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Table 1 Modifications to the protocol

From: The biobehavioral Women’s Health CoOp in Pretoria, South Africa: study protocol for a cluster-randomized design

Date

Amendment

6/2012

Started completing full intake process (i.e., consent, biological testing, and baseline interview) in the field in addition to the field site.

6/2012

Dropped recruitment through mobile units and added recruitment through outreach workers with most activities conducted at fixed field site. [Note: mobile units were never used to recruit any participants for the study]

6/2012

Reduced frequency of case management from weekly to monthly.

11/2012

Changed eligibility criteria from weekly use of 2 or more drugs (including alcohol) to weekly use of 1 or more drugs (including alcohol).

12/2012

Provided space onsite to store ARVs for participants who did not have a place to store them.

10/2013

Reduced proposed sample from 1050 to 600 minimum.

12/2013

Added onsite CD4 testing.

1/2014

Started completing some follow-up interviews in the field when participants were unable to return to the field site.

5/2014

Increased incentives for baseline interview from R70 to R100; for 6-month follow-up interviews from R100 to R150; and for 12-month follow-up interviews from R150 to R200. [Note: Rand to Dollar conversion rate is approximately R10 = US $1]

5/2014

Began collecting and storing dried bloodspots for future HIV viral load testing.