Article

A Mixed Methods and Triangulation Model for Increasing the Accuracy of Adherence and Sexual Behaviour Data: The Microbicides Development Program

Centre for International Health Research (CRESIB), University of Barcelona, Barcelona, Spain.
PLoS ONE (Impact Factor: 3.23). 07/2010; 5(7):e11600. DOI: 10.1371/journal.pone.0011600
Source: PubMed

ABSTRACT

The 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].
Data 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.
The 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.

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    • "It is important not to dismiss the large body of evidence on product use from these trials because of a lack of biological measures of adherence. Several non-ARV microbicide trials used multiple measurement methods [51] and reported similar disparities between self-reported point prevalent product use and composite or indirect measures of product use, as seen in ARV-based trials between self-reported point prevalent use and drug level counts. In spite of the limitations of the clinical trial setting, it was possible to collect data that went beyond acceptability to provide a more holistic picture of how women incorporated gel into their lives and partnerships across cultures that will be relevant to real-life use [52]. "
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    • "The trial design, methods and results have been described elsewhere (Nunn et al., 2009; McCormack et al., 2010; Pool et al., 2010a,b). Briefly, MDP301 was a phase 3 double blind randomized placebo-controlled trial investigating the safety and efficacy of the candidate microbicide PRO2000, formulated in a gel and inserted prior to sex via a vaginal applicator. "

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