Assessment of Knowledge and Adherence to the National Guidelines for Malaria Case Management in Pregnancy among Healthcare Providers and Drug Outlet Dispensers in rural, western Kenya Open Access

Abstract

Although prompt and effective treatment is a cornerstone of malaria control, information on healthcare provider adherence to malaria treatment guidelines in pregnancy is lacking. Incorrect or sub-optimal treatment can cause adverse consequences to the mother and fetus.

We conducted a cross-sectional study from September to November 2013, in all health facilities and randomly selected drug outlets in the Siaya County HDSS catchment area in western Kenya, to assess provider adherence to and knowledge of case management for uncomplicated malaria in pregnancy, including diagnosis, pregnancy assessment, and treatment. In health facilities, we used exit interviews of women of childbearing age, including pregnant women, who had been assessed for fever. Simulated clients posing as 1^st trimester pregnant women or as relatives of women in 3^rd trimester collected information from drug outlets. Information on treatment was recorded from prescriptions or after reviewing medications in patient's possession. Standardized questionnaires were used to assess provider knowledge of treatment guidelines.

Correct provider case management for malaria in pregnancy was observed in 32% of health facility cases and 3% of drug outlets; provider knowledge was 45% and 0%, respectively. Prescription of the correct drug for pregnancy trimester at the correct dosage was observed in 62% of cases in health facilities and 42% in drug outlets. Prescribing of correct drug and dosage was observed less often in 1^st trimester than in 2^nd/3^rd (27% vs. 0%, p<0.01, and 65% vs. 32%, p<0.01, at health facilities and drug outlets, respectively). Sulfadoxine-pyrimethamine, which is not recommended for treatment of acute malaria, was prescribed in 3% of cases in health facilities and 18% of simulations in drug outlets (p<0.01). Exposure to artemether-lumefantrine in 1^st trimester, which is contraindicated due to its unknown safety, occurred in 27% and 49% of cases in health facilities and drug outlets, respectively (p=0.04); none were a result of quinine stock-out.

This study highlights knowledge inadequacies and incorrect prescribing practices in the treatment of malaria in pregnancy. These should be addressed through comprehensive trainings and adequate supervision by the Kenya Ministry of Health to improve the quality of patient care and maximize therapeutic outcomes.

Table of Contents

Table of Contents

CHAPTER I 13

LITERATURE REVIEW 13

CHAPTER II 17

Assessment of Knowledge and Adherence to the National Guidelines for Malaria Case Management in Pregnancy among Healthcare Providers and Drug Outlet Dispensers in rural, western Kenya 17

Assessment of Knowledge and Adherence to the National Guidelines for Malaria Case Management in Pregnancy among Healthcare Providers and Drug Outlet Dispensers in rural, western Kenya 18

ABSTRACT 18

INTRODUCTION 20

METHODS 21

Study Site & Sampling 22

Data Collection 23

Data Management & Analysis 24

Ethics 26

RESULTS 26

Prescribing Practice and Dispensing Behaviours: Exit Interviews in Health Facilities 26

Prescribing Practice and Dispensing Behaviours: Simulated Clients in Drug Outlets 28

Knowledge of the National Malaria Treatment Guidelines among Providers 30

DISCUSSION 33

Limitations & Challenges 37

CONCLUSION 38

Disclaimer 39

Acknowledgements 39

Financial support 39

Potential conflicts of interest 39

REFERENCES 40

TABLES 42

Table 1. Definitions of Correct Practice & Adequate Knowledge 42

Table 2a. Exit Interview: Health Facility Characteristics 43

Table 2b. Health Facility Exit Interview: Respondent Characteristic 44

Table 3. Malaria Diagnostics practice in Health Facilities as observed through exit interviews stratified across facility type 45

Table 4. Pregnancy assessment practice in Health Facilities as observed in exit interviews stratified across pregnancy status 46

Table 5. Malaria treatment practice in Health Facilities as observed through exit interviews stratified across pregnancy status 47

Table 6. Malaria Case Management Practice in Health Facilities as observed through Exit Interviews, stratified across Health Facility Type 48

Table 7. Predictors of correct prescribing and diagnostic practice in health facilities 48

Table 8. Drug Outlet & Simulation Characteristics 49

Table 9. Malaria Diagnostics practice in drug outlets as observed through simulated clients across pregnancy status 50

Table 10. Pregnancy assessment practice in drug outlets as observed through simulated clients across pregnancy status 51

