Dual Rapid HIV & Syphilis Tests in Zambia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02445846

Enrollment

3010

Registered

2015-05-15

Start date

2014-05-31

Completion date

2016-01-31

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Syphilis

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.

Interventions

DEVICEdual HIV/syphilis rapid diagnostics tests

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026