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Boosting the Impact of SMC Through Simultaneous Screening and Treatment of Roommates (SMC-RST)

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ClinicalTrials.gov Identifier: NCT04816461
Recruitment Status : Not yet recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Institut de Recherche en Sciences de la Sante, Burkina Faso

Brief Summary:

Malaria represents a major public health concern in sub-Sahara Africa. Seasonal malaria chemoprevention (SMC) is one of the largest preventive measures. It consists to administer Amodiaquine+Sulfadoxine-Pyrimethamine to children aged 3-59 months on a monthly basis during the peak malaria transmission season. Despite its implementation, the burden of malaria is still very high in children under five years old in Burkina Faso. This raises questions about other hidden factors that can negatively affect the effectiveness of SMC intervention. Huge effort aiming at preventing human-vector contact were deployed such as the large-scale distribution of insecticide treated bed nets. Healthy humans are only infected via mosquitos if there are parasites reservoir around. Yet, there is no strategy aiming at protecting healthy humans from parasites reservoir. Under these circumstances, multiples humans sharing the same habitat could continually entertain the transmission cycle despite adequate existing measures. This would obviously jeopardize the expected impact of the SMC and the global effort to control the disease. In such context, we postulate that screening and treating malaria SMC-children's roommates could greatly improve the impact of SMC intervention and reduce malaria transmission in endemic settings.

The goal of our study is to improve the impact of SMC intervention in terms of reducing malaria morbidity and mortality in children under five years. Primary objectives include assessing whether SMC + children's roommates screening and treatment with Dihydro-artemisinin-piperaquine (DHAPPQ) is more effective than current routine implementation of SMC alone as well as the assessment of the tolerance and safety of AQSP and DHAPPQ. Secondary objectives include the assessment of the impact of the new strategy on the circulating parasite population in terms of selection of resistant strains and the assessment of determinants such as adherence and acceptability of the strategy.

Methodology: The study will be carried out in the Nanoro health district catchment area in Burkina Faso. This will be a randomized superiority trial. The unit of randomization will be the household and all eligible children from a household will be allocated to the same study group to avoid confusion. Households with 3 - 59 months old children will be assigned to either (i) control group (SMC alone) or (ii) intervention (SMC+ roommates screening with standard HRP2-RDT and treatment if positive) or (iii) intervention (SMC+ roommates screening with highly sensitive RDT and treatment if positive). The sample size will be 789 isolated households per arm, i.e. around 1,578 children under CPS coverage and 2,630 roommates expected. They will be followed-up for 24 months to fully cover two consecutive malaria transmission seasons and then two SMC cycles. Children will be actively followed-up during the malaria transmission seasons while in the dry seasons the followed-up will be passive.

Conclusion: The project will respond to a major public health concern by providing evidence of the efficacy of a new strategy which should necessarily complement the existing ones to achieve best impact in malaria control and elimination. The project is lifesaving and could be scaled up easily at country and regional level in case of promising results. In addition, if successful, the project will reinforce the capacity of the IRSS/CRUN by offering training opportunities to young researchers.


Condition or disease Intervention/treatment Phase
Malaria Drug: Amodiaquine Sulfadoxine-Pyrimethamin administration Drug: Dihydroartemisinin-Piperaquine Diagnostic Test: Standard HRP2-RDT Diagnostic Test: Highly sensitive RDT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Boosting the Impact of Seasonal Malaria Chemoprevention (SMC) Through Simultaneous Screening and Treatment of SMC-Children's Roommates in Burkina Faso
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive
SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive
Drug: Amodiaquine Sulfadoxine-Pyrimethamin administration
SMC treatment

Drug: Dihydroartemisinin-Piperaquine
Roommates treatment if they are positive to malaria

Diagnostic Test: Standard HRP2-RDT
Roommates screening with standard HRP2-RDT

Experimental: SMC+ roommates screening with highly sensitive RDT and treatment with DHAPPQ if positive
SMC+ roommates screening with highly sensitive RDT and treatment with DHAPPQ if positive
Drug: Amodiaquine Sulfadoxine-Pyrimethamin administration
SMC treatment

