Answering key questions on malaria drug delivery

Behaviour Change: Supporting interventions for introduction of malaria RDTs

in Cameroon & Nigeria

ACT Consortium LSHTM: Virginia Wiseman, Lindsay Mangham-Jefferies, Bonnie Cundill,

Clare Chandler, Neal Alexander, and Julia Langham

University of Yaoundé: Wilfred Mbacham, Olivia Achonduh, Akindeh Nji, et al.

University of Nigeria: Obinna Onwujekwe, Ogochukwu Ibe, Benjamin Uzochukwu, et al.

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Introduction

The ACT Consortium is a global research partnership

of public health and academic institutions

Goal: to develop and evaluate mechanisms to improve

delivery of artemisinin-based combination therapy (ACT)

Our 25 studies in 10 countries address ACT:

Access

Targeting

Safety

Quality

Research on Economics of ACTs (REACT):

Cameroon & Nigeria

Study objectives:

1) Understand quality of malaria case management in

different types of health facility

2) Design interventions to support the introduction of

malaria rapid diagnostic tests, with the National

Malaria Control Programmes

3) Implement interventions in selected study sites

4) Evaluate their effectiveness and cost-effectiveness

Policy context in Cameroon

• Malaria is endemic in Cameroon – Antimalarials available from range of public and

private providers and medicine retailers

– ACTs became first-line treatment in 2004

• Parasitological testing is available at many public and private facilities, but not medicine retail outlets

• In August 2009, Cameroon government announced intention to introduce RDTs

Formative research on malaria diagnosis & treatment (2009-10)

Goal: Understand malaria case management in Yaoundé and Bamenda

• Availability and use of parasitological testing

• Health workers’ practices when testing and treating febrile patients

• Provider & patient preferences for malaria testing and treatment

5 Answering key questions on malaria drug delivery

• Chandler C et al (2012) ‘As a clinician, you are not managing lab results, you are managing the patient’: how the enactment of malaria at health facilities in Cameroon compares with new WHO guidelines for the use of RDTs. Social Science and Medicine 74(10):1528-35 • Mangham LJ, et al (2011) Malaria Prevalence and Treatment of Febrile Patients Attending Health Facilities in Cameroon. Tropical Medicine and International Health 74(10):1528-35

Quantitative methods (2009): • Patient exit survey • Health worker survey • Facility survey

Qualitative methods (2010): • FGDs with health workers (public and mission) • FGDs with community members

Formative research: provider practices • ACTs widely available

• 81% of public and mission facilities had ACT in stock

• Many providers know ACT is recommended

• 75% of providers at public & mission facilities knew ACT was

recommended treatment

• Microscopy available but under used

• 90% facilities offered microscopy, but only ~ 1/3 of patients were tested

• Malaria is over-diagnosed

• 29% of febrile patients attending facilities had malaria

• 83% of patients who were test-negative were prescribed an antimalarial

• Quinine was also used to treat uncomplicated cases of malaria

“We prescribe them drugs and to boost their psychological

treatment we prescribe the test” [Nurse; mission facility, Yaoundé]

Provider perceptions of malaria testing

• Test results support treatment decisions, but do not substitute for clinical judgement

“Priority is always given to the clinical (symptoms) despite the

results of the thick blood smear” [Doctor, mission facility, Yaoundé]

• Malaria tests provide psychological treatment

“When we do the malaria test and it comes out negative, it does

not prevent the patient having his malaria .... We continue with

the antimalarial treatment” [Nurse, mission facility, Yaoundé]

7 Answering key questions on malaria drug delivery

“Most of the times I will send the patient for a malaria test just for the psychology of the patient, just

to please the patient, ... but if I have to decide, the lab test will not

count” [Doctor, mission hospital, Bamenda]

Provider perceptions of patients’ preferences

“So they come in saying ‘I have malaria’, so they consider all fevers

to be malaria. So if you do not prescribe what treats their malaria, you have not prescribed what treats

their illness” [Nurse, mission facility, Yaounde]

“Patients prefer malaria because ... they already conclude that it is

‘their’ malaria” Nurse, public facility, Bamenda]

• Patients prefer the illness to be malaria

• Role in managing the patient

“When you confirm to them it is malaria, he is happy, but when it is a different illness, he says ‘no I cannot have this, it is not me’”

[Nurse, public facility, Bamenda]

