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This Article Full Text Full Text (PDF) All Versions of this Article: AJPH.2008.157982v1 99/9/1556    most recent Submit a response View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Shah, S. Articles by Grady, C. PubMed PubMed Citation Articles by Shah, S. Articles by Grady, C. Related Collections Ethics Global Health

Seema Shah, JD, Stacey Elmer, BA and Christine Grady, RN, PhD

At the time of the study, Seema Shah was with the Department of Bioethics, Clinical Center, and the Henry Jackson Foundation Liaison Office, Division of AIDS, National Institutes of Health, Bethesda, MD. Stacy Elmer was an intern with the Department of Bioethics, National Institutes of Health, Bethesda. Christine Grady was with the Section on Human Subjects Research, Department of Bioethics, National Institutes of Health, Bethesda.

Correspondence: Correspondence should be sent to Seema Shah, Department of Bioethics, 10 Center Drive, 10/1C118, Bethesda, MD 20892-1156 (e-mail: shahse{at}mail.nih.gov). Reprints can be ordered at http://www.ajph.org by clicking the "Reprints/Eprints" link.

Despite recognition of the importance of posttrial access to antiretroviral therapy (ART), the implementation process has not been studied. We examined whether the National Institutes of Health (NIH) guidance document was being implemented in NIH-funded ART trials conducted in developing countries between July 2005 and June 2007.

All of the 18 studies we identified had posttrial access plans for trial participants. More than 70% had specific mechanisms for posttrial access, but none guaranteed long-term sponsor funding after the trials. The plans reflected variation in local contexts and the uncertainty of predicting local conditions in the long term.

The strength of the NIH guidance document may be that it encourages investigators to formulate plans in advance and to work with other stakeholders to provide access to ART.