MalariaPro-CCMNCT05223933
Proactive Community Case Management (Pro-CCM) in Rural Madagascar
A study testing Proactive community case management in people with Malaria and Case Management, run by Institut Pasteur de Madagascar at 22 sites in Madagascar.
Trial summary
The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Malaria, Case Management
- What is being tested?
- Proactive community case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 22 sitesMadagascar
- Study dates
- 12 Dec 2016to 29 Dec 2018
- 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 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fokontany in rural communes of Mananjary district (fokontany level of safety, accessibility by the study teams, and phone network availability was assessed).
- Agreement of the chief of Fokontany for the participation of his fokontany in the study
- Fokontany with at least 1,000 inhabitants
- Individual inclusion criteria:
- Resident in the relevant areas during the study period and consenting to participate
Who cannot join
- Fokontany with a total population of less than 1000 inhabitants
- Fokontany in an urban commune
- Fokontany in an area whose access is risky and perilous
- Individual exclusion criteria:
- None (Non-resident present at the time of passage were tested in the study if they have suggestive signs of malaria but they were considered as visitors)
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Madagascar22 sites
Fokontany Andranomavo
Mananjary, : Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambakoana
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambalamanasa
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambalaromba
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambinany Namorona
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Amboditandroho
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambohimiarina II
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambohinihaonana
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ambolotara
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Andranomiteka
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Anilavinany
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Ankazotokana
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Anosimparihy
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Kianjavato
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Mahavoky Sud
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Manotro
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Maroamboka
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Sahafotahina
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Sandravakoka
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Tanambao Sud
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Tanambaobe
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
Fokontany Tsarahafatra
Mananjary, Fianarantsoa, Vatovavy Fitovinany, 317
About this study
Official title: Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar
The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial:
- one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria.
- a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria).
Read more
Before the start of monitoring, an initial survey (Baseline) was carried out in the "fokontany" (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms.
As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods
Read the detailed description
This study aims to compare the prevalence of malaria in the rural community of Mananjary after the Malaria Home Care Program (PECADOM Plus).
The study will take place in fokontany rural communes of the district of Mananjary.
This district was chosen for the following reasons:
- High prevalence of malaria in this area (31% in subjects with fever and attending medical consultation in the CSB included in the sentinel IPM fever site)
- presence of Peace Corps Volunteers (PCV) in this district. Mananjary District is situated in southeastern Madagascar, located in the central part of the Vatovavy Fitovinany Region, in the province of Fianarantsoa. It is located at 21°13'52" South and 48°20'31" East. The district is composed of one urban commune and 28 rural communes. After obtaining the agreement of the ethics committee for the realization of the study, the coordinator or the assistant coordinator of the project will make courtesy visits to all administrative and health officials in the Vatovavy Fitovinany and Mananjary District (Regional Directorate, District Chief ...).A random draw of fokontany meeting the inclusion criteria will be carried out later, to identify the distribution of fokontany in the intervention arm and control arm in the project. In addition to the 22 fokontany required, a draw of 8 reserve fokontany will be made (4 for each arm).
A courtesy visit will be conducted in the fokontany raffled. The coordinator will check the number of inhabitants in these fokontany with the information gathered at the time of the preparation of the protocol (projection of the population according to the data of INSTAT, information from the Medical Inspector of Mananjary). If the fokontany will not be eligible, the reserve fokontany will replace them in the study.
- Conditions
- Malaria, Case Management
- Being tested
- Proactive community case management
- Keywords
- Malaria, Rural area, Community health workers
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive community case managementBehavioural
CHWs in the intervention arm conducted door-to-door fever screening for all inhabitants of all consenting households in their catchment area every fortnight. All individuals with temperature ≥ 37.5°C or history of self-reported fever in the previous two weeks were tested with an RDT; positive individuals who were not pregnant and did not have signs of severe disease were treated with artesunate-amodiaquine according to treatment guidelines. Individuals identified as requiring a referral during Pro-CCM visits were assisted with transfer to the healthcare center, with transportation handled by the project staff.
| Study group | Role | What they receive |
|---|---|---|
| Intervention fokontany | Experimental | Not described Receives: Behavioral: Proactive community case management |
| Control fokontany | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
Measured: an average of 1 year
Secondary outcomes (7)
percent of households visited every two weeks
percent of households visited every two weeks out of the number of the households registered in initial census
Measured: The event was assessed up to 30 weeks (15 biweekly visits).
percent of households gave consent
percent of households that were visited every two weeks and gave consent for the screening during each visit
Measured: The event was assessed up to 30 weeks (15 biweekly visits).
