P. Falciparum Infection Dynamics and Transmission to Inform Elimination

Last updated: March 25, 2022
Sponsor: London School of Hygiene and Tropical Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04053907
16642
OPP1173572
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Resident in the village.
  2. Willingness to participate in repeated assessments of health and infection status andto 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.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 4000
Study Start date:
August 15, 2019
Estimated Completion Date:
May 31, 2022

Study Description

In the current study, the investigators will first improve access to care in all villages by implementing community-based clinical case management (CCM) (year 1). In this year, the investigators will quantify gametocyte carriage and transmission from clinical cases passively recruited by CCM, and gametocyte carriage and transmission from asymptomatic infections detected in community surveys. These data will support the interpretation of the main study outcomes in year 2 when the investigators will directly compare the effect of CCM on the human reservoir of infection as compared to three different approaches, namely i) active fever screening and treatment that should detect symptomatic infections for early treatment; ii) Mass Screening and Treatment (MSAT) that will systematically screen, using point-of-care diagnostics, the whole population, with infected individuals immediately treated; and iii) mass drug administration (MDA) that will treat the whole population with a full course of an antimalarial treatment.

Connect with a study center

  • Medical research Council Unit The Gambia at LSHTM

    Basse Santa Su,
    Gambia

    Active - Recruiting

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