![]() |
![]() |
||||||||||||
|
02675 HOW RELIABLE DOES SELF-REPORTED SEX BEHAVIOUR NEED TO BE FOR VALID MICROBICIDE EFFICACY ESTIMATION? Desai, Kamal Objective: The primary objective of randomised clinical trials for microbicides is to determine effectiveness of protection against HIV. Observed effectiveness will be a function of several unknown parameters including the biological efficacy, consistency of use (compliance) and possibly epidemiological interaction between HIV and other STIs. If compliance can be accurately determined from sexual behaviour questionnaires, there is an opportunity to estimate biological efficacy. We examine to what extent misreporting in sexual behaviour data can be tolerated in validly estimating microbicide efficacy. Method: A stochastic mathematical model simulating microbicide clinical trials where biological efficacy, compliance and self-reported behaviours vary is employed. Two types of misreporting are assumed for compliance: random over/under-reporting (type 1) or over-reporting (type 2). Preliminary Results: If type 1 misreporting is not more than 30%, then efficacy of a microbicide conferring 40% reduction in susceptibility per act can be validly determined, otherwise efficacy is strongly underestimated. The effect of type 2 misreporting at low level is considerably worse than type 1 but equally underestimates at high levels. Further results will seek to quantify a minimum level of questionnaire validity. Conclusion: If sexual behaviour questionnaires can be developed to provide accurate data on microbicide compliance (as well as condom use, partners, etc), they will enhance ability to estimate product efficacy which, in conjunction with effectiveness estimates, will enhance interpretation of randomised controlled trials Dr Kamal Desai |
|||||||||||||