NCT02445846

Dual Rapid HIV & Syphilis Tests in Zambia

Field Performance Evaluation of Dual Rapid HIV & Syphilis Tests in Zambia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,010 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV
• Syphilis

Interventions

Type	Name	Description
DEVICE	dual HIV/syphilis rapid diagnostics tests

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-05-15
• Last updated: 2017-04-21

Locations

1 site across 1 country: Zambia