Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06516042

Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia

The purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in Metema District, Amhara Region, Ethiopia

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Delello Farm Sites

Gonder, Metema District, Ethiopia

About this study

A cluster randomized controlled trial will be used to evaluate the effectiveness, feasibility, and acceptability of targeted antimalarial drug administration (TDA) for seasonal migrant farmworkers in the Delello farm sites in Metema district, Amhara Region. Individual farm sites will be randomized 1:1:1 to either of two intervention options or control, where all farmworkers at intervention sites will receive either two or three rounds of dihydro artemisinin piperaquine over the primary farming season.

All study farm-sites will receive enhanced case management conducted by mobile health teams throughout the study period.

Cross-sectional surveys will be conducted in all arms at baseline and 4 to 6 weeks following the third round of TDA to assess the effectiveness of the intervention for reducing parasite prevalence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At the time of the study, be a seasonal farm worker at one of the selected farm sites in Metema district
  • Available and willingness to participate in the study and provide consent (or parental/guardian consent and asset in the case of minors)

Exclusion criteria

  • Severe illness (will be referred for care)
  • Inability to provide informed consent
  • Age 14-17 years old and not having a parent/guardian at the farm who can provide consent
  • Age <14 years old

Additional exclusion criteria for the intervention group:

  • Having received an antimalarial drug within the last 2 weeks
  • Having any of the contraindications to receiving DP:
  • History of cardiac rhythm disturbances, bradycardia, or heart failure
  • Concomitant treatment with drugs that prolong the QT interval (fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.) or drugs containing any of the following: flecainide, metoprolol, imipramine, amitriptyline, clomipramine
  • Known allergic reactions to DP or other artemisinin derivatives
  • Pregnancy

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

Participants that provide consent to participate in the TDA and are deemed eligible for treatment will receive a course of dihydroartemisinin-piperaquine (DP) if male, and artemether-lumefantrine (AL) if female. They will take the first dose of the treatment under direct observed therapy, and will receive the rest of the tablets to take on their own for days two and three.

Other names: Piperaquine/dihydroartemisinin

Primary outcomes

  1. Plasmodium falciparum (Pf) parasite prevalence

    Time frame: Up to 6 months

    Prevalence of Pf as determined by PCR at the end of the study

  2. Feasibility of TDA

    Time frame: Up to 6 months

    Feasibility of TDA measured through intervention coverage (% of participants treated among the total farm population) and cost effectiveness

  3. Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities

    Time frame: Up to 6 months

    Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities measured through drug adherence (% of participants completing the drugs as prescribed, as reported in the endline survey), survey response (self-reported values provided during endline survey), and qualitative interview data

Secondary outcomes

  1. Pf parasite prevalence in a subset of migrant farmworkers

    Time frame: Up to 2 months

    Pf parasite prevalence measured in a subset of migrant farmworkers upon return to their home village in the western highlands

  2. Safety and tolerability of TDA

    Time frame: Up to 6 months

    Safety and tolerability of TDA measured through the incidence of adverse events and survey responses

  3. Feasibility of enhanced case management through mobile clinics based on cost per case detected

    Time frame: Up to 6 months

    A cost assessment of providing enhanced case management through mobile clinics

  4. Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses

    Time frame: Up to 6 months

    Feasibility and acceptability of providing enhanced case management among the study team based on endline survey responses

  5. Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data

    Time frame: Up to 6 months

    Feasibility and acceptability of enhanced case management through mobile clinics based on information shared during qualitative interviews

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Federal Minstry of Health of Ethiopia

Registry information

Official study title

Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.