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

NCT05223933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2022-02-04

No results posted yet for this study

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. 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

Conditions

Interventions

BEHAVIORAL

Proactive community case management

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.

Sponsors & Collaborators

  • Peace Corps

    collaborator OTHER

  • National Malaria Control Programme, Madagascar

    collaborator OTHER_GOV

  • United States Agency for International Development (USAID)

    collaborator FED

  • Institut Pasteur de Madagascar

    lead OTHER

Principal Investigators

  • Rila Ratovoson, MD · Institut Pasteur de Madagascar

  • Milijaona Randrianarivelojosia, PhD · Institut Pasteur de Madagascar

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2016-12-12
Completion
2018-12-29

Countries

  • Madagascar

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223933 on ClinicalTrials.gov