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Table 3 Summary of Protocol Approval and Amendments

From: The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa

Date of approval Protocol and Amendments
1/2019 Initial submission to conduct the experimental phase of the study
3/2019 Request for SAMAREC to be the IRB of Record
3/2019 Revised research protocol and supporting materials to prepare for the full study phase
4/2019 Amended full study research activities to allow for the provision of PrEP
7/2019 Addition of participant follow-up consent documents and the 3-month follow-up questionnaire
10/2019 Minor revisions to study screener and eligibility criteria to ensure participants are not currently enrolled in another HIV project and to the study protocol regarding follow-up on pregnancy outcomes of participants who become pregnant during the course of the study
11/2019 Reduced the number of clinic staff follow-up visits from 3 to 2 appointments—specifically, 4- and 8-month follow-up appointments
2/2020 Minor modifications to study documents and protocol to prevent co-enrollment of participants involved in other HIV studies in the Tshwane area
3/2020 Modification to allow project staff to complete at-home data entry of de-identified data, and the submission of a staff agreement of confidentiality for at-home data entry because of the COVID-19 lockdown
4/2020 Minor modifications to clinician and support staff follow-up questionnaires and consenting procedures
4/2020 Notification to the IRB of resumption of limited face-to-face appointment with study participants during the COVID-19 lockdown
4/2020 Submission of the COVID-19 questionnaire to be administered via telephone during the COVID-19 lockdown