8 Answering key questions on malaria drug delivery

As a clinician you are not managing lab results you are managing the patient ... when the lab results come back you are not going to tell the patient that

you don’t have malaria. You are going to explain to the patient that ‘this test is negative but it doesn’t mean that you don’t have malaria’, so you still

go ahead and treat” [Doctor, public facility, Bamenda]

Policy dialogue & formative research underpinned intervention design

Formative Research: Malaria testing is under-used

Malaria is over-diagnosed

Supporting interventions aimed to change provider behaviour:

1) Increase use of malaria testing

2) Encourage providers to treat based on test results

3) Improve provider-patient communication

Dialogue with Policy Makers: Government plans to introduce

RDTs

9 Answering key questions on malaria drug delivery

Study setting

Public health centres & posts Pharmacies & drug stores

Enugu (urban) Udi (rural)

Public & mission hospitals + health centres Pharmacies & drug stores

Yaoundé (urban, Francophone) Bamenda (urban & rural, Anglophone)

ENUGU STATE, NIGERIA CAMEROON

Basic Training

Basic & Enhanced Interventions

Control Basic Intervention Enhanced Intervention

* No intervention (microscopy was available)

* Supply RDTs * 1-day basic training on malaria testing & treatment * Peer-to-peer training

* Supply RDTs * 1-day basic training on malaria testing & treatment * 2-day enhanced training on quality of care * Peer-to-peer training

Enhanced Training

Case studies & testimonials

6. Effect Communication Picture

Scenarios

Problem solving

Drama & role play

4. Adapting to change

Reflection & Discussion 3. Lecture on

malaria treatment

2. Practical on how to use RDT

1. Lecture on malaria diagnosis

5. Professionalism

Appropriate Tx Card Game

11 Answering key questions on malaria drug delivery

Achonduh O et al. Designing and implementing interventions to change clinicians’ practice in the management of uncomplicated malaria in Cameroon. Malaria Journal (2014)

Composite primary outcome

Correct treatment according to guidelines:

1) Test all febrile patients using microscopy or RDT

2) Positive result = prescribe ACT

3) Negative result = do not prescribe antimalarial

12 Answering key questions on malaria drug delivery

Cluster randomized trial:

RESULTS

13 Answering key questions on malaria drug delivery

1) Impact on treatment according to guidelines

Outcome Study arm # clusters (patients)

Prevalence n (%)

Adjusted RR (95% CI)

P value

Febrile patients tested for malaria

Control 9 (681) 539/681 (79%)

Basic 18 (1632) 1250/1632 (77%)

0.95 (0.76, 1.18)

0.62

Enhanced 19 (1669) 1309/1665 (79%)

0.96 (0.72, 1.28)

0.78

Treatment according to malaria guidelines

Control 9 (681) 246/659 (37%)

Basic 18 (1632) 670/1576 (42%)

1.04 (0.53, 2.07)

0.90

Enhanced 19 (1669) 890/1613 (55%)

1.17 (0.61, 2.25)

0.62

• No evidence of a significant effect on the primary outcome. • Differences were seen within the composite indicator, • and since the formative research in 2009. • Proportion tested for malaria was high across all arms (77-79%).

2) Breakdown of composite indicator Outcome Study arm # clusters Prevalence

n (%) Adjusted RR

(95% CI) P value

Test positive patients receiving ACT

Control 9 208/278 (75%)

Basic 18 287/398 (72%)

1.09 (0.76, 1.56)

0.61

Enhanced 19 363/498 (73%)

0.89 (0.55, 1.44)

0.62

Test negative patients receiving an antimalarial

Control 9 201/239 (84%)

Basic 18 413/796 (52%)

0.63 (0.28, 1.43)

0.25

Enhanced 19 232/759 (31%)

0.29 (0.11, 0.77)

0.02

• Significant reduction in test-negative patients receiving an antimalarial: basic vs control (RR=0.63, 95% CI 0.28-1.43) enhanced vs control (RR=0.29, 95% CI 0.11-0.77).

• Proportion of test-positive patients prescribed/received ACT similar, ~75%.

• Remaining 25% test-positive patients received either antimalarial or antibiotic (quinine, SP).

Mbacham W, Mangham-Jefferies L, Cundill B, Achonduh O, Chandler C., Ambebila J, Nkwescheu A, Forsah-Achu D, Ndiforchu V, Tchekountouo O, Akindeh-Nji M, Ongolo-Zogo P, Wiseman V. (2014) Improved treatment for uncomplicated malaria according to guidelines in Cameroon: a cluster randomised trial of the effectiveness of provider interventions. Lancet Global Health Volume 2, Issue 6, Pages e346 - e358.

