Evaluation of Targeted Mass Drug Administration for Malaria in Ethiopia
Evaluation of the Effect of Targeted Mass Drug Administration and Reactive Case Detection on Malaria Transmission and Elimination in East Hararghe Zone, Oromia, Ethiopia
1 other identifier
interventional
48,960
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2020
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedJune 12, 2020
June 1, 2020
2 years
January 2, 2020
June 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in malaria annual parasite incidence (API)
The effect of RCD or tMDA will be defined as a change in malaria API among residents measured by microscopy/RDT through health centers and health posts. The malaria API will be defined as all passively detected RDT or microscopy confirmed cases over a period of 12 months, who are residents of the kebele divided by the estimated population in the intervention kebele multiplied by 1000. The primary effectiveness endpoint will therefore be API among residents of the kebele at baseline and year 2 of each intervention group of study clusters, compared with the control clusters.
Two years
Secondary Outcomes (11)
Malaria burden, measured by antigen test
Two years
Malaria burden, measured by serology
Two years
Malaria burden, measured by molecular testing
Two years
Intervention coverage
Two years
Acceptability
Two years
- +6 more secondary outcomes
Study Arms (3)
Control arm
ACTIVE COMPARATORThe control arm will provide optimized malaria control interventions that includes strengthened surveillance systems and commodities management, scale-up of vector control and case management services.
Reactive Case Detection (RCD) arm
ACTIVE COMPARATOROptimized malaria control interventions as in the control arm. In addition, following identification of microscopy or RDT positive, passively-detected index cases at the health post or health center; individuals who reside within a 100-meter radius of the index case will receive diagnosis for malaria using a conventional RDT. Positive individuals will receive treatment and follow-up as per the national treatment guidelines. 14 days of primaquine (PQ) will only be administered to those found to be normal upon G6PD testing. Additional procedures will include the collection of a dried blood spot.
Targeted Mass Drug Administration (tMDA) arm
EXPERIMENTALOptimized malaria control interventions as in the control arm. In addition, following identification of microscopy or RDT positive index cases at the health post or health center, all eligible individuals who reside within a 100-meter radius of the index case will receive presumptive treatment with artemether-lumefantrine (AL) plus 14 days of primaquine (PQ) (0.25mg/kg daily). 14 days of primaquine (PQ) will only be administered to those found to be normal upon G6PD testing.
Interventions
Treatment for everyone except children \<6 months of age, pregnant women, women breastfeeding children \<6 months of age, and women 12-49 years of age with an unknown pregnancy status: * P. falciparum cases: artemether-lumefantrine (AL) plus single dose primaquine (PQ) (0.25mg/kg daily) * P. vivax cases: chloroquine (CQ) plus 14 days of PQ (0.25mg/kg daily) * Mixed infections: AL plus 14 days of PQ (0.25mg/kg daily) Treatment for pregnant women and women breastfeeding children \<6 months of age: * P. falciparum cases or mixed infections: Quinine (1st trimester); AL (2nd \& 3rd trimesters or breastfeeding) * P. vivax cases: Chloroquine (CQ)
Everyone who is eligible for the study except pregnant women and women breastfeeding children \<6 months of age AND who are confirmed to have normal G6PD status will be treated presumptively with artemether-lumefantrine (AL) plus 14 days of primaquine (PQ). Treatment will be given without RDT for malaria. * Women in the first trimester of pregnancy will be treated presumptively with quinine. * Women in the second and third trimesters or women who are breastfeeding will receive artemether-lumefantrine (AL). Again, treatment will be given without RDT for malaria.
Optimized malaria control interventions that includes strengthened surveillance systems and commodities management, scale-up of vector control and case management services including follow-up, and social and behavior change communication to seek prompt treatment and use long lasting insecticidal nets (LLINs). Case management includes passive detection of malaria cases and treatment with artemether-lumefantrine (AL) plus single low dose primaquine (PQ) (0.25mg/kg once) for Plasmodium falciparum (Pf) cases and chloroquine (CQ) plus 14 days of PQ (0.25mg/kg daily) for Plasmodium vivax (Pv) cases, and AL plus 14 days of PQ (0.25mg/kg daily) for mixed infections as well as follow-up at the health post or health center on days 3, 7, and 13 for those receiving 14 days of PQ to assess for adverse events and adherence as per the national treatment guidelines.
Eligibility Criteria
You may qualify if:
- Woreda-level: Of the 19 woredas with malaria risk, the ten woredas with the highest annual parasite incidence (API) in 2018 will be eligible for the study.
- For Kebeles:
- Kebeles in East Hararghe Zone targeted for implementation of elimination activities by the Ethiopian Federal Ministry of Health where there is ongoing PMI-supported malaria surveillance;
- Kebeles with reported API between 1 and 50;
- Kebeles in malarious districts with comparable optimization of malaria control interventions.
- For individual participants:
You may not qualify if:
- Able to provide informed written consent
- For kebeles: Kebeles planning on starting for the first time or discontinuing indoor residual spraying (IRS) campaigns in the next two years.
- For individual participants:
- Children less than 6 months of age or \<5 kg
- Known allergy or history of adverse reaction or chronic/congenital disease contra indicated to any of the intervention drugs: PQ, AL or CQ
- Individuals with severe malnutrition or signs of severe disease, with evidence of any organ failure or Hgb level \< 8gm/dl
- Household members already covered by the intervention less or equal to one month before
- In addition, the following individuals will be excluded from receiving primaquine:
- Phenotypically G6PD deficient individuals
- Pregnant women
- Lactating women breastfeeding infants less than 6 months of age or with unknown G6PD status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Armauer Hansen Research Institute, Ethiopialead
- Addis Continental Institute of Public Healthcollaborator
- U.S. President's Malaria Initiativecollaborator
- U.S. Centers for Disease Control and Preventioncollaborator
- United States Agency for International Development (USAID)collaborator
- Ethiopian Federal Ministry of Healthcollaborator
- Oromia Regional Health Bureaucollaborator
- Tulane Universitycollaborator
Study Sites (10)
Woreda 1:
Babīlē, Ethiopia
Woreda 2:
Fedīs, Ethiopia
Woreda 3:
Girawa, Ethiopia
Woreda 4:
Golo Oda, Ethiopia
Woreda 5:
Gursum, Ethiopia
Woreda 7:
Kersa, Ethiopia
Woreda 8:
Kombolcha, Ethiopia
Woreda 9:
Kurfa Chele, Ethiopia
Woreda 10:
Midega Tola, Ethiopia
Woreda 6:
‘Alemaya, Ethiopia
Related Publications (1)
Abdelmenan S, Teka H, Hwang J, Girma S, Chibsa S, Tongren E, Murphy M, Haile M, Dillu D, Kassim J, Behaksra S, Tadesse FG, Yukich J, Berhane Y, Worku A, Keating J, Zewde A, Gadisa E. Evaluation of the effect of targeted Mass Drug Administration and Reactive Case Detection on malaria transmission and elimination in Eastern Hararghe zone, Oromia, Ethiopia: a cluster randomized control trial. Trials. 2022 Apr 7;23(1):267. doi: 10.1186/s13063-022-06199-8.
PMID: 35392979DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Endalamaw Gadisa, PhD, MSc
AHRI Ethiopia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 27, 2020
Study Start
January 20, 2020
Primary Completion
January 20, 2022
Study Completion
January 20, 2022
Last Updated
June 12, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share