Human Immunodeficiency Virus and Malaria Co-Infection among Adults in the North-Central Zone of Nigeria, in the era of Improved access to Prevention and Control: A Study Protocol

TLDR: The aim of the research study is to provide epidemiological data of malaria among HIV positive individuals, establish the socio-economic determinants associated with HIV-malaria co- Infection, and develop a co-infection intervention model.

Abstract: Background: Despite a notable reduction in the incidence and prevalence of HIV and malaria, both diseases remain the leading cause of morbidity and mortality, especially in sub-Saharan Africa. The aim of the research study is to provide epidemiological data of malaria among HIV positive individuals, establish the socio-economic determinants associated with HIV-malaria co-infection, and develop a co-infection intervention model. This research study will enable health policymakers to develop new health policies in the management and care of HIV-malaria co-infected patients. Methods and Analysis: The study design will be a retrospective, descriptive cross-sectional study. Case files of HIV positive individuals receiving care and treatment will be randomly selected at six selected peri-urban secondary hospitals. Interviews will be conducted among HIV positive patients, health managers, and doctors at selected hospitals. A mixed method (quantitative and qualitative) will be adopted in the research study. Proportional allocation will be used to select an estimated 1,652 case files of registered patients to be reviewed across the study location. Statistical Package for Social Sciences version 25.0 will be used for data analysis. The categorical variable will be illustrated as a percentage and compared using Chi-square and Fisher’s exact test. Backward multivariate analysis will be used to evaluate HIV-malaria co-infection and associated health outcomes. The continuous variables will be summarised as mean, ± SD or median, interquartile range, and compared using student t-test or Wilcoxon test. Values of P < 0.05 will be considered significant. Qualitative data will be analysed using NVivo 12 software. Strengths and Limitations of This Study Strengths The proposed large sample size of case files to be reviewed will enhance the validity and precision of the research study. Limitations Data that will be generated might not be adequate to make a generalized conclusion for the whole country.    Q= Quarter. Since the study involves the use of secondary data (generated from patient case files), missing data is anticipated.   Strike actions by health care workers were also expected. Another limitation is that the research study will not be conducted as a prospective cohort study. Ethics and Dissemination Considering the research study involves the use of secondary data, the ethical approval issued to conduct the study covers the informed consent of the participants’ information. Copies of written informed consent, participant consent, and confidentiality forms will be provided to the participants both in English and in the native language, notably Hausa, TIV, and Yoruba. Verbal informed and signed informed consent to take part in the study will be obtained from the participants. This study was approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC)-Reference Number: (BE654/17). Ethical approval was also obtained from the Kwara State Ministry of Health (MOH/KS/EU/777/225), Benue State Ministry of Health (MOH/STA/204/56), and the Nasarawa State Ministry of Health: NHREC 18/06/2017). Findings from this study will be published in peer-reviewed local and international journals. Findings will also be made available to health policymakers at the state ministry of health and hospital facilities selected for the study. The principal investigators and the health providers will sensitize patients on the study outcome.