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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections, Syphilis

Intervention / Treatment
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* Other: None - Descriptive study


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Description of PMTCT service provision and uptake at healthcare facilities<br>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<br>* Descriptive study<br>|
| Neonatal admissions at Harare Children's Hospital<br>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<br>* Descriptive study<br>|
| Qualitative study<br>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<br>* Descriptive study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of pregnant women seen in antenatal care who are tested for HIV and syphilis | Based on data from Group 1 | Up to 6 years | 
| Proportion of HIV-positive pregnant women seen in antenatal care who are on antiretroviral therapy | Based on data from Group 1 | Up to 6 years | 
| Proportion of HIV-exposed infants seen in antenatal care who are tested for HIV by 6 weeks of age | Based on data from Group 1 | Up to 6 years | 
| Number of HIV-exposed neonates admitted to Sally Mugabe Central Hospital | Based on data from Group 2 | Up to 2 years | 
| Among neonates admitted to Sally Mugabe Central Hospital, number receiving HIV testing and prophylaxis | Based on data from Group 2 | Up to 2 years | 
| Case fatality rate per 1,000 HIV-exposed neonates admitted to Sally Mugabe Central Hospital | Based on data from Group 2 | Up to 2 years | 
| Number of pregnant women who experienced interruptions to PMTCT service delivery | Based on data from Group 3 | Up to 18 months | 
| Qualitative evaluation of the impact of COVID-19 on provision and uptake of PMTCT services | Based on data from Group 3 | Up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Syphilis, Pregnancy, Infants, Vertical Transmission, COVID-19