Abstract
BackgroundThe collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a “gold standard” the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented [1].Methodology/Principal FindingsData were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in “clinical trial culture” that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutions.Conclusions/SignificanceThe integration of qualitative social science and the use of mixed methods and triangulation in clinical trials are feasible, and can reveal (and resolve) inaccuracies in data on adherence and sensitive behaviours, as well as illuminating aspects of “trial culture” that may also affect data accuracy.
Highlights
The accurate measurement of product use and related behaviour in microbicide trials is important for a number of reasons.First, poor adherence reduces the chance of demonstrating effectiveness
After briefly describing the Microbicides Development Programme MDP301 Phase III trial, we describe in detail the mixed method/triangulation model that has been developed by the MDP team in an attempt to gather more accurate data on adherence and sexual behaviour
While a detailed consideration of these issues falls outside the scope of this paper, we are raising them here because we want to make clear that the triangulation model we describe here represents an attempt to move beyond comparing methods and trying to work out which is more accurate, toward developing a more composite and holistic picture, while at the same time accepting a necessary degree of uncertainty in the result
Summary
The accurate measurement of product use and related behaviour in microbicide trials (and in many other fields) is important for a number of reasons.First, poor adherence reduces the chance of demonstrating effectiveness. The accurate measurement of product use and related behaviour in microbicide trials (and in many other fields) is important for a number of reasons. If a trial shows overall benefit relating the level of protection to adherence is valuable in interpreting the results, and has important implications for predicting effectiveness in real-life settings. Having accurate data on product use and related behaviour is important for assessing safety [2,3]. The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIVrelated) research. This paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented [1]
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