Drug: Dihydroartemisinin-Piperaquine
Roommates treatment if they are positive to malaria

Diagnostic Test: Highly sensitive RDT
Roommates screening with highly sensitive RDT

Active Comparator: SMC alone
No roommates screening and treatment
Drug: Amodiaquine Sulfadoxine-Pyrimethamin administration
SMC treatment




Primary Outcome Measures :
  1. The incidence of uncomplicated malaria in each intervention arm versus SMC alone arm [ Time Frame: 1 year ]
    Incidence of uncomplicated malaria in each intervention arm versus SMC alone arm

  2. The incidence of severe malaria in each intervention arm versus SMC alone arm [ Time Frame: 1 year ]
    Incidence of severe malaria in each intervention arm versus SMC alone arm


Secondary Outcome Measures :
  1. The incidence of adverse events in each intervention arm versus SMC alone arm [ Time Frame: 5 months ]
    Incidence of adverse events in each arm



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Single household (not sharing the same concession with other households) with children under SMC coverage (aged 3-59 months) with at least one child under 35 months of age,
  • Household members residing within the HDSS catchment area,
  • Willingness of roommates to be screened and treated,
  • Ability to complete the study follow-up period,
  • Written consent obtained from parents/guardian
  • Written consent/assent obtained from roommates

Exclusion Criteria:

  • Household with children under SMC coverage who did not receive the SMC (Amodiaquine-Sulfadoxine-Pyrimethamine) or sharing the same concession with other households
  • Household with children under SMC coverage but at least one of his/her roommates refuse to be screened and treated (these children will still receive the SMC treatment as part of their routine malaria prevention policy)
  • Severely ill individual at the time of enrolment including severe malaria,
  • Known allergy to AQSP for children and DHAPPQ for roommates
  • Planned travel or inability to complete the study follow-up,
  • Participation to malaria vaccine trial
  • Unwillingness to participate to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816461


Contacts
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Contact: Paul Sondo, PhD 70070184 ext +226 paulsondo@yahoo.fr
Contact: Halidou Tinto, PhD 70346354 halidoutinto@gmail.com

Locations
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Burkina Faso
Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro
Nanoro, Boulkiemdé, Burkina Faso, 18 campus urcn
Contact: Paul M SONDO, PhD    70070184 ext +226    paulsondo@yahoo.fr   
Contact: Halidou TINTO, PhD    70346354 ext +226    halidoutinto@gmail.com   
Principal Investigator: Paul M Sondo, PhD         
Sub-Investigator: Marc Christian M Tahita, PhD         
Sub-Investigator: Hamidou M Ilboudo, PhD         
Sub-Investigator: Toussaint M Rouamba, PhD         
Sub-Investigator: Karim M Derra, MSc         
Sub-Investigator: Gauthier M Tougri, MD         
Sub-Investigator: Florence F Ouédraogo, Pharm D         
Sub-Investigator: Béatrice F Konseibo         
Sub-Investigator: Eli M Rouamba, MSc         
Sub-Investigator: Sabina F Dahlström Otienoburu         
Sub-Investigator: Bérenger M Kaboré, PhD         
Sub-Investigator: Kalynn F Kenon         
Sub-Investigator: Kadija F Ouédraogo         
Sub-Investigator: Wend-Timbe-Noma Arlette Raïssa F Zongo         
Sub-Investigator: Fadima F Bocoum         
Sub-Investigator: Kasia F Stepniewska         
Sub-Investigator: Mehul M Dhorba         
Sub-Investigator: Philippe Jean M Guérin         
Principal Investigator: Halidou M Tinto         
Sponsors and Collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso
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Responsible Party: Institut de Recherche en Sciences de la Sante, Burkina Faso
ClinicalTrials.gov Identifier: NCT04816461    
Other Study ID Numbers: IRSS006
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherche en Sciences de la Sante, Burkina Faso:
Chemoprevention
Roommate screening and treatment
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Piperaquine
Sulfadoxine
Amodiaquine
Artenimol
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents