Background: An estimated 90% of HIV-infected people are likely to develop oral lesions in the course of HIV infection. Oro-pharyngeal candidiasis (OPC), an early marker for HIV-infection, can be diagnosed during an oral examination (OE). Primary healthcare (PHC) providers in Kenya are neither trained nor sufficiently equipped to perform this simple, cheap and non-invasive examination. The PHC system in Kenya offers an opportunity to integrate early recognition and management of oral lesions into general health care. This study aims to estimate the effect of a multifaceted intervention for PHC providers in training them to perform an OE. Specifically, our primary objective is to establish whether the intervention is effective in increasing: i) the frequency of early detection of HIV-related oral lesions; and ii) referral rates for HIV-testing.
Design and methods: THE STUDY HAS BEEN DESIGNED IN TWO PARTS: a retrospective clinical data record study and a prospective cohort study with pre-post control group design, carried out in 2 administrative divisions in Nairobi East district. The intervention group will receive one day of training on recognition of HIV-related oral lesions and other common oral conditions. Reminder sessions will be held at individual health facilities. Routine tally sheets will be used to record all patients with HIV-related oral lesions, dental caries and periodontal disease. A convenience sample of all the PHC in a division will be used. It will not be possible to blind investigators or assessors. Expected impact of the study for Public Health. Early recognition and treatment of HIV infection influences long-term survival rates and will reduce healthcare expenditure.
Acknowledgments: The project is funded by the Netherlands organisation for international cooperation in higher education (NUFFIC). We would like to thank all participating health facilities and health care workers for their willingness to take part in this study. LNK also thanks the Kenya Ministry of Public Health and Sanitation for permission to carry out this study. We also thank Mr. J Mulder from Radboud University Nijmegen Medical Centre, Department of Methodology, Information Management and Statistics, Nijmegen, The Netherlands for statistical advice.
Funding: THIS STUDY IS FUNDED BY A RESEARCH GRANT FROM THE NETHERLANDS ORGANIZATION FOR INTERNATIONAL COOPERATION IN HIGHER EDUCATION (NUFFIC, GRANT NR: C&B-NFP-PHD.10/110), The Hague, The Netherlands.
Trial registration: Netherlands Trial Register NTR2627 (date registered 22(nd) November 2010).
Ethics approval: Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (approval number KNH-ERC/A/474), and The Ministry of Public Health and Sanitation (Ref. N. MPHS/IB/1/14 Vol. III).
Keywords: AIDS/HIV; detection; mucosal lesion.