Improving treatment of childhood diarrhea in sub‐Saharan Africa in the age of malaria control Peter Winch pwinch@jhsph.edu Department of International Health Social and Behavioral Interventions Program What I do Topics: – Maternal and child health • Newborn care in the home • Malaria, diarrhea, pneumonia treatment at the community level – Water and sanitation Countries where I work currently – Mali, Tanzania, Bangladesh, Nepal Influences and methods Influences – Medical anthropology – Linguistics – Epidemiology Methods – Formative research: Qualitative and quantitative research to design intervention content – Process evaluation/process learning – Outcome evaluation Overview Under-five mortality in sub-Saharan Africa Explanations for high under-five mortality Global health practice and under-five mortality Example: Evaluation of introduction of zinc for diarrhea in Tanzania Under-five mortality in sub-Saharan Africa Total numbers of deaths in children under-5 years of age (millions) 1970 Sub-Saharan Africa 3.1 Middle East and North Africa 1.3 South Asia 5.4 East Asia and Pacific 5.0 Latin America and Caribbean 1.2 Entire World 16.7 SSA proportion 19% Source: UNICEF State of the World’s Children Report 2009 Total numbers of deaths in children under-5 years of age (millions) 1970 Sub-Saharan Africa 3.1 Middle East and North Africa 1.3 South Asia 5.4 East Asia and Pacific 5.0 Latin America and Caribbean 1.2 Entire World 16.7 SSA proportion 19% Source: UNICEF State of the World’s Children Report 2009 1990 4.3 0.6 4.2 1.6 0.5 11.4 38% Total numbers of deaths in children under-5 years of age (millions) 1970 Sub-Saharan Africa 3.1 Middle East and North Africa 1.3 South Asia 5.4 East Asia and Pacific 5.0 Latin America and Caribbean 1.2 Entire World 16.7 SSA proportion 19% Source: UNICEF State of the World’s Children Report 2009 1990 4.3 0.6 4.2 1.6 0.5 11.4 38% 2008 4.4 0.4 2.8 0.8 0.2 8.8 50% Direct causes of <5 mortality sub-Saharan Africa Cause Pneumonia Diarrhoea Malaria Measles HIV/AIDS Neonatal causes Injuries % of deaths Causes of <5 mortality in Africa Cause % of deaths Pneumonia 21% Diarrhoea 16% Malaria 18% Measles 5% HIV/AIDS 6% Neonatal causes 26% Injuries 2% Malnutrition is important contributing factor in a large proportion of these deaths Source: J Bryce et al. Lancet 2005; 365: 1147-52 Under-five mortality rates per 1000 live births 1970 Sub-Saharan Africa 236 Middle East and North Africa 193 South Asia 197 East Asia and Pacific 120 Latin America and Caribbean 122 Entire World 142 SSA:World Ratio 1.7 Source: UNICEF State of the World’s Children Report 2009 1990 184 77 124 54 52 90 2.0 2008 144 43 76 28 23 65 2.2 Under-five mortality in subSaharan Africa: Observations Very high 50% of under-five mortality now occurs in sub-Saharan Africa Rates have been decreasing, but more slowly than in other world regions Countries with top <5 mortality rates in the world (2008) Country Under-five mortality Afghanistan Angola Chad Somalia Democratic Republic of the Congo Guinea-Bissau Mali Sierra Leone Nigeria Central African Republic Source: UNICEF State of the World’s Children Report 2009 257 220 209 200 199 195 194 194 186 173 Top <5 mortality rates in Africa Country Under-five mortality Angola Chad Somalia Democratic Republic of the Congo Guinea-Bissau Mali Sierra Leone Nigeria Central African Republic Burkina Faso Source: UNICEF State of the World’s Children Report 2009 220 209 200 199 195 194 194 186 173 169 Why do some countries have higher under-five mortality? Possible explanations HIV/AIDS Malaria Status and health of women Development traps I will take the 10 countries with highest under-five mortality rates as examples <5 mortality rates and estimated adult HIV prevalance Country Angola Chad Somalia DR Congo Guinea-Bissau Mali Sierra Leone Nigeria Central African Republic Burkina Faso <5 mortality rate 220 209 200 199 195 194 194 186 173 169 Source: UNICEF State of the World’s Children Report 2009 Adult HIV prev 2.1% 3.5% 0.5% -1.8% 1.5% 1.7% 3.1% 6.3% 1.6% HIV/AIDS as explanation for high under-five mortality rates HIV/AIDS definitely contributes to underfive mortality Not a good explanation for national-level variations Countries with highest HIV prevalence e.g. South Africa, Namibia, Swaziland, Botswana have relatively low under-five mortality Higher underfive mortality rates Higher HIV prevalence rates Malaria as an explanation Important cause of under-five mortality Widespread At best a partial explanation for nationallevel variation in under-five mortality Possible explanations HIV/AIDS Malaria Status and health of women Development traps Status and health of women Country Angola Chad Somalia DR Congo Guinea-Bissau Mali Sierra Leone Nigeria CAR Burkina Faso <5 Mortality Rate 220 209 200 199 195 194 194 186 173 169 Total Fertility Rate 5.8 6.2 6.4 6.0 5.7 5.5 5.2 5.3 4.8 5.9 Contraceptive prevalence rate 6% 3% 15% 21% 10% 8% 8% 15% 19% 17% Source: UNICEF State of the World’s Children Report 2009 Lifetime risk of Maternal Mortality 1 in 12 1 in 11 1 in 12 1 in 13 1 in 13 1 in 15 1 in 8 1 in 18 1 in 25 1 in 22 Status and health of women Countries with highest under-five mortality also have – High maternal mortality – High fertility rates – Lower rates of female literacy – Score poorly on other measures of women’s status Development traps Paul Collier describes a number of development traps in his recent book “The Bottom Billion”, e.g. – Being landlocked – Conflict and poor post-conflict transition – Resource curse: Overwhelming dependence on one single natural resource Development traps Country Angola Chad Somalia DR Congo Guinea-Bissau Mali Sierra Leone Nigeria CAR Burkina Faso <5 Mortality Rate 220 209 200 199 195 194 194 186 173 169 Landlocked N Y N N (Y) N Y N N Y Y Conflict or postconflict Y Y Y Y Y N (Y) Y N (Y) Y N Source: UNICEF State of the World’s Children Report 2009 Resource curse Y Y N N (Y) N N Y Y Y N Recap: Explanations Wide range of explanations, acting at different levels and through different mechanisms Ideally Global Health practice should take stock of these explanations, and address them in strategies to improve health in Africa What is Global Health, and what is it doing about under-five mortality in Africa? Some key tenets (Fried et al. Lancet 2010) Global health is public health. Dedication to better health for all, with particular attention to the needs of the most vulnerable populations, and a basic commitment to health as a human right. Belief in a global perspective on scientific inquiry and on the translation of knowledge into practice Why under-five mortality in Africa is a Global Health priority Concern for equity and justice – Half of the world’s under-five mortality occurs in sub-Saharan Africa – Preventive measures relatively inexpensive Global Health response to under-five mortality in Africa Disease-specific control programs – HIV/AIDS – Malaria Maternal and child health programs Research Training Product development – Vaccines, drugs, mosquito nets etc. Diarrhea in Sub-Saharan Africa Diarrhea in Sub-Saharan Africa About 700,000 of the 4.4 M deaths in under-five children each year Highest mortality between 6 and 24 months of age – Period of weaning – Child starting to eat solid food, crawl and walk – This increases exposure to diarrheal pathogens in the environment Diarrhea: What can we do? Prevention – Vaccines e.g. Rotavirus vaccine – Water and sanitation, handwashing Management of sick children – Oral rehydration therapy – 10-14 day treatment with zinc – Continued breastfeeding, feeding, fluids 1. Prevent dehydration thru increased appropriate home fluids & ORS 2. Continued feeding during & increased feeding after episode 3. Recognize signs of dehydration for early care-seeking-”new ORS” &/or other medical treatment 4. Give children zinc supplements for 10-14 days Zinc treatment for diarrhea Shown to: – Reduce under-five mortality – Reduce duration and severity of diarrhea – Prevent new cases of diarrhea in the months following the treatment Dispersible Zinc Tablets + Easily dissolves in a few drops of water or breast milk + Sweet, acceptable to young children + Blister-pack + 3 year shelf life + Not bulky or heavy so transport and storage costs are less + No ‘breakage” (unlike bottled syrup) Evaluation of introduction of zinc for diarrhea in Tanzania Categorical (Disease-specific) control programs in Tanzania Presidential Malaria Initiative (PMI) President’s Emergency Program For AIDS Relief (PEPFAR) Global Fund for AIDS, Tuberculosis and Malaria Trachoma eradication Filariasis eradication Coming soon: Obama administration’s initiative on maternal and child health Management of children with diarrhea in Tanzania What is happening Diarrhea not seen as a serious condition Antibiotics routinely given for simple diarrhea Children with fever and diarrhea treated for malaria only What we want Increased careseeking for diarrhea Children treated with zinc and ORS rather than antibiotics Children with fever and diarrhea treated with antimalarial, zinc and ORS Zinc introduction in Tanzania: Private sector Production of zinc tablets and ORS by local manufacturer (Shelys) Upgrading of shops and training of shopowners so their shops become Accredited Drug Distribution Outlets (ADDO) Introduction of zinc and ORS into ADDOs Detailing by drug company representatives – Visit health facilities and ADDOs – Talks on zinc and ORS Private sector: What we don’t want The alternative: ADDO shops Accredited Drug Dispensing Outlets Zinc introduction in Tanzania: Public sector Official public sector launching ceremony Procurement and distribution of zinc and ORS to health facilities Refresher training of health workers in Integrated Management of Childhood Illnesses (IMCI) – Assess all problems of sick child – Provide treatments for all problems – Counseling and follow-up Key elements in IMCI counseling Greet the parent State the diagnosis State the treatments, explain what each one is for Explain how to give the treatments Ask parent if she/he understood Zinc introduction in Tanzania Next slide: Intervention Impact Model – First step in planning an evaluation – Summarizes how all the pieces of the intervention are supposed to fit together to achieve an impact Advocacy and policy dialogue for introduction of zinc and low-osmolarity ORS Availability of essential drugs •Zinc •ORS •Antimalarials •Antibiotics Training & orientation •District health officials •Personnel in health facilities •ADDO shops Provision of quality care •Health facilities •ADDO shops, pharmacies Behavior change communication •Public sector launch •Mass media communication •Counselling of parents Household behaviors •Prompt careseeking for children with diarrhoea, fever, respiratory symptoms •Administration of 10 days of zinc to children with diarrhoea •Preparation and administration of ORS to children with diarrhoea •Administration of 3 days of ACT (ALu) to children with both diarrhoea and fever •Avoid antibiotics for uncomplicated diarrhoea Decreased diarrhoea-related morbidity and mortality Combination therapy for malaria Artemether – Rapid-acting with short half-life Lumefantrine – Longer-acting with long half-life The combination is called ALu in Tanzania, Coartem elsewhere Objectives (summary) 1. Assess adequacy and consequences of training by district health teams and short orientation on diarrhoea case management by drug company representatives 2. Examine quality of care for children presenting with diarrhoea, diarrhoea and fever and diarrhoea and acute respiratory infections in health facilities where zinc and low-osmolarity ORS introduced 3. Evaluate administration in the home of treatments to sick children with diarrhoea alone or with other symptoms such as fever 4. Assess reactions of health workers and parents to introduction of zinc and low osmolarity ORS Study sites Morogoro Rural District, Morogoro Region Same District, Kilimanjaro Region Methods 1. Observation in first-level health facilities 2. Observation of prescription practices for children under age 5 in first-level facilities 3. Follow-up interviews with caregivers of children under age 5 with diarrhoea previously seen at firstlevel facility 4. Qualitative interviews with caregivers of children under age 5 with diarrhoea previously seen at firstlevel facility 5. Qualitative interviews with health workers in firstlevel health facilities 6. Interviews with representatives of pharmaceutical companies that conduct training sessions on zinc sulphate Sample size 9 56 98 32 21 2 Data collection in health facilities During the study period, all (1-3 per facility) health workers with responsibility for seeing sick children as outpatients were observed in clinical consultation with sick children presenting with diarrhea with or without fever. One interviewer was stationed with the health workers dispensing medications and a second interviewer identified children with diarrhea whose care is to be observed Drug availability Zinc sulphate was widely prescribed All 9 government health facilities and private shops had both zinc and ORS in stock ALu was in stock in 7 out of 9 government health facilities and all ADDO shops visited Private sector orientation sessions and detailing In Morogoro Rural District many ADDO shop owners recalled receiving a training or briefing from a Shelys representative In Same District representatives only visited the drug shops to drop off supplies of pamphlets describing how to use the medication, but didn’t talk to anyone Drug reps talked about ORS and zinc, then went on to talk about antibiotics and other drugs we don’t want to promote Zinc and ORS prescription for children with diarrhea District Sample size Zinc tablets (20mg) ORS sachets Zinc AND ORS together Morogoro District 22 20 (90.1%) Same District 25 25 (100.0%) 9 (40.9%) 8 (36.4%) 12 (48.0%) 13 (52.0%) Zinc and ORS prescription for children with diarrhea Only 3 out of 47 cases of diarrhoea had diarrhoea alone. Prescription of zinc tablets was nearly universal: 45 out of 47 children Prescription of ORS was not universal for children presenting with diarrhoea Children presenting with both diarrhoea and fever, or both diarrhoea and vomiting, were much more likely to be prescribed ORS Prescription of ORS is NOT associated with a diagnosis of dehydration made by the health worker. Only 5 of the 12 children diagnosed with dehydration received ORS Antimicrobial prescription for children with diarrhea District Morogoro District Sample size 22 Cotrimoxazole 8 (36.4%) Tetracycline 0 (0.0%) Erythromycin 4 (18.2%) Amoxicillin 0 (0.0%) Metronidazole 1 (4.5%) Any antimicrobial 13 (59.1%) Same District 25 13 (52.0%) 1 (4.0%) 3 (12.0%) 1 (4.0%) 2 (8.0%) 16 (64.0%) Antimalarial prescription for children with diarrhea + fever District Sample size Zinc ArtemetherLumefantrine (ALu) Quinine Any antimalarial Any zinc AND any antimalarial