Fever incidence
percent of fever cases out of all individuals screened during each visit
Measured: The event was assessed up to 30 weeks (15 biweekly visits).
Malaria incidence
percent of persons with positive RDT and fever cases out of all individuals screened during each visit
Measured: The event was assessed up to 30 weeks (15 biweekly visits).
fever cases with RDT performed
percent of fever cases with RDT performed
Measured: The event was assessed up to 30 weeks (15 biweekly visits).
RDT-positive persons treated with an ACT
percent of RDT-positive persons treated with an ACT during each visit
Measured: The event was assessed up to 30 weeks (15 biweekly visits).
The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of anemia in the 2 arms
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start12 Dec 2016
- Primary completion12 Dec 2016
- Study completion29 Dec 2018
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 MalariaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a two-arm cluster randomized community intervention trial, with 11 fokontany in the intervention arm implementing malaria pro-CCM and 11 in the control arm. In both arms, CHWs provided passive integrative community case management (iCCM) among children under five per usual standard of care, including diagnosis with RDT for febrile illness, treatment with artesunate-amodiaquine according to RDT results, along with diagnosis and management of acute respiratory infections and diarrhea, and referral to a higher level of care if indicated. Oral rehydration salts, antibiotics were distributed to CHWs in the intervention arm to reinforce the iCCM activities already implemented.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Madagascar
- Sponsor type
- University, hospital or other
- Collaborators
- Peace Corps, National Malaria Control Programme, Madagascar, United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Rila Ratovoson, Institut Pasteur de Madagascar
- Investigators
- Rila Ratovoson, MD, Principal investigator, Institut Pasteur de MadagascarMilijaona Randrianarivelojosia, PhD, Study director, Institut Pasteur de Madagascar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223933
- Sponsor's protocol ID
- 2017-01
- Acronym
- Pro-CCM
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Ratovoson R, Garchitorena A, Kassie D, Ravelonarivo JA, Andrianaranjaka V, Razanatsiorimalala S, Razafimandimby A, Rakotomanana F, Ohlstein L, Mangahasimbola R, Randrianirisoa SAN, Razafindrakoto J, Dentinger CM, Williamson J, Kapesa L, Piola P, Randrianarivelojosia M, Thwing J, Steinhardt LC, Baril L. Proactive community case management decreased malaria prevalence in rural Madagascar: results from a cluster randomized trial. BMC Med. 2022 Oct 4;20(1):322. doi: 10.1186/s12916-022-02530-x.
PubMed 36192774
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar
- ClinicalTrials.gov ID
- NCT05223933
- Acronym / sponsor ID
- Pro-CCM / 2017-01
- Conditions
- Malaria, Case Management
- Keywords
- Malaria, Rural area, Community health workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Institut Pasteur de MadagascarUniversity, hospital or other
- Collaborators
- Peace Corps, National Malaria Control Programme, Madagascar, United States Agency for International Development (USAID)
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 4 Feb 2022 (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.
The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial:
- one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria.
- a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria).
Before the start of monitoring, an initial survey (Baseline) was carried out in the "fokontany" (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms.
As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods
Detailed description
This study aims to compare the prevalence of malaria in the rural community of Mananjary after the Malaria Home Care Program (PECADOM Plus).
The study will take place in fokontany rural communes of the district of Mananjary.
