ERASE - Impact of COVID-19 on Malaria Control

NCT05348746 | Unknown DMC

• 1 other identifier: Doctors with Africa CUAMM
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Measure incidence of malaria and malaria-related outcomes, evaluating potential impact of the SARS-CoV2 epidemic and of antimalarial resistance in Oyam and Kole district, Uganda with focus on pregnant women. Study design: Facility-based, prospective, observational study. Study population: All pregnant women at any gestational age presenting to the Aber Hospitals during the study period both at the emergency department or the Ante-Natal Care (ANC) clinic will be eligible to participate in this study. Methods: Women will be recruited at ANC visits and at the emergency department and screened against the inclusion criteria. Women will be followed until delivery and evaluated during the consecutives ANC visits. Outcomes will be assessed at the delivery or/and at the discharge if admitted to the hospital for any other causes related with the pregnancy or the malaria. Also, a subpopulation of nonpregnant individuals diagnosed with malaria will be recruited for resistance detection. Main study parameters/primary endpoints: Incidence of malaria and malaria-related adverse outcomes; impact of the COVID-19 pandemic on malaria care; prevalence of antimalarial resistance against artemisinin derivatives and sulphadoxine-pyrimethamine.

Conditions

Malaria; Malaria in Pregnancy

Keywords

Malaria resistance; COVID 19; Malaria in Pregnancy

Outcome Measures

Primary Outcomes (4)

• Impact of COVID 19 in Malaria care

  The investigators using retrospective data from 2018-2019 (pre COVID era) to 2020-2021 (COVID era) will evaluate i) access to antenatal care visits, in Oyam and Kole district for the period March 2022 to June 2023. Antenatal care visits: The percentage of women aged 15-49 with a live birth in a given time period that received antenatal care four or more times. Due to data limitations, it is not possible to determine the type of provider for each visit. Numerator: The number of women aged 15-49 with a live birth in a given time period that received antenatal care four or more times. Denominator: Total number of women aged 15-49 with a live birth in the same period.

  12 months

• Impact of COVID 19 in Malaria care

  The investigators using retrospective data from 2018-2019 (pre COVID era) to 2020-2021 (COVID era) will evaluate ii) IPTp (intermittent preventive treatment) coverage in Oyam and Kole district for the period March 2022 to June 2023. IPTp (intermittent preventive treatment) coverage will be study and define in two ways: * the proportion of women who had received at least one ITP dose during their pregnancy, designated as "ITP coverage-at least one dose"; * the proportion who had received both ITP doses recommended, designated as "ITP coverage-two doses."

  12 months

• Incidence of symptomatic and severe malaria in the study cohort

  Assess incidence of symptomatic and severe malaria in the study cohort in Oyam and Kole admitted to Aber Hospital and health district for the period March 2022 to June 2023.

  12 months

• Determinants of malaria prevention

  Due to survey KAP (knowledge, attitude and practice) for pregnant women admitted in antenatal clinic , the investigators will evaluate the determinants of malaria prevention and control compliance in pregnant women in Oyam and Kole district for the period March 2022 to June 2023

  12 months

Secondary Outcomes (3)

• Prevalence of Plasmodium species resistant

  12 months

• Incidence of maternal and fetal outcome

  15 months

• Local spread of P. falciparum polymorphisms

  24 months

Interventions

Advanced Analysis of Polymorphism OTHER

Assessment of Plasmodium falciparum drug resistance. Target P. falciparum drug resistance genes: Pfk13 propeller, Pfdhfr and Pfdhps. The polymorphisms analysis of the propeller domain of the Pfk13 gene will be performed by PCR amplifications and subsequent sequencing. Analysis of Pfdhfr gene at codons 51, 59, 108 and Pfdhps gene at codon positions 436, 437, 540, 581, 613 will be done by means of amplifications and subsequent Sanger sequencing. Molecular studies will be performed only for research purposes and will have no impact on the clinical management of study patients.

