|- candidate number||8693|
|- NTR Number||NTR2627|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-nov-2010|
|- Secondary IDs||10/110 NUFFIC C&B-NFP-PHD|
|- Public Title||The influence of a special training programme for early detection, diagnosis and management of HIV lesions in the mouth by primary health care workers in Nairobi East District in Kenya.|
|- Scientific Title||The influence of an oral health training programme for early detection, diagnosis and management of oral HIV lesions by primary health care workers in Nairobi East District in Kenya.|
|- hypothesis||The aim of this study is to develop and evaluate the effect of a training programme for PHC providers, in the early detection and diagnosis of oral HIV lesions as markers of HIV infection. In addition, oral health status regarding visible signs of periodontal disease, such as bleeding gums or loose teeth, and of dental decay (tooth cavities) will be assessed.
The following two scientific hypotheses will be studied:
1. Training of PHC providers in performing an oral examination will increase the ability of these providers, in comparison to that of untrained PHC providers, to detect oral HIV lesions, dental decay (tooth cavities) and periodontal disease;
2. In comparison with the current situation in which PHC providers remain untrained in this field, training of PHC providers in the recognition of oral HIV lesions will lead to an increase in the number of prescribed HIV tests on HF and division level.
|- Healt Condition(s) or Problem(s) studied||Oral HIV related lesions, OPC, Periodontal health|
|- Inclusion criteria||Health service providers (clinical officers and nurses) in Nairobi Njiru Division, Kenya (intervention group) and in Nairobi Makadara Division (control group).|
|- Exclusion criteria||All other health service providers in the divisions.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-mrt-2011|
|- Target number of participants||60|
|- Interventions||Intervention group:|
Group training session (8 hours) in:
1. Recognition and first management of oral -hiv related- lesions (OPC);
2. On the technique how to perform an oral examination;
3. How to fill a patient record, using lectures and skills lab training (on real patients with HIV related oral lesions).
In addition to these clinical lectures and skills practicals, feedback will be given about the attitude study performed earlier and about the content of the various evaluations. All participants will receive mouth masks, spatulas and a light torch, to be able to perform an oral examination and assess the oral situation. Reminder sessions (4 hours visits) will be organised after 3, 6 and 9 months at the health facility centers in the intervention division. Photos of early -HIV related- oral lesions will be used to enhance recognition, as well as reminders on how to fill a patient record.
No lectures or skills training sessions, only information on how to fill a patient record at start of intervention study. Remidner sessions on filling patient records (at 3, 6 and 9 months).
|- Primary outcome||Final assessment (after 1 year):|
1. Change in health care providers' knowledge on OPC (knowledge testing);
2. Change in referral rates for HIV testing of patients with OPC;
3. Change in frequency of oral examinations.
For all assessements: Intervention group compared to control group; intervention group and control group compared to baseline data, and to each other.
Data will be collected using patient interviews, patient records, knowledge testing by repeated questionnaires, tally sheets (frequencies HIV testing; total number of patients with HIV infection).
|- Secondary outcome||N/A|
|- Timepoints||1. Change in frequency of oral examinations after 3, 6 , 12 months (intervention group compared to control group, intervention group and control group compared to baseline data);|
2. Change in referral rates after 3,6, and 12 months;
3. Change in knowledge after 3,6, and 12 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Wil J.M. Sanden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Wil J.M. Sanden, van der|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre, Department of Global Oral Health|
(Source(s) of Monetary or Material Support)
|NUFFIC, the Netherlands|
|- Publications||Submission of study protocol (december 2010):|
Study protocol: The influence of an oral health training programme for early detection, diagnosis and management of oral HIV lesions by primary health care workers in Nairobi East District in Kenya, a randomised controlled trial.
|- Brief summary||An oral examination is a simple, cheap and a non-invasive test with many benefits to the patients, however, primary health care (PHC) providers in Kenya are not sufficiently equipped to do these examinations.
The PHC system in Kenya offers an opportunity to integrate the management of oral lesions into general care. With additional training, PHC providers could effectively diagnose and treat oral lesions in an early stage. The acceptance and feasibility of this integration process can be tested in a study covering early identification and management of oral lesions in the PHC setting in Kenya.
A randomised controlled trial in 2 remote administrative divisions in Nairobi East district. All PHC providers (nurses and clinical officers working in public PHC facilities) from each division will participate.
Training of the PHC providers:
A training programme will be administered to all PHC providers in the test division, to improve the competences and practical skills of these providers in:
1. Detection and diagnosis of OPC as early oral marker of HIV infection or an indication of HAART (highly active anti-retroviral therapy) failure in known HIV patients;
2. Detection of other common oral conditions, such as dental decay and periodontal disease. A pre-test assessment will be administered to PHC providers to test their knowledge and the comparability of the two groups.
|- Main changes (audit trail)|
|- RECORD||22-nov-2010 - 11-dec-2010|