Clinical trial NCT04839900: Proactive Community Case Management for Malaria in Zambia
Official title: A Cluster Randomized Controlled Trial of Pro-active Community Case Management for Malaria in Chadiza District, Eastern Province, Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria, Falciparum
Malaria
Keywords: Malaria
integrated community case management
proactive response
Zambia
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Zambia
name: Centers for Disease Control and Prevention
First posted: 2021-04-09
Enrollment: 10890
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This study will be a two arm, cluster-randomized controlled trial to determine whether year round weekly household visits by CHWs to detect and test people of all ages with fever or history of fever with RDTs (and offer diagnosis and referral or treatment of diarrhea and pneumonia for children under 5 years), and offer treatment with an ACT for those who test positive compared to standard passive iCCM by CHWs (which includes malaria case management for all ages in Zambia), is associated with a greater reduction in confirmed malaria cases and parasite prevalence over a 2-year follow-up period.

Randomization will occur at the level of the CHW catchment areas. Thirty-three clusters will be enrolled in each arm for a total of 66 clusters. Primary study outcomes will be evaluated based on household-level cross-sectional surveys conducted at baseline and end-line and confirmed malaria case data collected through the health system throughout the study period.

Primary objectives:

1. Assess whether year-round weekly proactive iCCM compared to passive iCCM with malaria case management for all ages reduces the prevalence of patent (by rapid diagnostic test (RDT)) and subpatent (by PCR) parasitemia detected at the household level in cross sectional household surveys.
2. Determine whether the confirmed malaria case incidence (detected by CHWs (either proactively or passively) and at health facilities) decreases over time in communities with weekly proactive iCCM compared to passive iCCM by comparing the difference in slope of confirmed malaria incidence in proactive vs routine arms using an interrupted time series analysis

Secondary objectives:

1. Assess whether access to care (proportion of the population with fever in the past two weeks who received care from a qualified health provider, including community health worker), promptness of care (within 24 and 48 hours of symptoms), access to diagnostic malaria testing (proportion of the population with fever in the past two weeks who received a diagnostic test for malaria), and treatment with artemisinin-based combination therapy (ACT) if RDT is reported positive, is improved by proactive iCCM compared to passive iCCM
2. Describe the incidence of febrile disease, by arm, as well as the incidence of symptomatic malaria infection (febrile persons with a positive RDT), detected during proactive iCCM visits
3. Compare the incidence of malaria, by arm, detected at health facilities
4. Compare the proportion of malaria cases detected at community vs health facility, by arm
5. Determine if proactive iCCM reduces severe disease (malaria in all ages, diarrhea and pneumonia among \< 5) compared to passive iCCM identified at health facility and community level)
6. Compare level of parasite exposure in intervention and control arms using multiplex bead based assay for long, medium and short duration antibodies
7. Determine programmatic cost per additional case detected and treated at the community level with proactive iCCM
8. Describe the feasibility, challenges, and benefits of proactive iCCM from the perspective of the facility health worker, CHW, and community members
9. Describe the benefits and challenges associated with incorporating diagnosis and treatment of pneumonia and diarrhea for children under 5 years

Eligibility criteria: All residents of all ages in the study area will be eligible to receive the CHW intervention.

All ages with fever

Primary outcomes:
measure: Parasite Prevalence
timeFrame: 24 months
measure: Confirmed malaria case incidence
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chadiza
country: Zambia
facility: Chadiza District Health Office
state: Eastern Provice
Study officials:
References: