Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Dec;24(8):649-660.
doi: 10.1177/1744987118824625. Epub 2019 Mar 26.

The conundrum of clinical trials and standard of care in sub-Saharan Africa - the research nurse perspective

Jane Frances Ndyetukira, Richard Kwizera, Florence Kugonza, Cynthia Ahimbisibwe, Carol Namujju, Alisat Sadiq, Alice Namudde  1 , Darlisha Williams  1 , Mahsa Abassi, Joshua Rhein, David R Boulware  2 , David B Meya  1   2   3
Affiliations

The conundrum of clinical trials and standard of care in sub-Saharan Africa - the research nurse perspective

Jane Frances Ndyetukira et al. J Res Nurs. 2019 Dec.

Abstract

Background: Nurses form a very important part of the health workforce in sub-Saharan Africa. Research nurses are critical to the implementation of clinical trials. The duties and responsibilities of a research nurse are complex and continue to evolve as new practices and guidelines are formulated.

Aims: In this paper, we have highlighted the major contributions of research nurses in HIV clinical trials in sub-Saharan Africa from the unique perspective of Ugandan nurses.

Methods: The requirements and challenges of two multi-site, randomised cryptococcal meningitis clinical trials in Uganda were assessed from the perspective of research nurses conducting complex research in resource-limited settings.

Results: Over the course of 8 years, approximately 1739 participants were screened and 934 people were enrolled into the two trials. The nurses found that patient education and engagement were among the most important predictors of success in minimising loss to follow-up.

Conclusions: Research nurses played a key role in communicating clinical research goals to patients, obtaining informed consent, minimising loss to follow-up, and ensuring that research practices are translated and implemented into standard of care. However, there remains a need to integrate the same level of care provided in clinical research studies to non-study patients.

Keywords: clinical research; cryptococcal infection; research nurse; standard-of-care; sub-Saharan Africa.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

    1. American Nurses Association (2001) Code of ethics for nurses with interpretive statements. American Nurses Association. Available at: https://www.nursingworld.org/practice-policy/nursing-excellence/ethics/c... (accessed 20 November 2017).
    1. Boulware DR, Meya DB, Muzoora C, et al. (2014) Timing of antiretroviral therapy after diagnosis of cryptococcal meningitis. New England Journal of Medicine 370: 2487–2498. - PMC - PubMed
    1. Dovlo D. (2007) Migration of nurses from Sub-Saharan Africa: A review of issues and challenges. Health Services Research 42: 1373–1388. - PMC - PubMed
    1. Govender N, Meintjes G, Bicanic T, et al. (2013) Guideline for the prevention, diagnosis and management of cryptococcal meningitis among HIV-infected persons: 2013 update. South African Journal of HIV Medicine 14: 76–86. - PMC - PubMed
    1. International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) (2017) Informed consent of trial subjects. Available at: http://ichgcp.net/48-informed-consent-of-trial-subjects (accessed 23 November 2017).

LinkOut - more resources