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Raymond, Elizabeth Ga; Moench, Thomasb; Feldblum, Paula; Hubacher, Davida
aFamily Health International, Research Triangle Park, North Carolina, USA
bReProtect, Inc., Baltimore, Maryland, USA.
Received 20 December, 2006
Accepted 11 January, 2007
The results reported by Morrison and colleagues  provide encouragement that hormonal contraceptives may not affect a woman's risk of HIV acquisition. As the authors note, however, their observational study design had limitations that compromise full confidence in their conclusions. Because of the vital importance of the issue, especially in light of the increasing popularity of hormonal methods in areas of high HIV incidence, more robust data are desirable. The accompanying editorial by Bulterys et al.  asserts that ‘unfortunately, no randomized clinical trial can be conducted owing to ethical and adherence issues resulting from randomly assigning women to contraceptive methods with substantially differing efficacy’. We agree, but a randomized study that compares methods with similar efficacy should be possible. To investigate the association between hormonal methods and HIV infection, women at risk could be assigned to use either a long-acting hormonal contraceptive, such as an injectable or an implant, or a copper-containing intrauterine device, which has no known effect on HIV acquisition . These methods have similar high contraceptive efficacy and minimal adherence problems, and current data and guidelines allow their safe use in women at risk of HIV exposure if appropriate screening is performed at initiation . This design would eliminate the very serious concern of selection bias. Although such a trial could not easily be masked, differences in relevant behavior between groups after enrollment (such as condom use) and in the validity of reporting of these behaviors would probably be less than in the study by Morrison et al. . We  and others (E. Stringer, personal communication) have recently completed successful studies confirming the feasibility of the randomized design, and we are currently conducting additional preparatory investigations in anticipation of a larger trial.
Sponsorship: United States Agency for International Development.
© 2007 Lippincott Williams & Wilkins, Inc.
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