VOICE (MTN-003) IT S ALL ABOUT THE ENDPOINTS. Edward Livant MT (ASCP), MPH University of Pittsburgh Medical Center MTN Network Laboratory
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1 VOICE (MTN-003) IT S ALL ABOUT THE ENDPOINTS Edward Livant MT (ASCP), MPH University of Pittsburgh Medical Center MTN Network Laboratory
2 Review of Sample 2
3 Testing starts here with rapid test (s). Negative Stop Positive Continue Discordant Continue
4 If you had a positive rapid test, you will perform a Western Blot. This is Sample 1 If the results are negative or Indeterminate, proceed to an RNA. Sites can consider a positive HIV rapid test indication to store plasma archive if possible. This is not a requirement. If the results are positive, proceed to sample 2.
5 If the RNA is Positive, proceed to sample 2. If the sample is negative, the algorithm is complete. We suggest you contact the Network Laboratory or protocol team in this situation for guidance.
6 If the Sample 2 Western Blot is negative or indeterminate, contact the MTN Network Laboratory for guidance. If the Sample 2 Western Blot is positive, local HIV diagnostic testing is complete. The Network Laboratory will do a third confirmatory test.
7 Know the differences: Sample 1 versus Sample 2 What triggers a sample 2?. Positive HIV rapid test with a positive HIV Western Blot Sample 2 requires collection of additional specimens. Use the Sample 2 checklist.
8 The checklist shows what specimens are needed at Sample 2: Western Blot Plasma archive CD4 HIV RNA
9 Specimen Collection at Sample 2 Specimens Required at Sample 2 Plasma Archive Must store minimum 6 ml of plasma; draw ml of whole blood Local Testing-draw amounts vary with site criteria CD4 Count RNA HIV-1 Viral Load HIV-1 Western Blot
10 Importance of Plasma archive Enrollment plasma archive and Sample 2 plasma archive have an even higher importance then routine visit archives Why?
11 Importance of Plasma archive Enrollment plasma archive and Sample 2 plasma archive have an even higher importance then routine visit archives Why? Plasma archive from enrollment shows that the participant was uninfected at enrollment. It is the only archive sample before the participant is on product.
12 Importance of Plasma archive Enrollment plasma archive and Sample 2 plasma archive have an even higher importance then routine visit archives Why? Sample 2 archive may help give a better idea of when infection occurred.
13 Importance of Plasma archive Enrollment plasma archive and Sample 2 plasma archive have an even higher importance then routine visit archives Why? Sample 2 archive is usually the earliest plasma available for resistance testing after infection. Resistance patterns can change over time.
14 Importance of Plasma archive Enrollment plasma archive and Sample 2 plasma archive have an even higher importance then routine visit archives Why? The plasma from enrollment and sample 2 are crucial to verify true endpoints.
15 Specimen Collection at Sample 2 and Enrollment If there is a problem with these plasma archives (missed, lost, sample damaged, etc..) You do not need to wait for permission from the NL or protocol team to call back participant Notify the NL or protocol team immediately to report problem and get guidance on documentation. These are the most precious samples in VOICE.
16 Additional Topics
17 Urine Dipstick Discussion Any Siemens dipstick can be used-the tests in the different combinations (4, 9) are the same. Any abnormal results on dipsticks should trigger participant follow up, even if not a protocol analyte for VOICE. (Bilirubin, Blood, etc ) Should all sites consider using the 4 test strip?
18 Operational Reminders From NL LDMS Reconciliations-why do I have to fix these CRF s? Because this will be the only way to resolve the errors and have correct data at SCHARP. DAIDS requires you run QC at least once per week for rapid tests if you test participants that week.
19 Operational Reminders From NL Make sure to use the Quidel Urine Pregnancy Kit. Do not use the Urine + Serum combo kit. Why? Because the combo kit has not been validated for use with vaginal gels. The urine kit has been validated for use with gels.
20 Examples of Emerging Issues Issue: Staff omitted RNA viral load from follow up algorithm Response: Make sure staff review algorithm frequently and note differences between screening and follow up
21 Examples of Emerging Issues Issue: Staff did not take swabs for storage during a pelvic exam Response: Review procedures for the sample collection required during pelvic exams
22 Examples of Emerging Issues Issue: Repeat labs missed. Response: Make sure to review procedures for when to repeat tests
23 Examples of Emerging Issues Issue: Missed plasma archive enrollment Response: Make all efforts possible to get enrollment archive samples. These are very precious because they cannot be truly recollected after the participant has started product. If it is missed or there is a problem in processing, recollect as soon as possible.
24 Examples of Emerging Issues Issue: Specimens collected outside the office at a home and a workplace. Response: Specimens cannot be collected outside of the clinic.
25 Examples of Emerging Issues Issue: Participant enrolled who had exclusionary lab results Response: Add additional reviews if necessary
26 Examples of Emerging Issues What do these examples teach us? Review the checklists prior to participant visits. Review procedures frequently.
27 Thank You-Questions?
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