MalariaREACTNCT01350752
Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria
A study testing RDTs & Provider Training on Malaria Diagnosis and Treatment, Extended provider training (Cameroon only) and School based malaria education (Nigeria only) in people with Malaria, run by London School of Hygiene and Tropical Medicine at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria
- What is being tested?
- RDTs & Provider Training on Malaria Diagnosis and Treatment, Extended provider training (Cameroon only) and School based malaria education (Nigeria only)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,513 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2011to Jan 2015
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- the patient is pregnant
- the patient is <6 months old
- the patient has signs or symptoms of severe malaria
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Cameroon2 sites
Various health facilities
Bamenda, North-West Region
Various health facilities
Yaoundé, Central Region
About this study
Official title: A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- RDTs & Provider Training on Malaria Diagnosis and Treatment, Extended provider training (Cameroon only), School based malaria education (Nigeria only)
- Keywords
- cost effectiveness, provider knowledge, schools
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDTs & Provider Training on Malaria Diagnosis and TreatmentBehavioural
Also called RDTs supplied: SD Bioline, Training course
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
Extended provider training (Cameroon only)Behavioural
Also called provider training, quality of care
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
School based malaria education (Nigeria only)Behavioural
Also called school based intervention, teachers, peer health educators
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment; Behavioral: Extended provider training (Cameroon only); Behavioral: School based malaria education (Nigeria only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: As patients exit the health facility
Secondary outcomes (1)
Health worker knowledge
Mean score (and standard deviation) in HW knowledge on malaria diagnosis and treatment
Measured: Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Masking
- None (open label)
- Enrolment
- 6,513 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Yaounde, University of Nigeria, Enugu Campus
- Responsible party
- Sponsor
- Investigators
- Virginia Wiseman, Principal investigator, London School of Hygiene and Tropical MedicineWilfred Mbacham, Principal investigator, University of Yaounde IObinna Onwujekwe, Principal investigator, University of Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350752
- Sponsor's protocol ID
- REACT
- Acronym
- REACT
- Status last verified
- Oct 2013
- First submitted
- 9 May 2011
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26309023Mbacham 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.
PubMed 25103303Achonduh 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.
PubMed 24885621Wiseman 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.
PubMed 22682276
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria
- ClinicalTrials.gov ID
- NCT01350752
- Acronym / sponsor ID
- REACT / REACT
- Conditions
- Malaria
- Keywords
- cost effectiveness, provider knowledge, schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,513 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Yaounde, University of Nigeria, Enugu Campus
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 May 2011 (estimated)
- 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: RDTs & Provider Training on Malaria Diagnosis and TreatmentCameroon: 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. |
| Extended intervention | Active comparator | Behavioral: RDTs & Provider Training on Malaria Diagnosis and Treatment, Behavioral: Extended provider training (Cameroon only), Behavioral: School based malaria education (Nigeria only)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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- the patient is pregnant
- the patient is <6 months old
- the patient has signs or symptoms of severe malaria
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 |
|---|---|---|
| RDTs & Provider Training on Malaria Diagnosis and TreatmentAlso: RDTs supplied: SD Bioline, Training courseIn 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 | Behavioural | Extended intervention, Provider Intervention |
| Extended provider training (Cameroon only)Also: provider training, quality of care2-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 | Behavioural | Extended intervention |
| School based malaria education (Nigeria only)Also: school based intervention, teachers, peer health educatorsSchools 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 | Behavioural | Extended intervention |
Primary outcome
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria
Time frame: As patients exit the health facility
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.
1 secondary outcome
Health worker knowledge
Time frame: Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions)
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 9 Sep 2016.
- Derived from this study: PubMed 26309023Onwujekwe 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.
- Derived from this study: PubMed 25103303Mbacham 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.
- Derived from this study: PubMed 24885621Achonduh 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.
- Derived from this study: PubMed 22682276Wiseman 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.
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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.
Virginia Wiseman principal investigator
London School of Hygiene and Tropical Medicine
Wilfred Mbacham principal investigator
University of Yaounde I
Obinna Onwujekwe principal investigator
University of Nigeria
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDTs & Provider Training on Malaria Diagnosis and Treatment, Extended provider training (Cameroon only) and School based malaria education (Nigeria only) in people with Malaria, run by London School of Hygiene and Tropical Medicine at 3 sites in 2 countries.
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 2 inclusion and 3 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cameroon, Nigeria. 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?
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria (time frame: As patients exit the health facility). 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 NCT01350752, which also lists 4 linked publications.
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 9 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.