Table 11. Correct Treatment and Dosage Characteristics by Pregnancy Status in Drug Outlets 52

Table 12. Malaria Case Management practice in drug outlets as observed via simulated clients stratified across Drug Outlet Type53

Table 13. Facility characteristics from the provider survey on national malaria treatment guidelines 54

Table 13b. Provider characteristics from the provider survey on national malaria treatment guidelines 55

Table 14. Malaria Treatment Guideline Awareness, comparing Health Facilities vs. Drug Outlets 56

Table 14 Extended. Malaria Treatment Guideline Awareness, comparing all facility types 57

Table 15. Adequate Provider Knowledge of Malaria in Pregnancy based on National treatment guidelines comparing HFs to DOs 58

Table 16. Comprehensive Care Practices Provided during Pregnancy, comparing Health Facilities vs. Drug Outlets 59

Table 17. Provider Characteristic Predictors of Adequate Knowledge of Malaria in Pregnancy Case-Management 60

Table 18. Other Knowledge Predictors of Adequate Case-Management Knowledge of Malaria in Pregnancy 60

Table 19. Pearson Correlation Coefficients for Provider Practice Scores vs Provider Knowledge Scores for all Providers, stratified by Pregnancy 61

FIGURES 62

Figure 1. Drug Outlet & Simulation Algorithm 62

CHAPTER III 63

Summary, Public Health Implications, Possible Future Directions 63

Improving Healthcare Provider Case Management Practices for Malaria in Pregnancy in Western Kenya: A Clustered Randomized Control Trial 64

Background Information and Scientific Rationale 64

Background Information 64

Rationale 65

Objectives 66

Study Objectives 66

Study Outcome Measures 67

Primary Outcome Measures 67

Secondary Outcome Measures 67

Study Design 67

Study Area 68

Study Population 68

Methodology 69

Phase 1 69

Before-and-after comparison of a simplified memo to improve provider adherence to treatment guidelines for malaria in pregnancy in health facilities 69

Phase 2 69

Before-and-after comparison and between-arm comparison of improved registers and improved registers plus SMS text message reminders to improve provider adherence to treatment guidelines for malaria in pregnancy in health facilities 69

Data Collection 70

Assessment of Correct MiP Case Management Practice in Health Facilities 71

Assessment of MiP Case Management Knowledge and Interventional Tool-Usage in Health Facilities 71

Interim Interventional Tool-Usage Assessment in Health Facilities 72

Data Management 72

Study Enrollment and Withdrawal 72

Subject Inclusion Criteria 72

Subject Exclusion Criteria 73

Treatment Assignment Procedures 73

Randomization Procedures 74

Study Schedule 74

Screening 74

Enrollment/Baseline 74

Follow-up 75

Assessment of Safety 75

Specification of Safety Parameters 75

Methods and Timing for Assessing, Recording, and Analyzing Safety Procedures 75

Adverse Events 75

Reporting Procedures 76

Type and Duration of Follow-up of Subjects after Adverse Events 76

Halting Rules 76

Safety Oversight 76

Statistical Considerations 77

Study Hypotheses 77

Phase 1 77

Phase 2 77

Sample Size Considerations 78

Planned Interim Analysis 79

Safety Review 79

Efficacy Review 79

Final Analysis Plan 79

Ethics/Protection of Human Subjects 81

Ethics Standard 81

Institutional Review Board 82

Informed Consent Process 82

Informed Consent/Assent 82

Exclusion of Women, Minorities, and Children (Special Populations) 83

Subject Confidentiality 83

Study Discontinuation 83

Appendix A 85

Study Design Schematic 85

Schedule of Events 85

National Guidelines for MiP Case Management 86

About this Master's Thesis

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• Permission granted by the author to include this thesis or dissertation in this repository. All rights reserved by the author. Please contact the author for information regarding the reproduction and use of this thesis or dissertation.

School	Rollins School of Public Health
Department	Epidemiology
Subfield / Discipline	Global Epidemiology - MPH & MSPH
Degree	MPH
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Health Sciences, Medicine and Surgery Health Sciences, Epidemiology
Keyword	case management pregnancy provider adherence Kenya malaria
Committee Chair / Thesis Advisor	Stein, Aryeh D, Emory University
Committee Members	Gutman, Julie R, Emory University
Partnering Agencies	US (Federal) agency other than CDC Non-US governmental agency (e.g., Minister of Health in Haiti) CDC

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