Impact of COVID-19 on Provision and Uptake of Prevention of Mother-to-child Transmission of HIV Services in Zimbabwe

NCT04782739 | Completed

• 1 other identifier: MRCZ/A/2682
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections; Syphilis

Keywords

HIV; Syphilis; Pregnancy; Infants; Vertical Transmission; COVID-19

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

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

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

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

Interventions

None - Descriptive study OTHER

Descriptive study

Description of PMTCT service provision and uptake at healthcare facilities; Neonatal admissions at Harare Children's Hospital; Qualitative study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• None
• Group 2:
• All neonates admitted to Sally Mugabe Central Hospital, from February 2019 to the end of the study
• None
• Group 3 - Pregnant/lactating women:
• 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
• None
• Group 3 - Community healthcare workers
• 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.
• None

Sponsors & Collaborators

• University of Zimbabwe: lead
• Ministry of Health and Child Welfare, Zimbabwe: collaborator
• Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe): collaborator
• PENTA Foundation: collaborator
• ViiV Healthcare: collaborator
• University College, London: collaborator

Study Sites (2)

Kuwadzana Polyclinic

Harare, Zimbabwe

Location

Mabvuku Polyclinic

Harare, Zimbabwe

Location

Related Publications (3)

• Chappell E, Chimwaza A, Manika N, Wedderburn CJ, Mupambireyi Nenguke Z, Gannon H, Cowan F, Gibb T, Heys M, Fitzgerald F, Phillips A, Chimhuya S, Gibb DM, Ford D, Mushavi A, Bwakura-Dangarembizi M. Impact of the COVID-19 pandemic on the provision and uptake of services for the prevention of mother-to-child transmission of HIV in Zimbabwe. PLOS Glob Public Health. 2023 Aug 14;3(8):e0002296. doi: 10.1371/journal.pgph.0002296. eCollection 2023.

  PMID: 37578953 RESULT

• Gannon H, Chappell E, Ford D, Gibb DM, Chimwaza A, Manika N, Wedderburn CJ, Nenguke ZM, Cowan FM, Gibb T, Phillips A, Mushavi A, Fitzgerald F, Heys M, Chimhuya S, Bwakura-Dangarembizi M. Effects of the COVID-19 pandemic on the outcomes of HIV-exposed neonates: a Zimbabwean tertiary hospital experience. BMC Pediatr. 2024 Jan 5;24(1):16. doi: 10.1186/s12887-023-04473-5.

  PMID: 38183019 RESULT

• Mupambireyi Z, Cowan FM, Chappell E, Chimwaza A, Manika N, Wedderburn CJ, Gannon H, Gibb T, Heys M, Fitzgerald F, Chimhuya S, Gibb D, Ford D, Mushavi A, Bwakura-Dangarembizi M. "Getting pregnant during COVID-19 was a big risk because getting help from the clinic was not easy": COVID-19 experiences of women and healthcare providers in Harare, Zimbabwe. PLOS Glob Public Health. 2024 Jan 8;4(1):e0002317. doi: 10.1371/journal.pgph.0002317. eCollection 2024.

  PMID: 38190418 RESULT

MeSH Terms

Conditions

HIV Infections; Syphilis; COVID-19

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mutsa Bwakura-Dangarembizi

  University of Zimbabwe Clinical Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 4, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

ZI (2)