Winnie Phiri, RN, RM Clinical Coordinator Lusaka, Zambia Lusaka 035 - - PowerPoint PPT Presentation

winnie phiri rn rm clinical coordinator lusaka zambia
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Winnie Phiri, RN, RM Clinical Coordinator Lusaka, Zambia Lusaka 035 - - PowerPoint PPT Presentation

Winnie Phiri, RN, RM Clinical Coordinator Lusaka, Zambia Lusaka 035 Flow Fitted to MTN 003 ~1 week 2 weeks 2 weeks SP3? Pre SP1 SP2 SP3/4?/ Screening Enrollment IC Booklet IC Booklet VCT given reviewed (hCG too? Appt for


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Winnie Phiri, RN, RM Clinical Coordinator Lusaka, Zambia

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Lusaka 035 Flow Fitted to MTN 003

SP1 SP3/4?/ Enrollment SP2 Pre Screening VCT

(hCG too? depending

  • n cost)

Appt for IUCD or implant Insertion

  • ff‐site

IC Booklet given IC Booklet reviewed Provide FP Provide FP, if not at SP1

SP3?

~1 week ≤ 2 weeks ≤ 2 weeks

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Review of Checklists/Worksheet

SP2 Checklist Screening Pelvic Checklist

Change in order ‐ shift down of SP2 Behavioral

Eligibility Form

Shortened wording

Between SP2 and Enrollment Worksheet

Additions of breastfeeding, adequate locator,

contraception

Suggested reformatting re eligible and non eligible

boxes

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Suggestion

Simplify U/A instructions and create a U/A Flow

Sheet to use throughout each screening attempt

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Ppt‐Reported Baseline Medical Menstrual History ‐ Site MO feedback

Uncomplicated ppt took approximately 30 minutes to

administer

Need more space for description Consider additional notes page Guide

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SP2/Enrollment Behavioral Eligibility Form

Issues: Q 3 Surgical sterilization of partner making ppt ineligible conflicts with Q4 and protocol page 42

None ppt is ineligible

Q4 24 months (2 years) versus “duration of study” Surgical sterilization of partner making ppt ineligible Q5 previous vaccine trial participation greater than 30 days ago Q6 24 months (2 years) versus “duration of study”

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Vaginal Test Results Form

Issues:

Who initials and dates this form?

  • the person who collects the specimens
  • the person who does the test
  • r the person who transcribes the results
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SP2 Medical Eligibility – Page 3

Issue:

Page 3 instructions arrow placement obscures text

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Who initial/dates here??

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