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RoutineCryptococcal Screening in Nyanza Province, Kenya
Jeremy Penner
XIXth International AIDS ConferenceTUSA08, 24 Jul 2012
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Outline
• Setting• Screening protocol• Treatment protocol• Intervention uptake• Patient outcomes
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Family AIDS Care and Education Services
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Screening Protocol• All new enrollments
– Hematology sample for baseline CD4 to central lab– Serum for RPR also part of baseline specimens
• Lab reflex testing, starting Nov 2009– If enrollment CD4 ≤ 100 cells/μl, perform latex agglutination for sCrAg
• If sCrAg + (titre ≥ 1:2)– Results and treatmentprotocol sent to site
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Treatment Protocol
“This patient has tested positive for cryptococcal infection…should be treated with…”
• Fluconazole– 1,200mg x 2 weeks– 800mg x 8 weeks– 200mg maintenance
• ART– At 2 weeks if asymptomatic– At 6 weeks if signs/symptoms of meningitis
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Uptake: Routine Program Data
Enrolled
CD4 Documented
CD4 ≤ 100
sCrA
g Docu
mented
sCrA
g +
Fluco
nazole
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000Only 68% of new enrollees had CD4 documented in lab database
10,385
15,260
1,865108
1,72679
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Uptake: Chart Reviews from 2 Districts
Enrolled
CD4 Documented
CD4 ≤ 100
sCrA
g Docu
mented
sCrA
g +
Fluco
nazole
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000 4,7574,348
806 508
53 47
91% had CD4performed
63% had sCrAgperformed 89% received
fluconazole
Overall Uptake:53%
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Outcomes: Methods• Inclusion criteria: Newly enrolling adults with
CD4 count ≤ 100 cells/μl • Intervention group:
– Enrolled between 1 Nov 09 & 31 May 10• Historical control:
– Enrolled between 1 Apr 09 & 31 Oct 09• Primary endpoint: All-cause mortality• Analysis: Cox proportional hazards
– Censored at date of death, last clinic visit, or home visit (for those confirmed alive)
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Eligibility and EnrollmentAll new enrollees
12,211
No information18 (0.1%)
Child <15 years 2,680 (22%)
CD4≤1001,595 (17%)
CD4>1007,118 (75%)
CD4 not done399 (4%)
File missing401 (4%)
Adult ≥ 15 years 9,513 (78%)
Charts abstracted1,547 (97%)
Dead 383 (25%)Alive 877 (57%)
Transfer 169 (11%)Unknown 118 (8%)
1,222 person-years follow-up
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ResultsControln=771
Interventionn=776
p
Age (years) 34 35 .94
Female 55% 53% .42
Body Mass Index 18.6 18.8 .40
CD4+ T-cell count (cells/μl) 45 41 .35
Started on ART during follow up period
76% 77% .63
Time between enrollment and ART initiation (weeks)
4 4 .08
Received anti-tuberculosis medication
27% 23% .10
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Kaplan-Meier Survival Curve Comparing Control to Intervention
HR=1.1, p=.41
HR=1.0 [0.9, 1.3]
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Survival Curves Comparing sCrAg + to sCrAg - in Intervention Group
HR=1.06, p=.09
HR=1.6 [1.0, 2.7]
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Summary• Limited uptake
– CD4: capacity of central labs; lab networking– sCrAg: stock-outs; lab staff turn-over; workload– Fluconazole: early deaths before starting treatment– Documentation
• Overall survival not improved compared to historical control– Poor uptake– Treatment may not be adequate
• Survival of sCrAg + patients better than expected if no intervention
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Acknowledgements• Crypto team:
– Ana-Claire Meyer– Caroline Kendi– Noel Odhiambo– Benard Otieno– Edwin Omondi– Elizabeth Opiyo– Patrick Oyaro– Elizabeth Bukusi– Craig Cohen
• FACES staff and patients, esp the Social Science Department
• Ministries of Health, Government of Kenya
• Institutions:– Kenya Medical Research Institute– University of California San
Francisco– US Centers for Disease Control and
Prevention, Kenya– University of British Columbia
• This work was supported by:– President’s Emergency Plan for
AIDS Relief (U62/CCU924511)– American Academy of Neurology
Foundation Practice Research Training Fellowship
– Fogarty International Clinical Research Fellowship (5 R24 TW00798; 3 R24 TW00798-02S1)
– Hellman Family Foundation