Overview

This trial is active, not recruiting.

Conditions malaria, malaria, falciparum
Treatments mda with dhap (eurartesim), focal mda with dhap (eurartesim)
Sponsor PATH
Collaborator Ministry of Health, Zambia
Start date September 2014
End date June 2016
Trial size 2430 participants
Trial identifier NCT02329301, PATH-WIRB-20140824

Summary

To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD 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 wider-scale deployment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All consenting community members eligible to receive DHAp will be provided age-appropriate treatment dose of DHAp regardless of the malaria rapid diagnostic test (RDT) result. Treatment will be administered in a house-to-house campaign.
mda with dhap (eurartesim) mass drug administration with DHAp
Eurartesim is the brand name.
(Experimental)
All consenting household members eligible to receive DHAp and living in a household where anyone in the household tests positive with a malaria rapid diagnostic test (RDT) will receive the age-appropriate treatment dose of DHAp. If no one in the household tests RDT positive then no one in the household will receive DHAp. Treatment will be administered in a house-to-house campaign.
focal mda with dhap (eurartesim) focal mass drug administration with DHAp
Eurartesim is the brand name.
(No Intervention)
The standard of care arm will reflect no community-based treatment interventions but will have the standard of care offered by the Ministry of Health and Ministry of Community Development, Mother and Child Health which applies to all arms. This includes available mosquito net coverage, indoor residual spraying and passive case detection of individuals seeking treatment from a health provider at a clinic or health post.

Primary Outcomes

Measure
Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
time frame: For up to 12 months
P.falciparum infection incidence rate among individuals ≥3 months
time frame: For up to 12 months

Secondary Outcomes

Measure
Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
time frame: For up to 48 months (including retrospectively)
Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group)
time frame: For up to 10 months

Eligibility Criteria

Male or female participants at least 3 months old.

Inclusion Criteria: - anyone not excluded and consenting Exclusion Criteria: - contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin - anyone seriously ill - currently taking antimalarial medicines - allergy to artemisinin drugs - pregnant women in first trimester - children under 3 months of age - reported heart condition

Additional Information

Official title Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
Principal investigator John M Miller, PhD
Description To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD 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 wider-scale deployment. In areas stratified by high and low malaria transmission, are 2 rounds of fMDA and MDA with DHAp 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 fMDA or MDA with DHAp over 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 fMDA and MDA with DHAp 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. The research objectives are: 1. In areas stratified by high and low malaria transmission, evaluate the relative effectiveness of 2 rounds of fMDA with DHAp (fMDA arm), 2 rounds of community-wide MDA with DHAp (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; 2. In areas stratified by high and low malaria transmission, assess the percent of health facility catchment areas (HFCA) with fMDA 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; 3. Quantify the population coverage of the fMDA 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; 4. Assess and compare the cost and cost-effectiveness of fMDA and MDA with DHAp to no mass treatment in areas of high and low transmission; 5. Assess the adherence of taking a full course of DHAp by the fMDA and MDA interventions in areas of high and low transmission, under best programmatic efforts using DOT to assure full treatment; 6. Assess the clearance of asexual stage parasites at day 7 following the administration of DHAp under the best programmatic efforts using DOT to assure full treatment; and 7. Assess the acceptability of participating in the fMDA and MDA interventions among community members and health care leaders in areas of high and low transmission. The study population includes: Population of ~560,000 people in ~112,000 households in 60 health facility catchment areas near Lake Kariba in Southern Province. Cluster randomized controlled trial in high and low transmission areas will be used to evaluate the fMDA and MDA interventions against current standard of care for the effect on population-wide parasite prevalence (RDT and more sensitive assay), community cohort infection incidence and routinely collected confirmed malaria case incidence. The primary outcomes are: 1. Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) 2. Pf infection incidence rate among individuals ≥3 months 3. Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages 4. RDT test positivity rate from fMDA and MDA interventions (plus control group) 5. Population coverage of the fMDA and MDA interventions at each round The entire population will be included in the study; interventions will be grouped/assigned randomly according to health facility catchment area (n= 60 health facilities), matched on potential confounding factors. Household surveys in the high transmission season before and after the interventions will be used for ascertaining malaria parasite prevalence. A longitudinal cohort will be used for ascertaining the infection incidence rate. The health system rapid reporting system will be used for ascertaining confirmed malaria case incidence.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by PATH.