Standard of care for HIV prevention technology research: a consensus document from Nigeria

Abstract

Aim: A framework of care includes the notion that care is that received from outside an individual and nurtures its body and soul. Defining care and the context of providing it is difficult especially with the ever changing and evolving field like that found operational in the HIV and AIDS research field. The standard of care for HIV and AIDS prevention trials continues to evolve and countries/communities are encouraged to define locally relevant standard of care guidelines. The paper reports on the consensus reached by stakeholders in Nigeria on the standard of care to be provided during HIV prevention research. It is an attempt by the community of stakeholders involved with New HIV Prevention Technology trials in Nigeria to define the standard of care for HIV prevention research in Nigeria. Method: Four consultative meetings involving policy makers, the national government and government agencies, representatives of donor communities, regulatory agencies in the country, community advocates, people living with HIV/AIDS, sex workers, people who engage in sac sex practices, researchers, women , youths, journalists and organizations that serve these various communities, were held. This is a report of the consensus reached on the standard of care for HIV prevention in Nigeria. Results: Such obligations include the provision of counselling and testing for trial participants throughout the trial and during the post-trial period using the most sensitive and specific test kits for the most prevalent HIV strains in the country. ART provision should also be provided for trial participants who seroconvert during the trial by the sponsors after which the trial participants are rolled unto the national governments' ART programme. Researchers and sponsors also have defined obligatory responsibilities to volunteers who screen out of the trial and to trial participants' spouse. The report also defines good research practice with respect to access to health care services as well as moral obligatory responsibilities of researchers and sponsors to trial participants. Conclusion: The consensus on standard of care for HIV prevention research in Nigeria is a step forward with respect to mapping the path for future HIV prevention research in Nigeria is a step forward with respect to mapping the path for future HIV preventive research in the country. As emerging issues emerge, there will be a need to review and define these standards again.