|- candidate number||8933|
|- NTR Number||NTR2697|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jan-2011|
|- Secondary IDs||C&B-NFP-PHD.10/110 NUFFIC|
|- Public Title||The effect of a special training programme on early detection of signs of HIV infection in the mouth by community health workers (CHW) in Nairobi East District in Kenya: A randomised controlled trial.|
|- Scientific Title||The effect of community mobilization on early detection of oral signs of HIV infection in Nairobi East District in Kenya: A randomised controlled trial.|
|- hypothesis||The aim of this study is to develop and evaluate a training program for CHWs in early detection or recognition of HIV suspected oro-facial lesions and to build their capacity and skill in mobilizing the community on HIV suspected oro-facial lesions.|
We also aim to evaluate the effect of community mobilization on the rates of facility based HIV testing as well as for highly active anti-retroviral therapy (HAART) failing patients to report back to the health facility (HF) for further care.
|- Healt Condition(s) or Problem(s) studied||Health care workers, OPC, HIV infection, Oral lesion|
|- Inclusion criteria||Community health workers in Nairobi, Njiru Division (i.e., Dandora 1, Dandora 2, Njiru and Ruai), and Makadara Division, (i.e., Kaloleni, Lungalunga, Remand and Police Band), Kenya.|
|- Exclusion criteria||All other health service providers in Nairobi, Kenia.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-dec-2011|
|- Target number of participants||400|
|- Interventions||Intervention group:|
Group training (8 hrs) in:
1. Recognition of oro-facial -hiv related- lesions;
2. Community mobilization techniques;
3. Using information education and communication (IEC) material;
4. Record keeping.
In addition, reminder sessions after 2 and 4 months are planned.
|- Primary outcome||Final assessment:|
1. Change in community health workers'knowledge on oro-facial lesions (knowledge testing);
2. Change in referral rates for HIV testing to the HF (clinical effect).
|- Secondary outcome||N/A|
|- Timepoints||1. Change in knowledge after 3, and 6 months;|
2. Change in referral rates to the HF after 3, and 6 monthsa.
|- Trial web site||N/A|
|- 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|
|- Brief summary||HIV related oro-facial lesions are typical in their clinical appearance and should be detected by community members. These lesions are painful and may compromise eating and swallowing. |
Besides being clinical markers of antiretroviral therapy failure and HIV disease progression, some of the lesions appear in the early stages of HIV infection and could be an early warning sign of HIV infection.
Although nearly 90% of HIV-infected people are likely to develop these lesions in the course of HIV infection, many patients do not seek care help in health facilities (HFs) because of stigmatisation and lack of information on available care.
A training program for community health workers (CHWs) in recognition of HIV related oro-facial lesions and referral of patients to the HF could effectively influence oral health seeking behaviour of the community. The effect of the CHW training program will be tested in the community health strategy setting in Nairobi East district in Kenya.
This will be a pragmatic trial using a pre- test – pos- test - control group study design in 2 remote administrative health districts, namely i.e., Njiru and Makadara. 400 CHWs from community units linked to 4 HFs in each district will participate. Allocation was by change.
Training of the CHWs:
CHWs will be trained in the test division to improve their knowledge and competences in:
1. Recognition of various oral HIV lesions;
2. Community mobilization and referral of patients from the community;
3. Use of CHS data tools.
A pre-test assessment will be administered to both CHW groups to test their knowledge and for comparability of the two groups.
|- Main changes (audit trail)|
|- RECORD||13-jan-2011 - 30-jan-2011|