Overview of Screening Visit
Procedures, Eligibility Criteria, and
Visit Flow
Screening Visit Procedures
• What are 2 the primary goals of the screening
visit procedures?
– Evaluate Eligibility
– Establish Baseline
Eligibility Criteria - Rationale
Rationale is to select participants who are
– Healthy but at risk for HIV infection
– Likely to be retained
– Likely to be adherent to product use plan
– At low risk for safety issues potentially
associated with product use
Inclusion Criteria
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Protocol
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Age 18-45
Able/willing to provide IC
Adequate locator info
HIV-uninfected
Sexually Active
Effective contraception use/intention
Agrees not to participate in other research
studies
Exclusion Criteria
• Pregnancy intention or
currently pregnant
• Currently breastfeeding
• Plans to relocate
• Travel away for >8 weeks
• Ongoing/untreated UTI
• STI/RTI requiring treatment
• ≥Grade 2 Pelvic Finding
• Known adverse reaction to
study product or latex
• Chronic vaginal candidiasis
• Uncontrolled chronic
condition
• PEP in past 6 months
• IVDU in past 12 months
• Gynecologic or genital
procedure or pregnancy
outcome w/in 90 days
• Participation other research
study w/in 60 days
• Participation in
VOICE/other PrEP studies
w/in 12 months
• AST, ALT, or platelet count
Grade 1 or higher
• Creatinine, hemoglobin, or
pap result Grade 2 or
higher
• IoR Discretion
Exclusion Criteria Timeframes
Screening Visit Timeline
Non-therapeutic
IV drug use
> 4 episodes vag
candidiasis
12 mos
Ppt in
VOICE or
other
PrEP
studies
6 months
PEP
-No Vaginal
Intercourse
90 days
60 days
Screening
-Gyne/Genital -Ppt in Research
involving
Procedure
-PregOutcome meds/devices
Enrollment Visit Timeline
28 days
Enrollment
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Components of Screening Visit
Administrative:
Screening IC
Assign PTID
Assess eligibility
Locator
Schedule Next Visit*
Reimbursement
Behavioral:
HIV pre-/ post-test
HIV/STI risk reduction
(offer condoms)
Contraceptive
Questionnaires:
 Demographics
 Screening Behavioral
Eligibility
Clinical:
Medical/Menstrual Hx
Concomitant Meds
Contraceptive
provision*†
Physical Exam
Pelvic Exam
Treatment or referral*
Laboratory:
Blood:
HIV Serology
CBC with platelets
Serum Chemistries
Syphilis Serology
Laboratory:
Urine:
Pregnancy
GC/CT
Urine culture*†
Pelvic:
Trichomonas
Herpes Lesion*†
Wet mount for
candidiasis or BV*†
Pap Smear*
Vaginal pH
Gram stain
Endocervical swab
LoA#1
Screening Window
Screening
Enrollment
28 Days
If needed, screening visit procedures can be completed over multiple visits.
One rescreen is allowed
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Screening Visit Checklist
ASPIRE Informed Consents
Screening
Off-Site
Enrollment
Specimen
Storage
• Can defer
to M1
• Long Term
Optional
IDIs/FGDs
• LoA#2
• Subset
• Spilhaus
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Screening Informed Consent
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Informed Consent Tools
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–
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Fact Sheets (5 total)
IC Booklet
IC Tabletop Flip Chart
Ring Use
Instructions/Important
Information sheet
Pelvic model & sample ring
QUESTIONS ON SCREENING
PROCEDURES?
SCREENING VISIT
CASE REPORT FORMS
Approach to ASPIRE CRF Training
• Focus on purpose/reason for each CRF
• Will try to address questions we received during the external
review of the CRFs
• Will not go item by item, but will practice form completion
using scenarios
• Will not review form instructions, but will refer to these as
needed
• CRFs can be found in your binder – Screening tab
• Questions from all encouraged - Let’s get started!
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Demographics (DEM-1)
 Not interviewer-administered/translated
 Collects required ppt descriptors (age, ethnicity) and
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descriptors requested for publications/reports
For drinks/week and cigarettes/day items, use estimates and
rounding as needed – does not have to be exact
Cell phone & ‘income on her own’ questions used to describe
participant SES
Question on travel time to the clinic used to assess ppt burden
and may relate to retention
Items reflect participant information at the time of her SV only
– not updated later unless correction is needed
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Screening Behavioral Eligibility CRF
• Ensures ppt behavioral eligibility items are asked and
documented in the same way across sites and ppts
• Interviewer-administered; in local language(s)
• Practice before administering for 1st time
• Read items aloud as they appear
– provide clarification as needed
• Complete all form items even if ppt provides response that
indicates she is not eligible
• Note item 17 includes IPM 027 participation
– Will be clarified in a Data Communique
• Review closely once completed to ensure all items are completed
as needed
• Reference form when completing matching items on Eligibility
Checklist
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Screening Menstrual History (SMH-1)
 Created to help sites document items relevant to a ppt’s
baseline menstrual history and bleeding pattern
 Is DataFax – data will go into the study database
 Items 3-7: complete based on the ppt’s usual menstrual
periods as experienced prior to the SV
 if ppt is amenorrheic (consistently or partially), complete items
based on the how the ppt describes her most recentlyexperience menstrual periods and provide additional details as
needed in item 8.
