Publications by authors named "Che-Chin Lie"
Background: High pregnancy rates undermine the conduct and interpretation of HIV prevention trials. We performed this analysis to identify baseline participant characteristics associated with increased risk of pregnancy in recent vaginal microbicide trials.
Study Design: We analyzed the data from four recently completed Phase III trials of candidate microbicides for prevention of HIV infection.
Article Synopsis
- Poor retention in HIV prevention trials can skew results, especially in developing countries, highlighting the need to understand why participants drop out.
- In a study involving over 7,000 women, 21.4% were lost to follow-up or discontinued early, with factors like younger age and less education contributing to non-retention.
- Focusing on retaining younger, less educated women—who may also face higher HIV infection rates—could improve the overall effectiveness and reliability of these trials.
HIV prevention trials typically randomize thousands of participants to active or control intervention arms, with regular (e.g. monthly) clinic visits over one or more years of follow-up.
View Article and Find Full Text PDFBackground: Analyzing pooled data from 4 recent microbicide trials, we aimed to determine characteristics of participants at higher risk of HIV and sexually transmitted infections (STIs), to inform targeted recruitment, preserved study power, and potentially smaller study sizes in future trials.
Methods: We evaluated the relationships between participants' characteristics and the incidence of HIV, STIs, and reproductive tract infections (RTIs). We calculated incidence rates as the number of infection events divided by the person-years of observation.