Skip to main content
OpenTrials
Completed

NCT Number: NCT02445846

Dual Rapid HIV & Syphilis Tests in Zambia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dual HIV/syphilis rapid diagnostics tests

Device

Other names: Chembio and Standard Disgnostics

Primary outcomes

  1. performance of dual rapid HIV/syphilis tests

    Time frame: 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 outcomes

  1. acceptability of use of dual rapid HIV/syphilis tests

    Time frame: day 1/enrollment

    the operational characteristics and acceptability of the tests to patients and health care providers will be measured.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 15, 2015
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.