MalariaNCT04724161
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Mozambique
An observational study of Malaria, run by PATH at 1 site in Mozambique.
Trial summary
This study outlines a plan for conducting a routine assessment of malaria infection prevalence and intervention coverage using antenatal care (ANC) attendees. This will be a non-randomized assessment of the potential to use pregnant women attending their first ANC visit as a pragmatic sentinel population to monitor… Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Malaria
- What is being tested?
- ANC surveillance
- How many people
- 19,215 participants
- Where
- 1 siteMozambique
- Study dates
- 9 Dec 2020to 30 Sep 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be selected from among all women attending select ANC clinics in three districts in Mozambique: Changara, Guro, and Chemba.
Who may be able to join
- Attending ANC first visit at participating health facility
- Pregnant women 18 years or older
- Pregnant women ages 12 to 17 accompanied by a legal guardian who can provide consent
Who cannot join
- Women with signs of severe malaria as determined by the ANC clinician
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
Programa Nacional de Controle da Malaria, Ministry of Health
Maputo
About this study
This study outlines a plan for conducting a routine assessment of malaria infection prevalence and intervention coverage using antenatal care (ANC) attendees. This will be a non-randomized assessment of the potential to use pregnant women attending their first ANC visit as a pragmatic sentinel population to monitor prevalence of malaria and the coverage of malaria control interventions. The use of a questionnaire, to include standard malaria rapid diagnostic testing, will be piloted with consenting women attending their first ANC visit at 21 individual health facilities across three of the New Net Project pilot study districts in western Mozambique: seven facilities each from Changara, Chemba, and Guro Districts. The results of the ANC questionnaires will be analyzed to see how well they correlate to similar malaria prevalence and intervention coverage estimates obtained during the contemporary community-based cross-sectional surveys administered during New Net Project pilot evaluation activities.
As part of the New Nets Project, Mozambique is deploying next-generation ITNs through mass campaigns in pre-determined provinces. The present study aims to leverage planned New Nets Project cross-sectional surveys and strengthened routine case surveillance data in three of the study districts (Changara, Guro, and Chemba) to assess (1) whether the malaria infection prevalence data collected during ANC surveillance correlates with the cross-sectional survey estimates of community infection prevalence in children 6 to 59 months and (2) if intervention coverage data (particularly ITN ownership and use) collected from ANC surveillance are valid and representative of the population as a whole. These additional data could catalyze a new model of surveillance for malaria, and greatly simplify evaluation of the impact of new interventions, as ANC surveillance could potentially replace or supplement cross-sectional household surveys and provide more granular and timely data.
All pregnant women attending first ANC visit at seven health facilities in each study district will be eligible for enrollment. Potential participants will be approached during their visit by a health facility worker. During group counselling sessions at initial intake, women will be informed of this pilot surveillance activity, and written informed consent will be obtained from each woman individually prior to routine ANC testing. All consenting women attending ANC first visit at a participating health facility will be tested for malaria using an RDT and asked to complete a study questionnaire which will include questions about the participant's net use, and care seeking behavior. It is expected to take 15 minutes to complete. Women who test positive for malaria will be given treatment according to national guidelines. There is no additional benefit to individual participants.
Read the detailed description
Data from public health surveillance systems are used for multiple purposes, including measuring the burden and monitoring the trends of a disease; guiding the planning, implementation, and evaluation of prevention and control programs; and prioritizing the allocation of health resources. In addition to routine health surveillance activities, public health programs often collect additional data on health indicators, as well as intervention coverage and program utilization, via nationally representative household surveys, such as the Demographic and Health Survey and the Malaria Indicator Survey (MIS).
These household surveys provide data to help measure the burden of and monitor trends in malaria, including data on the prevalence of symptomatic and asymptomatic infections in the population. Additionally, because the surveys provide data on monitoring and coverage impact indicators, they help guide the planning, implementation, and evaluation of prevention and control programs, and prioritization of the allocation of national malaria control program (NMCP) resources. Indeed, these representative surveys have become key tools for benchmarking progress towards malaria control and elimination.
Nevertheless, the surveys are expensive to conduct and are limited by long periodic intervals (e.g., every two to five years) and broad sampling strategies (i.e. generating national or regional estimates of disease burden and intervention coverage) that fail to capture seasonal trends or sub-regional heterogeneity, limiting their use for real-time or locally targeted planning and response.
