RESEARCH PROPOSAL - Makerere University

1 PREVALENCE OF ADVERSE NEONATAL OUTCOME AND ASSOCIATION WITH HIV INFECTION AMONG POSTNATAL WOMEN IN MTWARA REGIONAL HOSPITAL-TANZANIA PRINCIPAL INVESTIGATOR DR. JOSEPH .C. HOKORORO MD (Dar) A DISSERTATION TO BE SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF DEGREE OF MASTER OF SCIENCE IN CLINICAL EPIDEMIOLOGY AND BIOSTATISTICS OF Makerere University . MAY 2009 ii DECLARATION I hereby declare to the best of my knowledge that the work presented in this dissertation has not been presented for any award in any institution and has never been published anywhere.

2 All the work is original unless otherwise stated. I m therefore presenting it for the award of Degree of Master of Science (Clinical Epidemiology and Biostatistics) of Makerere University , Kampala, Uganda .. Joseph Christopher Hokororo Doctor of medicine (Dar es salaam) This dissertation has been submitted for examination with the approval of the following supervisors.. Dr. Charles Karamagi, MMED (paed) (Mak),PHD (Berg.)

3 Director of Clinical Epidemiology Unity and Senior lecturer of paediatrics and clinical Epidemiology . Makerere University , Uganda .. Dr. Kaye Dan, MMED (obs/gyn) (Mak), PHD (Mak) Senior Lecturer Department of Obstetrics and Gynaecology Makerere University , Uganda .. Prof. Karimu Manji, MMED (paed) (Dar), PHD (berg). Consultant paediatrician and Professor of Paediatrics Muhimbili University of Health and Allied Sciences.

4 Dar es salaam, Tanzania iii DEDICATION Dedicated to my beloved wife Dr. Frida W. Mghamba To my son Chris Junior To my parents Mr. Hokororo Christopher and Mrs. Hokororo Imelda for bringing me up as a potential academician. iv AKNOWLEDGMENT First and foremost I thank the almighty Omnipotent, Omniscient and Omnipresent God for giving me strength and courage throughout the period of my studies and for his guidance and for helping me to complete this dissertation.

5 Secondly, I extend my heartfelt gratitude to my supervisors Dr. Charles Karamagi, Dr. Kaye Dan and Prof. Karimu Manji for their invaluable guidance rendered to me and for taking their time to read through my work. I am extremely grateful for their tireless criticisms and suggestions made from concept paper up to report writing. I would like to acknowledge and thank the Tanzania Ministry of Health and Social Welfare for sponsoring the entire study. Further more, I would like to thank Mtwara regional Hospital administration for giving me permission to conduct the study in their Hospital.

6 My thanks go to all my RESEARCH assistants (Dr. Kimbau and Dr Minja) and study participants for their priceless input in this project. I will always be grateful to the Director of Clinical Epidemiology Unit, Dr. Charles Karamagi, the Acting Director Ms Joan Nakayaga Kalyango, staff and students of Clinical Epidemiology Unit (CEB II, 2008/2009), for their guidance throughout the course work and criticisms of dissertation draft. v TABLE OF CONTENTS DECLARATION .. ii DEDICATION.

7 Iii iv TABLE OF CONTENTS ..v LIST OF TABLES .. vii LIST OF APPENDICES .. ix LIST OF OPERATIONAL DEFINITIONS .. xi ABSTRACT .. xii CHAPTER ONE ..1 Introduction ..1 Literature Review ..3 Introduction ..3 The prevalence of adverse neonatal outcome ..3 Adverse neonatal outcome and its association with HIV infection among postnatal women ..6 Other factors associated with adverse neonatal outcome among post ..6 CHAPTER Problem statement ..9 10 Conceptual framework .. 10 RESEARCH questions.

8 12 Objectives of the study .. 12 General objective .. 12 Specific objectives .. 12 12 Null Hypothesis .. 12 Alternative Hypothesis .. 13 CHAPTER 14 Methods .. 14 Study design .. 14 vi Study Setting .. 14 Population .. 14 Selection criteria .. 14 Sampling procedure .. 14 Sample size Estimation .. 14 Measurements .. 17 Predictor Variables .. 17 Data Collection, Management and 18 Data collection .. 18 Data 19 Data Analysis .. 19 Quality Control .. 20 Ethical 20 CHAPTER FOUR.

9 21 Results .. 21 Description of the study 21 Socio-demographic characteristics of the participants .. 22 Prevalence of adverse neonatal 26 Association between independent variable(s) and adverse neonatal outcome .. 28 Results from the multivariate analysis .. 35 CHAPTER FIVE .. 37 Discussion .. 37 Prevalence of adverse neonatal 37 Association between hiv infection and adverse neonatal outcome .. 40 Limitations of the study .. 44 CHAPTER SIX .. 46 Conclusions and recommendations .. 46 Conclusions.

10 46 Recommendations .. 46 REFERENCE .. 47 vii LIST OF TABLES Table 1: Baseline characteristics of the postnatal women (n=480) .. 23 Table 2: Socio demographic characteristics comparison of postnatal women with hiv positive (n=160) and hiv negative (n=320) .. 24 Table 3: Description of hiv status of the postnatal women (n=160) .. 25 Table 4: Prevalence (descriptive) of neonatal adverse outcome .. 26 Table 5: Contribution of various levels to the general adverse neonatal outcome .. 27 Table 6: Prevalence of adverse neonatal outcome at various demographic characteristics.