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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The effect of heterogeneity on HIV prevention trials
Clinical Trials, Volume 8, No. 2, Year 2011
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Description
Background: Randomized controlled trials (RCTs) for the prevention of HIV heterosexual acquisition are usually conducted among adult African populations with high heterogeneity in individual risk of infection. Purpose: The objectives were to (a) review how this heterogeneity has been considered when designing and interpreting such RCTs, (b) evaluate its effect on the findings and the statistical power of these trials, and (c) assess the potential advantages of using the crossover design with single failure-time endpoint. Methods: Individual-level HIV prevention RCTs conducted in Africa and published in the period 1998-2008 were reviewed. Using Monte Carlo simulations and statistical calculations, we assessed the effect of heterogeneity on the findings and the statistical power of HIV prevention RCTs. Results: All reviewed RCTs used the parallel design. The heterogeneity in individual risk of infection within study sites was not used for stratification nor generally considered in the design and interpretation of RCTs. Simulations showed that in the context of high HIV incidence, high heterogeneity can lead to a substantial underestimation of the impact of an intervention and reduced statistical power. Calculations demonstrated that the crossover design allowed for similar or better estimation and statistical power. The crossover design has the ethical advantage of sharing the potential benefits and risks of the intervention between participants. Limitations: Only trials with two treatment arms and two follow-up periods were modeled. The baseline risk of infection of each participant was assumed to be constant over time and HIV status was assessed at the end of each follow-up period. Conclusions: The heterogeneity in individual risk of HIV infection is an underestimated problem which should be taken into account when designing and interpreting RCTs that test prevention methods of HIV heterosexual acquisition in adult African populations with high HIV incidence. When the effects of tested interventions are rapidly reversible, the use of the crossover design should be considered. © The Author(s), 2011.
Authors & Co-Authors
Auvert, Bertran
France, Villejuif
Centre de Recherche en Épidémiologie et Santé Des Populations
France, Versailles
Université de Versailles Saint-quentin-en-yvelines
Sitta, Rémi
France, Villejuif
Centre de Recherche en Épidémiologie et Santé Des Populations
Zarca, Kevin
France, Villejuif
Centre de Recherche en Épidémiologie et Santé Des Populations
Mahiané, Séverin Guy
France, Villejuif
Centre de Recherche en Épidémiologie et Santé Des Populations
Pretorius, Carel C.
South Africa, Stellenbosch
Stellenbosch University
United States, Glastonbury
Avenir Health
Lissouba, Pascale
France, Villejuif
Centre de Recherche en Épidémiologie et Santé Des Populations
Statistics
Citations: 13
Authors: 6
Affiliations: 4
Identifiers
Doi:
10.1177/1740774511398923
ISSN:
17407745
e-ISSN:
17407753
Research Areas
Genetics And Genomics
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study