ERASE - Rise Against Malaria Project - Support for Malaria Prevention, Diagnosis and Treatment in the Context of the Covid-19 Pandemic Among Pregnant Women in Northern Uganda: a Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Impact of COVID 19 in Malaria care
Study Overview
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.
Detailed Description
- INTRODUCTION
1.1. Malaria epidemiology and global trends Globally, there were an estimated 241 million malaria cases in 2020 in 85 malaria endemic countries, increasing from 227 million in 2019, with most of this increase coming from countries in the WHO African Region.
Although it still represents a major threat for public health, over the last twenty years tremendous progress has been made on malaria control, averting an estimate of 1.5 billion cases and saving 7.6 million lives. Malaria mortality fell by 60% over the period from 2000 to 2019, especially in Africa, where political commitment, ignited by the 2000 Abuja declaration has been the key to success. Along with strong political leadership, these data outline the potential benefit in malaria control and prevention brought by public health programs. However, despite the astonishing results achieved in the last two decades, in 2020, COVID-19 pandemic added a crucial challenge in the fight against the disease, posing a major risk for Low and Middle Income Countries (LMICs). In fact, in sub-Saharan countries, along with the substantial danger posed directly to the already fragile healthcare systems, malaria control has been threatened by supply-chain interruptions and by individual decision-making adaptation. Indeed, malaria control relies heavily on individual choice to seek care, and early messaging targeted on reducing SARS-CoV2 transmission advised people to stay home in case of fever. According to geostatistical models, these factors may contribute to an estimated increase, in a worst-case scenario, of 21% malaria cases and nearly double malaria-related deaths in the upcoming years. Furthermore, the true COVID-19 burden in sub-Saharan countries is unknown and, according to seroprevalence studies, it is likely to be largely underestimated . All these factors, according to the latest WHO World Malaria Report, contributed to a reverse of the reducing trend in malaria case incidence (59 cases per 1000 people at risk in 2020, compared to 56 in 2019) and malaria deaths, that passed from 534,000 in 2019 to 602,000 in 2020.
Other substantial challenges towards malaria eradication are drug-resistance, acquisition of mutations impairing diagnosis - especially those affecting the sensitivity of rapid-diagnostic tests - access to treatment and supply of malaria prevention tools such as insecticide-treated mosquito nets (ITN), Indoor Residual Spraying (IRS), Seasonal Malaria Chemoprevention (SMC) and Intermittent Preventive Treatment for pregnant women (IPTp).
1.3 RESEARCH QUESTIONS
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Inclusion criteria will be:
- •. 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
Exclusion Criteria
- •Ongoing labor or delivery
- •Non-pregnant subpopulation
- •Inclusion criteria for this population will be:
- •microscopically confirmed diagnose of malaria ;
- •provision of informed consent;
- •agreement to avoid antimalarial medications given outside the study protocol;
- •agreement to be re-assessed for parasitemia at day 3 Exclusion Criteria
- •too ill to participate in the study according to clinician judgment
Outcomes
Primary Outcomes
Impact of COVID 19 in Malaria care
Time Frame: 12 months
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."
Determinants of malaria prevention
Time Frame: 12 months
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
Incidence of symptomatic and severe malaria in the study cohort
Time Frame: 12 months
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.
Secondary Outcomes
- Prevalence of Plasmodium species resistant(12 months)
- Incidence of maternal and fetal outcome(15 months)
- Local spread of P. falciparum polymorphisms(24 months)