Planning for posttrial access to antiretroviral treatment for research participants in developing countries

Am J Public Health. 2009 Sep;99(9):1556-62. doi: 10.2105/AJPH.2008.157982. Epub 2009 Jul 16.

Abstract

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Review

MeSH terms

  • Adult
  • Africa
  • Anti-Retroviral Agents / economics
  • Anti-Retroviral Agents / therapeutic use*
  • Asia
  • Child
  • Child, Preschool
  • Clinical Trials as Topic / standards*
  • Continuity of Patient Care / economics
  • Continuity of Patient Care / standards*
  • Costs and Cost Analysis
  • Developing Countries
  • Guideline Adherence / economics
  • Guidelines as Topic
  • HIV Infections / drug therapy*
  • Haiti
  • Health Services Accessibility / economics
  • Health Services Accessibility / standards*
  • Humans
  • National Institutes of Health (U.S.) / standards
  • Research Subjects
  • South America
  • United States
  • Young Adult

Substances

  • Anti-Retroviral Agents