ASSERMalaria: Additional Screening With Sensitives RDTs and Malaria

Sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04147546
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP) (Other)
340
Enrollment
1
Location
2
Arms
17.9
Anticipated Duration (Months)
19
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Operational Feasibility, Impact of Additional Screening Using Highly-sensitives RDTs Combined With High Coverage of IPTp on Placental Malaria and Low Birth Weight
Actual Study Start Date :
Aug 31, 2020
Actual Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

ArmIntervention/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

    Outcome Measures

    Primary Outcome Measures

    1. Placental malaria prevalence [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)

    2. Low birthweight prevalence [36 months]

      The prevalence of low birthweight (defined as birth weight less than 2,500 g) will be compared between the two arms.

    3. Peripheral maternal malaria infection prevalence [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of NanoroOuagadougouKadiogoBurkina Faso218 CMS 11

    Sponsors and Collaborators

    • Institut de Recherche en Sciences de la Sante, Burkina Faso
    • European and Developing Countries Clinical Trials Partnership (EDCTP)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Institut de Recherche en Sciences de la Sante, Burkina Faso
    ClinicalTrials.gov Identifier:
    NCT04147546
    Other Study ID Numbers:
    • IRSS0005
    First Posted:
    Nov 1, 2019
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 22, 2021