Morogoro District Same District 1 (6.7%) 6 (40%) 4 (26.7%) 2 (12.5%) 2 (12.5%) 2 (12.5%) 15 13 (86.7%) 6 (40.0%) 16 16 (100.0%) 1 (6.3%) Antimalarial prescription for children with diarrhea + fever ALu was the antimalarial most frequently prescribed For children presenting with diarrhea and fever, treatments for diarrhea were prescribed much more than treatments for malaria Of the 22 cases of malaria diagnosed by the health worker among 31 children presenting with diarrhoea and fever, only 5 (22.7%) were prescribed an antimalarial Testing for malaria was not performed as part of this study, so we cannot determine how many of the cases receiving a diagnosis of malaria were parasitemic. Counseling of parents by health workers Overall counselling quality was assessed through an 18-point additive scale for each of the three treatments: zinc, ORS and ALu. Counselling quality was highest for ALu (Mean of 11.6 points out of 18), followed by zinc (mean of 10.8 points) and ORS (mean of 7.8 points). Items in counseling index Does the dispenser … Does the caretaker … 1 say which disease/problem the drug is 9 give first dose to child in front of for? dispenser? 2 say anything at all about the dose of theDoes the dispenser … drug? 10. make any attempt to see if the 3 say how many times to take the drug caretaker understands the instructions? each day? 11. ask if the caretaker knows how many 4 say how many days to take the drug? days to give drug? 5 explain that all the oral tablets must be 12. ask if the caretaker knows how many finished to complete the course of times a day to give drug? treatment even if the child appears to 13. ask if the caretaker knows how many get better? tablets to give each time? 6 give the first dose of the tablet to the 14. look at caretaker when talking to child? her/him? 7 show a tablet and say how many tablets 15. nod when caretaker says something? to take each time? 16. use harsh language or get irritated? 8 ask caretaker to show how much tablet 17. ask caretaker if the explanation is clear? to give? 18. ask caretaker if she/he has any questions? Counseling of parents of children with diarrhea by health workers Prescribing practice Zinc tablets ORS Freq (%) Freq (%) Number of times this treatment was 47 27 prescribed Health worker states that 40 (85.1%) 19 (70.4%) prescription must be completed Health worker describes what 25 (53.2%) 4 (14.8%) problem the prescribed drug is for Health worker makes an effort to 46 (97.0%) 5 (18.5%) determine if caretaker understands Mean score on 18-point scale of 10.8 +/- 3.6 7.8 +/- 4.2 counselling quality +/- SD ALu Freq (%) 20 19 (95.0%) 13 (61.9%) 20 (100%) 11.6 +/- 3.7 Administration of zinc in the home N = 68 caregivers of children prescribed zinc sulphate Administration of ALu in the home N = 44 caregivers of children prescribed ALu Observations/conclusions Strengths and weaknesses of private sector involvement Strengths Increases access to products in remote areas More variety of products available Greater reach of orientation sessions Weaknesses Different forms of products cause confusion Drug reps having competing priorities: Promote sales and collaborate with public health objectives Some drug reps don’t discuss, just drop off materials Malaria and diarrhea: Coordination problems Malaria programs don’t include diarrhea in their training Many public service announcements about malaria treatment, nothing about diarrhea – Better drug administration for ALu than zinc Zinc introduction was more recent, so now providers treating fever + diarrhea with zinc only, previously they treated with the antimalarial drug only Difficulties with promoting management of multiple symptoms Communities need to be made aware of the need for zinc, ORS and ALu in combination for children presenting with fever and diarrhoea, where appropriate depending on local rates of malaria prevalence and policies on malaria rapid testing. Such messages may vary by region, and should be coordinated with plans for introduction of rapid testing for malaria. Investigators and funding Investigators – Ifakara Health Institute: Selemani S Mbuyita, Ahmed M Makemba, Idda Kinyonge – Johns Hopkins Bloomberg School of Public Health: Ashley I. Bennett, Peter J. Winch, Rolf D. Klemm Funding – Tanzania Mission of the U.S. Agency for International Development, under the terms of Award No. GHS-A-00-03-00019-00 (Global Research Activity Cooperative Agreement). Acknowledgements Dr. Neema Rusibamayila of the Ministry of Health and Social Welfare; Dr. Nemes Iriya of the World Health Organization Tanzania country office; Ráz Stevenson, Malia Boggs, Neal Brandes, Esther Lwanga and Emily Wainwright of the United States Agency for International Development; Bongo Mgeni, Christian Winger, Nadra Franklin and Camille Saade of the Academy for Educational Development and the A2Z project; Council Health Management Teams, health personnel and study participants in Morogoro and Same Districts.