
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Summary • HIV surveillance data were aggregated in selected
sites to inform study design and randomization for HPTN 065 (TLC-Plus)
• Linkage to care at baseline – Levels of linkage to care were similar in Bronx, NY and
Washington DC.
– More cases were being identified in Washington DC.
• Suppressed VL at baseline – Levels of viral suppression were modest and similar in
Bronx and Washington DC
– Includes patients not on ART.
– More PLWH were in care in the Bronx
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Implications
• HIV surveillance data has the potential to provide information for assessment of site level outcomes – an opportunity for conducting rigorous implementation science
• Additional resources provided at DoH to facilitate obtaining timely information – especially needed for site identification
• Upload of complete lab data (CD4 and viral load) into eHARs facilitates uniform assessment of outcomes across jurisdictions
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Acknowledgments • Special thanks to HIV surveillance staff in New York City, Washington DC.
• HPTN 065 is sponsored by the NIAID and NIMH under Cooperative Agreement #UM1 AI068619 and #UM1 AI068617, by the CDC, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, via an interagency agreement.
• The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.