Last Updated

18 Nov 2020

Targeting malaria high-risk populations with tailored intervention packages: A study to assess feasibility and effectiveness in Northern Namibia

Objectives

To determine the effectiveness, cost-effectiveness, acceptability and feasibility of targeted delivery of a malaria intervention package for improving coverage and reducing Plasmodium falciparum malaria transmission among high-risk populations (HRPs).

The study will specifically assess the coverage and impact of interventions delivered at worksites to agricultural workers and cattle herders, including presumptive treatment with artemether-lumefantrine (AL) administered alongside vector control interventions (indoor residual spraying [IRS], long-lasting insecticidal nets [LLINs], and topical repellents).

Principal Investigator
Rationale and Abstract

This study is the second phase of work in Zambezi and Ohangwena Regions, Namibia, building off a formative phase of work that characterized the risk behaviors migratory patterns, health-seeking behaviors, intervention strategies and social networks of previously identified HRPs. The investigators hypothesize that targeted delivery of interventions will lead to improved coverage in these groups and to a reduction in transmission.

Primary outcomes will include the coverage of each intervention at worksites over the study period and PCR-based P. falciparum prevalence measured at endline.

Secondary outcomes around effectiveness will be assessed through incident case data providing measures of incidence in HRP and non-HRP populations, odds of infection associated with each intervention in cases compared to controls and entomological data collection

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Estimated Enrollment: 3500 participants

The effectiveness of the interventions will be compared against areas with no study interventions (standard of care) over the course of implementation.

Following a baseline cross-sectional survey in November/December 2019, the interventions will consist of 2 rounds of presumptive treatment spaced at least one month apart between January and March, and delivery of vector control interventions at worksites and key access points with support from employers, with the primary evaluation to be conducted through an endline cross-sectional survey in April/May 2020.

In addition, operational and feasibility outcomes will be assessed through qualitative data collection, population size estimation of HRP groups and a global positioning system (GPS) logger study.