ACTwatch Baseline and Endline Household Survey Results 2009 ...

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  • www.ACTwatch.info Copyright 2012 Population Services International (PSI). All rights reserved.

    Evidence for Malaria Medicines Policy

    ACTwatch Baseline and Endline

    Household Survey Results 2009-2012: Benin, Democratic Republic of the Congo,

    Madagascar, Nigeria, Uganda, Zambia

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    Acknowledgements

    ACTwatch is funded by the Bill and Melinda Gates Foundation.

    This study was implemented by Population Services International (PSI).

    ACTwatchs Advisory Committee:

    Mr. Suprotik Basu Advisor to the UN Secretary General's Special Envoy for Malaria

    Mr. Rik Bosman Supply Chain Expert, Former Senior Vice President, Unilever

    Ms. Renia Coghlan Global Access Associate Director, Medicines for Malaria Venture (MMV)

    Dr. Thom Eisele Assistant Professor, Tulane University

    Mr. Louis Da Gama Malaria Advocacy & Communications Director, Global Health Advocates

    Dr. Paul Lalvani Executive Director, RaPID Pharmacovigilance Program

    Dr. Ramanan Laxminarayan

    Senior Fellow, Resources for the Future

    Dr. Matthew Lynch Malaria Program Director, VOICES, Johns Hopkins University Centre for Communication Programs

    Dr. Bernard Nahlen Deputy Coordinator, President's Malaria Initiative (PMI)

    Dr. Jayesh M. Pandit Head, Pharmacovigilance Department, Pharmacy and Poisons Board-Kenya

    Dr. Melanie Renshaw Chief Technical Advisor, ALMA

    Mr. Oliver Sabot Vice President, Vaccines Clinton Foundation

    Ms. Rima Shretta Senior Program Associate, Strengthening Pharmaceutical Systems Program, Management Sciences for Health

    Dr. Rick Steketee Science Director, Malaria Control and Evaluation Partnership in Africa (MACEPA)

    Dr. Warren Stevens Health Economist

    Dr. Gladys Tetteh Deputy Director Country Programs, Systems for Improved Access to Pharmaceuticals and Services, Management Sciences for Health

    Prof. Nick White, OBE Professor of Tropical Medicine, Mahidol and Oxford Universities

    Prof. Prashant Yadav Director-Healthcare Delivery Research and Senior Research Fellow, William Davidson Institute, University of Michigan

    Dr. Shunmay Yeung Paediatrician & Senior Lecturer, LSHTM

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    The ACTwatch Group is comprised of the following individuals:

    PSI ACTwatch Central Dr. Kathryn OConnell, Principal Investigator;

    Hellen Gatakaa, Senior Research Associate; Stephen Poyer, Illah Evance, Julius Njogu, Research Associates; Meghan Bruce, Policy Advocate and Communications Specialist, Linda Ongwenyi, ACTwatch Project Assistant, Tanya Shewchuk, Project Director.

    PSI ACTwatch Country Program Coordinators

    Cyprien Zinsou, ABMS/Benin; Sochea Phok, PSI/Cambodia; Dr. Louis Akulayi, SFH/DRC; Jacky Raharinjatovo, PSI/Madagascar; Ekundayo Arogundade, SFH/Nigeria; Peter Buyungo, PACE/Uganda; Felton Mpasela, SFH/Zambia.

    LSHTM Dr. Kara Hanson, Principal Investigator;

    Dr. Catherine Goodman, Benjamin Palafox, Edith Patouillard, Sarah Tougher, Immo Kleinschmidt, co-investigators. LSHTM is responsible for the supply chain research component of ACTwatch.

    In Benin, the DRC, Madagascar, Nigeria, Uganda, and Zambia: Association Bninoise pour le Marketing Social (ABMS) - Benin Cyprien Zinsou Sethson Kassegne Ghyslain Guedegbe Stephen Poyer Association de Sant Familiale (ASF) - DRC Dr. Louis Akulayi Tshisungu Willy Mpwate Nsuele Stephen Poyer Lanto Razafindralambo Population Services International (PSI) - Madagascar Iarimalanto Rabary Jacky Raharinjatovo Dr. Justin Rahariniaina Sitraka Ramamonjisoa Angela Camilleri Julius Njogu Society for Family Health (SFH) - Nigeria Dr. Jennifer Anyanti Dr. Samson Adebayo Ekundayo D. Arogundade Tsione Solomon Julie Archer

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    Program for Accessible Health, Communication & Education (PACE) - Uganda Peter Buyungo Dr. Simon Sensalire Dr. Susan Kambabazi Emily Carter

    Mitsuru Toda Society for Family Health (SFH) - Zambia Mr. Felton Mpasela Nicholas Shiliya Edward Ngoma Illah Evance Additional support for household survey implementation and/or analysis was provided by: Dr. Megan Littrell, PSI Research Technical Advisor Dr. Adam Bennett, Tulane University Cristin Fergus, Tulane University Rebecca Geary, London School of Hygiene and Tropical Medicine

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    Suggested citation: ACTwatch Group, ABMS/Benin, ASF/DRC, PSI/Madagascar, SFH/Nigeria, PACE/Uganda, and SFH/Zambia. 2013. ACTwatch Baseline and Endline Household Survey Results 2009-2012: Benin, Democratic Republic of Congo, Madagascar, Nigeria, Uganda, Zambia. Washington, DC: Population Services International. Available at: www.actwatch.info For further information contact:

    Association Bninoise pour le Marketing Social (ABMS) Cyprien Zinsou Lot 919 Immeuble Montcho Sikcodji - Cotonou Republic of Benin Phone: + 229 21327713/14 Email: [email protected]

    Association de Sant Familiale (ASF) - DRC Dr. Louis Akulayi Tshisungu 232, Avenue Tombalbaye Croisement Kasa Democratic Republic of Congo Phone: +243 998 23 96 80 Email: [email protected]

    PSI - Madagascar Mr. Jacky Raharinjatovo ACTwatch Country Program Coordinator Immeuble Fiaro Ampefiloha BP 7748 Antananarivo Madagascar Phone: + 261 202262984

    Email: [email protected]

    Society for Family Health (SFH) - Nigeria Dr. Jennifer Anyanti Research Director Society for Family Health/Nigeria 8, Portharcourt Crescent, Area 11, Garki Abuja, Nigeria Phone: + 234 8033116065 Email: [email protected]

    PACE - Uganda Mr. Peter Buyungo Director, Research Department Uganda Plot 2 Ibis Vale, Kololo P.O. Box 27659, Kampala Phone: +256 312-351100 / +256 414-230080 Email: [email protected]

    Society for Family Health (SFH) - Zambia Mr. Felton Mpasela ACTwatch Country Program Coordinator Plot 549, Ituna Road P.O. Box 50770 Lusaka, Zambia Phone: + 260 211257407 Email: [email protected]

    ACTwatch Central Tanya Shewchuk ACTwatch Project Director Malaria Control & Child Survival Department Population Services International P.O. Box 14355-00800 Nairobi, Kenya Phone: +254 20 4440125/6/7/8 Email: [email protected]

    http://www.actwatch.info/mailto:[email protected]:[email protected]

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    Table of Contents

    TABLE OF CONTENTS ....................................................................................................................................... V

    LIST OF TABLES .............................................................................................................................................. VI

    LIST OF FIGURES ........................................................................................................................................... VIII

    DEFINITIONS .................................................................................................................................................. IX

    ABBREVIATIONS ............................................................................................................................................ XI

    1. EXECUTIVE SUMMARY ......................................................................................................................... XII

    1.1. OVERVIEW OF ACTWATCH ........................................................................................................................ XII 1.2. HOUSEHOLD SURVEY METHODS ................................................................................................................. XII 1.3. HOUSEHOLD SURVEY DESCRIPTION ............................................................................................................ XIII 1.4. HOUSEHOLD SURVEY KEY FINDINGS ............................................................................................................ XIV

    2. BACKGROUND ........................................................................................................................................ 1

    2.1. OVERVIEW OF THE ACTWATCH RESEARCH PROJECT ........................................................................................ 1 2.2. AFFORDABLE MEDICINES FACILITY FOR MALARIA ............................................................................................ 1 2.3. COUNTRY BACKGROUNDS ........................................................................................................................... 3

    3. HOUSEHOLD SURVEY METHODS ........................................................................................................... 15

    3.1. INTRODUCTION ...................................................................................................................................... 15 3.2. SAMPLING ............................................................................................................................................. 16 3.3. DATA COLLECTION .................................................................................................................................. 19 3.4. DATA QUALITY ASSURANCE ....................................................................................................................... 19 3.5. DATA PROCESSING AND ANALYSIS .............................................................................................................. 20 3.6. ETHICAL APPROVAL ................................................................................................................................. 20

    4. HOUSEHOLD SURVEY CONTEXTUAL INFORMATION.............................................................................. 21

    4.1. INTRODUCTION ...................................................................................................................................... 21 4.2. METHODS ............................................................................................................................................. 21

