National Health Research Ethics Committee Research Articles

Evaluating the impact of the global evidence, local adaptation (GELA) project for enhancing evidence-informed guideline recommendations for newborn and young child health in three African countries: a mixed-methods protocol

BackgroundPoverty-related diseases (PRD) remain amongst the leading causes of death in children under-5 years in sub-Saharan Africa (SSA). Clinical practice guidelines (CPGs) based on the best available evidence are key to strengthening health systems and helping to enhance equitable health access for children under five. However, the CPG development process is complex and resource-intensive, with substantial scope for improving the process in SSA, which is the goal of the Global Evidence, Local Adaptation (GELA) project. The impact of research on PRD will be maximized through enhancing researchers and decision makers’ capacity to use global research to develop locally relevant CPGs in the field of newborn and child health. The project will be implemented in three SSA countries, Malawi, South Africa and Nigeria, over a 3-year period. This research protocol is for the monitoring and evaluation work package of the project. The aim of this work package is to monitor the various GELA project activities and evaluate the influence these may have on evidence-informed decision-making and guideline adaptation capacities and processes. The specific project activities we will monitor include (1) our ongoing engagement with local stakeholders, (2) their capacity needs and development, (3) their understanding and use of evidence from reviews of qualitative research and, (4) their overall views and experiences of the project.MethodsWe will use a longitudinal, mixed-methods study design, informed by an overarching project Theory of Change. A series of interconnected qualitative and quantitative data collections methods will be used, including knowledge translation tracking sheets and case studies, capacity assessment online surveys, user testing and in-depth interviews, and non-participant observations of project activities. Participants will comprise of project staff, members of the CPG panels and steering committees in Malawi, South Africa and Nigeria, as well as other local stakeholders in these three African countries.DiscussionOngoing monitoring and evaluation will help ensure the relationship between researchers and stakeholders is supported from the project start. This can facilitate achievement of common goals and enable researchers in South Africa, Malawi and Nigeria to make adjustments to project activities to maximize stakeholder engagement and research utilization. Ethical approval has been provided by South African Medical Research Council Human Research Ethics Committee (EC015-7/2022); The College of Medicine Research and Ethics Committee, Malawi (P.07/22/3687); National Health Research Ethics Committee of Nigeria (01/01/2007).

Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial

IntroductionPostpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80%...

Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol

IntroductionNon-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted...

A protocol for the study of environmental risk factors and candidate gene–environment interactions in neurodegenerative disorders in Nigeria (SERGEND): A cross-sectional descriptive study

Introduction: The risk of developing neurodegenerative disorders (NDDs) such as Alzheimer’s disease and related dementias (ADRD) and Parkinson’s disease and atypical parkinsonism (PDAP), has been alluded to arise predominantly from the interplay between environmental exposures and genetic variability. The contributions of these factors to NDD in Black sub-Saharan Africans are largely unknown. The broad aim of SERGEND is to investigate the effect of specific environmental exposures and genetic variability on the risk of developing ADRD and PDAP in our population. Methods: The SERGEND, a national, multi-center, cross-sectional, descriptive study, will be conducted in Nigeria, within academic hospitals located in all six geopolitical zones of the country. The study population will comprise 3000 consenting adult Nigerians aged 18 years and above, residing within the recruiting geopolitical zone in the preceding 12 months. Cases will be persons with ADRD or PDAP and age-matched healthy controls. Assessments will include dementia and parkinsonism-specific case ascertainment, disease severity, functional status, and environmental risk factors assessment. Genotyping for APOE and SNCA REP1 polymorphic variability will be conducted. Future analyses will be performed on biobanked samples. Ethics and Dissemination: The study protocol was approved by the National Health Research Ethics Committee in Nigeria, with institutional HREC concordant approval for all participating sites before enrollment of the study participants. Written informed consent was obtained from all study participants or identified proxies. The study results will be published in peer-reviewed journals and as conference abstracts. Trial Registration: International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (www.isrctn.com). Trial registration number: ISRCTN10548575. Locator ID: https://doi.org/10.1186/ISRCTN10548575.

Views of Nigerian civil servants about compulsory COVID-19 vaccination: A qualitative study.

