NCT01350752

Brief Summary

The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness implications of interventions designed to improve health worker practice in providing treatment for uncomplicated malaria to febrile patients attending health facilities in Cameroon and Nigeria.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,513

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 9, 2016

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

May 9, 2011

Last Update Submit

September 8, 2016

Conditions

Malaria

Keywords

cost effectivenessprovider knowledgeschools

Outcome Measures

Primary Outcomes (1)

  • Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria

    Recommended treatment is defined as * Febrile patients should be tested for malaria, either using microscopy or using a RDT * Artemisinin-based Combination Therapy (ACT) should be provided if the patient has a positive malaria test result * No antimalarial should be provided if patient has a negative test result.

    As patients exit the health facility

Secondary Outcomes (1)

  • Health worker knowledge

    Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions)

Study Arms (3)

Control

NO INTERVENTION

In Cameroon: Existing practice (with microscopy widely available) In Nigeria: Expected practice (RDTs will be provided with basic instructions)

Provider Intervention

ACTIVE COMPARATOR

Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment. This involved 1-day training on: 1) Malaria Diagnosis; 2) Rapid Diagnostic Testing; 3) Malaria Treatment. These modules explain that all febrile patients should be tested for malaria; procedures for using an RDT; that confirmed cases of uncomplicated malaria should be treated with an ACT; and test-negative patients should not be given an antimalarial. Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment. This involved a 2-day training workshop and support visits. The training covered the following topics: causes and symptoms of malaria; demonstration on how to use an RDT; updated malaria guidelines; and communications skills. The training used a combination of seminars and facilitated small-group work, such as a treatment algorithm game, problem-solving exercises, self-developed participatory drama and role-playing.

Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment

Extended intervention

ACTIVE COMPARATOR

Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment AND enhanced provider training on improving quality of care. Clinicians received 3-days of training: the first day was identical to the basic intervention, while the remainder of the course covered three additional modules targeting improvements in quality of care: 4) Adapting to Change; 5) Professionalism; 6) Communicating Effectively. Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment AND School-based malaria education intervention (with drama, peer-health education and distribution of health education materials). In addition, teachers and Peer Health Educators were offered support to hold malaria events in which parents, guardians, and other community members could participate in the same types of activities.

Behavioral: RDTs & Provider Training on Malaria Diagnosis and TreatmentBehavioral: Extended provider training (Cameroon only)Behavioral: School based malaria education (Nigeria only)

Interventions

RDTs & Provider Training on Malaria Diagnosis and TreatmentBEHAVIORAL

In Cameroon and Nigeria, malaria RDTs will be made available in health facilities and health care providers will receive training and job aids on malaria diagnosis and treatment. The training course covers the following topics: clinical and parasitological diagnosis of malaria, how to use a rapid diagnostic test, algorithm based on malaria test result, recommended treatment for confirmed malaria cases (including dosage and regimen for artemisinin-based combination therapies), advice for treatment of test-negative patients

Also known as: RDTs supplied: SD Bioline, Training course
Extended interventionProvider Intervention
Extended provider training (Cameroon only)BEHAVIORAL

2-day training course which supplements basic provider training on malaria diagnosis and treatment, which focuses on understanding change in malaria treatment guidelines, professionalism, and communication skills

Also known as: provider training, quality of care
Extended intervention
School based malaria education (Nigeria only)BEHAVIORAL

Schools will be invited to undertake activities to raise awareness about malaria RDTs and treatment among children and community members. The intervention includes training teachers on peer health education, malaria awareness activities and providing support to hold a malaria educational event

Also known as: school based intervention, teachers, peer health educators
Extended intervention

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the patient (or their caregiver) reports that the patient is suffering from a fever or has a history of fever in this illness episode
  • the patient is present at the health facility

You may not qualify if:

  • the patient is pregnant
  • the patient is \<6 months old
  • the patient has signs or symptoms of severe malaria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Various health facilities

Yaoundé, Central Region, Cameroon

Location

Various health facilities

Bamenda, North-West Region, Cameroon

Location

Various health facilities

Enugu, Enugu State, Nigeria

Location

Related Publications (4)

  • Onwujekwe O, Mangham-Jefferies L, Cundill B, Alexander N, Langham J, Ibe O, Uzochukwu B, Wiseman V. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial. PLoS One. 2015 Aug 26;10(8):e0133832. doi: 10.1371/journal.pone.0133832. eCollection 2015.

    PMID: 26309023DERIVED

  • Mbacham WF, Mangham-Jefferies L, Cundill B, Achonduh OA, Chandler CI, Ambebila JN, Nkwescheu A, Forsah-Achu D, Ndiforchu V, Tchekountouo O, Akindeh-Nji M, Ongolo-Zogo P, Wiseman V. Basic or enhanced clinician training to improve adherence to malaria treatment guidelines: a cluster-randomised trial in two areas of Cameroon. Lancet Glob Health. 2014 Jun;2(6):e346-58. doi: 10.1016/S2214-109X(14)70201-3. Epub 2014 Apr 25.

    PMID: 25103303DERIVED

  • Achonduh OA, Mbacham WF, Mangham-Jefferies L, Cundill B, Chandler C, Pamen-Ngako J, Lele AK, Ndong IC, Ndive SN, Ambebila JN, Orang-Ojong BB, Metoh TN, Akindeh-Nji M, Wiseman V. Designing and implementing interventions to change clinicians' practice in the management of uncomplicated malaria: lessons from Cameroon. Malar J. 2014 May 29;13:204. doi: 10.1186/1475-2875-13-204.

    PMID: 24885621DERIVED

  • Wiseman V, Ogochukwu E, Emmanuel N, Lindsay J M, Bonnie C, Jane E, Eloka U, Benjamin U, Obinna O. A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria: study protocol for a randomized controlled trial. Trials. 2012 Jun 9;13:81. doi: 10.1186/1745-6215-13-81.

    PMID: 22682276DERIVED

MeSH Terms

Conditions

Malaria

Interventions

TherapeuticsQuality of Health CareLongitudinal Studies

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Health Services AdministrationHealth Care Quality, Access, and EvaluationCohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Virginia Wiseman

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Wilfred Mbacham

    University of Yaounde I

    PRINCIPAL INVESTIGATOR

  • Obinna Onwujekwe

    University of Nigeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2012

Study Completion

January 1, 2015

Last Updated

September 9, 2016

Record last verified: 2013-10

Locations

CA(2)NG(1)