Evaluation of Targeted Mass Drug Administration for Malaria in Ethiopia

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.

Conditions

• Malaria

Interventions

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.

Sponsors & Collaborators

• Addis Continental Institute of Public Health

  collaborator OTHER

• U.S. President's Malaria Initiative

  collaborator UNKNOWN

• U.S. Centers for Disease Control and Prevention

  collaborator UNKNOWN

• United States Agency for International Development (USAID)

  collaborator FED

• Ethiopian Federal Ministry of Health

  collaborator UNKNOWN

• Oromia Regional Health Bureau

  collaborator UNKNOWN

• Tulane University

  collaborator OTHER

• Armauer Hansen Research Institute, Ethiopia

  lead OTHER

Principal Investigators

• Endalamaw Gadisa, PhD, MSc · AHRI Ethiopia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-20

Primary Completion

2022-01-20

Completion

2022-01-20

Countries

• Ethiopia

Study Locations