    5. HOUSEHOLD SURVEY RESULTS ............................................................................................................. 22

    5.1. DESCRIPTION OF SAMPLES AND CHARACTERISTICS OF HOUSEHOLDS ................................................................... 22 5.2. TREATMENT OF FEVER ............................................................................................................................. 30 5.3. DIAGNOSTICS ......................................................................................................................................... 36 5.4. TYPE OF ANTIMALARIALS TAKEN AND SOURCE OF ANTIMALARIALS ..................................................................... 39 5.5 INITIAL SOURCES OF CARE ......................................................................................................................... 58 5.6 AWARENESS AND EXPOSURE TO THE AMFM ..................................................................................................... 61

    6. DISCUSSION .......................................................................................................................................... 69

    6.1 LIMITATIONS .............................................................................................................................................. 70 6.2 FURTHER RESEARCH ..................................................................................................................................... 70

    7. REFERENCES ......................................................................................................................................... 71

    8. ACKNOWLEDGEMENTS ......................................................................................................................... 77

    9. APPENDICES ......................................................................................................................................... 78

    9.1. TREATMENT OF CHILDREN WITH FEVER IN THE POOREST HOUSEHOLDS AT ENDLINE ............................................... 78 9.2. TIMING OF DATA COLLECTION FOR HOUSEHOLD SURVEYS AND ARRIVAL OF COPAID (AMFM) ACTS BY COUNTRY ....... 79 9.3. TREATMENT OF FEVER AMONG CHILDREN UNDER FIVE YEARS BY SELECTED BACKGROUND CHARACTERISTICS .............. 80

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    List of Tables Table 1.1. 1: Description of the baseline and endline household surveys ........................................................... xiii

    Table 2.3. 1: Timing of data collection for household surveys and arrival of copaid ACTs in Madagascar ............ 7 Table 2.3.2: Timing of data collection for household surveys and arrival of copaid ACTs in Nigeria ..................... 9 Table 2.3.3: Timing of data collection for household surveys and arrival of copaid ACTs in Uganda .................. 12

    Table 3.1. 1: Timing of data collection for household surveys ............................................................................. 15

    Table 3.2. 1: Definition of cluster and enumerations areas, by country .............................................................. 16 Table 3.2.2: Stratification, by country .................................................................................................................. 17 Table 3.2.3: Number of EAs selected by strata for each country ......................................................................... 18

    Table 5.1.1: Results of the household and individual interviews ......................................................................... 22 Table 5.1. 2: Demographic characteristics, Benin................................................................................................. 24 Table 5.1. 3: Demographic characteristics, DRC ................................................................................................... 25 Table 5.1. 4: Demographic characteristics, Madagascar ...................................................................................... 26 Table 5.1. 5: Demographic characteristics, Nigeria .............................................................................................. 27 Table 5.1. 6: Demographic characteristics, Uganda ............................................................................................. 28 Table 5.1. 7: Demographic characteristics, Zambia .............................................................................................. 29

    Table 5.2.1: Treatment of children with fever ...................................................................................................... 30 Table 5.2. 2: Prompt treatment of children with fever ........................................................................................ 33

    Table 5.3.1: Diagnosis of fever among children under five 36

    Table 5.4.1: Treatment with ACT among children under five............................................................................... 39 Table 5.4. 2: Treatment with ACT with the AMFm logo among children under five ............................................ 41 Table 5.4. 3: Prompt treatment with ACT among children under five ................................................................. 43 Table 5.4. 4: Prompt treatment with ACT with the AMFm logo among children under five ............................... 45 Table 5.4. 5: Treatment with ACT among children under five who received an antimalarial .............................. 47 Table 5.4. 6: Source of antimalarials .................................................................................................................... 49 Table 5.4. 7: Source of ACTs ................................................................................................................................. 52 Table 5.4. 8: Source of ACTs with the AMFm logo, among children under five with fever who received an AMFm

    logo ACT ...................................................................................................................................................... 55

    Table 5.5. 1: Care seeking behaviour: first place to seek care.............................................................................. 58

    Table 5.6. 1: Caregiver awareness of and exposure to the AMFm logo and initiative (endline only) 61 Table 5.6. 2: Sources of exposure to the AMFm logo 62 Table 5.6. 3: Sources of exposure to the AMFm initiative 63 Table 5.6. 4: Meaning of the AMFm logo 64 Table 5.6. 5: Knowledge of the recommended price for AMFm medicine 65 Table 5.6. 6: Knowledge of the use of AMFm medicine 66 Table 5.6. 7: Caregiver use of ACTs with the AMFm logo 67 Table 5.6. 8: Source of ACTs with the AMFm logo 68

    Table 5.6. 1: Caregiver awareness of and exposure to the AMFm logo and initiative (endline only) .................. 61 Table 5.6. 2: Sources of exposure to the AMFm logo ........................................................................................... 62 Table 5.6. 3: Sources of exposure to the AMFm initiative .................................................................................... 63 Table 5.6. 4: Meaning of the AMFm logo ............................................................................................................. 64 Table 5.6. 5: Knowledge of the recommended price for AMFm medicine ........................................................... 65 Table 5.6. 6: Knowledge of the use of AMFm medicine ....................................................................................... 66

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    Table 5.6. 7: Caregiver use of ACTs with the AMFm logo ..................................................................................... 67 Table 5.6. 8: Source of ACTs with the AMFm logo................................................................................................ 68

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    List of Figures Figure 1: Diagnosis of fever among children under five ....................................................................................... xiv Figure 2: Treatment with any antimalarial among children under five ................................................................ xiv Figure 3: Treatment with Artemisinin-based Combination Therapy (ACT) among children under five with fever

    .................................................................................................................................................................... xv Figure 4: Treatment with ACT among children under five who received an antimalarial .................................... xv Figure 5: Source of antimalarials among children under five who received an antimalarial ............................... xvi Figure 6: Source of ACTs among children under five who received an ACT ......................................................... xvi Figure 7: Caregiver awareness of and exposure to the AMFm logo and initiative .............................................. xvii Figure 2.3. 1: Location of the AMFm Phase 1 countries ......................................................................................... 3

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    Definitions Antimalarial Any medicine recognized by the WHO for the treatment of malaria.

    Affordable Medicines Facility malaria (AMFm)

    The AMFm is a financing mechanism designed to increase the provision of affordable ACTs through the public, private not-for-profit (e.g., NGO) and private for-profit sectors. The AMFm is being evaluated in a first phase that includes 9 pilots in 8 countries: Cambodia, Ghana, Kenya, Madagascar, Niger, Nigeria, Republic of Tanzania (mainland and Zanzibar) and Uganda.

    Artemisinin-based Combination Therapy (ACT)

    An antimalarial that combines artemisinin or one of its derivatives with an antimalarial or antimalarials of a different class. Refer to Combination Therapy (below).

    AMFm logo All AMFm co-paid ACT packaging bears a logo (the "ACTm leaf logo") to facilitate communication campaigns and product identification. The logo is applied to all quality-assured ACTs purchased through the AMFm.

    Artemisinin monotherapy An antimalarial medicine that has a single active compound, where this active compound is artemisinin or one of its derivatives.

    Cluster The primary sampling unit in the multi-stage sample drawn for the household survey. For each ACTwatch country the household survey clusters are the same units as those selected for sampling in the Outlet Survey. The clusters were defined as follows in each of the countries:

    Benin: arrondissements DRC: aires de sant Madagascar: communes Nigeria: localities Uganda: subcounties (parishes in Kampala) Zambia: wards

    Combination therapy

    The use of two or more classes of antimalarial drugs/molecules in the treatment of malaria that have independent modes of action.

    Dosing/treatment regimen The posology or timing and number of doses of an antimalarial used to treat malaria. This schedule often varies by patient weight.

    Enumeration Area (EA) The secondary sampling unit for the household survey. It is an administrative unit that generally has a population size of 250-500. These units frequently are defined by geographical, health or political boundaries. The enumeration areas were defined as follows in each of the countries:

    Benin: census enumeration areas (most often villages/quartiers) DRC: villages in rural areas and quartiers in urban areas Madagascar: fokontany Nigeria: supervisory areas (SAs) Uganda: villages

    Zambia: standard enumeration areas (SEAs)

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    First-line treatment The government recommended treatment for uncomplicated malaria. The first-line treatment is as follows in each of the countries:

    Benin: artemether-lumefantrine, 20mg/120mg DRC: artesunate-amodiaquine, 50mg/153mg Madagascar: artesunate-amodiaquine, 50mg/153mg Uganda: artemether-lumefantrine, 20mg/120mg Nigeria: artemether-lumefantrine, 20mg/120mg and artesunate-amodiaquine, 50mg/153mg Zambia: artemether-lumefantrine, 20mg/120mg

    Monotherapy An antimalarial medicine that has a single mode of action. This may be a medicine with a single active compound or a synergistic combination of two compounds with related mechanisms of action. Antimalarial monotherapies include amodiaquine, quinine, chloroquine, and sulphadoxine-pyrimethamine.

