Last Updated

14 Dec 2018

Speeding up malaria elimination; a cluster randomized controlled trial of mass drug administration in Southeast Myanmar, an area with artemisinin resistance

Objectives

The main objective of this pilot project is to conduct Targeted Malaria Elimination (TME) in hotspots of malaria transmission intensity and high migration in Southeast Myanmar (South Kayin/Karen State).

The specific objectives are to assess the feasibility, acceptability, safety and effect on malaria of mass drug administration (MDA). 

Funding Information
Global Fund under the Regional Artemisinin Initiative (RAI)
Rationale and Abstract
  • Drug & regimen: 3 rounds in 3 consecutive months (March, April and May 2015) of dihydroartemisinin-piperaquine + primaquine (single low dose)
  • Intervention by arms: MDA + routine malaria interventions (intervention) vs routine malaria interventions alone (control)
  • Concomitant interventions: Routine malaria control activities, LLIN distribution, village health workers which diagnose malaria with RDTs and treat using artemether-lumefantrine) for Plasmodium falciparum infections and chloroquine for Plasmodium vivax infections, and community engagement
  • Target & size population: The study area in Myanmar is 60 km long and close to the Thai border. Sixteen clusters were selected and 58 villages were screened for eligibility. Of a total population of 8721 inhabitants, the target population for the study were 75-1200 people per village. The villages were selected as hotspots if they had 30% prevalence of all malaria species and/or 10% prevalence of Plasmodium falciparum by PCR. The MDA in the intervention villages included a total of 5481 people and control villages had 3240 people.
  • Exclusion criteria: 
    • Children < 1 year
    • Pregnant women in the 1st trimester
    • No primaquine for pregnant women all trimesters (pregnant women in the 2nd and 3rd trimesters would be eligible for DHP but not primaquine)
    • Concomitant illness
    • Refused consent
  • Outcome measures: 
    • (Primary) Malaria prevalence (using ultrasensitive PCR) at 5, 10, 15, 21 months from the start of MDA. 
    • (Secondary) Proportion of Kelch 13 mutations in Plasmodium falciparum infections, number of MDA participants with adverse events, incidence of symptomatic Plasmodium falciparum infections in the study area.
  • Time of follow-up: 21 months
Study Design

Type: Interventional
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Primary purpose: Treatment