Congenital and postnatal CMV infection in the era of WHO PMTCT Option B+ in rural South Africa
South Africa, 2016 - 2019
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AHRI.CMV.2022.v2
Congenital and postnatal CMV infection in the era of WHO PMTCT Option B+ in rural South Africa
| Name | Country code |
|---|---|
| South Africa | ZA |
Over a period of 2 years we screened 2,616 newborns at Hlabisa Hospital, using saliva swabs (for CMV PCR) to identify 100 infants with congenital CMV infection. Infants with clinically apparent or symptomatic congenital CMV infection at birth were referred for further clinical management including potential antiviral therapy. Infants without clinical findings at birth (asymptomatic congenital CMV infection) were followed to monitor hearing function and growth development. Outcomes included anthropometric measures, development milestones, and hearing assessment, which were assessed at Hlabisa Hospital at 3-months intervals during the first 1 year (primary outcome).
We also followed up 300 infants presenting for postnatal follow-up at Somkhele Clinic with absence of CMV infection at birth for a year (at 6, 14 weeks, 6 months and 1 year), to determine the occurrence, risk factors and outcomes of postnatal CMV infection.
The study provides reliable data of the birth prevalence of congenital CMV infection in HIV-exposed and HIV-unexposed new-borns. In addition, the project will yield preliminary estimates on the frequency and timing of acquisition of postnatal CMV infection during infancy and begin to examine the impact of CMV infection acquired in infancy on childhood morbidity. Exploring the impact of HIV infection on CMV infection of infants and CMV-associated hearing loss as well as overall childhood morbidity will inform the relevance of CMV infections in populations with high maternal HIV prevalence, as well as the importance of developing strategies to prevent or reduce the disease burden associated with CMV infection.
Purpose of the Study
The purpose of this study is to determine the prevalence, risk factors and outcomes of congenital and postnatal CMV infection among infants born in a public sector hospital in rural KwaZulu-Natal between 2016 and 2018.
We hypothesize that maternal HIV infection increases the risk of intrauterine CMV transmission and predisposes CMV-infected infants to adverse outcomes even in the era of option B+.
Study specific objectives:
· To determine the birth and postnatal prevalence of congenital CMV infection among HIV-exposed and HIV-unexposed new-borns.
· To examine whether maternal HIV infection or other maternal factors predict in utero CMV transmission.
· To determine the prevalence of new-born CMV disease and CMV-associated sequelae in HIV-exposed and unexposed new-borns.
· To examine the timing of postnatal CMV acquisition in HIV-exposed and unexposed new-borns.
· To explore the predictors of early (CMV negative at birth and positive at six or 14 weeks) versus delayed postnatal CMV infection (CMV negative at birth, six and 14 weeks, and positive at one year).
· To assess the impact of CMV infection (both congenital and postnatal) on growth, neuro and immunological development, and overall childhood morbidity and mortality at two years of age.
· To describe whole genome sequences from KwaZulu-Natal isolates and to look for an association between viral genetics and/or tissue compartmentalization, and congenital CMV disease, and CMV viral load.
The type of data included in the file (The following data sources used): Chart records (mother medical chart, infant medical chart for health histort and health card for anthropometry). Interviews. Biological/laboratory tests; and Clinical tests - audiometry (tympanometry followed by Otoaccoustic Emissions (OAE) testing for screening, infants with failed OAE will be referred for diagnostic testing - Auditory evoked Brainstem Responses (ABR) at Albert Luthuli Central Hospital. This study draws on quantitative data sources. Most exposure and all outcome data will be measured using objective instruments.
Single specimen; study participant
Version
V2.0.0
Scope
| Topic | Vocabulary | URI |
|---|---|---|
| MeSH subject headings Clinical; congenital CMV (cCMV) | Africa Health Research Institute | AHRI |
Coverage
Demographic surveillance area of the Africa Health Research Institute; KwaZulu-Natal, uMkhanyakude district.
From 2016 to 2019 we screened 2,616 new-borns at Hlabisa Hospital, using saliva swabs (for CMV PCR) to identify 100 infants with congenital CMV infection. Infants with clinically apparent or symptomatic congenital CMV infection at birth were referred for further clinical management including potential antiviral therapy. Infants without clinical findings at birth (asymptomatic congenital CMV infection) were followed to monitor hearing function and growth development.
Producers and sponsors
| Name | Affiliation |
|---|---|
| Prof Deenan Pillay | Africa Health Research Institute (AHRI) |
| Suresh B. Boppana | University of Alabama, USA |
| Karen Fowler | University of Alabama, USA |
| Prakash Jeena | UKZN, South Africa |
| Benn Sartorius | UKZN, South Africa |
| Nigel Klein | AHRI, South Africa |
| Olivier Koole | AHRI, South Africa |
| Name |
|---|
| Africa Health Research Institute |
| Name | Role |
|---|---|
| National Institutes of Health, USA | Funder |
| Name | Affiliation | Role |
|---|---|---|
| Osee Behuhuma | Africa Health Research Institute (AHRI) | Clinical oversight |
| Anita Edwards | Africa Health Research Institute (AHRI) | Audiological testing consulting |
| Theresa Smit | Africa Health Research Institute (AHRI) | Lab oversight |
Sampling
Approximately 4800 new-borns at Hlabisa Hospital expected to be screened, using saliva swabs (for CMV PCR) to identify approximately 100 infants with congenital CMV infection. Infants with clinically apparent or symptomatic congenital CMV infection at birth who were referred for further clinical management including potential antiviral therapy. Infants without clinical findings at birth (asymptomatic congenital CMV infection) were followed to monitor hearing and growth and development.
Data collection
| Start | End |
|---|---|
| 2016-01-04 | 2019-12-04 |
Data Access
The representative of the Receiving Organization agrees to comply with the following conditions:
- Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
- Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.
- The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes.
- The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.
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- Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.
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- The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
- This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.
- If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.
- Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties.
Pillay, D., Boppana, S., Fowler, K., Jeena, P., Sartorius, B., Klein, N., & Koole, O. R. (2022). Congenital and postnatal CMV infection in the era of WHO PMTCT Option B+ in rural South Africa [Data set]. Africa Health Research Institute. https://doi.org/10.23664/AHRI.CMV.2022
Metadata production
DDI.AHRI.CMV.2022.v2
| Name |
|---|
| Africa Health Research Institute |