Cameroon REACT study: It “worked.” Why?

Interventions → no significant increase in proportion of patients treated according to guidelines,

but enhanced training did substantially + significantly reduce unnecessary use of antimalarials for patients with negative test.

Suggested explanations:

• An enhanced training programme, designed to translate knowledge into prescribing practice and improve quality of care, can significantly reduce the unnecessary use of antimalarial drugs.

• Basic training that focuses only on how to use RDTs and the content of malaria treatment guidelines is not likely to bring about behaviour change needed for national roll-out of RDTs.

Study setting

Public health centres & posts Pharmacies & drug stores

Enugu (urban) Udi (rural)

Public & mission hospitals + health centres Pharmacies & drug stores

Yaoundé (urban, Francophone) Bamenda (urban & rural, Anglophone)

ENUGU STATE, NIGERIA CAMEROON

Nigeria REACT study: Summary

• Stratified cluster-randomized trial comparing 3 scenarios: 1) RDTs with basic instruction

2) RDTs with provider training

3) same, plus school-based community intervention

• Primary outcome: proportion of patients treated according to guidelines (composite indicator = patients tested for malaria and treatment

based on result)

RESULTS:

• No differences in composite indicator (p = 0.36)

• With or without extensive supporting interventions, levels of testing remained very low (34%, 48%, 37%; p = 0.47)

Obinna Onwujekwe, Lindsay Mangham-Jefferies, Bonnie Cundill, Neal Alexander, Julia Langham, Ogochukwu Ibe, Benjamin Uzochukwu, Virginia Wiseman (Aug 2015) Effectiveness of provider and community interventions to improve treatment of uncomplicated malaria in Nigeria: A cluster randomized controlled trial. PLOS, doi: 10.1371/journal.pone.0133832.

Nigeria REACT study: Why didn’t it “work”?

Interventions → no significant increase in proportion of patients treated according to guidelines.

Suggested explanations:

a) Persistently low levels of testing across all arms; but, more patients

tested in public facilities vs private. Price hikes? Affordability?

b) Interventions not different enough; e.g. instruction on how to use RDTs

(control) covered some material from provider training.

c) Interventions evaluated in near-real-world setting, so variation in uptake

expected.

d) Evaluation coincided with major ACT shortages in which public facilities.

e) ? Diluted by other interventions.

Obinna Onwujekwe, Lindsay Mangham-Jefferies, Bonnie Cundill, Neal Alexander, Julia Langham, Ogochukwu Ibe, Benjamin Uzochukwu, Virginia Wiseman (Aug 2015) Effectiveness of provider and community interventions to improve treatment of uncomplicated malaria in Nigeria: A cluster randomized controlled trial. PLOS, doi: 10.1371/journal.pone.0133832.

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Behaviour change in malaria &

fever case management

Thoughtful, “enhanced” RDT training programmes for health

workers and communities, designed with formative

research and consideration of the health care context, can

significantly improve some aspects of case management.

However, multiple factors in the wider context also affect the

actual impact of behaviour change efforts.

To maximise the impact of investment in malaria control, we

must look at not just local factors – must also address

broader systems and political issues.

Acknowledgements

• All patients, caregivers & health workers that participated in the study

• Cameroon National Malaria Control Programme, and local stakeholders

• Funding from Bill & Melinda Gates Foundation to ACT Consortium

• Colleagues from University of Yaoundé & LSHTM

21 Answering key questions on malaria drug delivery

Assessed for eligibility (122 facilities) 50 in Yaoundé, 72 in Bamenda

64 facilities eligible (32 per stratum)

Excluded: 10 specialist facilities 24 too few patients 12 included in pilot roll-out of RDTs 6 too close (for contamination reasons)

Number randomised (47 facilities)

Bamenda (22 facilities) Yaoundé (24 facilities)

1 facility withdrew consent after randomisation

Control 5 facilities

Basic

8 facilities Enhanced

9 facilities

Control 4 facilities

Basic

10 facilities Enhanced

10 facilities

Cluster Randomized Trial

• Real-world evaluation

- Limit Hawthorne effect of research activities on provider behaviour

- Cascade training

- Did not control availability of RDTs & ACTs

23 Answering key questions on malaria drug delivery

Wiseman V et al. (2012). A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: study protocol for a cluster randomized controlled trial. Trials; 13:4.

• Evaluation after 3 months

- Patient exit survey

- Facility record of malaria tests completed

- Provider survey

- Implementation records