Last Updated: 30/10/2014
Assessing the Effectiveness of Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
Objectives
The main objective of this project is to quantify the relative effectiveness, cost, and cost-effectiveness of focal MDA and MDA with Dihydroartemisinin + Piperaquine (DP) against no mass treatment for reducing P. falciparum parasite prevalence, confirmed outpatient department malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wide-scale deployment.
Specific objectives:
- In areas stratified by high and low malaria transmission, evaluate the relative effectiveness of 2 rounds of focal MDA with DP (fMDA arm), 2 rounds of community-wide MDA with DP (MDA arm) and no mass treatment (current standard of care – control arm) on the outcomes of reducing malaria parasite prevalence, confirmed case incidence and infection incidence over a 12 month period;
- In areas stratified by high and low malaria transmission, assess the percentage of health facility catchment areas (HFCA) with focal MDA and MDA interventions that are able to reduce annual confirmed malaria case incidence to below 25 cases per 1,000 catchment population, which would permit the transition to a passive case investigation approach for malaria elimination;
- Quantify the population coverage of the focal MDA and MDA interventions in the study areas, including the identification of systematic barriers to achieving high coverage, under best programmatic efforts using directly observed treatment (DOT) to assure full treatment;
- Assess and compare the cost and cost-effectiveness of focal MDA and MDA with DP to no mass treatment in areas of high and low transmission;
- Assess the adherence of taking a full course of DP by the focal MDA and MDA interventions in areas of high and low transmission, under best programmatic efforts using DOT to assure full treatment;
- Assess the clearance of asexual stage parasites at day 7 following the administration of DP under the best programmatic efforts using DOT to assure full treatment; and
- Assess the acceptability of participating in the focal MDA and MDA interventions among community members and healthcare leaders in areas of high and low transmission.
In areas stratified by high and low malaria transmission, are 2 rounds of focal MDA and MDA with DP more effective than no mass treatment (current standard of care) at reducing malaria parasite prevalence, health facility confirmed case incidence and community infection incidence over a 12 month period?
- Null hypothesis (H0): There is no benefit of 2 rounds of focal MDA or MDA with DP over the current standard of care (national policy of case management) at reducing malaria parasite prevalence, health facility confirmed case incidence and community infection incidence over a 12 month period.
- Research hypothesis (HR): 2 rounds of focal MDA and MDA with DP during the low transmission season will be significantly more effective than no mass treatment (standard of care) at reducing malaria parasite prevalence, health facility confirmed case incidence and community infection incidence over a 12 month period.
Methodology:
- Drug & regimen: 2 rounds of dihydroartemisinin-piperaquine administered for 3 days (4mg/kg/day and 18mg/kg/day respectively), with the first and last courses given as DOT by the study team
- Concomitant interventions: Standard of care (mosquito net coverage, indoor residual spraying, passive case detection, enhanced case management and surveillance)
- Target population: 60 health facility catchment areas in 10 districts
- Exclusion criteria:
- contraindications from manufacturer
- anyone seriously ill or reported heart conditions
- currently taking antimalarial medicines
- allergy to artemisinin drugs
- pregnant women in the first trimester
- children under 3 months of age
- Outcome measures:
- Primary:
- Parasite prevalence during the high transmission season among children <6 years old for up to 12 months, measured by RDT
- P. falciparum infection incidence rate among individuals ≥3 months for up to 12 months
- Secondary:
- Total and confirmed outpatient malaria case incidence and inpatient malaria case incidence among all ages for up to 48 months
- Malaria rapid diagnostic test test positivity rate from focal mass drug administration and mass drug administration interventions (plus control group) for up to 10 months
- Primary:
- Clinicaltrials.gov ID: NCT02329301
Type: Interventional
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Primary purpose: Treatment
Short-term Impact of Mass Drug Administration With Dihydroartemisinin Plus Piperaquine on Malaria in Southern Province Zambia: A Cluster-Randomized Controlled Trial Assessing the effectiveness of household-level focal mass drug administration and community-wide mass drug administration for reducing malaria parasite infection prevalence and incidence in Southern Province, ZambiaA Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, ZambiaImpact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, ZambiaTreatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, ZambiaCost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, ZambiaAdherence to Mass Drug Administration with Dihydroartemisinin–Piperaquine and Plasmodium falciparum Clearance in Southern Province, ZambiaAssessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods
Sep 2014 — Dec 2020
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