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Routine Cryptococcal Screening in Nyanza Province, Kenya. Jeremy Penner XIXth International AIDS Conference TUSA08, 24 Jul 2012. Outline. Setting Screening protocol Treatment protocol Intervention uptake Patient outcomes. Family AIDS Care and Education Services. Screening Protocol.
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RoutineCryptococcal Screening in Nyanza Province, Kenya Jeremy Penner XIXth International AIDS Conference TUSA08, 24 Jul 2012
Outline • Setting • Screening protocol • Treatment protocol • Intervention uptake • Patient outcomes
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 treatment protocol sent to site
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
Uptake: Chart Reviews from 2 Districts 91% had CD4 performed Overall Uptake: 53% 63% had sCrAg performed 89% received fluconazole
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)
Eligibility and Enrollment All new enrollees 12,211 No information 18 (0.1%) Adult ≥ 15 years 9,513 (78%) Child <15 years 2,680 (22%) File missing 401 (4%) CD4≤100 1,595 (17%) CD4>100 7,118 (75%) CD4 not done 399 (4%) Charts abstracted 1,547 (97%) Dead 383 (25%) Alive 877 (57%) Transfer 169 (11%) Unknown 118 (8%) 1,222 person-years follow-up
Kaplan-Meier Survival Curve Comparing Control to Intervention HR=1.0 [0.9, 1.3] HR=1.1, p=.41
Survival Curves Comparing sCrAg + to sCrAg - in Intervention Group HR=1.6 [1.0, 2.7] HR=1.06, p=.09
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
Acknowledgements • Crypto team: • Ana-Claire Meyer • Caroline Kendi • Noel Odhiambo • BenardOtieno • 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