Table 3 Summary of Protocol Approval and Amendments
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 |