    Non-artemisinin therapy An antimalarial treatment that does not contain artemisinin or any of its derivatives.

    Oral artemisinin monotherapy

    Artemisinin or one of its derivatives in a dosage form with an oral route of administration. These include tablets, suspensions, and syrups and exclude suppositories and injections, which are used in the treatment of severe malaria.

    Rapid Diagnostic Test (RDT) for malaria

    Malaria rapid diagnostic tests, sometimes called "dipsticks" or malaria rapid diagnostic devices, assist in the diagnosis of malaria by providing evidence of the presence of malaria parasites in human blood. RDTs do not require laboratory equipment, and can be performed and interpreted by non-clinical staff.

    Screened A household that was administered the screening questions (1.11 and 1.11a at baseline, and 1.11 and 1.12 at endline) of the household survey questionnaire.

    Screening criteria The set of requirements that must be satisfied before the full questionnaire is administered. In this survey a household met the screening criteria if it included a child under five who had experienced fever in the two weeks prior to the interview. In addition, at endline a series of questions to capture awareness of the AMFm was administered to 1) caregivers of children under five in households that did not meet the main screening criteria, and 2) any caregivers of children under five with no reported fever in households that met the screening criteria.

    Treatment/dosing regimen The posology or timing and number of doses of an antimalarial used to treat malaria. This schedule often varies by patient weight.

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    Abbreviations ACT Artemisinin-based Combination Therapy

    AL Artemether-lumefantrine

    AMFm Affordable Medicines Facility malaria

    ASAQ Artesunate-amodiaquine

    CHW Community Health Worker

    CI Confidence Interval

    CQ Chloroquine

    DfID Department for International Development

    DHA-PPQ Dihydroartemisinin-piperaquine

    DHS Demographic and Health Survey

    DRC Democratic Republic of Congo

    EA Enumeration Areas

    Global Fund Global Fund to Fight AIDS, Tuberculosis, and Malaria

    GPS Global Positioning System

    IMF International Monetary Fund

    IPTp Intermittent Preventive Treatment in pregnancy

    IQR Interquartile Range

    IRS Indoor Residual Spraying

    ITN Insecticide Treated Net

    LGA Local Government Authority

    LLIN Long-lasting Insecticidal Net

    LSHTM London School of Hygiene and Tropical Medicine

    MIS Malaria Indicator Survey

    MOH Ministry of Health

    nAT Non-artemisinin Therapy

    NGO Non-governmental organization

    NMCP National Malaria Control Program

    NMS National Medical Stores

    PMI Presidents Malaria Initiative

    PPS Probability proportional to size

    PSI Population Services International

    RDT Rapid Diagnostic Test

    SP Sulfadoxine-pyrimethamine

    UN United Nations

    UNICEF United Nations Children Emergency Fund

    USAID United States Agency for International Development

    USD United States Dollar

    WHO World Health Organization

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    1. Executive Summary

    1.1. Overview of ACTwatch

    The ACTwatch Household Survey is a population-based survey conducted in each of the seven

    ACTwatch countries (Benin, Cambodia, the Democratic Republic of Congo [DRC], Madagascar,

    Nigeria, Uganda and Zambia). The survey is one of three ACTwatch research components, and is led

    by Population Services International (PSI). The other elements of ACTwatch research are Outlet

    Surveys led by PSI (OConnell et al., 2011) and Supply Chain Research led by the London School of

    Hygiene & Tropical Medicine (LSHTM) (Shewchuk et al., 2011).

    The objective of the household survey component is to monitor consumer treatment-seeking

    behavior for fever in children under the age of five, including types of medicines (specifically,

    antimalarials) and diagnoses obtained, sources visited for advice, treatment and diagnosis, the price

    paid for antimalarials, and caregiver knowledge and awareness of fever symptoms and antimalarials

    (Littrell et al., 2011).

    1.2. Household Survey Methods

    This study uses data from cross-sectional household surveys of childrens caregivers. Nationally-

    representative samples of households in Benin, the DRC, Madagascar, Nigeria, Uganda and Zambia

    were drawn using multi-staged cluster sampling. Stratification and sampling varied by country. In

    Madagascar and Zambia, stratification was conducted with urban and rural domains. In the DRC the

    sample was stratified across four geographic regions and in Nigeria across six geo-political regions. In

    Uganda, two strata were included for low/moderate and high malaria transmission areas. In Benin, a

    single domain was used. At endline in Uganda and Nigeria stratification was by urban and rural

    areas. Estimated fever prevalence was used to identify the number of households necessary to

    screen in order to yield the desired number of children with fever.

    All caregivers with a child under five who had experienced fever in the two weeks prior to interview

    were eligible for inclusion and were asked questions about their treatment of the recent fever

    episode. In addition, in Madagascar, Nigeria and Uganda at endline all caregivers of children under

    five, irrespective of a childs fever status, were eligible for a subset of questions about the Affordable

    Medicines Facility malaria (AMFm).

    The household survey was designed to monitor all key malaria treatment indicators, as well as

    additional indicators addressing sources of treatment for fever, antimalarials and diagnostics.

    Validation and data checking steps occurred during and after data collection. Double data entry was

    conducted using Microsoft Access (Microsoft Cooperation, Seattle, WA, USA). Stata 11 (Stata Corp,

    College Station, TX) was used for all analyses. To obtain the national estimates provided in this

    report, data were weighted.

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    1.3. Household Survey Description

    The survey dates, number of households enumerated, and number of children under five included in the analysis is presented in table 1.1.1.

    Table 1.1.1: Description of the baseline and endline household surveys

    Benin DRC Madagascar Nigeria Uganda Zambia

    Baseline Endline Baseline Endline1 Baseline Endline Baseline Endline Baseline Endline Baseline Endline

    Survey dates April 15

    th

    May 08th

    2009

    June 24th

    July 10

    th

    2011

    April 27th

    June 21

    st

    2010

    Dec1st

    2008 - January 12

    th

    2009

    April 23rd

    - June 10

    th

    2012

    August 11th

    Sept 23

    rd

    2009

    June 18th

    July 28

    th

    2012

    March 16th

    -April 20th

    2009

    April 19th

    May 11

    th

    2012

    April 14th

    - July 4

    th

    2009

    May 25th

    - Sept 18

    th

    2011

    Households selected 2,352 3,322 8,426 n/a 5,085 15,195 4,649 8,258 2,064 5,306 2,234 8,998

    Households screened 2,312 3,275 8,369 n/a 4,394 14,026 4,616 7,863 2,603 5,067 2,208 8,207

    Children under five with fever for whom treatment-seeking behaviour was recorded.

    927 1,015 2,665 n/a 2,120 2,388 3,273 1,551 1,752 2,273 1,886 1,327

    Caregivers completing the AMFm section

    2.

    n/a n/a n/a n/a n/a 6,781 n/a 3,681 n/a 3,193 n/a n/a

    1 In the DRC, a household follow-up survey was not conducted.

    2 The AMFm section was only administered at endline for the pilot AMFm countries (Madagascar, Nigeria and Uganda).

    Source: ACTwatch Group et al., 2013. ACTwatch Baseline and Endline Household Survey Results 2009-2012: Benin, Democratic Republic of the Congo, Madagascar, Nigeria, Uganda, and Zambia.

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    1.4. Household Survey Key findings

    Data collection took place during the annual rainy season in 2009 for the baseline surveys (except for

    DRC, which took place in 2010), and 2012 for endline surveys in all countries except Benin and

    Zambia (2011) and DRC where no follow-up survey was conducted. This section provides an

    overview of the survey results over time.

    Figure 1: Diagnosis of fever among children under five Diagnostic testing of children with fever remained low across all countries, ranging between 5% in Benin to

    37% in Zambia at endline. However, slight increases were observed in all countries with Madagascar and

    Uganda almost doubling the proportion of children with fever who receive diagnosis: 7% to 12% and 10% to

    18% respectively.

    Figure 2: Treatment with any antimalarial among children under five The percentage of children with fever who received any antimalarial ranged from 19% in Madagascar to 54% in

    Uganda at endline with slight increases observed between baseline and endline in Benin, Nigeria, Uganda and

    Zambia. In Madagascar, there was a decrease from 47% at baseline to 19% at endline with the decrease

    observed in both urban and rural and across all wealth quintiles (data not shown).

    4

    14

    7 6 10

    34

    5 n/a

    12 7

    18

    37

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    Benin DRC Madagascar Nigeria Uganda Zambia

    Baseline Endline

    42 40

    47

    32

    50

    39

    51

    n/a

    19

    37

    54

    41

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    Benin DRC Madagascar Nigeria Uganda Zambia

    Baseline Endline

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    Figure 3: Treatment with Artemisinin-based Combination Therapy (ACT) among children under five with fever The percentage of children with fever who received an ACT increased over time in all countries, with increases

    evident in both urban and rural areas. In Benin, there was a substantial increase in use from 10% to 28%

    between 2009 and 2011. In Uganda, 44% of children with fever received an ACT at endline compared to 20% at

    baseline. Overall levels of treatment were lower in Madagascar and Nigeria, but the percentage of children

    with fever receiving an ACT more than doubled in both countries (Madagascar 3% to 8%; Nigeria 4% to 11%).

