Interim data monitoring to enroll higher-risk participants in HIV prevention trials.

ABSTRACT:

Background

Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria.

Methods

We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses.

Results

A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, an

SUBMITTER: Halpern V 

PROVIDER: S-EPMC2708194 | biostudies-literature | 2009 Jun

REPOSITORIES: biostudies-literature