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Table 1 Modifications to protocol

From: mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina

Date Approved

Modification

September 2016

Revised eligibility criterion; increased incentive amounts

October 2016

Addition of Certificate of Confidentiality

December 2016

Changed type of drug screening test used; addition of participant stamp card; inclusion of risk-reduction materials for YWC arms

June 2017

Revised eligibility criterion

August 2017

Addition of peer consultant program to assist in recruitment of potential participants for study participation

December 2017

Changed study design from a three-arm parallel group design to a three-arm crossover design; added referral prompts to survey instrument and updated consents to reflect change

January 2018

Changed distressed respondents’ protocol about who to contact