    Figure 4: Treatment with ACT among children under five who received an antimalarial Treatment with ACT among children under five who received any antimalairal increased substantially in all

    countries, in both urban and rural areas. Absolute increases were lowest in Nigeria (19% to 33% urban; 10% to

    28% rural) and greatest in Uganda (24% to 75% urban; 41% to 84% rural). In Zambia at endline, 90% of children

    in rural areas and 75% of children in urgan areas who received any antimalarial got an ACT. Overall levels at

    endline were lowest in Nigeria and Madagascar.

    10

    4 3 4

    20 21

    28

    n/a

    8 11

    44

    35

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    Benin DRC Madagascar Nigeria Uganda Zambia

    Baseline Endline

    29

    20

    9 11 10 7

    19

    10

    24

    41

    50

    56

    47

    58

    n/a n/a

    37

    45

    33 28

    75

    84

    75

    90

    0

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    Urban Rural Urban Rural Urban Rural Urban Rural Urban Rural Urban Rural

    Benin DRC Madagascar Nigeria Uganda Zambia

    Baseline Endline

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    Figure 5: Source of antimalarials among children under five who received an antimalarial The public/not-for-profit sector remained the main source of antimalarials in Benin (for 49% of children who

    received any antimalarial) and Zambia (80%) while in Uganda and Nigeria, the private sector was the main

    source of antimalarials at both baseline and endline. In Madagascar, there was a decrease in percentage of

    children receiving an antimalarial from the private sector (61% to 39%) and an increase in the public/not-for-

    profit sector (27% to 46%).

    Figure 6: Source of ACTs among children under five who received an ACT The public/not-for-profit sector played an important role in ACT distribution among children under five with

    fever in Benin, Madagascar and Zambia at both baseline and endline while the private sector remained the

    main source of ACTs in Nigeria. The percentage of children receiving ACTs from the private sector increased

    from 29% to 42% in Uganda although close to 40% still received ACTs from the public not-for-profit sector.

    36

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  • www.ACTwatch.info xvii|Page www.ACTwatch.info P a g e | xvii

    Figure 7: Caregiver awareness of and exposure to the AMFm logo and initiative Less than 50% of caregivers of children under five, regardless of the childs fever status, had seen or heard of

    the AMFm logo or initiative in the three AMFm pilot countries. Among those who had seen the logo, less than

    10% mention it is a cheaper/effective antimalarial and only 8% in Nigeria and 12% in Uganda said there was a

    recommended price for the logo drug (data not shown).

    39

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  • www.ACTwatch.info 1|Page www.ACTwatch.info P a g e | 1

    2. Background

    2.1. Overview of the ACTwatch Research Project

    In 2008, Population Services International (PSI) in partnership with the London School of Hygiene

    and Tropical Medicine (LSHTM) launched a five-year multi-country research project called ACTwatch

    (Shewchuk et al., 2011). The project is designed to provide a comprehensive picture of the

    antimalarial market to inform national and international antimalarial drug policy evolution. The

    research is designed to detect changes in the availability, price and use of antimalarials over time

    and between sectors, and to monitor the effects of policy or intervention developments at country

    level.

    ACTwatch addresses both the supply and demand sides of the market. The supply side is evaluated

    by collecting level and trend data on antimalarials and rapid diagnostic tests (RDTs) in public and

    private sector outlets and wholesalers of antimalarial drugs (OConnell et al., 2011). To evaluate

    demand, data are collected at the household level on consumer treatment-seeking behavior and

    knowledge. In combination, the research components thread together the antimalarial market and

    consumer behavior (Littrell et al., 2011). Findings can help determine where and to what extent

    interventions may positively impact access to and use of quality-assured ACTs and RDTs as well as

    resistance containment efforts.

    The first phase of the project was conducted in seven malaria-endemic countries between 2008 and

    2012: Benin, Cambodia, the Democratic Republic of Congo, Madagascar, Nigeria, Uganda and

    Zambia. Countries were selected with the aim of studying a diverse range of markets from which

    comparisons and contrasts could be made.

    Information on other ACTwatch studies can be found at www.ACTwatch.info.

    2.2. Affordable Medicines Facility for Malaria

    The success of malaria control efforts depends on a high level of coverage in the use of effective

    antimalarials such as artemisinin-based combination therapies (ACTs). Although these antimalarials

    have been procured in large amounts by countries, evidence suggests that ACT use still remains far

    below target levels. Reasons suggested for the low uptake of ACTs include interruptions in public

    sector supply; limited availability outside major urban centres; the high prices of the drugs,

    particularly in the private sector; lack of provider adherence to new recommendations; and patient

    self-treatment with other more common and cheaper antimalarials (Sabot et al., 2009). Lowering

    the cost of ACTs to the end user through a subsidy mechanism could be an effective way to increase

    their uptake (Arrow et al., 2004).

    In response to this issue, the Affordable Medicines Facility malaria (AMFm) was established,

    hosted by The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). As described by

    Adeyi and Atun (2010), AMFm is a financing mechanism designed to incorporate three elements: (1)

    price reductions through negotiations with manufacturers of ACTs; (2) a buyer subsidy, via a co-

    http://www.actwatch.info/

  • www.ACTwatch.info 2|Page www.ACTwatch.info P a g e | 2

    payment at the top of the global supply chain by AMFm on behalf of eligible buyers from the public,

    private for-profit and private not-for-profit sectors; and (3) support of interventions to promote

    appropriate use of ACTs. Examples of these supporting interventions include training providers

    and outreach to communities to promote ACT utilization. AMFm was tested in a first phase that

    includes nine pilots in eight countries: Cambodia, Ghana, Kenya, Madagascar, Niger, Nigeria,

    Republic of Tanzania (mainland and Zanzibar) and Uganda.

    The AMFm pilot was being evaluated on the outcome of four components related to the availability,

    affordability, market share and use of ACTs. These questions are formulated as follows:

    1. Has the AMFm mechanism helped increase the availability of quality-assured ACTs to

    patients across public, private for-profit and not-for-profit sectors, in rural/urban areas?

    2. Has the AMFm mechanism helped to reduce the cost of quality-assured ACTs to patients at

    public, private for-profit and not-for-profit outlets in rural/urban areas to a price comparable

    to the price of most popular antimalarials?

    3. Has the AMFm mechanism helped increase use of quality-assured ACTs, including among

    vulnerable groups, such as poor people, rural residents and children?

    4. Has the AMFm mechanism helped increase the market share of quality-assured ACTs

    relative to all antimalarial treatments in the public, private for-profit and not-for-profit

    sectors in rural/urban areas?

    The final independent evaluation report on the AMFm pilot was released in October 2012,

    concluding that the AMFm had had a significant impact in the private-for-profit sector in six of eight

    countries though less impact in the public sector of most. In November 2012, the Global Fund Board

    decided that the AMFm would not continue as a stand-alone programme but would instead

    integrate some of its key elements into the Global Funds core funding processes. In addition, it was

    decided that the pilot phase of the AMFm would be extended for another year (to the end of 2013)

    to allow for a smooth transition and continuity of access to affordable ACTs. The independent

    evaluation and the Global Fund Board based their conclusions in part on evidence gathered through

    ACTwatch outlet and household surveys.

    Additional information on the AMFm can be found on the AMFm website (Global Fund, 2012). More

    information on the independent evaluation can be found in the final report (AMFm Independent

    Evaluation Team, 2012a).

  • www.ACTwatch.info 3|Page www.ACTwatch.info P a g e | 3

    2.3. Country backgrounds

    2.3.1 Overview of ACTwatch Countries ACTwatch undertook household surveys in seven countries: Benin, Cambodia, DRC, Madagascar,

    Nigeria, Uganda and Zambia (Figure 2.3.1). This trends report covers the surveys in the six sub-

    Saharan countries. An overview of each is given below, and additional detail is provided in the

    individual country-specific household survey reports (available at www.actwatch.info).

    Figure 2.3.1: Location of the ACTwatch study countries

    2.3.2 Benin

    Benin is located in the West Africa sub-region and is bordered by Niger and Burkina Faso to the

    north, Nigeria to the east and Togo to the west. In 2010 the population was estimated at 8.8 million,

    with 1.5 million children under 5 years of age (Population Division, 2011). Approximately 60% of

    people are live in rural areas (Population Division, 2010). In the past decade per capita gross

    domestic product (GDP) has increased from $1,300 to just over $1,400; 47% of the population still

    live below the standard poverty line of $1.25 a day. In 2011 Benin was ranked 167th out of 187

    countries in the Human Development Index (UNDP, 2011). One in eight children die before reaching

    their fifth birthday (INSAE, 2007), and life expectancy at birth in 2009 was 54 years for men and 60

    years for women (WHO, 2011a). Malaria is considered to be the leading cause of morbidity and

    mortality among children under five, accounting for 41% of outpatient visits and 29% of

  • www.ACTwatch.info 4|Page www.ACTwatch.info P a g e | 4

    hospitalizations for this age group (INSAE, 2007). Government figures for 2010 report 900,000

    confirmed malaria cases across all age groups, and a further 350,000 probable cases (WHO, 2010b).

