Boosting the Impact of SMC Through Simultaneous Screening and Treatment of Roommates

NCT04816461 | Completed Phase 4

• 1 other identifier: IRSS006
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

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) . The sample size will be 526 isolated households per arm, i.e. around 1,052 children under CPS coverage and 1,315 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.

Conditions

Malaria; Malaria Prophylaxis; Mass Testing and Treatment

Keywords

Chemoprevention; Roommate screening and treatment

Outcome Measures

Primary Outcomes (2)

• The incidence of uncomplicated malaria in each intervention arm versus SMC alone arm

  Incidence of uncomplicated malaria in each intervention arm versus SMC alone arm

  1 year

• The incidence of severe malaria in each intervention arm versus SMC alone arm

  Incidence of severe malaria in each intervention arm versus SMC alone arm

  1 year

Secondary Outcomes (1)

• The incidence of adverse events in each intervention arm versus SMC alone arm

  5 months

Study Arms (2)

SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive

EXPERIMENTAL

SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive

Drug: Amodiaquine Sulfadoxine-Pyrimethamin administration; Drug: Dihydroartemisinin-Piperaquine; Diagnostic Test: Standard HRP2-RDT

SMC alone

ACTIVE COMPARATOR

No roommates screening and treatment

Drug: Amodiaquine Sulfadoxine-Pyrimethamin administration

Interventions

Amodiaquine Sulfadoxine-Pyrimethamin administration DRUG

SMC treatment

SMC alone; SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive

Dihydroartemisinin-Piperaquine DRUG

Roommates treatment if they are positive to malaria

SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive

Standard HRP2-RDT DIAGNOSTIC_TEST

Roommates screening with standard HRP2-RDT

SMC+ roommates screening with standard HRP2-RDT and treatment with DHAPPQ if positive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso: lead

Study Sites (1)

Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro

Nanoro, Boulkiemdé, 18 campus urcn, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: July 7, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

BU (1)