Dual Rapid HIV & Syphilis Tests in Zambia

Field Performance Evaluation of 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lusaka, Zambia
        • Centre for Infectious Disease Research in Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women
Pregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia
Other Names:
  • Chembio and Standard Disgnostics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1/enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1/enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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