    The public health system operates through three tiers, linked to the three levels of health care and

    their associated structures. Healthcare consumers at government facilities are expected to pay for

    consultations, diagnostic tests, procedures and medicines. In line with the general policy at the time

    of data collection, treatment of uncomplicated malaria is provided at public facilities for a fee (policy

    changes were introduced after the household survey was conducted). In addition to government-run

    facilities, the health sector includes private-for-profit facilities, NGO- and faith-based clinics and

    hospitals, licensed pharmacies, and unlicensed drug vendors selling from permanent sites or

    hawking their products from site to site.

    Malaria epidemiology in Benin can be characterized as stable endemic and, as such, the risk of an

    epidemic is considered to be low. The entire population is at risk of infection. Transmission is more

    intense in the (more populated) southern third of the country, while a single seasonal peak is

    observed in the north. The predominant parasite species is P. falciparum.

    Benin adopted artemether-lumefantrine (AL) as the first-line treatment for uncomplicated malaria in

    March 2004 (PNLP, 2005). Artesunate-amodiaquine (ASAQ) is recommended for children under six

    months of age, when AL is not available or when patients cannot tolerate AL. Parenteral quinine is

    recommended for the treatment of severe malaria and as pre-referral treatment. Artesunate

    injection and suppositories are included in the national policy as a pre-referral treatment for severe

    malaria. Oral artemisinin monotherapies have been banned in Benin since 2008 (WHO, 2010b).

    Although the policy change to ACT occurred in 2004, it was a further four years before this policy

    was truly active at the national level, and ACTs only became widely available in the public sector in

    2009 (PMI, 2009). Prior to 2009, ACT was most commonly available through the private sector,

    which has historically been an important distribution channel of antimalarials in Benin (Tougher et

    al, 2009). Procurement of ACT is currently supported by a number of donors, including the Global

    Fund, Presidents Malaria Initiative (PMI) and the United Nations Childrens Fund (UNICEF).

    At the time of data collection the treatment policy in place for children under five was based

    presumptive diagnosis, while treatment for older patients was recommended only for those with a

    positive diagnostic test. In line with World Health Organization (WHO) guidelines, the malaria case

    management policy was modified in February 2011 to recommend universal diagnostic testing for

    malaria. Although signaled in February 2011, the change was not widely implemented until late

    2011. With donor support, RDTs have been extensively scaled-up alongside ACTs, although

    implementation and commodity management have been similarly challenging. In mid-2010 the

    government had 460,000 RDTs for use in the public health system, divided between health facilities

    and the central medical stores. However, a health facility survey conducted in early 2011 estimated

    that 30% of facilities had expired RDTs in their stocks (PMI, 2011). RDTs are to be used at all levels of

    the health system except the community level, and to be provided free of charge. In addition to

    RDTs, hospitals and larger health centres are supposed to provide microscopy, although such

    facilities often lack functional equipment and laboratory workers skills are often sub-optimal.

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    2.3.2 DRC

    DRC has a population of 68.7 million (CIA World Fact Book, 2009) and the per capita GDP is $300

    (2008 estimate), ranking DRC second lowest in the world. An estimated 80% of the population lives

    below the poverty line. The country has experienced two decades of civil war and there is continuing

    violence in the east of the country that can be characterized as a humanitarian crisis (International

    Crisis Group, 2010). It is estimated that one in five children die before reaching their fifth birthday

    (UNICEF, 2009). Malaria is one of the leading causes of mortality in DRC and the country has one of

    the highest malaria burdens in Africa. There were an estimated 23.6 million malaria cases in 2006,

    and annually 96,000 deaths are attributed to malaria (WHO, 2008).

    97% of the population lives in areas with stable, perennial malaria transmission (with seasonal peaks

    in the countrys tropical zone) while the remaining 3% lives in areas with unstable malaria

    (Programme National de Lutte contre le Paludisme, Ministere de la Sante RDC, 2007).

    In 2005, the national malaria control program adopted artesunate-amodiaquine (ASAQ) as the first-

    line treatment for uncomplicated malaria. Quinine is the recommended treatment should the first-

    line treatment fail, and for the treatment of severe malaria. Sulfadoxine-pyremethamine (SP) is used

    for Intermittent Preventive Treatment of malaria in pregnancy (IPTp). The Ministry of Health (MOH)

    introduced community case management guidelines in 2007 that included community-level

    deployment of ACTs. The policy on diagnosis is quite narrow, restricting its focus to treatment

    failure and complicated malaria. At the peripheral level (health centre), there is generally no

    diagnostic capacity and suspected malaria cases are treated based on clinical signs. At the referral

    level, the guideline states that laboratory confirmation is obligatory where there is no response to

    first-line treatment of clinically diagnosed malaria and for complicated malaria cases.

    The health sector in DRC is largely unregulated and scant information exists regarding the private

    sector. The public sector is built around the health zone (zone de sant), an administrative area at

    the periphery that typically covers a population of 100,000 people. Each health zone is organized

    around a central office, which includes a general referral hospital and is divided into health areas

    where health centres operate. There are currently more than 6,000 health centres scattered across

    515 health zones covering the country (Programme National de Lutte contre le Paludisme, Ministere

    de la Sante RDC, 2007). The public health system relies on a cost-recovery model and antimalarial

    treatment is available to patients for a fee that varies across public health facilities. ACTs are

    procured through external funding from the Global Fund, United States Agency for International

    Development (USAID), and the World Bank amongst other donors.

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    2.3.3 Madagascar

    Madagascar is the fourth largest island in the world with a population of approximately 21 million

    (Institut National de la Statistique, 2010). In February 2009, a political crisis destabilized

    Madagascars government and negatively impacted economic growth. The GDP decreased by 4.6%

    in 2009, while the population living below the poverty line increased from 68.7% in 2005 to 76.5% in

    2010. A substantial portion of financial and technical aid was suspended in 2009 and the

    government cut its national health budget by more than 30% from 2008 to 2010 (PMI, 2011). The

    most common causes of death for children under five are malaria, diarrheal diseases and respiratory

    infections, often related to high rates of undernutrition (Institut National de la Statistique, 2009).

    Malaria is endemic in 90% of Madagascar, though the entire population is at risk (PMI, 2011).

    Transmission patterns vary across the island with year-round transmission in the north, stable

    perennial transmission on the east and west coasts and unstable seasonal transmission in the south

    and central highlandsregions prone to epidemics. Rainy season lasts from late October to April

    with cyclone season from December to April, accompanied by flooding and increased risk of malaria.

    Approximately 75% of the population lives in low and unstable transmission regions, while 25% live

    in areas of high and intense transmission (AMFm Independent Evaluation Team, 2012b). Over

    220,000 probable and confirmed cases of malaria were reported in 2011 (WHO, 2012).

    The public health system operates across 111 health districts and is divided into central, regional,

    district and community levels (PMI, 2011). The public health sector provides 70% of primary health

    contacts in rural areas and 40% in urban areas, distributed across of 138 hospitals, 1,335 secondary

    health centers, 1,059 primary health centers, and 14,989 community health workers (CHW) (AMFm

    Independent Evaluation Team, 2012b). Public sector drugs are imported and distributed through the

    central medical store, with the exception of ACTs, which are purchased by the Unit de Gestion de

    Projets and distributed by the National Malaria Program. The private sector consists of 44 hospitals

    and 724 private health centers, as well as 22 pharmaceutical wholesalers, 200 pharmacies and more

    than 1,000 rural pharmacies.

    Malaria prevention strategies include LLIN distribution and targeted IRS and IPTp in endemic districts

    (PMI, 2011). Campaign and routine distribution of LLINs has increased household ownership of at

    least one net from 72% in the 2008/2009 DHS to 94% in the 2011 MIS (INSTAT and ICF Macro, 2010

    and INSTAT and ICF International, 2012). Net use has similarly increased from 58% to 89% of children

    under five sleeping under a net in the previous night. In 2011, 79% of households in target districts

    had been treated with IRS in the past year. While only 35% of pregnant women receive at least one

    dose of SP for malaria prevention despite antenatal care attendance over 85% (INSTAT and ICF

    International, 2012).