This district was chosen for the following reasons:
- High prevalence of malaria in this area (31% in subjects with fever and attending medical consultation in the CSB included in the sentinel IPM fever site)
- presence of Peace Corps Volunteers (PCV) in this district. Mananjary District is situated in southeastern Madagascar, located in the central part of the Vatovavy Fitovinany Region, in the province of Fianarantsoa. It is located at 21°13'52" South and 48°20'31" East. The district is composed of one urban commune and 28 rural communes. After obtaining the agreement of the ethics committee for the realization of the study, the coordinator or the assistant coordinator of the project will make courtesy visits to all administrative and health officials in the Vatovavy Fitovinany and Mananjary District (Regional Directorate, District Chief ...).A random draw of fokontany meeting the inclusion criteria will be carried out later, to identify the distribution of fokontany in the intervention arm and control arm in the project. In addition to the 22 fokontany required, a draw of 8 reserve fokontany will be made (4 for each arm).
A courtesy visit will be conducted in the fokontany raffled. The coordinator will check the number of inhabitants in these fokontany with the information gathered at the time of the preparation of the protocol (projection of the population according to the data of INSTAT, information from the Medical Inspector of Mananjary). If the fokontany will not be eligible, the reserve fokontany will replace them in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was a two-arm cluster randomized community intervention trial, with 11 fokontany in the intervention arm implementing malaria pro-CCM and 11 in the control arm. In both arms, CHWs provided passive integrative community case management (iCCM) among children under five per usual standard of care, including diagnosis with RDT for febrile illness, treatment with artesunate-amodiaquine according to RDT results, along with diagnosis and management of acute respiratory infections and diarrhea, and referral to a higher level of care if indicated. Oral rehydration salts, antibiotics were distributed to CHWs in the intervention arm to reinforce the iCCM activities already implemented.
| Arm | Type | Receives |
|---|---|---|
| Intervention fokontany | Experimental | Behavioral: Proactive community case management |
| Control fokontany | No intervention | – |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individual inclusion criteria:
Key exclusion criteria (5 listed)
- Individual exclusion criteria:
- None (Non-resident present at the time of passage were tested in the study if they have suggestive signs of malaria but they were considered as visitors)
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 community case managementCHWs in the intervention arm conducted door-to-door fever screening for all inhabitants of all consenting households in their catchment area every fortnight. All individuals with temperature ≥ 37.5°C or history of self-reported fever in the previous two weeks were tested with an RDT; positive individuals who were not pregnant and did not have signs of severe disease were treated with artesunate-amodiaquine according to treatment guidelines. Individuals identified as requiring a referral during Pro-CCM visits were assisted with transfer to the healthcare center, with transportation handled by the project staff. | Behavioural | Intervention fokontany |
Primary outcome
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany.
Time frame: an average of 1 year
Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of malaria RDT positivity in the 2 arms
7 secondary outcomes
percent of households visited every two weeks
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
percent of households gave consent
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
Fever incidence
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
Malaria incidence
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
fever cases with RDT performed
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
RDT-positive persons treated with an ACT
Time frame: The event was assessed up to 30 weeks (15 biweekly visits).
The change in the prevalence of anemia in women aged between 15 and 49 years old in the intervention versus control fokontany
Time frame: an average of 1 year
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 4 Feb 2022.
- Derived from this study: PubMed 36192774Ratovoson R, Garchitorena A, Kassie D, Ravelonarivo JA, Andrianaranjaka V, Razanatsiorimalala S, Razafimandimby A, Rakotomanana F, Ohlstein L, Mangahasimbola R, Randrianirisoa SAN, Razafindrakoto J, Dentinger CM, Williamson J, Kapesa L, Piola P, Randrianarivelojosia M, Thwing J, Steinhardt LC, Baril L. Proactive community case management decreased malaria prevalence in rural Madagascar: results from a cluster randomized trial. BMC Med. 2022 Oct 4;20(1):322. doi: 10.1186/s12916-022-02530-x.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Rila Ratovoson, MD principal investigator
Institut Pasteur de Madagascar
Milijaona Randrianarivelojosia, PhD study director
Institut Pasteur de Madagascar
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive community case management in people with Malaria and Case Management, run by Institut Pasteur de Madagascar at 22 sites in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Madagascar. 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?
The primary endpoint of the study was the change in the prevalence of malaria RDT positivity in the intervention versus control fokontany. (time frame: an average of 1 year). 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 NCT05223933, 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 4 Feb 2022.