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1/2019
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Initial submission to conduct the experimental phase of the study
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3/2019
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Request for SAMAREC to be the IRB of Record
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3/2019
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Revised research protocol and supporting materials to prepare for the full study phase
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4/2019
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Amended full study research activities to allow for the provision of PrEP
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7/2019
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Addition of participant follow-up consent documents and the 3-month follow-up questionnaire
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10/2019
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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
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11/2019
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Reduced the number of clinic staff follow-up visits from 3 to 2 appointments—specifically, 4- and 8-month follow-up appointments
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2/2020
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Minor modifications to study documents and protocol to prevent co-enrollment of participants involved in other HIV studies in the Tshwane area
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3/2020
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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
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4/2020
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Minor modifications to clinician and support staff follow-up questionnaires and consenting procedures
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4/2020
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Notification to the IRB of resumption of limited face-to-face appointment with study participants during the COVID-19 lockdown
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4/2020
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Submission of the COVID-19 questionnaire to be administered via telephone during the COVID-19 lockdown
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