    In 2006, Madagascar adopted ASAQ as the first-line treatment for uncomplicated malaria and AL as

    the second-line treatment (PNLP, 2005). Public health facilities provide ACTs free of charge and

    began to introduce RDTs in 2005. Community distribution of ACTs by CHWs was initiated in late

    2008, though treatment has been largely presumptive as RDTs were only permitted at the

    community level in 2010 (PMI, 2011). Drugstores and pharmacies can legally dispense ACTs in

    Madagascar with a prescription. Despite changes in national treatment protocols, chloroquine has

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    been widely available on the market, leading to a recent ban on distribution outside of hospitals

    which went into effect July 2012 (PNLP, direct correspondence, 2012).

    Generally, health facility utilization is low in Madagascar. For malaria, treatment seeking for children

    with a fever was only 44% in 2011 and prompt treatment with an ACT was only 0.4% in the

    2008/2009 DHS and 2% in the 2011 MIS (INSTAT and ICF Macro, 2010 and INSTAT and ICF

    International, 2012). Efforts to increase availability and use of ACTs have been made through public

    sector distribution, as well as initiatives through private and community channels. A social marketing

    project funded by the Global Fund distributed subsidized ASAQ, branded as ACTipal, through

    CHWs, pharmacies and drugstores from 2008 until discontinuation of the brand in 2012 (PMI, 2011).

    USAID and UNICEF have also supported scale-up of cIMCI through CHWs in rural villages.

    Madagascar participated in the AMFm program providing manufacturer-level subsidy for ACTs

    beginning in May 2010 (AMFm Independent Evaluation Team, 2012b). The first shipment of AMFm

    drugs arrived to private sector first-line buyers in October 2010 and to the public sector in February

    2011. While availability of ACTs generally increased, the project experienced wide-spread stock-outs

    in the public and private sectors, exacerbated by malaria epidemics in 2011 and 2012 in the South

    and South East regions. In addition, promotional support for subsidized ACTs was substantially

    limited by enforcement of national regulations on drug advertising. By June 2012, a total of 2.6

    million ACT treatments were ordered through the AMFm in Madagascar (CHAI, direct

    correspondence, 2012).

    Table 2.3.1 presents the timing of the baseline and endline household surveys, and the time

    between the midpoint of fieldwork and the first arrival of copaid drugs in each country.

    Table 2.3.1: Timing of data collection for household surveys and arrival of copaid ACTs in Madagascar

    Start date End date

    Date of first arrival of copaid drugs

    in country

    Time prior to the arrival of AMFm drugs

    in country

    Baseline

    Madagascar Dec 1, 2008 Jan 12, 2009 Oct 14, 2010 22 months

    Endline Time after arrival of

    AMFm drugs in country

    Madagascar Apr 23, 2012 June 10, 2012 Oct 14, 2010 18 months

    Additional information on the country background, AMFm context and events is described elsewhere (see: AMFm Independent Evaluation Team, 2012b; ACTwatch Group and PSI/Madagascar 2010, 2011, 2013).

  • www.ACTwatch.info 8|Page www.ACTwatch.info P a g e | 8

    2.3.4 Nigeria Nigeria is the most populous country in Africa with a population of 162.5 million ((UN Population

    Division, 2010). The country is divided into six geopolitical zones, 36 states (plus the capital Abuja)

    and 774 Local Government Authorities (LGAs) (PMI, 2011). Authority is largely decentralized with

    substantial autonomy for state governments and limited influence of the federal government over

    local affairs. Despite rich oil resources and economic growth over the past decade, 55% of the

    population continues to live below the poverty line (AMFm Independent Evaluation Team, 2012b).

    The south of the country is better on most socioeconomic indicators than the north, including lower

    under five and maternal mortality rates.

    Malaria is a major public health issue in Nigeria, with 97% of the population at risk of malaria (PMI,

    2011). Nigeria has five ecological strata ranging from desert savannah to rainforest to mangrove

    swampeach with varied patterns of malaria transmission. The south experiences year-round

    transmission while the north faces seasonal transmission during its three-month rainy season.

    Malaria is the leading cause of death in children under five and leads to an estimated 225,000 deaths

    annually (NMCP, 2009). It accounts for 50% of the total disease burden and health expenditures in

    Nigeria and 30% of hospitalizations.

    The public sector health system operates at the federal, state and local level with the Federal

    Ministry of Health responsible for policy, research and tertiary care and state and local authorities

    overseeing secondary and primary care services (AMFm Independent Evaluation Team, 2012b).

    Supply chain management in the public sector is complex and fragmented with multiple donors and

    government authorities managing separate procurement and distribution processes leading to weak

    coordination and frequent stock-outs of essential medicines (PMI, 2011).

    Nigeria has a robust private sector that provides 65% of health care across the country, particularly

    at proprietary patent medicine vendors (PPMVs), which are often the first choice of health care for

    the poor (AMFm Independent Evaluation Team, 2012b). Among patients with suspected malaria,

    more than half seek care first in the private sector. Medicines in the private sector are distributed

    through a vast network of wholesalers, distributors, pharmacists, medical representatives and

    PPMVs (PMI, 2011).

    Prevention efforts in Nigiera include LLIN distribution, targeted IRS and IPTp. A mass campaign

    distributed 34 million LLINs to 22 of Nigerias 37 states by May 2011 (PMI, 2011). A total of 63 million

    nets are needed to reach universal coverage targets of two nets per household nationwide. The MIS

    indicated that household ownership of at least one ITN has increased to 42% in 2010 from only 8% in

    the 2008 DHS (NPC, NMCP and ICF International, 2012; NPC and ICF Macro, 2009). In the same

    survey, 29% of children under five slept under an ITN the previous nighta substantial increase from

    6% in 2008. Coverage for the 250,000 households targeted for IRS in seven states is only 15%, while

    IPTp efforts have similarly struggled with only 13.2% of pregnant women receiving two or more

    doses of SP in 2010 (NPC, NMCP and ICF International, 2012).

    The Federal Ministry of Health adopted AL as the first-line treatment for uncomplicated malaria in

    2005 with ASAQ as the alternate first-line after detecting high levels of failure for chloroquine and SP

    in drug efficacy trials (PMI, 2011). ACTs were classified as over-the-counter medicines in 2006 and

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    oral artemisinin monotherapies were banned for import or manufacturing in the same year. Policy

    states that ACTs are provided in public facilities free of charge. While local pharmaceutical

    manufacturing is abundant in Nigeria, none of the producers are WHO pre-qualified to manufacture

    ACTs (AMFm Independent Evaluation Team, 2012b). In 2010, Nigeria aligned its national treatment

    guidelines with the WHO to recommend universal diagnostic testing for suspected malaria (PMI,

    2011). Microscopy capacity and RDT availability is low, however, and it is estimated that a total of 50

    to 60 million RDTs would be required each year to achieve universal access to malaria diagnosis in

    the public sector.

    Several initiatives have provided ACTs to Nigeria, including programs supported by the World Bank,

    PMI and the Global Fund. Nigeria signed an agreement for the AMFm pilot in September 2010 and

    received the first shipment of drugs in January 2011 (AMFm Independent Evaluation Team, 2012b).

    The National Malaria Control program procured ACTs through the Voluntary Pooled Procurement

    (VPP) system, while the Society for Family Health (SFH) and the 28 of the 54 registered first-line

    buyers placed orders directly with the manufacturers. National advocacy and promotion efforts

    were successful in the first year and Nigerias ACT demand outstripped international supply. By the

    end of 2011, a total of 78 million treatments had been ordered in Nigeria, of which about 39 million

    had been delivered. This represents 40% of the total ACTs delivered through the AMFm.

    Table 2.3.2 presents the timing of the baseline and endline household surveys, and the time

    between the midpoint of fieldwork and the first arrival of copaid drugs in each country.

    Table 2.3.2: Timing of data collection for household surveys and arrival of copaid ACTs in Nigeria

    Start date End date

    Date of first arrival of copaid drugs

    In-country

    Time prior to the arrival of AMFm drugs

    in-country

    Baseline

    Nigeria Aug 11, 2009 Sept 23, 2009 Jan 25, 2011 17 months

    Endline Time after arrival of

    AMFm drugs in-country

    Nigeria June 18, 2012 July 28, 2012 Jan 25, 2011 15 months

    Additional information on the country background, AMFm context and events is described elsewhere (see: AMFm Independent Evaluation Team, 2012b;; ACTwatch Group and SFH/Nigeria 2010, 2011, 2013).

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    2.3.5 Uganda Uganda is located in East Africa, bordered by South Sudan to the north, Kenya to the east, Tanzania

    and Rwanda to the south and Democratic Republic of Congo (DRC) to the West. In 2010 the

    population was estimated at 34.5 million, 24% of whom were five years of age or younger

    (Population Division, 2011). Approximately 84% of people live in rural areas (UN Population Division,

    2010). Though the GDP has increased by 5.8% from 2009 to 2010, over one-third of the population

    continues to live below the poverty line (AMFm Independent Evaluation Team, 2012b). Inflation

    rates in Uganda reached 30% in 2011, leading to increases in the price of fuel, food and other goods,

    including medicine (USAID, direct correspondence, 2012).

