ANC COVID-19 Surveillance

The purpose of this observational study is to determine the seroprevalence of SARS-CoV-2 antibodies in the community with pregnant women aged 15-49 years attending first antenatal care as the sentinel population. Further, the study seeks:

* To determine the feasibility and acceptability of SARS-CoV-2 antibody tests among pregnant women * To estimate the prevalence of HIV-COVID 19 co-infection among pregnant women aged 15-49 years * To determine sociodemographic factors associated with SARS-CoV-2 seropositivity among pregnant women * To compare trends in seroprevalence among pregnant women with routine surveillance data to determine if ANC sentinel surveillance is a viable surveillance strategy for SARS-CoV-2

The main question it aims to answer is:

- What is the seroprevalence of antibodies to SARS-CoV-2 among pregnant women attending first ANC visit in Zambia?

Participants will be expected to give consent to participating in the study on the day of their first antenatal visit. They should allow the collection of a dried blood spot for SARS-CoV-2 antibody test.

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Key information

Conditions

SARS-CoV-2 Seroprevalence COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Infectious Disease Research in Zambia

Lusaka, 10101, Zambia

About this study

This surveillance platform may be able to provide key information on the spread of the SARS-CoV-2 virus through the general population. By using serologic testing to understand trends in the proportion of pregnant women over time who were exposed to SARS-CoV-2, we will be able to understand not only the ultimate proportion of pregnant women who were ever infected, but also be able to track and potentially detect outbreaks (e.g. in areas with increasing positivity rates), unlike data that would be available from a single cross-sectional survey, which could give the overall prevalence at a single point in time.

Zambia is experiencing a SARS-CoV-2 epidemic. From March 18, 2020 to February 19, 2021, at total of 73,203 confirmed cases have been reported in Zambia. However, the true number is likely much larger, because surveillance systems for SARS-CoV-2 in Zambia are incomplete.

Since 2020, the coronavirus disease has become a major public health concern and sustainable and efficient surveillance platforms are urgently needed; assessing women attending 1st ANC should provide insights into transmission trends in the general population. This activity will determine what proportion of pregnant women demonstrate evidence of SARS-CoV-2 infection over time. The findings of this research may be used to change the way health system monitors the epidemic and ensures health services are made available with minimal disruptions.

The study was implemented at 39 public health facilities. A sample of 20 pregnant women attending their first ANC visit at the selected study sites will be enrolled into the study until the monthly sample size is reached.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Confirmed pregnant and are registered for their first ANC visit
Aged 15 to 49 years
Able to provide consent to participate and have blood sample collected for the SARS-CoV-2 antibody test

Exclusion criteria

Not first ANC visit for the pregnant woman
Women less than 15 years or above 49 years old
Women not able to provide consent for study participation

Treatment and study plan

Primary outcomes

SARS-CoV-2 seroprevalence

Time frame: 13 months

Number of participants with a positive test result divided by the total number of participants with a valid test result by month and district.

Secondary outcomes

Vaccine Uptake

Time frame: 13 months

Number of participants reporting prior confirmed COVID-19 and having received a COVID-19 vaccine.

Sponsors and collaborators

Lead sponsor

Centre for Infectious Disease Research in Zambia

Other

Registry information

Official study title

Assessing SARS-CoV-2 (COVID-19) Seroprevalence During Routine Antenatal Care Visits in Zambia

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Jun 15, 2025
Registry last updated: Jun 15, 2025

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.

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

Completed