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Ethical issues in intervention studies on the prevention and management of diabetes and hypertension in sub-Saharan Africa
  1. Elizabeth Shayo1,
  2. Marie Claire Van Hout2,
  3. Josephine Birungi3,
  4. Anupam Garrib4,
  5. Sokoine Kivuyo1,
  6. Sayoki Mfinanga1,
  7. Moffat J Nyrienda3,5,
  8. Ivan Namakoola3,
  9. Joseph Okebe6,
  10. Kaushik Ramaiya7,
  11. Max Oscar Bachmann8,
  12. Walter Cullen9,
  13. Jeffrey V Lazarus10,11,
  14. Geoff Gill12,
  15. Tinevimbo Shiri6,
  16. Dominic Bukenya3,
  17. Hazel Snell6,
  18. Mastula Nanfuka13,
  19. Luis E Cuevas4,
  20. Meshack Shimwela14,
  21. Gerald Mutungi15,
  22. Joshua Musinguzi16,
  23. Janneth Mghamba17,
  24. Kenneth Mugisha13,
  25. Shabbar Jaffar6,
  26. Peter G Smith18,
  27. Nelson Kaulukusi Sewankambo19
  1. 1National Institutes for Medical Research, Dar es Salaam, United Republic of Tanzania
  2. 2Faculty of Education, Health & Community, Liverpool John Moores University, Liverpool, Merseyside, UK
  3. 3MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda
  4. 4Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom
  5. 5Faculty of Epidemiology and Public Health, London School of Hygiene and Tropical Medicine, London, UK
  6. 6Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK
  7. 7Shree Hindu Mandal Hospital, Dar es Salaam, Tanzania
  8. 8Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK
  9. 9School of Medicine, University College Dublin, Dublin, Ireland
  10. 10Hospital Clinic, University of Barcelona, Instituto de Salud Global de Barcelona, Barcelona, Spain
  11. 11CHIP, Rigshospitalet, Kobenhavn, Denmark
  12. 12Emeritus Professor of International Medicine, Liverpool School of Tropical Medicine, Liverpool, United Kingdom
  13. 13The AIDS Support Organisation, Kampala, Uganda
  14. 14Temeke Hospital, Dar es Salaam, Tanzania
  15. 15Non-communicable Disease Control Programme, Ministry of Health, Kampala, Uganda
  16. 16AIDS Control Programme, Ministry of Health, Kampala, Uganda
  17. 17Department of Preventive Services, Ministry of Health and Social Welfare, Dar es Salaam, Tanzania
  18. 18MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
  19. 19College of Health Sciences, Makerere University, Kampala, Uganda
  1. Correspondence to Dr Shabbar Jaffar; shabbar.jaffar{at}lstmed.ac.uk

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Summary box

  • Conducting intervention studies in Africa, where medicines supply for chronic conditions is inequitable and patchy, raises major ethical issues.

  • Here we discuss what should the ethical approach be for a research programme in terms of provision of a steady and sustainable supply of medicines for patients with diabetes and hypertension.

Introduction

The incidence of diabetes and hypertension has risen sharply in sub-Saharan Africa alongside a continuing high burden of HIV infection.1 In many settings, the prevalence figures among adults are 4%–5% for diabetes, above 25% for hypertension and 5%–20% for HIV infection.2–4 All these conditions require lifelong treatment, and they have increased substantially the demand for chronic care services in Africa, where health systems have, until recently, focused on tackling acute infectious diseases.5

There is considerable inequity in service provision for chronic diseases. HIV services, including antiretroviral therapy, are available widely for free and are organised typically in stand-alone clinics. Over 65% of people estimated to be living with HIV infection are in regular care.6 In contrast, this figure is only about 5%–20% for people living with diabetes or hypertension.3 7 A major challenge is that medicines for diabetes and hypertension are generally not provided free of charge and have to be purchased by patients. Even in those countries that do provide free medicines for hypertension and diabetes, shortages are common and patients then have to purchase the medicines from private suppliers.

Our research collaboration is evaluating a biomedical diabetes preventive intervention in people living with HIV infection in a placebo-controlled randomised trial and, separately, evaluating integrated healthcare provision compared with standard care for people living with HIV, diabetes or hypertension in a cluster-randomised controlled trial.8 There are no data on the effectiveness of these approaches from Africa. Therefore, these trials have clinical and health …

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