 If the participant reports more than 99 days between her usual
menses, record “99” for item 3 (maximum boxes) and provide
more details in item 8
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SMH-1 continued…
 Item 6 (last menses day) – mark “ongoing” if on menses at SV;
do not need to update at EV
 Item 8
 Describe as best as possible participant’s baseline bleeding
pattern and associated symptoms
 Update as needed at EV if bleeding pattern or symptoms
changes (Ex. due to new HC method)
 Per note at bottom, update PRE CRF as needed with baseline
irregular bleeding/menstrual symptoms
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Screening Visit Physical Exam (SPX-1)
 DataFax form
 All items require a response – all systems listed in
‘Findings’ portion of the form required to be evaluated
 Use Notes line to describe abnormal findings
 Option to use notes line to describe normal findings as well (ex.
normally healed scar)
 Make sure Staff Initials/Date are in order if one person
does vitals and a separate person does the exam
assessments (use brackets as needed)
 Record medically-relevant findings onto PRE CRF (per
previous presentation)
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Pelvic Exam Diagram (non-DataFax)
 Used as the source document for all normal and
abnormal pelvic exam findings
 When completing, keep in mind that someone else
may look at this form prior to the participant’s next
pelvic exam. Be descriptive!
 Record all abnormal findings on the Screening
Pelvic Exam CRF (diagrams form is source)
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Screening Pelvic Exam (SPE-1)
 Completed at SV to all abnormal pelvic exam findings
observed
 Columns arranged by location with a general ‘other’
column
 Lists abnormalities using terms in FGGT and CONRAD
manual
 Record abnormal findings on PRE CRF per note below
items 1b, including location
 If a 2nd (repeat) screening pelvic exam performed,
complete new SPE-1 and PE Diagrams; fax repeat SPE-1
only once enrolled
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Pre-existing Conditions Log (PRE)
• Used to document in one place each participant’s
baseline medical/menstrual history
• Will include ppt-reported conditions as well as
abnormalities captured on:
– Pelvic Exam Diagrams, Screening Pelvic Exam CRFs
– Screening and Enrollment Physical Exam CRFs
– Grade 1 and higher laboratory results on Screening
Lab Results CRF
– Newly-diagnosed (at SV) STIs per Screening STI Test
Results CRF
Pre-existing Conditions CRF – con’t
• Page number – start with 01, go up as needed
• Condition
– Follow guidelines for AE text except do record past
surgeries as needed
– Be as descriptive as possible
• Onset Date (Month and Year)
– If uncertain, use best estimate; year required
• Comments
– Add info on frequency and duration of chronic
condition outbreaks; other relevant info for the
“snapshot”
Pre-existing Conditions CRF – con’t
• Ongoing at Enrollment?
– Leave blank at SV if ongoing; complete at EV
– Chronic/recurrent diagnoses are ongoing
• Severity Grade
– Assess per Tox Table and FGGT
– Mark “not gradable” if condition is below Grade 1 or resolved at
time of report (ex. C-section entry)
– At Enrollment Visit:
• If condition has resolved, do not update severity grade
• If severity grade has or on or prior to EV, update as needed
• Review all PRE CRF pages at SV and EV to ensure a complete
medical history (including current conditions) is created
– Info may be needed for Clinical Queries or auditors months or
years after originally-recorded
Pre-existing Conditions CRF – con’t
• Entries can be added and modified postenrollment
– Ppt may have forgotten to report a symptom
– Perhaps something that was thought to be not relevant
is later considered relevant; if so, add to PRE
– May need to collapse signs/symptoms into a diagnosis
– Write a chart note to explain why an entry is being
added/modified during follow-up
• Document meds taken for PRE on Concomitant
Medications Log CRF
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Concomitant Medications Log (CM-1)
 Completed starting at the SV; updated as needed at EV and during
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follow-up
Record trade name whenever possible; if not, use generic name
For injectable contraceptives, record separate entry for each
injection
For OCPs, record one entry for each pill pack
For all other injectable treatments, document single entry for tx.
