Clinical trial NCT02445846: Dual Rapid HIV & Syphilis Tests in Zambia
Official title: Field Performance Evaluation of Dual Rapid HIV & Syphilis Tests in Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Syphilis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2015-05-15
Enrollment: 3010
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: performance of dual rapid HIV/syphilis tests
timeFrame: day 1/enrollment
Secondary outcomes:
measure: acceptability of use of dual rapid HIV/syphilis tests
timeFrame: day 1/enrollment
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Margaret Kasaro, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
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