Eligibility Criteria

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

Study Population

Target population All pregnant women living in Oyam and Kole districts. Accessible population Pregnant women in Oyam and Kole district coming for antenatal care in Aber Hospital and selected Healthcare facilities during the study period March 2022 to June 2023. Non-pregnant subpopulation For epidemiological assessment of resistance against sulfadoxine-pyrimetamine and artemisinin derivatives, a sub-population of individuals diagnosed with microscopically confirmed malaria in Aber hospital will be also recruited. This population is necessary to reach an adequate sample size for resistance detection.

You may qualify if:

• . Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound;
• Provision of informed consent;
• Agreement to come to the study clinic for any febrile episode or other illness;
• Plan to deliver in the hospital

You may not qualify if:

• Ongoing labor or delivery
• Non-pregnant subpopulation
• microscopically confirmed diagnose of malaria ;
• provision of informed consent;
• agreement to avoid antimalarial medications given outside the study protocol;
• too ill to participate in the study according to clinician judgment

Sponsors & Collaborators

• Doctors with Africa - CUAMM: lead
• University of Bari "Aldo Moro", Bari Italy: collaborator
• Istituto Superiore di Sanità, Rome, Italy.: collaborator
• Catholic University of the Sacred Heart: collaborator
• Doctors with Africa CUAMM, Kampala Uganda: collaborator
• Doctors with Africa-Cuamm, Padua, Italy: collaborator

Related Publications (2)

• Segala FV, Ictho J, L'Episcopia M, Onapa E, De Vita E, Novara R, Olung N, Totaro V, Olal L, Patti G, Bingom C, Farina U, Papagni R, Agaro C, Bavaro DF, Amone J, Dall'Oglio G, Ngole B, Marotta C, Okori S, Zarcone M, Ogwang J, Severini C, Lochoro P, Putoto G, Saracino A, Di Gennaro F. Impact of the COVID-19 pandemic on malaria in pregnancy indicators in Northern Uganda: a joinpoint regression analysis. Pathog Glob Health. 2024 May;118(3):253-261. doi: 10.1080/20477724.2023.2273023. Epub 2023 Oct 23.

  PMID: 37872763 DERIVED

• Segala FV, Di Gennaro F, Ictho J, L'Episcopia M, Onapa E, Marotta C, De Vita E, Amone J, Iacobelli V, Ogwang J, Dall'Oglio G, Ngole B, Murri R, Olal L, Fantoni M, Okori S, Putoto G, Severini C, Lochoro P, Saracino A. Impact of antimalarial resistance and COVID-19 pandemic on malaria care among pregnant women in Northern Uganda (ERASE): protocol of a prospective observational study. BMC Infect Dis. 2022 Aug 4;22(1):668. doi: 10.1186/s12879-022-07645-3.

  PMID: 35927713 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Target P. falciparum drug resistance genes: Pfk13 propeller, Pfdhfr and Pfdhps. The polymorphisms analysis of the propeller domain of the Pfk13 gene will be performed by PCR amplifications and subsequent sequencing. Analysis of Pfdhfr gene at codons 51, 59, 108 and Pfdhps gene at codon positions 436, 437, 540, 581, 613 will be done by means of amplifications and subsequent Sanger sequencing. he obtained sequences will be compiled and analyzed by Accelrys DS Gene software. PlasmoDB gene identification no. PF3D7\_1343700 (P. falciparum 3D7 strain) will be used as reference in the numbering of nucleotide and amino acid positions. Molecular studies will be performed only for research purposes and will have no impact on the clinical management of study patients.

MeSH Terms

Conditions

Malaria; COVID-19

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Francesco Di Gennaro, MD

CONTACT

+393924804707; cicciodigennaro@yahoo.it

Francesco Vladimiro Segala, MD

CONTACT

+3383402021; f.segala@cuamm.org

Study Design

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

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 27, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04