If exact dose/units not known, put best description possible
“Taken for AE” item will always be ‘no’ for entries at SV
For each contraceptive entry, record a response for “If
contraceptive, was it dispensed at research center?”
Update PRE CRF if CM completion reveals conditions not already
reported or observed
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Screening Specimen Storage (SSS-1)
 Documents collection of the 2 SV stored specimens
1. Vaginal Smear for gram stain
2. Endocervical swab
 Blood visible on swab?: used to inform swab analyses
done at Network Lab
 Mark specimens as “stored” if collected and sent for storage;
update if you find out later that specimens were not stored
 Also collects results of syphilis testing
 Complete only 1 CRF for each participant per screening
attempt
 Will not collect specimens for storage or complete form if a repeat 2nd
pelvic exam is done
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Screening Visit LDMS Tracking Sheet
Optional
Note Visit
Code of SV
is preprinted =
97.0
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Screening Laboratory Results (SLR-1)
 Complete CRF as SV results become available
 If severity grade box present, assess for severity grade
per Tox Table
 If below grade 1, leave box blank
 If Grade 1 or higher, add to Pre-existing Conditions form
 Notes on eligibility are present when applicable
 If some or all tests are repeated prior to randomization:
 Complete a new SLR
 Only fax 2nd SLR CRF completed, once ppt enrolls
OR
 Use Alternate Collection Date if not all results on CRF
repeated
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Screening Laboratory Results (SLR-1)
Using
alternate
collection
date to
update
partial lab
results
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Screening STI Test Results (SST-1)
 Captures results of Trich, GC, CT tests done at SVA
 Will also capture wet mount results, if done
 If any STIs diagnosed, record on PRE CRF
 Will allow us to report on how many ppts had STIs
prior to enrollment
 Vaginal fluid pH assessed only if clinically indicated
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Eligibility Criteria (ECI-1)
 Allows SCHARP to report on # ppts screened, # enrolled,
#
screen fails and reasons for screen fails
 Item 3:
 “participant did not complete all screening procedures” – ppt
was eligible but did not complete all screening procedures
(including EV)
 “Eligible but declined enrollment” – participant was eligible but
she chose not to enroll
 “Not eligible” –ppt completed procedures as planned but does
not meet all eligibility criteria
 Item 4: Mark all reasons that apply
 4g: Mark if ppt participant in VOICE or other HIV prevention trial using
antiretroviral medication in the past 12 months
 Included in the SV form packet; complete only if screen fail
 Move to EV packet and complete then if EV scheduled
Screening Visit QA/QC
 Before ppt leaves:
 Review visit checklist for completeness
 Review Screening Behavioral Eligibility Criteria form for completeness
 Make sure lab requisition docs/LDMS Sheet and lab specimens are in
order
 Review pelvic exam/physical exam forms and make sure all needed
items are on PRE
 Make sure you have a way to be alerted once local lab results come
back (or don’t come back)
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Complete SLR, SST, PRE as needed, Eligibility Checklist as needed
 Do not fax any forms until ppt enrolls; fax ECI if ppt will not proceed
to EV
 Make sure systems are in place for EV, including scheduling, ppt
files, Pharmacy is aware of potential EV, etc.
DataFax Overview Video – Atlas
ADDITIONAL TOOLS
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Eligibility Checklist
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PTID Name Linkage Log
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Screening
Screen Fail
Enrollment
Screening
Documentation for Screen Failures
• Save IC forms (IC/coversheet).
• Document reasons for ineligibility and date of
determination as per the Eligibility Checklist
• ECI-1 CRF – complete and fax to SCHARP (do not fax
any other CRFs for the ppt).
• Document necessary referrals in ppt’s file; document
that clinically significant abnormalities were
communicated to ppt (Ex. Grade 3 lab value)
• Make sure all SD is complete up until the time that
ineligibility was determined, including SV Checklist
• File all documents per MTN Data Management SOP
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Last Day to Enroll Calculator
Additional Tools
• Participant Tracking Database
• Coenrollment database/system
Activity
Screening Visit Activity
• Pair up with the person sitting next to you
• Everyone will receive a screening packet of
CRFs/source documents. This participant has
completed her screening visit, and all labs are
currently pending.
• Complete the screening visit column on the
Eligibility Checklist in your training binders to
evaluate/document her eligibility thus far.
Screening Visit References
 Eligibility criteria
protocol Sections 5.2/ 5.3
 Screening procedures
protocol Section 7.2
 Accrual
SSP Sections 4.2.1 – 4.3.4
 Visit Checklist Templates
SSP Section 7