NCT04241705

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48,960 (estimated)
• Sponsor: Armauer Hansen Research Institute, Ethiopia · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
OTHER	Treatment of positive individuals per national treatment guidelines	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)
OTHER	Presumptive treatment with artemether-lumefantrine (AL) plus 14 days of primaquine (PQ)	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.
OTHER	Optimized malaria control interventions	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.

Timeline

• Start date: 2020-01-20
• Primary completion: 2022-01-20
• Completion: 2022-01-20
• First posted: 2020-01-27
• Last updated: 2020-06-12

Locations

10 sites across 1 country: Ethiopia