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Study Design. Repeated cross-sectional surveys to monitor changes over time:1994199820022004Conducted in the same way each time for comparability of data and to be certain that any changes are real:Person: pregnant women attending ante natal clinic Place: original sites maintained with some a
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1. 2002 HIV Sentinel Surveillance QA Experience in Zambia Ms Chanda Mulenga, Dr Victor Mudenda, Dr Mwaka Monze, & Dr Francis Kasolo
2. Study Design Repeated cross-sectional surveys to monitor changes over time:
1994 1998 2002 2004
Conducted in the same way each time for comparability of data and to be certain that any changes are real:
Person: pregnant women attending ante natal clinic
Place: original sites maintained with some additions
Time: four month period
Data: same questionnaire
Unlinked anonymous HIV testing model using a blood sample collected during routine ante-natal care
3. Sentinel Surveillance Site Map Map of 24 Sentinel Surveillance Sites for 2002:
Zambia is 3-5 times the size of the US, in terms of travel time for health officials. In rainy season a number of clinics are inaccessible.
Logistics remain a tremendous challenge for every part of the Zambian health system; this includes transport of people, supplies, equipment, documents and information. Perhaps the last is most amenable to quick intervention. 71 of 72 districts have at least 1 computer, and most of these have telephone service in proximity to the computer. A major hurdle has been keeping phone bills paid. Map of 24 Sentinel Surveillance Sites for 2002:
Zambia is 3-5 times the size of the US, in terms of travel time for health officials. In rainy season a number of clinics are inaccessible.
Logistics remain a tremendous challenge for every part of the Zambian health system; this includes transport of people, supplies, equipment, documents and information. Perhaps the last is most amenable to quick intervention. 71 of 72 districts have at least 1 computer, and most of these have telephone service in proximity to the computer. A major hurdle has been keeping phone bills paid.
4. Sentinel Surveillance Sites Per Administrative Zone Northern Zone: Tropical Diseases Research Center (TDRC), Ndola
Ndola
Ibenga
Mansa
Nchelenge
Kasaba
Kasama
Isoka
Solwezi
Mukinge
Kabompo
Serenje
Southern Zone: University Teaching Hospital, Virology Laboratory, Lusaka
Lusaka (Chelstone, Chilenje, Kalingalinga, Matero)
Luangwa
Kabwe
Kapiri Mposhi
Chipata
Minga
Mongu
Kalabo
Livingstone
Macha
5. Study Population ESS Recruitment criteria
Pregnant women
Attending ANC at study site for 1st time this pregnancy
Accepting routine syphilis testing
Sample size
First such 500 women per site (800 for Ndola and Lusaka sites) or
Women enrolled during 4 month enrollment period
7. MAINTAINING ANONYMITY & CONFIDENTIALITY Lab tests and interview/blood drawing done by different individuals
Specimens preserved and tested in batch on date later than date of collection
Specimens and results will have an anonymous ID number not linked in any way to the client
A maximum of two lab staff will have access to lab results and two midwives will have access to the questionnaires
No site staff will have access to both questionnaires and results
8. MAINTAINING ANONYMITY & CONFIDENTIALITY Clients anonymous questionnaire will be stored securely and separate from anonymous lab data at the same site
During supervisory visits the supervisor will review both sets of records separately and in a confidential manner
The questionnaire and lab results will be linked at data entry but the ID numbers will be replaced with different anonymous numbers
The linked dataset will be treated as confidential and access will be restricted
9. WHO/UNAIDS Testing Strategies Strategy I – up to one test
Strategy II – up to two test
Strategy III – up to three test
ANC Sentinel Surveillance – Strategy III
(even though Zambia prevalence is 15.6%)
10. Types of kits used for 2002 ANC SS ANC SS
Capillus– at field collection sites
ELISA-Welcozyme- at central lab
Bionor- Magnetic EIA- central lab for tie break
11. ESS Testing Algorithm And EQA
12. Zambia QA Process in 2002 Post Test QA following Data Analysis effort
3 test protocol provided opportunity to assess internal integrity of results
Mix of Field vs. Central parts of algorithm provided opportunity to assess field lab effect
Mix of Field sites provided opportunity to assess site admin. group effect
14. Algorithm performance Expected
N,P,P frequency should be about 0.2%
Observed
About 10% of 10,000 Neg. were retested
Of the 1,300 retested, 32 were N,P,P or 2%
31 of 32 were in one of two reference labs
16. Post test QA Occurrence Management Intensive review revealed several testing processes in field and reference labs needing strengthening
The case of the N,P,P results review validated the initial N result
Retested specimens from sites where expected and observed differed significantly
17. Lessons Learned Comparison of Expected and Observed results in a 3 test protocol can yield a useful QA process
Testing in both field and central labs also provides a basis for checking quality
19. Thank you