Extrait

Background and study aims Contact tracing for tuberculosis (TB) involves visiting the home of TB patients who agree, in order to screen other household members for HIV and TB. Those found to have previously undiagnosed HIV are then referred for a CD4 count (that measures the level of a substance called CD4 in the blood) to decide whether or not they need antiretroviral therapy (drug therapy) and for access to preventive medication including isoniazid and co-trimoxazole. We want to know whether finding out the CD4 count instantly using a point-of-care machine in the household increases the chance that people newly diagnosed with HIV attend a clinic for care. We also want to know whether provision of isoniazid to the household will increase usage and completion of this important preventive therapy that reduces the risk of TB. Who can participate? Newly diagnosed adult TB patients in two districts of South Africa and their household members. What does the study involve? TB patients will be told about the study in the TB clinic and if they are eligible and consent, their household will be recruited to the study and randomly allocated to one of three groups: A, B and C. The household will then be visited and consenting household members screened for TB and HIV. All households will then be re-visited three and six months later to find out whether care was sought and if so, from where. Those diagnosed as HIV infected in households allocated to group B will also receive an immediate CD4 count. In addition, those in group C will be able to receive a course of either co-trimoxazole (if their CD4 count is <350) or isoniazid (CD4 count >350) monthly in their homes if they consent. Group A receives standard care. What are the possible benefits and risks of participating? All participating household members will be screened for TB and HIV, increasing their chances of receiving important care. Those diagnosed as HIV infected in households allocated to groups B or C will also receive additional treatment designed to improve their care. The main risk of participating is possible new knowledge of HIV or TB status, which may be psychologically distressing for participants. Where is the study run from? The Aurum Institute in Johannesburg, South Africa, in collaboration with the London School of Hygiene and Tropical Medicine, UK. When is study starting and how long is it expected to run for? The study has started recruiting in 2013 and will continue until early 2014. Follow-up will continue for another six months after this. Who is funding the study? Sanofi-Aventis, South Africa. Who is the main contact? Dr Liesl Page-Shipp, [email protected] Dr James Lewis, [email protected]

Critère d'inclusion

• Tuberculosis (TB)

Liens

• ictrp
• isrctn