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Completed

NCT Number: NCT05223933

Proactive Community Case Management (Pro-CCM) in Rural 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).

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

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Key information

Conditions

Malaria Case Management Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

2 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fokontany Andranomavo, Mananjary, : Fianarantsoa, Vatovavy Fitovinany, Madagascar

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria in community:
  • 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

Exclusion criteria

  • Exclusion criteria in community:
  • 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)

Treatment and study plan

Proactive community case management

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. percent of households visited every two weeks

    Time frame: The event was assessed up to 30 weeks (15 biweekly visits).

    percent of households visited every two weeks out of the number of the households registered in initial census

  2. percent of households gave consent

    Time frame: The event was assessed up to 30 weeks (15 biweekly visits).

    percent of households that were visited every two weeks and gave consent for the screening during each visit

  3. Fever incidence

    Time frame: The event was assessed up to 30 weeks (15 biweekly visits).

    percent of fever cases out of all individuals screened during each visit

  4. Malaria incidence

    Time frame: The event was assessed up to 30 weeks (15 biweekly visits).

    percent of persons with positive RDT and fever cases out of all individuals screened during each visit

  5. fever cases with RDT performed

    Time frame: The event was assessed up to 30 weeks (15 biweekly visits).

    percent of fever cases with RDT performed

  6. RDT-positive persons treated with an ACT

    Time frame: The event was assessed up to 30 weeks (15 biweekly visits).

    percent of RDT-positive persons treated with an ACT during each visit

  7. 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

    Difference in differences (DiD) approach comparing baseline to endline is used to compare the prevalence of anemia in the 2 arms

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Madagascar

Other

Collaborators

  • National Malaria Control Programme, Madagascar
  • Peace Corps
  • United States Agency for International Development (USAID)

Registry information

Official study title

Randomized Cluster Trial to Measure the Effectiveness of Home Care in Hyperendemic Rural Areas in Madagascar

Acronym: Pro-CCM

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Feb 4, 2022
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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