Routine health information systems, on the other hand, may provide a continuous, granular data source representative of all age groups, primarily to help measure the burden and monitor the trends of symptomatic malaria and other diseases. Many countries have implemented standardized, electronic-based health management information system (HMIS), on platforms such as District Health Information System 2 (DHIS2), which provide monthly health facility data in real time. Despite being a potential source of valuable public health information, several factors limit the utility of HMIS data and should be considered carefully. One key limitation is the quality and representativity of the data being reported into HMIS, which is affected not only by general data issues, but also by factors such as case management practices and stockouts. These limitations require monitoring and health systems strengthening to overcome. HMIS data on case numbers may also be biased because some symptomatic patients may not present to a facility for care or may not seek care at all, and it can be difficult to interpret the incidence because of uncertainties surrounding regional and local population estimates. Further, not all health facilities report into HMIS; in many countries, the data derive predominantly from public health facilities. If the population using alternative sources of care for diagnosis and treatment of malaria (e.g., private facilities or traditional healers) varies over time, or differs from those using public facilities, the data trends observed in the HMIS may not be representative. Finally, as HMIS data are limited to patients presenting with symptomatic illness, it is not possible to assess the burden and epidemiology of asymptomatic infections, which are believed to represent the majority of malaria infections in many populations. Representativeness and validity of routine data may also be affected by diagnostic testing practices, which in turn may vary by health care provider performance, seasonality, and availability of diagnostic commodities. Finally, data on monitoring and coverage of malaria control interventions, such as insecticide treated bed nets (ITNs), are not typically collected during routine health visits or reported in HMIS.
To build on the strengths and address the limitations of these two complementary surveillance approaches, collecting data on parasite prevalence and coverage of malaria control interventions during antenatal care (ANC) clinic visits may provide an easily accessible, reliable, and representative source for monitoring population trends in malaria control with a higher degree of granularity than is possible in nationally representative household surveys. ANC coverage is high across sub-Saharan Africa; about 90% of women make at least one ANC visit in each pregnancy. Only six countries reported that fewer than 80% of women attended ANC at least once during their most recent pregnancy. Thus, pregnant women attending their first ANC visit are likely to be representative of the overall population of pregnant women. Pregnant women attending their first ANC visit are an ideal population for monitoring trends in malaria prevalence over time, as monthly ANC attendance remains relatively constant over time (minimal effects of seasonality) and is independent of malaria symptoms, thus giving a general infection prevalence estimate similar to that of a community survey. It has been demonstrated that malaria parasite prevalence among pregnant women correlates with the prevalence among children under five years of age. This highlights the possibility that pregnant women could be a good sentinel population for representative measures of trends in malaria prevalence and raises the question of whether pregnant women would be a good source of data on coverage of malaria control interventions that could be readily tracked over time. Once scaled up, these systems may also provide these data more frequently, at a finer spatial scale, and at a lower cost than household surveys.
In Mozambique, the NMCP is distributing new ITNs in mass campaigns. The New Nets Project is funding community surveys in six provinces, including rapid diagnostic test (RDT) testing in these provinces, to look at the impact of ITNs. This presents an important opportunity to validate whether the coverage of malaria control interventions and measures of parasite prevalence among pregnant women at first ANC visits is representative of the population at large in Mozambique.
In three districts, pregnant women presenting for their first ANC visit will be consented and tested for malaria using an RDT and asked to complete a study questionnaire. A comparison of results obtained at first ANC visits will be made to results from concurrent household surveys conducted by the New Nets Project. If validated and found to be a sustainable change to ANC visit procedures, data from the ANC sentinel population could be used to augment or even replace much of the data collected through the use of Malaria Indicator Surveys, which are expensive and infrequently conducted and generally only powered to the regional level. This data could then be triangulated with malaria burden data from the outpatient department to understand variation in community prevalence (as measured through ANC) and malaria clinical incidence, thereby guiding programmatic decision-making and response.
- Conditions
- Malaria
- Being tested
- ANC surveillance
- Keywords
- Antenatal care, Surveillance, Malaria, Epidemiology, Net use, Net coverage, Prevalence
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANC surveillanceDiagnostic test
Clinic-based testing of all pregnant women during antenatal care visits using national standards and commercially available malaria rapid diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women attending first ANC visit | Pregnant women attending their first ANC visit at selected health facilities in Changara, Guro, and Chemba districts. Receives: Diagnostic Test: ANC surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANC malaria infection prevalence
Malaria infection prevalence among pregnant women attending their first ANC visit.
