Clinical trial NCT01350752: Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria
Official title: A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: cost effectiveness
provider knowledge
schools
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University of Yaounde
name: University of Nigeria, Enugu Campus
First posted: 2011-05-10
Enrollment: 6513
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: NIGERIA

Two interventions will be evaluated: (i) provider intervention including introducing RDTs with detailed instructions, one-off training, job aides and on-the-site supportive supervisory visits and (ii) combined provider intervention \[as under (i)\]and community-based intervention (using primary and secondary schools as focal points)including school malaria events with drama, peer-health education, distribution of health education materials. Types of facilities include: public primary health facilities, private pharmacies and private Patent Medicine Dealers (PMDs)in Enugu State. The two sites in Enugu State are: Enugu urban (comprising of Enugu East, Enugu South and Enugu North Local government areas (LGA) and Udi LGA. The impact of the interventions will be evaluated using a 3-arm stratified, cluster randomized trial with a cluster defined as a geographical community and the two study sites as the strata. The three arms of the trial are:

* Intervention - Provider intervention
* Intervention - Provider plus school-based malaria activities
* Control - Expected practice (once RDTs have been introduced)

CAMEROON

Two interventions will be evaluated: (i) the introduction of rapid diagnostic tests (RDTs) with basic provider training on malaria diagnosis and treatment; and (ii) the basic provider training \[as under (i)\] plus enhanced provider training to improve the quality of care that includes aspects of interactive self awareness, communication modules between health workers and also between health workers and patients. Types of facilities include: public district hospitals, public health centres (including integrated health centres), mission hospitals and mission health centres (including integrated health centres)in Yaoundé and Bamenda Health Districts. A stratified, cluster randomized trial will be used in which health facilities are the cluster and the two study sites are the strata. The three arms of the trial are:

* Intervention - RDTs with basic provider training;
* Intervention - RDTs with basic plus enhanced provider training;
* Control - which represents current practice and neither intervention will be implemented.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria
timeFrame: As patients exit the health facility
Secondary outcomes:
measure: Health worker knowledge
timeFrame: Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions)
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Various health facilities
state: Central Region
city: Bamenda
country: Cameroon
facility: Various health facilities
state: North West Region
city: Enugu
country: Nigeria
facility: Various health facilities
state: Enugu State
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Virginia Wiseman
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Yaounde I
name: Wilfred Mbacham
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nigeria
name: Obinna Onwujekwe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.