Assessing the Accuracy of Adherence and Sexual Behaviour Data in the MDP301 Vaginal Microbicides Trial Using a Mixed Methods and Triangulation Model

Abstract

BackgroundAccurate data on adherence and sexual behaviour are 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. The Microbicides Development Programme has developed a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour.Methodology/Principal FindingsData were collected from a random subsample of 725 women using structured case record form (CRF) interviews, coital diaries (CD) and in-depth interviews (IDI). Returned used and unused gel applicators were counted and additional data collected through focus group discussions and ethnography. The model is described in detail in a companion paper [1]. When CRF, CD and IDI are compared there is some inconsistency with regard to reporting of sexual behaviour, gel or condom use in more than half. Inaccuracies are least prevalent in the IDI and most prevalent in the CRF, where participants tend to under-report frequency of sex and gel and condom use. Women reported more sex, gel and condom use than their partners. IDI data on adherence match the applicator-return data more closely than the CRF. The main reasons for inaccuracies are participants forgetting, interviewer error, desirability bias, problems with the definition and delineation of key concepts (e.g. “sex act”). Most inaccuracies were unintentional and could be rectified during data collection.Conclusions/SignificanceThe CRF – the main source of self-report data on behaviour and adherence in many studies – was the least accurate with regard to measuring sexual behaviour, gel and condom use. This has important implications for the use of structured questionnaires for the collection of data on sexual behaviour and adherence. Integrating in-depth interviews and triangulation into clinical trials could increase the richness and accuracy of behavioural and adherence data.

Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study

“…l Sometimes the qualitative research was reported briefly in a mixed methods article 123,125,127 or was extremely descriptive -almost like a mini-survey. 126 This did not damage the utility of the research but did generate concerns about its credibility.…”

“…123 The second was that qualitative research should be used to collect difficult to measure processes and outcomes within the trial, even if numbers were large and it was time consuming and expensive. 124,125 The best option might be dependent on the situation, with attention needing to be paid to the trade-off between efficiency and accuracy.…”

Exploring Discordance Between Biologic and Self-Reported Measures of Semen Exposure: A Qualitative Study Among Female Patients Attending an STI Clinic in Jamaica

“…This study expands upon a history of using qualitative methods to better understand and complement data obtained from quantitative surveys, as well as to improve the validity of survey data [e.g., 24,25,29,31]. The primary innovation represented by this study is the additional incorporation of commercially available PSA rapid test results.…”

“…Although most explanations were possible, we were limited in our ability to assess their veracity; self-reported data are inherently subjective, regardless of the format. As others have shown, qualitative data, even when collected in order to clarify issues, can still contain inaccuracies [24,25].…”

“…Notably, in Plummer's study and most other studies that compare biomarker data to self-reported data, the analysis took place months or years after data collection. In a microbicide trial among women in Africa, Pool et al [25] further demonstrated both the difficulty and utility of triangulating data this way, using an objective marker (i.e., returned, used vaginal microbicide gel applicators), survey data, coital diaries, and qualitative interviews. Interviewing study participants just days after they had returned gel applicators and completed questionnaires, Pool et al determined that data from qualitative interviews were more accurate than the coital diary or survey data and matched most closely the information provided by the returned applicators.…”