    Malaria is a major public health problem in Uganda. Perennial transmission occurs in 95% of Uganda

    with the remaining 5% experiencing unstable and epidemic-prone transmission (PMI, 2011d). The

    2009 Malaria Indicator Survey indicates that 99% of malaria cases are caused by P. falciparum (UBOS

    et al, 2010). Malaria is the most frequently reported disease in both public and private health

    facilitiesaccounting for 25-40% of outpatient visits at health facilities and 9-14% of all hospital

    deaths (PMI, 2011d). Among children under five, about half of all deaths are attributed to malaria,

    while across Uganda malaria is estimated to account for approximately 70,000-110,000 deaths

    annually (NMCP, 2010).

    Ugandas public sector health system is decentralized and consists of five levels of service: national,

    regional and district-level hospitals; sub-district-level health centers, subcounty-level health centers,

    parish-level health centers and Village Health Teams (AMFm Independent Evaluation Team, 2012b).

    Public health facilities procure medicines through the National Medical Stores (NMS). In early 2010,

    the Ministry of Health introduced a push system of supply to lower-level health facilities operating

    at the subcounty and parish level (PMI, 2011d). Each health center at this level receives a standard

    kit of essential drugs and health supplies on a bimonthly basis. One study shows that the system has

    resulted in a 69% decrease in the number of days facilities are stocked out of five tracer drugs,

    including ACTs (MOH, 2010). At a facility level, there are some reports of excess stocks as well as

    splitting or stacking doses to correct imbalances in age-specific treatments (USAID, direct

    correspondence, 2012). Hospitals and health centers at the district level continue to order based on

    determined needs directly from the NMS.

    The private sector makes up 46% of Ugandas health facilities (PMI, 2011d). An estimated 82% of

    households first seek care from drug shops, private clinics and private not-for-profit providers, while

    55% of children with fever receive treatment from private facilities. Private not-for-profit facilities

    are predominantly faith-based organizations which procure drugs and medical supplies from the

    Joint Medical Stores (AMFm Independent Evaluation Team, 2012b). Private for-profit facilities

    include primary and secondary-care health facilities, retail pharmacies, licensed drug shops and

    unregistered drug shops that operate illegally. Pharmacies are permitted to dispense prescription-

    only medicines under the supervision of a registered pharmacist, while drug shops are only

    permitted to sell over-the-counter medicines. For-profit providers purchase medicines and supplies

    through a private sector supply chain that includes 250 wholesale pharmacies, 70 drug importers

    and distributors and 15 local manufacturers. In December 2010, the Kampala manufacturing site for

    Quality Chemicals Industries Limited became Africas first local supplier to receive WHO pre-

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    qualification to produce ACTs. The company is licensed to produce artemether/lumefantrine (AL)

    through the company Cipla Limited, based in India.

    Malaria prevention strategies include LLIN distribution, targeted IRS and IPTp. A national campaign

    in 2010/2011 distributed 7.2 million LLINs to pregnant women and children under five with plans for

    a follow-on campaign of 10.4 million in mid-2012 to reach universal coverage (PMI, 2011d).

    Campaign and routine distribution of LLINs has increased household ownership of at least one LLIN

    from 9% in the 2009 MIS to 39% in the 2011 PMI bed net coverage survey. Net use has similarly

    increased from 11% to 43% of children under five sleeping under a net in the previous night.

    IRS efforts target four high-transmission districts in northern Uganda (Kitgum, Pader, Apac, and

    Oyam) with large populations of internally displaced persons (PMI, 2011d). The program has

    achieved over 95% coverage in targeted households through several spraying rounds annually. IPTp

    is implemented nationally through focused antenatal care, however only 45% of pregnant women

    received at least one dose of SP in 2009 despite ANC attendance over 90%.

    The first-line treatment for malaria has been AL since 2004 and the current second-line treatment is

    dihydroartemisinin piperaquine and quinine (AMFm Independent Evaluation Team, 2012b). Oral

    artemisinin monotherapies were banned in 2007 and ACTs became classified as an over-the-counter

    drug in 2008. Although public health facilities in Uganda provide diagnosis and ACTs free of charge,

    only 36% of children under five were treated with an antimalarial the same or next day after onset of

    fever, according to the 2009 MIS (UBOS et al, 2010). In the same survey, only 13.7% were treated in

    the first 24 hours with an ACT. This may reflect the chronic stock-outs across Uganda in this period

    as a result of grant interruptions, procurement delays and weak supply chains in-country (PMI,

    2011d).

    Efforts to increase availability and use of ACTs have been made through public sector distribution, as

    well as initiatives through private and community channels. In 2008, a pilot led by the Ministry of

    Health and Medicines for Malaria Venture introduced subsidized ACTs to the private sector in four

    districts (Budaka, Pallisa, Kaliro and Kamuli) (AMFm Independent Evaluation Team, 2012b). The ACT

    was Coartem (AL) repackaged with a green leaf logo which served as the prototype for the global

    AMFm logo. The pilot ended in 2010 and stocks likely remained on the market at the time of

    baseline surveys.

    Uganda was one of the first countries in Africa to introduce community management of fever,

    distributing ACTs through Community Medicine Distributors in rural areas. Despite early adoption,

    the program has been plagued by shortages of AL, with only 9% of households in 2009 reporting

    Community Medicine Distributors in their community with available malaria treatment (UBOS,

    2010). The Global Fund, Canadian International Development Agency, Gates Foundation and UNICEF

    currently support pilot efforts to scale-up integrated community case management in rural districts

    (PMI, 2011d).

    In February 2011, Uganda signed its AMFm grant, making it the last of participating countries to

    receive the manufacturer-level subsidy (AMFm Independent Evaluation Team, 2012b). Negotiations

    were held up over concerns that the inexpensive AMFm drugs would cause financial harm to local

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    manufacturer, Quality Chemicals Industries Limited. Once WHO granted pre-qualification for local AL

    production in December of 2010, negotiations advanced. The initial order of AMFm drugs was

    further delayed by quantification discussions and confusion over public sector suppliers. The first

    order of copaid ACTs was finally delivered to the NMS in July 2011 and a total of 20.7 million

    treatment courses were approved and delivered to the public sector in 2011. DfID and PMI made

    emergency procurements to re-supply dwindling stocks to the public and not-for-profit sector during

    AMFm negotiations.

    The private not-for-profit sector procured its AMFm drugs through three registered first line buyers,

    receiving its first supply of copaid ACTs in April 2011 (AMFm Independent Evaluation Team, 2012b).

    A total of 1.1 million treatments were ordered and 0.6 million treatments were delivered to the Joint

    Medical Stores by the end of 2011. The private for-profit sector made orders through four registered

    first line buyers. A total of 15 orders were approved in 2011 for 7.9 million treatment courses and

    6.9 million treatments were delivered by the end of the year. Supporting interventions for

    promotion of AMFm drugs had not begun as of August 2012 (USAID, direct correspondence, 2012).

    Table 2.3.3 presents the timing of the baseline and endline household surveys, and the time

    between the midpoint of fieldwork and the first arrival of copaid drugs in each country.

    Table 2.3.3: Timing of data collection for household surveys and arrival of copaid ACTs in Uganda

    Start date End date

    Date of first arrival of copaid drugs

    In-country

    Time prior to the arrival of AMFm drugs

    in-country

    Baseline

    Uganda March 16, 2009 April 20, 2009 Apr 23, 2011 24 months

    Endline Time after arrival of

    AMFm drugs in-country

    Uganda Apr 19, 2012 May 11, 2012 Apr 23, 2011 12 months

    Additional information on the country background, AMFm context and events is described elsewhere (see: AMFm Independent Evaluation Team, 2012b;) ACTwatch Group and PSI/Uganda and PACE/Uganda 2010, 2011, 2013).

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    2.3.6 Zambia Zambias population was approximately 13.9 million in 2010 (Population Division at Department of

    Economic and Social Affairs at the United Nations, 2011), of which an estimated 65% live in rural

    areas (Population Division,, 2011). Zambia has experienced positive economic growth with a real

    growth rate of 6.7% (US Department of State, 2012). The per capita GDP was estimated $1,600 in

    2011 and 64% of the population were estimated to live under the poverty line in 2006 (CIA, 2012).

    Malaria transmission occurs across the country throughout the year, with the peak occurring during

    the rainy season from November to April. Transmission intensity varies across the country and has

    been categorized as follows: (i) areas that have less than 1% parasite prevalence (Lusaka), (ii) areas

    with parasite prevalence that ranges between 1% and less than 10% (Central, Copperbelt, North-

    Western, Southern, and Western Provinces) and (iii) areas with parasite prevalence greater than

    20% (Eastern, Luapula, and Northern Provinces) (Zambia National Malaria Control Center, 2011).

    Malaria incidence was estimated at 358 cases per 1,000 persons in 2007 (Mouzin, et al., 2011) and

    4.3 million cases of malaria were reported with 6,000 deaths (40% of all infant mortality) (Mouzin, et

    al., 2011). In 2010, the number of malaria cases was lower with an estimated 4.2 million cases of

    malaria and 4,834 deaths (Zambia Ministry of Health National Malaria Control Center, 2011). The

    MIS showed a decline in malaria prevalence from 22% in 2006 to 10.2% in 2008 (Zambia Ministry of

    Health, 2011).

