Malaria, FalciparumProACTNCT04839900
Proactive Community Case Management for Malaria in Zambia
A study testing Proactive iCCM in people with Malaria, Falciparum and Malaria, run by PATH at 1 site in Zambia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria, Falciparum, Malaria
- What is being tested?
- Proactive iCCM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,890 participants
- Where
- 1 siteZambia
- Study dates
- 15 Apr 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
All residents of all ages in the study area will be eligible to receive the CHW intervention.
All ages with fever
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial of Pro-active Community Case Management for Malaria in Chadiza District, Eastern Province, Zambia
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.
Read the 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:
- 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.
- 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:
- 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
- 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
- Compare the incidence of malaria, by arm, detected at health facilities
- Compare the proportion of malaria cases detected at community vs health facility, by arm
- 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)
- Compare level of parasite exposure in intervention and control arms using multiplex bead based assay for long, medium and short duration antibodies
- Determine programmatic cost per additional case detected and treated at the community level with proactive iCCM
- Describe the feasibility, challenges, and benefits of proactive iCCM from the perspective of the facility health worker, CHW, and community members
- Describe the benefits and challenges associated with incorporating diagnosis and treatment of pneumonia and diarrhea for children under 5 years
- Conditions
- Malaria, Falciparum, Malaria
- Being tested
- Proactive iCCM
- Keywords
- Malaria, integrated community case management, proactive response, Zambia
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive iCCMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite Prevalence
- 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.
Measured: 24 months
Confirmed malaria case incidence
- 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Apr 2021
- Primary completion30 Jun 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 10,890 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Zambia, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839900
- Sponsor's protocol ID
- 1704068
- Acronym
- ProACT
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Future analyses might be required and an approval will be sought and granted by the local governing research ethics, Eres Converge, before such analyses can be performed. Any request for potential future secondary use will need review and approval by an IRB committee with full disclosure of the previous study protocol and Eres Converge committee reviews. Any transfer of samples and data to a collaborator or other agent/institute will be governed by the local rules and regulations, including those set forth by the Zambia National Health Research Authority for Material Transfer Agreements and the Ministry of Health in accordance with the Eres Converge.
Publications
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.
PubMed 40412814
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of Pro-active Community Case Management for Malaria in Chadiza District, Eastern Province, Zambia
- ClinicalTrials.gov ID
- NCT04839900
- Acronym / sponsor ID
- ProACT / 1704068
- Conditions
- Malaria, Falciparum, Malaria
- Keywords
- Malaria, integrated community case management, proactive response, Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,890 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Ministry of Health, Zambia, Centers for Disease Control and Prevention
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- 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
- 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
- Compare the incidence of malaria, by arm, detected at health facilities
- Compare the proportion of malaria cases detected at community vs health facility, by arm
- 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)
- Compare level of parasite exposure in intervention and control arms using multiplex bead based assay for long, medium and short duration antibodies
- Determine programmatic cost per additional case detected and treated at the community level with proactive iCCM
- Describe the feasibility, challenges, and benefits of proactive iCCM from the perspective of the facility health worker, CHW, and community members
- Describe the benefits and challenges associated with incorporating diagnosis and treatment of pneumonia and diarrhea for children under 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proactive iCCM | Active comparator | Other: Proactive iCCMCommunity 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). |
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive iCCMCHWs 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. | Other | Proactive iCCM |
Primary outcome
Parasite Prevalence
Time frame: 24 months
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.
Confirmed malaria case incidence
Time frame: 24 months
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Derived from this study: PubMed 40412814Rutagwera 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.
- Individual participant dataSharing planned: Undecided. Future analyses might be required and an approval will be sought and granted by the local governing research ethics, Eres Converge, before such analyses can be performed. Any request for potential future secondary use will need review and approval by an IRB committee with full disclosure of the previous study protocol and Eres Converge committee reviews. Any transfer of samples and data to a collaborator or other agent/institute will be governed by the local rules and regulations, including those set forth by the Zambia National Health Research Authority for Material Transfer Agreements and the Ministry of Health in accordance with the Eres Converge.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive iCCM in people with Malaria, Falciparum and Malaria, run by PATH at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite Prevalence (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.