Behaviour Change: Supporting interventions for introduction of malaria RDTs in Cameroon & Nigeria

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. Answering key questions on malaria drug delivery

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 2

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 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 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 Answering key questions on malaria drug delivery 5

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

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] 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] Malaria tests provide psychological treatment We prescribe them drugs and to boost their psychological treatment we prescribe the test [Nurse; mission facility, Yaoundé] 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] Answering key questions on malaria drug delivery 7

Provider perceptions of patients preferences Patients prefer the illness to be malaria 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] Role in managing the patient Patients prefer malaria because... they already conclude that it is their malaria Nurse, public facility, Bamenda] 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] 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] Answering key questions on malaria drug delivery 8

Policy dialogue & formative research underpinned intervention design Formative Research: Malaria testing is under-used Malaria is over-diagnosed Dialogue with Policy Makers: Government plans to introduce RDTs 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 Answering key questions on malaria drug delivery 9

Study setting Enugu (urban) Udi (rural) ENUGU STATE, NIGERIA Public health centres & posts Pharmacies & drug stores CAMEROON Yaoundé (urban, Francophone) Bamenda (urban & rural, Anglophone) Public & mission hospitals + health centres Pharmacies & drug stores

Basic & Enhanced Interventions Achonduh O et al. Designing and implementing interventions to change clinicians practice in the management of uncomplicated malaria in Cameroon. Malaria Journal (2014) Basic Training Enhanced Training Appropriate Tx Card Game 1. Lecture on malaria diagnosis 2. Practical on how to use RDT 3. Lecture on malaria treatment 4. Adapting to change 5. Professionalism 6. Effect Communication Case studies & testimonials Drama & role play Problem solving Reflection & Discussion Picture Scenarios 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 Answering key questions on malaria drug delivery 11

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 Answering key questions on malaria drug delivery 12

Cluster randomized trial: RESULTS Answering key questions on malaria drug delivery 13

1) Impact on treatment according to guidelines Outcome Study arm # clusters (patients) Febrile patients tested for malaria Treatment according to malaria guidelines Prevalence n (%) Control 9 (681) 539/681 (79%) Basic 18 (1632) 1250/1632 (77%) Enhanced 19 (1669) 1309/1665 (79%) Control 9 (681) 246/659 (37%) Basic 18 (1632) 670/1576 (42%) Enhanced 19 (1669) 890/1613 (55%) Adjusted RR (95% CI) 0.95 (0.76, 1.18) 0.96 (0.72, 1.28) 1.04 (0.53, 2.07) 1.17 (0.61, 2.25) 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%). P value 0.62 0.78 0.90 0.62

2) Breakdown of composite indicator Outcome Study arm # clusters Prevalence n (%) Test positive patients receiving ACT Test negative patients receiving an antimalarial Control 9 208/278 (75%) Basic 18 287/398 (72%) Enhanced 19 363/498 (73%) Control 9 201/239 (84%) Basic 18 413/796 (52%) Enhanced 19 232/759 (31%) Adjusted RR (95% CI) 1.09 (0.76, 1.56) 0.89 (0.55, 1.44) 0.63 (0.28, 1.43) 0.29 (0.11, 0.77) P value 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). 0.61 0.62 0.25 0.02

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. 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.

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.

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. 20

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 Answering key questions on malaria drug delivery 21

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) 1 facility withdrew consent after randomisation Bamenda (22 facilities) Yaoundé (24 facilities) 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 Evaluation after 3 months - Patient exit survey - Facility record of malaria tests completed - Provider survey - Implementation records 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. Answering key questions on malaria drug delivery 23