Paper short abstract:

This paper will discuss the concept of real-world research by examining conflicting perspectives about the ‘standard-of-care’ in an implementation study evaluating the effectiveness of offering antiretroviral treatment as prevention in a government-managed health system in Swaziland.

Paper long abstract:

The goal of the Early Access to ART for All implementation study is to evaluate the effectiveness of offering antiretroviral treatment for prevention in a government-managed health system in Swaziland. The study is being implemented in 14 rural health facilities which is expected to provide evidence of implementation challenges in the "real-world". But in order to measure changes between the control and intervention phase, the participating facilities have to enact the study protocol in the same way. This results in an ambiguous balance between standardizing practices in order to increase comparability and not intervening because of the principle of real-world implementation.

This paper will discuss the concept of real-world research by analyzing conflicting perspectives of study team members about the notion of the 'standard-of-care', what that is, or ought to be, when doing implementation research. In doing so I will explore how diverging notions of standards of care relate to study team members' expectations of what the study aims to achieve, for themselves, for the population of Swaziland and for the scientific community.

The analysis draws on experiences of being involved as the social science coordinator within the study team over a period of three years, of which twelve months consisted of ethnographic fieldwork carried out in Swaziland between February 2014 and February 2015. I attended over 40 team meetings, and conducted 10 interviews with study staff members and 10 interviews with health providers of study facilities, in addition to doing participant observation in one of the participating health facilities.