Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-06 @ 12:22 AM
Study NCT ID:
NCT04241705
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Targeted Mass Drug Administration for Malaria in Ethiopia
Sponsor:
Armauer Hansen Research Institute, Ethiopia
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Targeted Mass Drug Administration and Reactive Case Detection on Malaria Transmission and Elimination in East Hararghe Zone, Oromia, Ethiopia
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Reactive and proactive case detection measures are widely implemented by national malaria elimination programs globally. Similarly, the Ethiopian Federal Ministry of Health decided to include reactive case detection (RCD) and targeted mass drug administration (tMDA) approaches as part of their elimination strategy, along with rigorous evaluation. This study aims to evaluate the impact on annual parasite incidence (API) and cost-effectiveness of implementing tMDA and RCD within a 100-meter radius of passively detected index case, compared with standard of care in the control arm. In addition, cross-sectional surveys will measure the change in malaria prevalence over the two-year study intervention period. The aim is to generate evidence to inform Ethiopia's national strategy for malaria elimination.
Detailed Description:
Study design: Cluster randomized controlled trial
Primary aim: To compare the effect of targeted mass drug administration (tMDA) versus reactive case detection (RCD) on reducing malaria incidence
Study site: Elimination targeted areas within East Hararghe Zones, Oromia Regional State, which is comprised of 24 woredas/districts
Cluster or unit of randomization: Kebeles will be randomized to the control, RCD or tMDA arms using simple randomization
Evaluation methods: The primary outcome measure of annual parasite incidence (API) will be obtained through routine surveillance data at all health facilities (health centers and health posts).
Secondary outcomes will be measured through cross-sectional surveys and study monitoring data:
1. Case investigation. At the time of diagnosis of the index case and enrollment of community members to the study, a short questionnaire will be administered to collect demographic data and assess malaria risk, including past malaria treatment and travel history, access to malaria interventions, occupation, etc.
2. Cross-sectional surveys. At baseline and end of the study period (year 2), cross-sectional household surveys will be conducted to assess malaria prevalence, household and individual risk factors for malaria, including access to malaria interventions. It will also assess knowledge of, attitude towards, and participation in the study intervention.
3. Longitudinal feasibility measurements: Coverage of RCD or tMDA in the target population, acceptability of RCD or tMDA in the target population, serious adverse event (SAE) reports, adherence measured by self-report and pill count, and cost data from all arms
4. Laboratory testing: The conventional rapid diagnostic test (RDT) for malaria will be used in the RCD arm. Dried blood spots (DBS) will be collected for molecular and serological testing during the cross-sectional surveys in all arms. DBS collected in incident cases as part of routine surveillance as well as during the RCD activities will also be utilized for antigen, antibody, and molecular testing. G6PD testing will be used in the RCD and tMDA arm to guide primaquine (PQ) treatment.
Sample size: To measure the primary outcome, change in incidence, 16,000 Households (HH) (16 clusters, 1,000 HH each) per arm will be included in the study. For the cross-sectional surveys, 320 randomly selected HHs per arm (16 clusters, 20HH/cluster) will be included.
Primary aim: To compare the effect of targeted mass drug administration (tMDA) versus reactive case detection (RCD) on reducing malaria incidence
Study site: Elimination targeted areas within East Hararghe Zones, Oromia Regional State, which is comprised of 24 woredas/districts
Cluster or unit of randomization: Kebeles will be randomized to the control, RCD or tMDA arms using simple randomization
Evaluation methods: The primary outcome measure of annual parasite incidence (API) will be obtained through routine surveillance data at all health facilities (health centers and health posts).
Secondary outcomes will be measured through cross-sectional surveys and study monitoring data:
1. Case investigation. At the time of diagnosis of the index case and enrollment of community members to the study, a short questionnaire will be administered to collect demographic data and assess malaria risk, including past malaria treatment and travel history, access to malaria interventions, occupation, etc.
2. Cross-sectional surveys. At baseline and end of the study period (year 2), cross-sectional household surveys will be conducted to assess malaria prevalence, household and individual risk factors for malaria, including access to malaria interventions. It will also assess knowledge of, attitude towards, and participation in the study intervention.
3. Longitudinal feasibility measurements: Coverage of RCD or tMDA in the target population, acceptability of RCD or tMDA in the target population, serious adverse event (SAE) reports, adherence measured by self-report and pill count, and cost data from all arms
4. Laboratory testing: The conventional rapid diagnostic test (RDT) for malaria will be used in the RCD arm. Dried blood spots (DBS) will be collected for molecular and serological testing during the cross-sectional surveys in all arms. DBS collected in incident cases as part of routine surveillance as well as during the RCD activities will also be utilized for antigen, antibody, and molecular testing. G6PD testing will be used in the RCD and tMDA arm to guide primaquine (PQ) treatment.
Sample size: To measure the primary outcome, change in incidence, 16,000 Households (HH) (16 clusters, 1,000 HH each) per arm will be included in the study. For the cross-sectional surveys, 320 randomly selected HHs per arm (16 clusters, 20HH/cluster) will be included.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: