An observational study in HIV Infections and Syphilis, sponsored by University of Zimbabwe. Completed at 2 sites in Zimbabwe. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by University of Zimbabwe · Observational
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.
Objectives (i) and (ii) will be met by a retrospective analysis of existing MoHCC data sources, allowing a comprehensive description and evaluation of the effects of the pandemic nationally on pMTCT services and, at a local level, on specialised neonatal care. All public healthcare facilities in Zimbabwe complete monthly returns of aggregate data on numbers of women attending antenatal care (ANC) and having HIV and syphilis testing and treatment during pregnancy, and information on HIV testing, prophylaxis for HIV-exposed infants and treatment of HIV-infected infants. These data are entered onto the DHIS-2 platform. Additionally, the national laboratory database includes data on infant HIV PCR testing.
Data will be extracted from the MoHCC DHIS-2 platform for the 5 years prior to measures taken for lockdown for COVID-19 (which started before any significant community transmission of COVID-19), until at least 6 months after the pandemic in Zimbabwe and corresponding measures end (if possible, depending on the course of the pandemic). National data include returns for 1560 healthcare facilities across 10 provinces. Descriptive analyses will focus on the year prior to lockdown, the period of the pandemic/associated response in Zimbabwe and a minimum of 6 months afterwards; we will describe changes in indicators nationally and by province. The national laboratory data will be used as an independent (unlinked) data source to verify trends in EID. Coverage of ART during pregnancy, infant prophylaxis and ART in infants with HIV will be estimated by combining data from MoHCC returns with Spectrum estimates, as is done routinely. Interrupted time series models will be used to estimate trends in indicators across the three time periods (five years pre-pandemic, during the pandemic, 6-months post pandemic), accounting for seasonal patterns and trends prior to the pandemic.
Objective (ii) will be addressed by analysis of NeoTree data. NeoTree is an application used in the neonatal unit at Harare Children's Hospital which combines data collection by healthcare workers in real-time with interactive decision support and education for improving quality of care.
Objective (iii) will use a qualitative design to provide complementary data to enhance the quantitative results. Longitudinal in-depth individual interviews with pregnant and lactating women, and with healthcare workers will be conducted at the Harare. Participants willing and able to provide informed consent will be purposively recruited from the Family and Child Health unit at Harare Children's Hospital. Participants will take part in two waves of data collection, at study start and after six months.
Objective (v) will draw out key messages from this mixed-methods approach for communication and education. We will design, produce and disseminate educational materials in various media. We will build on existing materials already available in Shona (www.picturinghealth.org) and study findings from objectives (i)-(iv) to develop, pilot and evaluate educational materials for women and families on accessing healthcare safely, and disseminate materials to healthcare workers and policymakers. These will include social media targeted video and short animations in Shona, designed to be easily adaptable to other settings for wider dissemination.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 30 is below the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of Zimbabwe is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Group 1:
Inclusion criteria:
Exclusion criteria:
None
Group 2:
Inclusion criteria:
Exclusion criteria:
None
Group 3 - Pregnant/lactating women:
Inclusion criteria:
Exclusion criteria:
None
Group 3 - Community healthcare workers
Inclusion criteria:
Exclusion criteria:
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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
Proportion of pregnant women seen in antenatal care who are tested for HIV and syphilis
Based on data from Group 1
Time frame: 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
Time frame: 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
Time frame: Up to 6 years
Number of HIV-exposed neonates admitted to Sally Mugabe Central Hospital
Based on data from Group 2
Time frame: Up to 2 years
Among neonates admitted to Sally Mugabe Central Hospital, number receiving HIV testing and prophylaxis
Based on data from Group 2
Time frame: 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
Time frame: Up to 2 years
Number of pregnant women who experienced interruptions to PMTCT service delivery
Based on data from Group 3
Time frame: 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
Time frame: Up to 18 months
Ran from Mar 2021 to primary completion in Dec 2022, 21 months.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 21 months is below that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Zimbabwe