Dual Rapid HIV & Syphilis Tests in Zambia

Completed

• Conditions: HIV; Syphilis
• Interventions: Device: dual HIV/syphilis rapid diagnostics tests

• Registration Number: NCT02445846
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3010

Inclusion Criteria

• Pregnant women attending their first antenatal care visit at a study clinic
• 18 years of age or older
• Willing and able to provide informed consent for study participation

Exclusion Criteria

• Prior participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	dual HIV/syphilis rapid diagnostics tests	Pregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia

Primary Outcome Measures

Name	Time	Method
performance of dual rapid HIV/syphilis tests	day 1/enrollment	The performance of the rapid study tests will be assessed by determining the specificity and the sensitivity when compared to reference standard assays

Secondary Outcome Measures

Name	Time	Method
acceptability of use of dual rapid HIV/syphilis tests	day 1/enrollment	the operational characteristics and acceptability of the tests to patients and health care providers will be measured.

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia