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Overview of Screening Visit Procedures, PTID Assignment, Screening & Enrolment Logs, and Screen Failures. To keep in mind during screening & enrollment. What do we want to learn from HOPE?
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Overview of Screening Visit Procedures, PTID Assignment, Screening & Enrolment Logs, and Screen Failures
To keep in mind during screening & enrollment What do we want to learn from HOPE? • When offered the ring as a CHOICE, will women use it with high adherence and safety, and achieve HIV protection? • How acceptable and feasible is the delivery of the microbicide vaginal ring?
Components of Screening Visit Slide 1 • Questionnaires: • Demographics • Screening Behavioral Eligibility Administrative: • Screening IC • Assign PTID • Assess eligibility • Locator • Schedule Next Visit* • Reimbursement Behavioral: • HIV pre- & post-test • HIV/STI risk reduction (offer condoms) • Contraceptive counseling
Components of Screening Visit Slide 2 Clinical: • Medical/Menstrual Hx • Concomitant Meds • Contraceptive provision* • Physical Exam • Pelvic Exam • Treatment or referral* Laboratory: Urine: • Pregnancy • GC/CT • Urine culture*† Pelvic: • Trichomonas • Pap Smear* Laboratory: Blood: • HIV Serology • CBC with platelets • Serum Chemistries • Syphilis Serology
Screening Window Enrollment Screening 56 Days If needed, screening visit procedures can be completed over multiple visits. There is no limit to screening attempts
MTN-025/HOPE Inclusion Criteria • Previously enrolled in MTN-020 (ASPIRE) • Able and willing to provide written informed consent • Able and willing to provide adequate locator information • HIV-uninfected • Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation. Effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs) • Agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation
MTN-025/HOPE Exclusion Criteria • Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial • Per participant report at Screening: • Plans to relocate away from the study site during study participation • Plans to travel away from the study site for more than three consecutive months during study participation • Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP) PEP use at Screening is not exclusionary. Participants may be enrolled after the PEP regimen is complete and a negative HIV test is documented within 56 days of providing informed consent for Screening. • With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment Participation in the ‘Decliner Population’ does not preclude MTN-025 full study participation in the future.
MTN-025/HOPE Exclusion Criteria • Is pregnant at Screening/Enrollment or planning to become pregnant in the participant’s anticipated study participation period • Is currently breastfeeding • Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines Note: Otherwise eligible participants may be enrolled after completing treatment if all symptoms have resolved. • Clinically apparent Grade 3 pelvic exam finding
MTN-025/HOPE Exclusion Criteria • Has any of the following laboratory abnormalities at Screening Visit: • Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3 • Creatinine > Grade 3 • Hemoglobin > Grade 3 • Platelet count > Grade 3 • Pap result ≥ Grade 3 • Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Enrollment Screening Screen Fail
Documentation for Screen Failures • Screening IC forms (IC/coversheet). • Document reasons for ineligibility and date of determination as per the Eligibility Checklist • ECI-1 and pre-screening CRF only – complete and enter into Medidata • Document necessary referrals in ppt’s file; document that clinically significant abnormalities were communicated to ppt (Ex. Grade 3 lab value) • Make sure all screening documentation is complete up until the time that ineligibility was determined, including screening visit Checklist • File or enter data for all documents per MTN Data Management SOP
Screening Pop Quiz Get out your quiz paper!
Screening Pop Quiz • If a participant screens out of HOPE, can she participate in the HOPE decliner group?
Screening Pop Quiz • How many screening attempts can be made for each participant?
Screening Pop Quiz • Name one difference between the eligibility criteria for HOPE and ASPIRE.
Screening Pop Quiz • Where does the pre-screening ID come from?
Screening Pop Quiz • How many days long is the screening window?
Screening Pop Quiz How did you do? • NO - Only participants who actively decline study participation (i.e., express disinterest in enrollment) should be considered for decliner group enrollment. • Trick question! No limit. • Variable • Medidata! • 56 days long
Screening Visit References • Eligibility criteria protocol Sections 5.2/ 5.3 • Screening procedures protocol Section 7.2; SSP Section 4 • Visit Checklist Templates MTN Website