title: A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme.
abstract: BACKGROUND
  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].
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Centre for International Health Research (CRESIB), University of Barcelona, Barcelona, Spain. robert.pool@cresib.cat
authors.forename: Robert
authors.initials: R
authors.lastname: Pool
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Montgomery
authors.forename: Neetha S
authors.initials: NS
authors.lastname: Morar
authors.forename: Oliver
authors.initials: O
authors.lastname: Mweemba
authors.forename: Agnes
authors.initials: A
authors.lastname: Ssali
authors.forename: Mitzy
authors.initials: M
authors.lastname: Gafos
authors.forename: Shelley
authors.initials: S
authors.lastname: Lees
authors.forename: Jonathan
authors.initials: J
authors.lastname: Stadler
authors.forename: Angela
authors.initials: A
authors.lastname: Crook
authors.forename: Andrew
authors.initials: A
authors.lastname: Nunn
authors.forename: Richard
authors.initials: R
authors.lastname: Hayes
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
mesh_terms: D000282:Administration, Intravaginal; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D012725:Sexual Behavior; D014622:Vaginal Creams, Foams, and Jellies
chemical_list: D000890:Anti-Infective Agents; D014622:Vaginal Creams, Foams, and Jellies