    The Zambian health care system is decentralized and the public sector plays an important role in the

    delivery and management of health services. The public sector is divided into several tiers: health

    posts and community outreach; health centers; and three levels of hospitals (PMI, 2011e). Only 20-

    30% of the sick patients seek treatment from private practitioners in Zambia (Sipilanyambe et al.,

    2008). Health services that are operated by the Ministry of Health are provided free of charge.

    Private drug stores are common and only dispense medicines registered as over-the-counter, but in

    practice, they often dispense prescription-only medicines.

    Zambia was the first country in Africa to change its first-line treatment to an ACT in 2002 (Mouzin et

    al., 2011; Sipilanyambe, et al., 2008). AL is the first-line treatment for uncomplicated malaria. SP is

    the alternative first-line treatment in pregnant women and children less than 5kg1. Oral quinine is

    the second-line treatment in cases of failure of first-line drugs in all age groups. Severe malaria is

    treated with quinine injection (Zambia Ministry of Health, 2011). In Zambia, ACTs are classified as

    prescription-only medications and are therefore not sold legally through unlicensed private sector

    providers.

    Zambia has greatly strengthened the capacity to diagnose and confirm malaria cases with laboratory

    microscopy and RDTs (Zambia National Malaria Control Center, 2011). RDTs have been made

    available since 2007, and free distribution of RDTs in health centers was piloted in 2008 and scaled

    up nationally after an intense training period (Mouzin et al., 2011). Approximately 2 million RDTs are

    1During the early implementation of the treatment policy in 2004, AL was not recommended for children less than 10kg. SP was recommended instead. The policy was shifted in late 2005, where AL was recommended for children weighing 5 to 9kg (Zurovac, et al., 2007).

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    distributed yearly (Mouzin et al., 2011). According to the 2010 MIS, the treatment of febrile children

    with antimalarial drugs declined from 52.8% in 2006 to 43.1% in 2008 to 34% in 2010, due to

    increasing availability of RDTs. The percentage of febrile children under age 5 with reported finger

    stick for presumed diagnostic testing was 10.9% in 2008 and 16.7% in 2010 (Zambia National Malaria

    Control Center, 2011).

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    3. Household Survey Methods

    3.1. Introduction

    Household surveys were carried out in Benin, DRC, Madagascar, Nigeria, Uganda and Zambia with

    the objectives of assessing ACT use for fevers in children under five, source of ACTs, and diagnostic

    practices. Baseline and endline surveys were conducted in all countries except DRC where only one

    survey was conducted, in 2010. ACTwatch also conducted surveys in Cambodia and these results are

    reported elsewhere (ACTwatch Group and PSI/Cambodia 2009, 2011).

    The timing of the baseline and endline household surveys conducted in the six malaria endemic

    countries included in this report is presented in Table 3.1.1.

    Table 3.1.1: Timing of data collection for household surveys

    Start date End date

    Baseline

    Benin April 15, 2009 May 08, 2009

    DRC Apr 27, 2010 June 21, 2010

    Madagascar Dec 1, 2008 Jan 12, 2009

    Nigeria Aug 11, 2009 Sept 23, 2009

    Uganda March 16, 2009 April 20, 2009

    Zambia April 14, 2009 July 4, 2009

    Endline

    Benin June 24, 2011 July 10, 2011

    Cambodia Nov 6, 2011 Dec 12, 2011

    DRC -- --

    Madagascar Apr 23, 2012 June 10, 2012

    Nigeria June 18, 2012 July 28, 2012

    Uganda Apr 19, 2012 May 11, 2012

    Zambia May 25, 2011 Sept, 18 2011

    Source: ACTwatch Group et al., 2013. ACTwatch Baseline and Endline Household Survey Results 2009-2012: Benin, Democratic Republic of the Congo, Madagascar, Nigeria, Uganda, Zambia.

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    3.2. Sampling

    Nationally representative samples were selected using multi-stage sampling. The primary sampling

    units, clusters, were administrative areas that had already been selected as part of the ACTwatch

    outlet survey in each country. A list of second stage units, generically called enumeration areas (EA),

    was drawn for each cluster. EAs are administrative units such as actual census enumeration areas,

    villages, or supervisor areas, with an average of 250-500 inhabitants. Clusters and EAs were selected

    with probability proportional to population size (PPS) at each stage. (Littrell et al., 2011) Table 3.2.1

    provides a list of the clusters and EAs used in each country.

    Table 3.2.1: Definition of cluster and enumerations areas, by country

    Baseline Clusters Enumeration Areas

    Benin Arrondissement Census enumeration areas

    DRC Aires de sant Villages/quartiers

    Madagascar Communes Fokontany

    Nigeria Localities Supervisory areas (SAs)

    Uganda Subcounties (parishes in Kampala)

    Villages

    Zambia Wards Standard enumeration areas (SEAs)

    Source: ACTwatch Group et al., 2013. ACTwatch Baseline and Endline Household Survey Results 2009-2012: Benin, Democratic Republic of the Congo, Madagascar, Nigeria, Uganda, Zambia.

    At baseline, the samples were stratified depending on the country context (Table 3.1.3) (Shewchuk

    et al., 2011). In Madagascar and Zambia, stratification was conducted with urban and rural domains.

    In the DRC the sample was stratified across four geographic regions, and in Nigeria, across six geo-

    political regions. In Uganda, two strata were included for low/moderate and high malaria

    transmission areas. In Benin, a single domain was used. At endline, stratification was modified for

    Nigeria and Uganda, to urban and rural, as a means to coordinate efforts with the Independent

    Evaluation of the AMFm and Outlet Survey sampling and stratification guidelines.

    Full household listings were not available at baseline and so enumeration area size, together with

    the average household size from DHS figures, was used to derive the sampling interval applied

    during systematic random sampling of households. At endline a household census was conducted in

    each EA and households were then randomly selected.

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    Table 3.2.2: Stratification, by country

    Country Baseline Endline

    Benin n/a n/a

    DRC

    1. North-East Provinces: Oriental, Nord Kivu, Sud Kivu, and Maniema

    2. North West Provinces: Bas-Congo, Bandundu, and Equateur

    3. Centre-South Provinces: Katanga, Kasai Oriental, and Kasai Occidental

    4. Capital city: Kinshasa

    n/a

    Source: Localized censuses in health zones conducted between 2001 and 2004, with the support of various INGOS

    Madagascar 1. Urban areas 2. Rural areas

    1. Urban areas 2. Rural areas

    Source: Cartographie censitaire de la population 2009. Institut National de Statistique.

    Nigeria

    1. North-Central states: Benue, Abuja-FCT, Kogi, Kwara, Nasarawa, Niger, Plateau

    2. North East states: Adamawa, Bauchi, Borno, Gombe, Taraba, Yobe

    3. North West states: Jigawa, Kaduna, Kano, Katsina, Kebbi, Sokoto, Zamfara

    4. South East states: Abia, Anambra, Ebonyi, Enugu, Imo

    3. South South states: Akwa ibom, Bayelsa, Cross rivers, Delta, Edo, Rivers

    4. South West states: Ekiti, Lagos, Ogun, Ondo, Osun, Oyo

    1. Urban areas 2. Rural areas

    Source: Nigeria National Population Commission

    Uganda 1. Low malaria transmission areas 2. Medium to high malaria transmission

    areas

    1. Urban areas 2. Rural areas

    Source: Malaria Control Programme, Ministry of Health, Uganda

    Zambia 1. Urban areas 2. Rural areas

    1. Urban areas 2. Rural areas

    Source: Zambia Population Census Frame, 2000. Central Statistical Office, Lusaka, Zambia

    For all surveys the sample size was estimated for each country to be able to detect a 10 percentage

    point change between the baseline and endline values of the indicator: the proportion of children

    under five years with fever in the two weeks preceding the survey who received any antimalarial

    treatment. The sample size was calculated based on the following parameters, using the most recent

    figures from the DHS and MIS at the time of data collection for the baseline and endline, and

    powered to detect differences between strata.

    Estimated fever prevalence was used to calculate the number of households necessary to

    screen in order to yield the desired number of children with fever.

    The estimated number of children under five in a household was used in collaboration with

    the estimated fever prevalence above to calculate the number of households necessary to

    screen in order to yield the desired number of children with fever.

    The samples were designed to detect differences with 95% significance and 80% power.

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    A design effect of two was assumed, to account for the clustered survey design.

    Based on the approach and parameters described above, it was estimated that 3,181 households in

    Benin, 2,168 in DRC, 8,250 in Madagascar, 9,171 in Nigeria, 3,777 in Uganda and 6,441 in Zambia

    would need to be visited at baseline in order to find a sufficient number of febrile cases. At endline,