Several randomized, controlled trials (RCTs) have tested strategies to prevent sexual acquisition of HIV infection, but their quality has been variable. We aimed to identify, describe, and evaluate the quality of RCTs studying biomedical interventions to prevent HIV acquisition by sexual transmission.
We conducted a systematic review to identify all RCTs evaluating the efficacy of biomedical HIV prevention interventions. We assessed seven generic and content-specific quality components important in HIV prevention trials, factors influencing study power, co-interventions provided, and trial ethics.
We identified 26 eligible RCTs. The median number of quality components judged to be inadequate or unclear was 3 (range, 1-4) in 1992-1998, 3 (range, 1-4) in 1999-2003, and 0 (range 0-2) in 2004-2008 (p < 0.001). Common problems that may have biased results included low retention (median 84%), poor adherence to interventions requiring ongoing use (median ≤78%), and lower HIV incidence than expected a priori (in 8 of 11 trials where evaluable).
Reporting of trials of biomedical HIV prevention interventions has improved over time. However, quality improvement is needed in several key areas that influence study power, including participant retention, adherence to interventions, and estimation of expected HIV incidence.
Keywords: HIV, primary prevention, clinical trial, systematic review, research methodology, statistical bias