The purpose of this study is to provide evidence on the performance and operational characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in Zambia for their introduction into antenatal care and other settings.
Early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. To improve the number of women tested and treated, the Centre for Infectious Disease Research in Zambia (CIDRZ) and the Ministry of Community Development, Mother and Health (MCDMCH) this field study will assess the effectiveness of newly developed dual HIV and syphilis rapid diagnostic tests (RDTs) manufactured by Chembio and Standard Diagnostics in Lusaka District antenatal clinics. The specific objectives of this field performance evaluation of the rapid diagnostics are to determine the antenatal clinic-based performance of dual HIV/syphilis RDTs compared to that of current reference standard assays, and to assess the operational characteristics and acceptability of these dual HIV/syphilis RDTs to patients and health care providers This cross-sectional study of 3,765 pregnant women will validate the performance of Chembio and Standard Diagnostics dual HIV and Syphilis RDTs.
Study Type
OBSERVATIONAL
Enrollment
3,010
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
performance of dual rapid HIV/syphilis tests
The performance of the rapid study tests will be assessed by determining the specificity and the sensitivity when compared to reference standard assays
Time frame: day 1/enrollment
acceptability of use of dual rapid HIV/syphilis tests
the operational characteristics and acceptability of the tests to patients and health care providers will be measured.
Time frame: day 1/enrollment
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