Clinical trial NCT04094727: Malaria High-Risk Populations in Namibia
Official title: Targeting Malaria High-risk Populations With Tailored Intervention Packages: A Study to Assess Feasibility and Effectiveness in Northern Namibia
Conditions: Malaria
Summary: This study aims to determine the effectiveness, cost-effectiveness, acceptability, and feasibility of targeted delivery of a package of malaria interventions for improving effective coverage and reducing Plasmodium falciparum malaria transmission among malaria high-risk populations in Northern Namibia. Previous research identified cattle herders and agricultural workers as populations at higher risk of infection. The investigators hypothesize that targeted delivery of interventions will lead improve coverage in these groups and lead to a reduction in P. falciparum transmission.
Interventions:
description: All eligible HRPs will be presumptively treated with artemether-lumefantrine (AL) at two timepoints, separated by at least one month. All individuals who have provided informed consent, meet eligibility criteria, are not pregnant or breastfeeding, and who do not have symptoms associated with severe malaria or another severe illness, will be offered an age-appropriate course of AL (age-specific blister packages). AL is currently the first line drug used for uncomplicated malaria in Namibia, and has been used previously in northern Namibia for focal mass drug administration and has no severe adverse effects and is well-tolerated, with high adherence and acceptability in this context. AL requires two daily doses for three consecutive days, for a total of six doses. The first antimalarial dose will be delivered by directly observed therapy (DOT) and subsequent doses will be left with the subject, with instructions to self-administer them.
name: Presumptive treatment with Artemether-lumefantrine (AL)
other_name: Coartem
type: Drug
description: The mop up indoor residual spraying (IRS) campaign will be targeted to farms and cattle posts/kraals in intervention areas in December 2019 to fill gaps from the routine spray campaign (September to November 2019) and utilize the same insecticides and protocols as the national campaign. The team will spray each unsprayed structure with the recommended solution of dichloro-diphenyl-trichloroethane (DDT) for traditional structures and/or Actellic for modern structures, tarps and tents.<br/>Alternative vector control interventions, including LLINs (long-lasting insecticide treated bed nets), sprayed tents/tarps and topical repellents will be distributed to eligible HRPs between November and January 2020 during one round.
name: Enhanced vector control
other_name: Indoor residual spraying (IRS)
Long-lasting insecticide treated bed nets
Topical repellents
type: Other
Study arms:
design_group_description: For all eligible HRPs in intervention areas, after obtaining informed consent, presumptive treatment for malaria will be carried out using artemether-lumefantrine (AL) at two time points.<br/>Enhanced vector control activities will include: (1) a mop up indoor residual spraying (IRS) campaign and (2) distribution of long-lasting insecticide-treated nets (LLINs) and/or vector control packs with topical repellent.<br/>The intervention arm will also receive the standard of care in Namibia.
design_group_title: Presumptive treatment and enhanced vector control
design_group_type: Experimental
design_group_description: The control arm will receive the standard of care in Namibia: passive case detection through health facilities and health extension workers, routine indoor residual spraying (IRS), and reactive case detection (RACD) accompanied by reactive IRS.
design_group_title: Standard of care
design_group_type: No Intervention
Sponsor: The University of California, San Francisco
Collaborators: The University of Texas Southwestern Medical Center
University of Namibia
University of Notre Dame
Namibia Ministry of Health & Social Services
London School of Hygiene & Tropical Medicine
Drug name mappings:
name: 复方蒿甲醚
lang: CN
name: Artemether/Lumefantrine
lang: EN
name: アルテメテル/ルメファントリン
lang: JP