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Clinical Trials

MainTitle

Dual Rapid HIV & Syphilis Tests in Zambia

This study has been completed
Sponsor
University of North Carolina, Chapel Hill

Collaborator
World Health Organization

Information provided by (Responsible Party)
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier
NCT02445846

First received: May 13, 2015
Last updated: April 20, 2017
Last Verified: February 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV
Syphilis

Device : dual HIV/syphilis rapid diagnostics tests

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Field Performance Evaluation of Dual Rapid HIV & Syphilis Tests in Zambia

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures

  • 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 Outcome Measures:
  • 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.

Enrollment: 3010
Study Start Date: May 2014
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Pregnant women
Pregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia
Device: dual HIV/syphilis rapid diagnostics tests
Other Name: Chembio and Standard Disgnostics

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Pregnant women, regardless of HIV status, seeking antenatal care at Chipata, Chawama, or Kamwala District Health Centres in Lusaka, Zambia.

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02445846

Locations

Zambia
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia

Sponsors and Collaborators

University of North Carolina, Chapel Hill
World Health Organization

Investigators

Principal Investigator: Margaret Kasaro, MBChB, MSc University of North Carolina, Chapel Hill
More Information

More Information


Responsible Party: University of North Carolina, Chapel Hill  
ClinicalTrials.gov Identifier: NCT02445846   History of Changes  
Other Study ID Numbers: 14-0528  
Study First Received: May 13, 2015  
Last Updated: April 20, 2017  

Additional relevant MeSH terms:
Syphilis

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.