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Evaluation of the Impact of the COVID-19 Pandemic on Provision and Uptake of Services for the Prevention of Mother-to-child Transmission of HIV and Syphilis in Zimbabwe

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ClinicalTrials.gov Identifier: NCT04782739
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : December 22, 2022
Sponsor:
Collaborators:
Ministry of Health and Child Welfare, Zimbabwe
Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
PENTA Foundation
ViiV Healthcare
University College, London
Information provided by (Responsible Party):
University of Zimbabwe

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The COVID-19 pandemic and response are likely to lead to severe unintended consequences for the prevention of mother-to-child transmission (PMTCT) of HIV and syphilis. Zimbabwe has made huge progress in coverage of antenatal testing of HIV and syphilis, which reached 98% and 91% in 2019, and is aiming for dual elimination. However, there is emerging evidence of disruption to health services due to COVID-19, similar to that seen in prior epidemics, which may reverse this progress. Mathematical modelling has estimated 3 and 6 month interruptions to ART supply would lead to 1.67 and 2.07 times more babies being born with HIV in SSA over the next year respectively. This study aims to provide real-world data to understand the effects of COVID-19 on the provision and uptake of PMTCT services. Our study has five objectives. Firstly, to conduct a retrospective analysis of national data routinely collected by healthcare facilities to explore changes before, during and after the pandemic in key indicators related to antenatal testing and treatment of HIV and syphilis, and management of HIV-exposed and infected infants. Secondly, data on neonates admitted to Sally Mugabe Central Hospital, already collected for the NeoTree study, will be analysed to explore the impact of COVID-19 on the number of HIV-exposed infants hospitalised, their clinical status at presentation and outcomes. Thirdly, qualitative studies with mothers and healthcare workers will explore barriers to optimal engagement with care and provision of PMTCT services respectively. Fourthly, quantitative results on testing and ART provision will be used to model the impact of disruptions on the rate of PMTCT of HIV enabling policy makers to plan for subsequent waves of COVID-19 and future epidemics. Finally, educational materials will be developed, piloted and disseminated during the project to provide information to pregnant women on safe access to PMTCT services.

Condition or disease Intervention/treatment
HIV Infections Syphilis Other: None - Descriptive study

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Official Title: Evaluation of the Impact of the COVID-19 Pandemic on Provision and Uptake of Services for the Prevention of Mother-to-child Transmission of HIV and Syphilis in Zimbabwe
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Description of PMTCT service provision and uptake at healthcare facilities
Aggregated data will be collected from all 1560 public healthcare facilities in Zimbabwe on key indicators including antenatal testing and treatment of HIV and syphilis, and management of HIV-exposed and HIV-positive infants. Data will be collected from March 2015 (5 years prior to the pandemic) to the end of the study, to explore trends over time.
 Other: None - Descriptive study
Descriptive study
Neonatal admissions at Harare Children's Hospital
Individual-level patient data will be collected on all neonates admitted for care at Harare Children's Hospital, including on patient characteristics, clinical status at presentation and outcomes. Data will be collected from February 2019 to the end of the study, to explore trends over time.
 Other: None - Descriptive study
Descriptive study
Qualitative study
Qualitative study of 20 pregnant/lactating women accessing routine PMTCT services and 10 community healthcare workers from the Mabvuku and Kuwadzana Polyclinics. The estimated enrolment of 30 participants given in the study design section above refers to participants from this group only.
 Other: None - Descriptive study
Descriptive study


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of pregnant women seen in antenatal care who are tested for HIV and syphilis [ Time Frame: Up to 6 years ]
    Based on data from Group 1

  2. Proportion of HIV-positive pregnant women seen in antenatal care who are on antiretroviral therapy [ Time Frame: Up to 6 years ]
    Based on data from Group 1

  3. Proportion of HIV-exposed infants seen in antenatal care who are tested for HIV by 6 weeks of age [ Time Frame: Up to 6 years ]
    Based on data from Group 1

  4. Number of HIV-exposed neonates admitted to Sally Mugabe Central Hospital [ Time Frame: Up to 2 years ]
    Based on data from Group 2

  5. Among neonates admitted to Sally Mugabe Central Hospital, number receiving HIV testing and prophylaxis [ Time Frame: Up to 2 years ]
    Based on data from Group 2

  6. Case fatality rate per 1,000 HIV-exposed neonates admitted to Sally Mugabe Central Hospital [ Time Frame: Up to 2 years ]
    Based on data from Group 2

  7. Number of pregnant women who experienced interruptions to PMTCT service delivery [ Time Frame: Up to 18 months ]
    Based on data from Group 3

  8. Qualitative evaluation of the impact of COVID-19 on provision and uptake of PMTCT services [ Time Frame: Up to 18 months ]
    Based on data from Group 3


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group 1:

Anonymous aggregated data will be collated retrospectively for all pregnant women/infants receiving care at all public healthcare facilities in Zimbabwe, from March 2015 to the end of the study

Group 2:

All neonates admitted to Sally Mugabe Central Hospital, from February 2019 to the end of the study

Group 3:

Pregnant/lactating women and community healthcare workers from the Mabvuku and Kuwadzana Polyclinics

Criteria

Group 1:

Inclusion criteria:

• Anonymous aggregated data will be collated retrospectively for all pregnant women/infants receiving care at all public healthcare facilities in Zimbabwe, from March 2015 to the end of the study

Exclusion criteria:

None

Group 2:

Inclusion criteria:

• All neonates admitted to Sally Mugabe Central Hospital, from February 2019 to the end of the study

Exclusion criteria:

None

Group 3 - Pregnant/lactating women:

Inclusion criteria:

  • Accessing antenatal or postnatal services at Mabvuku and Kuwadzana clinics
  • Have lived in the Mabvuku and Kuwadzana clinics catchment area during the national lockdown
  • Willing and able to give written or audio informed consent for participation.
  • Willing to participate in the follow-up study

Exclusion criteria:

None

Group 3 - Community healthcare workers

Inclusion criteria:

  • Working and interacting directly with women seeking antenatal or postnatal care services
  • Working at the health facility/ community during and prior to the lockdown
  • Willing and able to give written or audio informed consent for participation.

Exclusion criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782739


Contacts
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Contact: Mutsa Bwakura-Dangarembizi +263 242 705995 mbwakura@uzchs-ctrc.org

Locations
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Zimbabwe
Kuwadzana Polyclinic Recruiting
Harare, Zimbabwe
Mabvuku Polyclinic Recruiting
Harare, Zimbabwe
Sponsors and Collaborators
University of Zimbabwe
Ministry of Health and Child Welfare, Zimbabwe
Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
PENTA Foundation
ViiV Healthcare
University College, London
Investigators
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Principal Investigator: Mutsa Bwakura-Dangarembizi University of Zimbabwe Clinical Research Centre
More Information
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Additional Information:

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Responsible Party: University of Zimbabwe
ClinicalTrials.gov Identifier: NCT04782739    
Other Study ID Numbers: MRCZ/A/2682
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zimbabwe:
HIV
Syphilis
Pregnancy
 Infants
Vertical Transmission
COVID-19
Additional relevant MeSH terms:
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COVID-19
Syphilis
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Communicable Diseases
Sexually Transmitted Diseases
Genital Diseases
Urogenital Diseases
Treponemal Infections
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial