Additional Screening With Sensitives RDTs and Malaria (ASSERMalaria)

March 29, 2023 updated by: Institut de Recherche en Sciences de la Sante, Burkina Faso

Operational Feasibility, Impact of Additional Screening Using Highly-sensitives RDTs Combined With High Coverage of IPTp on Placental Malaria and Low Birth Weight

National malaria control strategies in pregnant women relies primarily on effective case management along with the use of long lasting insecticide-treated nets (LLINs)throughout pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in the second and third trimesters in malaria-endemic regions in sub-Saharan Africa (SSA). For the latter, 3 or more doses are recommended by the national malaria control program (NMCP) but available data suggests that only 19% of eligible women received this in 2016 despite observed high attendance to antenatal clinic (ANC). Adherence to IPTp may be affected by perceptions, acceptability and contextual factors that need to be understood and therefore improve the effectiveness of this health interventions. In addition, all malaria cases should be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any treatment. Despite the crucial role of RDTs in improving malaria case management SSA, many malaria cases are missed in pregnant women due to the power performance of recommended RDTs which are unable to detect very low parasitaemia. Identifying lower density infections in pregnant women by the use of highly-sensitive RDTs and clearing them with an effective ACT could improve the outcome of the pregnancy in addition to IPTp-SP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MiP remains a major public health issue in Burkina Faso, which would compromise the achievement of Sustainable Development Goals for maternal and child health (22). Malaria control program have been implemented by the Burkinabe Ministry of Health (MoH) since 2000; nevertheless, lower coverage and delays in implementation of these programs may have reduced their effectiveness.

In Burkina Faso, recommended preventions strategies for malaria imply the administration of at least 3 doses of IPTp during ANCs and before delivery (23). IPTp have been proven to have a great impact on PM, LBW and peripheral malaria infection at delivery so increasing the number of IPTp doses given is a priority. Strategies to increase the number of IPTp doses and the coverage using reminders could improve this health intervention effectiveness. This can be considered as follow up of the Cosmic study (24) recommendations.

However with increasing drug resistance, there is a progressively diminished efficacy of IPTp-SP in clearing existing infections and a shortening of the post-treatment prophylaxis period (25). Moreover, pregnant women can generally be infected with low parasites densities between ANCs compromising the outcome of the pregnancy (26). Therefore, additional screening with HS-RDTs between ANCs and treatment using ACTs with long Post-treatment prophylaxis effect in addition to IPTp-SP could have a great impact both for the mothers and their offspring's.

This proposal aims to determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on placental malaria (PM) and low birth weight (LBW) in a context of IPTp-SP, in rural central Burkina Faso. The findings obtained from this study will help to assist the MoH in the implementation of the appropriate interventions in this group at risk.

Objectives

General objective

- To determine the operational feasibility and the impact of additional screening with HS-RDTs and treatment with DP on PM, LBW and peripheral malaria infection at delivery in in Burkina Faso

Specific objectives are the following:

  • To determine the gain of additional screening with HS-RDTs and treatment with DP against PM, LBW and peripheral malaria infection at delivery
  • To assess the determinants of the poor coverage and improve the number of IPTp doses received using phone call or SMS as a reminder

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
    • Kadiogo
      • Ouagadougou, Kadiogo, Burkina Faso, 218 CMS 11
        • Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age of 16 to 24 weeks at their first booking
  • At least (≥) 16 years old
  • Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery
  • Willing to deliver at the health facility
  • Willing to provide biological samples as and when required during the study period (blood and placental biopsy)
  • Ability to provide written informed consent

Exclusion Criteria:

  • A history of sensitivity to sulphonamides or to any of the study drugs;
  • History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
  • History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
  • Any significant illness at the time of screening that requires hospitalization, including severe malaria;
  • Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
  • Prior enrolment in the study or concurrent enrolment in another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm

A full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home.

At each ANC visit, study nurses will perform an HS-RDT for participants in this arm. Reminders will be sent in this group in order to improve IPTp-SP uptake
Diagnostic test: Additional screening using ultra sensitive RDTs
At each ANC visit, study nurses will perform an HS-RDT for participants in the intervention arm
Other Names:
  • Malaria Ag Pf ultra-sensitive RDT
Drug: Dihydroartemisinin-piperaquin
All pregnant women with a positive HS-RDT will be treated with a full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home
Other: Reminders
Before each scheduled ANC visit, reminders using SMS or phone call will be used. This is order to increase ANC attendance
No Intervention: Control arm

A full course of artemether-lumefantrine (AL) over 3 days. The first dose of AL will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home.

At each ANC visit, study nurses will perform a conventional RDT for participants in this arm if the participant have symptoms suggestive of malaria. No reminder will be sent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental malaria prevalence
Time Frame: 36 months
The prevalence of placental malaria infection will be determined in the two arms. Placentas will be identified as not infected (no evidence of parasite or pigment); active infection (presence of parasites and pigment) and chronic infection (absence of parasites and presence of pigment)
36 months
Low birthweight prevalence
Time Frame: 36 months
The prevalence of low birthweight (defined as birth weight less than 2,500 g) will be compared between the two arms.
36 months
Peripheral maternal malaria infection prevalence
Time Frame: 36 months
At delivery, malaria will be diagnosed using peripheral thick smears. Parasite density will be estimated by counting the number of asexual parasites per 200 leukocytes in the thick blood film and assuming white blood cells (WBC) count of 8,000/μl
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche en Sciences de la Sante, Burkina Faso

Collaborators

European and Developing Countries Clinical Trials Partnership (EDCTP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT04147546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance to the EDCTP2 grant agreement, all data generated through this study will be shared in order to allow for third parties to access, mine, exploit, reproduce and disseminate, free of charge

IPD Sharing Time Frame

At the end of the study and after all publications accepted

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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