Measured: December 2020 to December 2022
Secondary outcomes (1)
Correlation between cross-sectional and ANC population indicator values
District-level correlation between indicator values estimated from the ANC population and similar estimates from contemporary household cross-sectional surveys conducted by the New Nets Project.
Measured: December 2020 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start9 Dec 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 19,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Mozambique, Tropical Health LLP, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Baltazar Candrinho, MD, Principal investigator, Programa Nacional de Controle da Malaria, Ministry of HealthJoseph Wagman, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724161
- Sponsor's protocol ID
- 1594989
- Status last verified
- Sep 2022
- First submitted
- 21 Jan 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001 Jul 27;50(RR-13):1-35; quiz CE1-7.
PubMed 18634202Mayor A, Menendez C, Walker PGT. Targeting Pregnant Women for Malaria Surveillance. Trends Parasitol. 2019 Sep;35(9):677-686. doi: 10.1016/j.pt.2019.07.005. Epub 2019 Aug 5.
PubMed 31395496Lindblade KA, Steinhardt L, Samuels A, Kachur SP, Slutsker L. The silent threat: asymptomatic parasitemia and malaria transmission. Expert Rev Anti Infect Ther. 2013 Jun;11(6):623-39. doi: 10.1586/eri.13.45.
PubMed 23750733Ataguba JE. A reassessment of global antenatal care coverage for improving maternal health using sub-Saharan Africa as a case study. PLoS One. 2018 Oct 5;13(10):e0204822. doi: 10.1371/journal.pone.0204822. eCollection 2018.
PubMed 30289886van Eijk AM, Hill J, Noor AM, Snow RW, ter Kuile FO. Prevalence of malaria infection in pregnant women compared with children for tracking malaria transmission in sub-Saharan Africa: a systematic review and meta-analysis. Lancet Glob Health. 2015 Oct;3(10):e617-28. doi: 10.1016/S2214-109X(15)00049-2. Epub 2015 Aug 19.
PubMed 26296450
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Mozambique
- ClinicalTrials.gov ID
- NCT04724161
- Acronym / sponsor ID
- 1594989
- Conditions
- Malaria
- Keywords
- Antenatal care, Surveillance, Malaria, Epidemiology, Net use, Net coverage, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,215 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Ministry of Health, Mozambique, Tropical Health LLP, Centers for Disease Control and Prevention
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Jan 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.
This study outlines a plan for conducting a routine assessment of malaria infection prevalence and intervention coverage using antenatal care (ANC) attendees. This will be a non-randomized assessment of the potential to use pregnant women attending their first ANC visit as a pragmatic sentinel population to monitor prevalence of malaria and the coverage of malaria control interventions. The use of a questionnaire, to include standard malaria rapid diagnostic testing, will be piloted with consenting women attending their first ANC visit at 21 individual health facilities across three of the New Net Project pilot study districts in western Mozambique: seven facilities each from Changara, Chemba, and Guro Districts. The results of the ANC questionnaires will be analyzed to see how well they correlate to similar malaria prevalence and intervention coverage estimates obtained during the contemporary community-based cross-sectional surveys administered during New Net Project pilot evaluation activities.
As part of the New Nets Project, Mozambique is deploying next-generation ITNs through mass campaigns in pre-determined provinces. The present study aims to leverage planned New Nets Project cross-sectional surveys and strengthened routine case surveillance data in three of the study districts (Changara, Guro, and Chemba) to assess (1) whether the malaria infection prevalence data collected during ANC surveillance correlates with the cross-sectional survey estimates of community infection prevalence in children 6 to 59 months and (2) if intervention coverage data (particularly ITN ownership and use) collected from ANC surveillance are valid and representative of the population as a whole. These additional data could catalyze a new model of surveillance for malaria, and greatly simplify evaluation of the impact of new interventions, as ANC surveillance could potentially replace or supplement cross-sectional household surveys and provide more granular and timely data.
