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Table 1 Modifications to the Study Protocol

From: The Young Women’s Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV

Date of Approval

Modification

August 2016

Reduced incentive amounts. Participants who have two positive (reactive) test results for their screening tests will not undergo a third (confirmatory) test. Increased the number of clusters from 12 to 24. Revised the screener, consent forms, and questionnaire to reflect protocol changes and the supplemental forms to reflect feedback during instrumentation programming and testing.

October 2016

Young women who cannot sign their signature or do not have a signature, will be asked to provide an inked fingerprint in place of a signature in accordance with South African Good Clinical Practice (GCP) guidelines. The alcohol breathalyser test was moved to the beginning of the intake appointment to have a valid assessment of alcohol use. Case management will consist of calls or in-person check-ins. Revised the consent form and locator form to reflect changes regarding case management and the baseline questionnaire and significant individual contact form based on instrument programming and testing.

April 2017

Addition of 6-month follow-up protocol: Submission of the 6-month follow-up consent form and 6- and-12-month questionnaire.

October 2017

Addition of 12-month follow-up protocol: Submission of the 12-month follow-up consent form.

Updated all previously approved consent forms and the Rights of Research Participants Card to reflect change in chairperson.

November 2017

Made a minor change to the 12-month follow-up consent form. Edited the ACASI section of the baseline and follow-up instruments, which included adding referral prompts related to self-reported violence experienced in the past 3 months.