Proactive Community Case Management for Malaria in Zambia

Malaria Clinical Trial

— ProACT  

Official title:

A Cluster Randomized Controlled Trial of Pro-active Community Case Management for Malaria in Chadiza District, Eastern Province, Zambia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839900
• Other study ID #: 1704068
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: PATH
• Contact: Busiku Hamainza, PhD
• Phone: +260977941761
• Email: bossbusk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10890
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

All ages with fever

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Other:
• Proactive iCCM
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.

Locations

Country	Name	City	State
Zambia	Chadiza District Health Office	Chadiza	Eastern Provice

Sponsors (3)

Lead Sponsor	Collaborator
PATH	Centers for Disease Control and Prevention, Ministry of Health, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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