All pregnant women attending first ANC visit at seven health facilities in each study district will be eligible for enrollment. Potential participants will be approached during their visit by a health facility worker. During group counselling sessions at initial intake, women will be informed of this pilot surveillance activity, and written informed consent will be obtained from each woman individually prior to routine ANC testing. All consenting women attending ANC first visit at a participating health facility will be tested for malaria using an RDT and asked to complete a study questionnaire which will include questions about the participant's net use, and care seeking behavior. It is expected to take 15 minutes to complete. Women who test positive for malaria will be given treatment according to national guidelines. There is no additional benefit to individual participants.
Detailed description
Data from public health surveillance systems are used for multiple purposes, including measuring the burden and monitoring the trends of a disease; guiding the planning, implementation, and evaluation of prevention and control programs; and prioritizing the allocation of health resources. In addition to routine health surveillance activities, public health programs often collect additional data on health indicators, as well as intervention coverage and program utilization, via nationally representative household surveys, such as the Demographic and Health Survey and the Malaria Indicator Survey (MIS).
These household surveys provide data to help measure the burden of and monitor trends in malaria, including data on the prevalence of symptomatic and asymptomatic infections in the population. Additionally, because the surveys provide data on monitoring and coverage impact indicators, they help guide the planning, implementation, and evaluation of prevention and control programs, and prioritization of the allocation of national malaria control program (NMCP) resources. Indeed, these representative surveys have become key tools for benchmarking progress towards malaria control and elimination.
Nevertheless, the surveys are expensive to conduct and are limited by long periodic intervals (e.g., every two to five years) and broad sampling strategies (i.e. generating national or regional estimates of disease burden and intervention coverage) that fail to capture seasonal trends or sub-regional heterogeneity, limiting their use for real-time or locally targeted planning and response.
Routine health information systems, on the other hand, may provide a continuous, granular data source representative of all age groups, primarily to help measure the burden and monitor the trends of symptomatic malaria and other diseases. Many countries have implemented standardized, electronic-based health management information system (HMIS), on platforms such as District Health Information System 2 (DHIS2), which provide monthly health facility data in real time. Despite being a potential source of valuable public health information, several factors limit the utility of HMIS data and should be considered carefully. One key limitation is the quality and representativity of the data being reported into HMIS, which is affected not only by general data issues, but also by factors such as case management practices and stockouts. These limitations require monitoring and health systems strengthening to overcome. HMIS data on case numbers may also be biased because some symptomatic patients may not present to a facility for care or may not seek care at all, and it can be difficult to interpret the incidence because of uncertainties surrounding regional and local population estimates. Further, not all health facilities report into HMIS; in many countries, the data derive predominantly from public health facilities. If the population using alternative sources of care for diagnosis and treatment of malaria (e.g., private facilities or traditional healers) varies over time, or differs from those using public facilities, the data trends observed in the HMIS may not be representative. Finally, as HMIS data are limited to patients presenting with symptomatic illness, it is not possible to assess the burden and epidemiology of asymptomatic infections, which are believed to represent the majority of malaria infections in many populations. Representativeness and validity of routine data may also be affected by diagnostic testing practices, which in turn may vary by health care provider performance, seasonality, and availability of diagnostic commodities. Finally, data on monitoring and coverage of malaria control interventions, such as insecticide treated bed nets (ITNs), are not typically collected during routine health visits or reported in HMIS.
To build on the strengths and address the limitations of these two complementary surveillance approaches, collecting data on parasite prevalence and coverage of malaria control interventions during antenatal care (ANC) clinic visits may provide an easily accessible, reliable, and representative source for monitoring population trends in malaria control with a higher degree of granularity than is possible in nationally representative household surveys. ANC coverage is high across sub-Saharan Africa; about 90% of women make at least one ANC visit in each pregnancy. Only six countries reported that fewer than 80% of women attended ANC at least once during their most recent pregnancy. Thus, pregnant women attending their first ANC visit are likely to be representative of the overall population of pregnant women. Pregnant women attending their first ANC visit are an ideal population for monitoring trends in malaria prevalence over time, as monthly ANC attendance remains relatively constant over time (minimal effects of seasonality) and is independent of malaria symptoms, thus giving a general infection prevalence estimate similar to that of a community survey. It has been demonstrated that malaria parasite prevalence among pregnant women correlates with the prevalence among children under five years of age. This highlights the possibility that pregnant women could be a good sentinel population for representative measures of trends in malaria prevalence and raises the question of whether pregnant women would be a good source of data on coverage of malaria control interventions that could be readily tracked over time. Once scaled up, these systems may also provide these data more frequently, at a finer spatial scale, and at a lower cost than household surveys.
