HIV InfectionsNCT04782739
Impact of COVID-19 on Provision and Uptake of Prevention of Mother-to-child Transmission of HIV Services in Zimbabwe
An observational study of HIV Infections and Syphilis, run by University of Zimbabwe at 2 sites in Zimbabwe.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Syphilis
- What is being tested?
- None - Descriptive study
- How many people
- 30 participants
- Where
- 2 sitesZimbabwe
- Study dates
- 15 Mar 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
- All neonates admitted to Sally Mugabe Central Hospital, from February 2019 to the end of the study
- 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
Show all 9Show fewer
- 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.
Who cannot join
- None
- Group 2:
- None
- Group 3 - Pregnant/lactating women:
- None
- Group 3 - Community healthcare workers
- None
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- HIV Infections, Syphilis
- Being tested
- None - Descriptive study
- Keywords
- HIV, Syphilis, Pregnancy, Infants, Vertical Transmission, COVID-19
- Medical subject headings
- HIV Infections, Syphilis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - Descriptive studyOther
Descriptive study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: None - Descriptive study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pregnant women seen in antenatal care who are tested for HIV and syphilis
Based on data from Group 1
Measured: 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
Measured: 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
Measured: Up to 6 years
Number of HIV-exposed neonates admitted to Sally Mugabe Central Hospital
Based on data from Group 2
Measured: Up to 2 years
Among neonates admitted to Sally Mugabe Central Hospital, number receiving HIV testing and prophylaxis
Based on data from Group 2
Measured: 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
Measured: Up to 2 years
Number of pregnant women who experienced interruptions to PMTCT service delivery
Based on data from Group 3
Measured: 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
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Mutsa Bwakura-Dangarembizi, Principal investigator, University of Zimbabwe Clinical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782739
- Sponsor's protocol ID
- MRCZ/A/2682
- Status last verified
- May 2024
- First submitted
- 23 Feb 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37578953Gannon 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.
PubMed 38183019Mupambireyi 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.
PubMed 38190418
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04782739
- Acronym / sponsor ID
- MRCZ/A/2682
- Conditions
- HIV Infections, Syphilis
- Keywords
- HIV, Syphilis, Pregnancy, Infants, Vertical Transmission, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- 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
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Description of PMTCT service provision and uptake at healthcare facilities | – | Other: None - Descriptive studyAggregated 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. |
| Neonatal admissions at Harare Children's Hospital | – | Other: None - Descriptive studyIndividual-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. |
| Qualitative study | – | Other: None - Descriptive studyQualitative 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
- All neonates admitted to Sally Mugabe Central Hospital, from February 2019 to the end of the study
- 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.
Key exclusion criteria (7 listed)
- None
- None
- None
- Group 3 - Community healthcare workers
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - Descriptive studyDescriptive study | Other | Description of PMTCT service provision and uptake at healthcare facilities, Neonatal admissions at Harare Children's Hospital, Qualitative study |
Primary outcome
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
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
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
Number of HIV-exposed neonates admitted to Sally Mugabe Central Hospital
Time frame: Up to 2 years
Based on data from Group 2
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
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
Number of pregnant women who experienced interruptions to PMTCT service delivery
Time frame: Up to 18 months
Based on data from Group 3
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 37578953Chappell 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.
- Results publication: PubMed 38183019Gannon 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.
- Results publication: PubMed 38190418Mupambireyi 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mutsa Bwakura-Dangarembizi principal investigator
University of Zimbabwe Clinical Research Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Syphilis, run by University of Zimbabwe at 2 sites in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pregnant women seen in antenatal care who are tested for HIV and syphilis (time frame: Up to 6 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.