Proactive Community Case Management for Malaria in Zambia

NCT04839900 | Completed

• 1 other identifier: 1704068
• Study Type: interventional
• Target: 10,890
• Locations: 1 country
• Sites: 1

Brief Summary

To study if a proactive strategy of weekly household visits by community health workers (CHWs) to identify people with malaria symptoms, offer diagnostic testing, and treatment for those with positive tests in Chadiza District, Eastern Province, can decrease malaria incidence and prevalence compared to conventional community case management.

Conditions

Malaria, Falciparum; Malaria

Keywords

Malaria; integrated community case management; proactive response; Zambia

Outcome Measures

Primary Outcomes (2)

• Parasite Prevalence

  1\) Difference in parasite prevalence in intervention vs control clusters over time measured by RDT and PCR among all age groups (stratified by \< 15 and 15+ years), detected through baseline and endline cross-sectional surveys conducted at the end of the transmission season.

  24 months

• Confirmed malaria case incidence

  2\) Difference in slope of trend lines of total numbers of febrile patients detected and malaria cases diagnosed monthly (CHWs + HF) in intervention vs control clusters (CHWs + HF)

  24 months

Study Arms (2)

Proactive iCCM

ACTIVE COMPARATOR

Community health workers (CHWs) will conduct weekly visits of all households in their communities to detect children \< 5 years with diarrhea or cough, and people of all ages complaining of fever or history of fever. Weekly household visits will be conducted year round. CHWs will be available for consultation throughout the week for sick visit consultations as per national iCCM policy (with malaria case management for all ages).

Other: Proactive iCCM

Standard Passive iCCM

NO INTERVENTION

Community health workers (CHWs) will provide case management per national iCCM policy to all who are brought for consultation, but will not conduct household visits to provide active case detection. CHWs will be available for consultation throughout the week for sick visit consultations as per national iCCM policy (with malaria case management for all ages).

Interventions

Proactive iCCM OTHER

CHWs in the proactive iCCM intervention arm will conduct weekly visits of all households in their communities to detect children \< 5 years with diarrhea or cough, and people of all ages complaining of fever or history of fever. People with fever or history of fever in the past 48 hours, or any person with symptoms suggestive of malaria (chills, headache, muscle ache, fatigue, etc), will receive an RDT; those with positive results will be defined as confirmed malaria cases, and will receive the first line antimalarial. Any child under 5 years with diarrhea will be treated with oral rehydration solution (ORS) and zinc, and any child meeting diagnostic criteria for pneumonia will receive the first line antibiotic recommended per national iCCM policy. If the CHW does not have the indicated therapy on hand, the patient will be referred for treatment.

Proactive iCCM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

All residents of all ages in the study area will be eligible to receive the CHW intervention. All ages with fever

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• PATH: lead
• Ministry of Health, Zambia: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Chadiza District Health Office

Chadiza, Eastern Provice, Zambia

Location

Related Publications (1)

• Rutagwera MI, Ferriss EL, Kabamba BM, Porter T, Kangale CC, Gallalee S, Simataa M, Miller JM, Phiri-Chibawe C, Musunse M, Nyendwa P, Kapenda V, Psychas P, Gutman JR, Hawela M, Banda I, Chitambala-Otiono S, Bennett A, Hamainza B, Thwing JI. Impact of proactive malaria community case management (proCCM) on parasite prevalence and incidence from 2021 to 2023: a randomised controlled trial in Chadiza District, Eastern Province, Zambia. BMJ Glob Health. 2025 May 24;10(5):e017697. doi: 10.1136/bmjgh-2024-017697.

  PMID: 40412814 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two arm, cluster-randomized controlled trial (CRCT) will be conducted to determine whether proactive iCCM (arm 1)-- year-round weekly household visits by CHWs to test people of all ages with fever or history of fever with RDTs and offer treatment with an ACT for those who test positive (and treatment or referral of diarrhea and pneumonia for children under 5 years) -- compared to standard passive iCCM (arm 2)- malaria case management for all ages, and treatment or referral of diarrhea and pneumonia for children under 5 years, conducted by CHWs -- is associated with a greater reduction in confirmed malaria cases and parasite prevalence over a 2-year follow-up period. \] Clusters defined by CHW location will be randomly allocated to receive either proactive iCCM or standard passive iCCM.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: April 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

ZA (1)