A systematic review of the quality of trials evaluating biomedical HIV prevention interventions shows that many lack power.

HIV Clinical Trials
Susan M GrahamAhmed M Bayoumi

Abstract

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 in adequate or unclear was 3 (range 1-4) in 1992-1998, 3 (range 1-4) in 1999-2003, and 0 (range0-2) in 2004-2008 (p < .001). Common problems that may have biased results included low retention (median 84%), poor adherence to interventions requiring on going use (median < or =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 partic...Continue Reading

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Citations

Aug 31, 2011·AIDS and Behavior·Elizabeth E TolleyRewa Kohli
Mar 9, 2011·Contemporary Clinical Trials·Paul J FeldblumKofi Opoku
Feb 28, 2015·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Marie-Claude BoilySharmistha Mishra
Aug 7, 2013·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Ron BrookmeyerSusan H Eshleman

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