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Analysing direct effects in randomized trials with secondary interventions: an application to human immunodeficiency virus prevention trials

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  • Michael Rosenblum
  • Nicholas P. Jewell
  • Mark van der Laan
  • Stephen Shiboski
  • Ariane van der Straten
  • Nancy Padian

Abstract

Summary. The ‘Methods for improving reproductive health in Africa’ trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing infection by the human immunodeficiency virus (HIV) among susceptible women. 5045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the ‘gold standard’ HIV prevention barrier method. There was much lower reported use of condoms in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention‐to‐treat analysis. We adapt an analysis technique from causal inference to estimate the ‘direct effects’ of assignment to the diaphragm arm, adjusting for use of condoms in an appropriate sense. Issues raised in the trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed.

Suggested Citation

  • Michael Rosenblum & Nicholas P. Jewell & Mark van der Laan & Stephen Shiboski & Ariane van der Straten & Nancy Padian, 2009. "Analysing direct effects in randomized trials with secondary interventions: an application to human immunodeficiency virus prevention trials," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 172(2), pages 443-465, April.
    • Handle: RePEc:bla:jorssa:v:172:y:2009:i:2:p:443-465
    DOI: 10.1111/j.1467-985X.2009.00585.x
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    Cited by:

    1. Jean‐Louis Arcand & Eric Djimeu Wouabe, 2010. "Teacher training and HIV/AIDS prevention in West Africa: regression discontinuity design evidence from the Cameroon," Health Economics, John Wiley & Sons, Ltd., vol. 19(S1), pages 36-54, September.
    2. Stijn Vansteelandt & Tyler J. VanderWeele, 2012. "Natural Direct and Indirect Effects on the Exposed: Effect Decomposition under Weaker Assumptions," Biometrics, The International Biometric Society, vol. 68(4), pages 1019-1027, December.
    3. Jouni Kuha & John H. Goldthorpe, 2010. "Path analysis for discrete variables: the role of education in social mobility," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 173(2), pages 351-369, April.

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