Malaria High-Risk Populations in Namibia
NCT04094727 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3302
Last updated 2020-11-03
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.
Conditions
Interventions
- DRUG
-
Presumptive treatment with Artemether-lumefantrine (AL)
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.
- OTHER
-
Enhanced vector control
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. 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.
Sponsors & Collaborators
-
University of Namibia
collaborator OTHER -
Ministry of Health and Social Services, Namibia
collaborator OTHER_GOV -
University of Texas Southwestern Medical Center
collaborator OTHER -
University of Notre Dame
collaborator OTHER -
London School of Hygiene and Tropical Medicine
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Jennifer Smith, PhD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-10-31
- Primary Completion
- 2020-06-30
- Completion
- 2020-06-30
Countries
- Namibia
Study Locations
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