P. Falciparum Infection Dynamics and Transmission to Inform Elimination

NCT04053907 | Unknown DMC

• 2 other identifiers: 16642OPP1173572
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. More specifically, in the 2019 transmission season (June-December) (Year 1), community case management of malaria (CCM) will be implemented in all eight villages as improved standard of care; in the 2020 transmission season (Year 2), the eight study villages will be divided into 4 study arms. CCM will continue in all villages; two villages will continue with CCM only (Arm 1, control); the three other pairs of villages will receive active fever screening and treatment (Arm 2); monthly mass screening and treatment (MSAT) (Arm 3); and mass drug administration (MDA) during the last 3 months of the dry season (April-June) (Arm 4). For MDA, the whole population (except for those not fulfilling the entry criteria) will be treated with a full course of dihydroartemisinin-piperaquine (DP) (320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet) per manufacturer's guidelines (once daily for 3 days and according to body weight). The MDA treatment will be repeated 3 times at monthly intervals.

Conditions

Malaria

Keywords

falciparum; gametocyte; elimination; anopheles; transmission; diagnostic

Outcome Measures

Primary Outcomes (2)

• Parasite prevalence by molecular detection at the end of study (cross-sectional survey).

  The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2.

  16 weeks

• Parasite density by molecular detection at the end of study (cross-sectional survey).

  The primary outcome measure is parasite density (parasite/µL) in the cross-sectional survey conducted at the end of the transmission season of year 2.

  16 weeks

Secondary Outcomes (6)

• Gametocyte prevalence by molecular methods at the end of study (cross-sectional survey).

  16 weeks

• Gametocyte density by molecular methods at the end of study (cross-sectional survey).

  16 weeks

• Gametocyte prevalence of male and female gametocytes by molecular methods among P. falciparum infections at all study visits.

  Throughout study, an average of 18 months

• Gametocyte density of male and female gametocytes by molecular methods among P. falciparum infections at all study visits.

  Throughout study, an average of 18 months

• Incidence of malaria infections

  Throughout study, an average of 18 months

Other Outcomes (19)

• The detectability of infections by highly-sensitive rapid diagnostic tests related to histidine rich protein-2 (HRP2) concentrations.

  Throughout study, an average of 18 months

• The detectability of infections by highly-sensitive rapid diagnostic tests related to duration of infection.

  Throughout study, an average of 18 months

• The detectability of infections by rapid diagnostic tests related to duration of infection.

  Throughout study, an average of 18 months

Study Arms (4)

CCM:Standard of Care

NO INTERVENTION

Community Case Management (CCM), with passively monitored malaria incidence by community health workers using standard RDTs and artemisinin-based combination therapy (ACT), artemether-lumefantrine (AL) according to national guidelines.

CCM plus weekly fever screening and treatment

EXPERIMENTAL

CCM plus active case detection (ACD) by fever screening and treatment if positive. Trained village health workers (VHW) recruited for this study will carry out weekly visits of all residents and screen for fever using research-grade thermometers. A standard RDT will be performed in all individuals with a body temperature ≥37.5°C or with reported fever in the last 24 hours. RDT positive individuals will be treated with AL according to national guidelines.

Other: Community Case Management; Other: Weekly fever screening and treatment

CCM plus MSAT

EXPERIMENTAL

CCM plus monthly screening for malaria infection and treatment of positive individuals, regardless of symptoms. Screening will be performed by research staff and timed to ensure a gap of 25-35 days between screening rounds; Positive individuals will be treated with AL, according to national guidelines.

Other: Community Case Management; Other: Monthly malaria screening

CCM plus dry season MDA

EXPERIMENTAL

CCM plus plus 3 monthly rounds of MDA with a long-acting ACT (dihydroartemisinin-piperaquine, DP) starting in the dry season (April, May, June) (tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight).

Other: Community Case Management; Other: MDA

Interventions

Community Case Management OTHER

Community Case Management (CCM), consisting of community health workers able to diagnose malaria by standard RDTs and treating positive individuals with artemether-lumefantrine (AL), according to national guidelines.

CCM plus MSAT; CCM plus dry season MDA; CCM plus weekly fever screening and treatment

Weekly fever screening and treatment OTHER

Consists of weekly visits by trained VHW who will screen for fever by taking the axillary temperature. If the body temperature is ≥37.5°C, a standard RDT will be performed and, if positive, the individual will be treated with AL, according to national guidelines.

CCM plus weekly fever screening and treatment

Monthly malaria screening OTHER

CCM plus monthly screening of the whole population with high sensitive RDT (HS-RDT); positive individuals will be treated with AL regardless of symptoms (MSAT).

CCM plus MSAT

MDA OTHER

CCM plus 3 monthly rounds of MDA with dihydroartemisinin-piperaquine (DP) starting during the dry season, before the malaria transmission season starts.

CCM plus dry season MDA

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident in the village.
• Willingness to participate in repeated assessments of health and infection status and to donate a maximum of 30 mL (milliliter) of blood (children \<5 years of age), 37 mL (milliliter) of blood (children \<10 years of age) or 52 mL (milliliter) of blood (older individuals) during an 18-month period.

You may not qualify if:

• Any chronic illness that would affect study participation.
• Pre-existing severe chronic health conditions
• History of intolerance to artemether-lumefantrine.
• Participants \< 6months old and pregnant women in the first trimester (only for Arm with MDA-DP treatment).
• Hypersensitivity to DP (only for Arm with MDA-DP treatment).
• Taking drugs that influence cardiac function or prolong QTcorrected interval (only for Arm with MDA-DP treatment).

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Medical Research Council Unit, The Gambia: collaborator
• National Malaria Control Programme, The Gambia: collaborator
• Radboud University Medical Center: collaborator
• University of California, San Francisco: collaborator
• Institute for Disease Modeling: collaborator

Study Sites (1)

Medical research Council Unit The Gambia at LSHTM

Basse Santa Su, The Gambia

RECRUITING

MeSH Terms

Conditions

Malaria; Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Drakeley, PhD

  London School Hygiene and Tropical medicine

  PRINCIPAL INVESTIGATOR

• Umberto D'Alessandro, PhD, MD

  MRC Unit The Gambia @ LSHTM

  PRINCIPAL INVESTIGATOR

• Teun Bousema, PhD

  Radboud University Medical Centre, Nijmegen, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Drakeley, PhD

CONTACT

+44 (0)20 7927 2289; Chris.drakeley@lshtm.ac.uk

Umberto D'Alessandro, PhD, MD

CONTACT

+220 4495442/6; udalessandro@mrc.gm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 13, 2019
• Study Start: August 15, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TH (1)