In Mozambique, the NMCP is distributing new ITNs in mass campaigns. The New Nets Project is funding community surveys in six provinces, including rapid diagnostic test (RDT) testing in these provinces, to look at the impact of ITNs. This presents an important opportunity to validate whether the coverage of malaria control interventions and measures of parasite prevalence among pregnant women at first ANC visits is representative of the population at large in Mozambique.
In three districts, pregnant women presenting for their first ANC visit will be consented and tested for malaria using an RDT and asked to complete a study questionnaire. A comparison of results obtained at first ANC visits will be made to results from concurrent household surveys conducted by the New Nets Project. If validated and found to be a sustainable change to ANC visit procedures, data from the ANC sentinel population could be used to augment or even replace much of the data collected through the use of Malaria Indicator Surveys, which are expensive and infrequently conducted and generally only powered to the regional level. This data could then be triangulated with malaria burden data from the outpatient department to understand variation in community prevalence (as measured through ANC) and malaria clinical incidence, thereby guiding programmatic decision-making and response.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women attending first ANC visit | – | Diagnostic Test: ANC surveillancePregnant women attending their first ANC visit at selected health facilities in Changara, Guro, and Chemba districts. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be selected from among all women attending select ANC clinics in three districts in Mozambique: Changara, Guro, and Chemba.
Key inclusion criteria (3 listed)
- Attending ANC first visit at participating health facility
- Pregnant women 18 years or older
- Pregnant women ages 12 to 17 accompanied by a legal guardian who can provide consent
Key exclusion criteria (1 listed)
- Women with signs of severe malaria as determined by the ANC clinician
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 |
|---|---|---|
| ANC surveillanceClinic-based testing of all pregnant women during antenatal care visits using national standards and commercially available malaria rapid diagnostic tests | Diagnostic test | Pregnant women attending first ANC visit |
Primary outcome
ANC malaria infection prevalence
Time frame: December 2020 to December 2022
Malaria infection prevalence among pregnant women attending their first ANC visit.
1 secondary outcome
Correlation between cross-sectional and ANC population indicator values
Time frame: December 2020 to December 2022
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 12 Dec 2022.
- Background: PubMed 18634202German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001 Jul 27;50(RR-13):1-35; quiz CE1-7.
- Background: PubMed 31395496Mayor A, Menendez C, Walker PGT. Targeting Pregnant Women for Malaria Surveillance. Trends Parasitol. 2019 Sep;35(9):677-686. doi: 10.1016/j.pt.2019.07.005. Epub 2019 Aug 5.
- Background: PubMed 23750733Lindblade KA, Steinhardt L, Samuels A, Kachur SP, Slutsker L. The silent threat: asymptomatic parasitemia and malaria transmission. Expert Rev Anti Infect Ther. 2013 Jun;11(6):623-39. doi: 10.1586/eri.13.45.
- Background: PubMed 30289886Ataguba JE. A reassessment of global antenatal care coverage for improving maternal health using sub-Saharan Africa as a case study. PLoS One. 2018 Oct 5;13(10):e0204822. doi: 10.1371/journal.pone.0204822. eCollection 2018.
- Background: PubMed 26296450van Eijk AM, Hill J, Noor AM, Snow RW, ter Kuile FO. Prevalence of malaria infection in pregnant women compared with children for tracking malaria transmission in sub-Saharan Africa: a systematic review and meta-analysis. Lancet Glob Health. 2015 Oct;3(10):e617-28. doi: 10.1016/S2214-109X(15)00049-2. Epub 2015 Aug 19.
- ICF. The DHS Program STATcompiler. Funded by USAID.Link provided by the sponsor.
- Ministério da Saúde (MISAU), Instituto Nacional de Estatística (INE), and ICF. Survey of Indicators on Immunization, Malaria and HIV/AIDS in Mozambique (IMASIDA) 2015.Link provided by the sponsor.
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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.
Baltazar Candrinho, MD principal investigator
Programa Nacional de Controle da Malaria, Ministry of Health
Joseph Wagman, PhD principal investigator
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by PATH at 1 site in Mozambique.
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 3 inclusion and 1 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. 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?
ANC malaria infection prevalence (time frame: December 2020 to December 2022). 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 NCT04724161, which also lists 5 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 12 Dec 2022.