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Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya
  1. D N Shaffer1,2,
  2. V N Yebei3,
  3. J B Ballidawa3,
  4. J E Sidle1,2,
  5. J Y Greene1,
  6. E M Meslin4,
  7. S J N Kimaiyo1,
  8. W M Tierney1,5
  1. 1Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA
  2. 2Department of Medicine, Moi University Faculty of Health Sciences, Eldoret, Kenya
  3. 3Department of Behavioral Science, Moi University Faculty of Health Sciences, Eldoret, Kenya
  4. 4Indiana University Center for Bioethics, Indianapolis, IN, USA
  5. 5Regenstrief Institute, Incorporated, Indianapolis, IN, USA
  1. Correspondence to:
 Dr D N Shaffer
 The Walter Reed Project, USAMRU-K, Unit 64109, APO AE 09831-4109, Kenya; dshaffer{at}


Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial.

Design: Qualitative study with focus groups.

Setting: Teaching and referral hospital and rural health centre in western Kenya.

Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators.

Results: Eighty nine individuals participated in a total of 11 focus groups over a four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidisation of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants.

Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants.

  • AIDS
  • Kenya
  • clinical trial

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  • This study was funded by the Department of Medicine of the Indiana University School of Medicine and in part by grant number 1-D43-TW01082 from the Fogarty International Center, National Institutes of Health. Other than academic relationship to authors, the Department of Medicine of the Indiana University School of Medicine as the study sponsor had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication. The researchers declare independence from the funders of this study.

  • Competing interests: the authors declare that they have no competing interests, particularly financial, with regard to participation in the focus group study, and/or preparation and submission of this manuscript for review.

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