COVID-19 caused unforeseen global burden, although vaccine strategy rapidly stalled transmission and protected those at risk. Many governments made vaccination mandatory for public space access. This study aimed to elucidate perception of Nigerian civil servants towards mandatory COVID-19 vaccination and elicited their recommendations. This study was conducted in twelve purposively selected states in the six geopolitical zones and the Federal Capital Territory (FCT), Nigeria. Relevant ministries, departments and agencies were selected within the study sites. It was a qualitative study that interviewed consenting civil servants. Ethical approval was obtained from the National Health Research Ethics Committee. Interviews were conducted in person, following a pre-test. Data was analysed using NVivo software version 12. Most participants were willing to take the vaccine if their safety was assured. However, enforcement to do so was a hindrance. Most participants commended the government for the effort to curb COVID-19 transmission and create awareness but were displeased with planning and handling of misconceptions. They recommended a more committed approach to vaccine production and funding by the government. Participants were willing to take the COVID-19 vaccines because the gains of protection outweighed the risks. They suggested a less involuntary approach through reinforcing awareness creation and avoiding threats.Contribution:There is limited qualitative research on perception of Nigerian civil servants regarding mandatory COVID-19 vaccination. Being the main driving force of Nigeria's public service, their views are invaluable. Findings could contribute to future policies in times of emergency.

Determinants of Human Papillomavirus Vaccine Acceptance among Caregivers in Nigeria: A Fogg Behavior Model-Based Approach.

Human papillomavirus (HPV) vaccine uptake among adolescent girls is critical to reducing the burden of HPV-related cancers in Nigeria. This study assesses the factors influencing caregivers' acceptance of HPV vaccination for their charges, using the Fogg Behavior Model (FBM) as a theoretical framework. We analyzed cross-sectional data from 1429 caregivers of girls aged 9-17 in six Nigerian states, using a survey instrument based on the FBM. Participants were recruited via Facebook and Instagram advertisements and interviewed through Facebook Messenger in August and September 2023. The study received ethical clearance from Nigeria's National Health Research Ethics Committee. We applied bivariate and multivariate analyses to assess the relationships between the caregiver's perception of how likely their adolescent girl was to get vaccinated in the next 12 months and motivation, ability, social factors (such as discussions with family and friends), injunctive norms, previous COVID-19 vaccination, and respondents' sociodemographic characteristics. Adjusted odds ratios derived from logistic regression analyses revealed that caregivers' motivation and ability, as well as social factors, were significantly associated with their perception that the adolescent girl in their care would get vaccinated within the next 12 months. Our findings suggest that behavioral interventions tailored to enhance motivation, ability, and social support among caregivers could significantly increase HPV vaccine uptake among adolescent girls in Nigeria.

Improving access to family planning for women with disabilities in Kaduna city, Nigeria: study protocol for a pragmatic cluster-randomized controlled trial with integrated process evaluation

BackgroundGlobally, women with disabilities are less likely to have access to family planning services compared to their peers without disabilities. However, evidence of effective interventions for promoting their sexual and reproductive health and rights remains limited, particularly in low- and middle-income settings. To help address disparities, an inclusive sexual and reproductive health project was developed to increase access to modern contraceptive methods and reduce unmet need for family planning for women of reproductive age with disabilities in Kaduna city, Nigeria. The project uses demand-side, supply-side and contextual interventions, with an adaptive management approach. This protocol presents a study to evaluate the project’s impact.MethodsA pragmatic cluster-randomized controlled trial design with surveys at baseline and endline will be used to evaluate interventions delivered for at least 1 year at health facility and community levels in comparison to ‘standard’ state provision of family planning services, in the context of state-wide and national broadcast media and advocacy. Randomization will be conducted based on the health facility catchment area, with 19 clusters in the intervention arm and 18 in the control arm. The primary outcome measure will be access to family planning. It was calculated that at least 950 women aged 18 to 49 years with disabilities (475 in each arm) will be recruited to detect a 50% increase in access compared to the control arm. For each woman with disabilities enrolled, a neighbouring woman without disabilities in the same cluster and age group will be recruited to assess whether the intervention has a specific effect amongst women with disabilities. The trial will be complemented by an integrated process evaluation. Ethical approval for the study has been given by the National Health Research Ethics Committee of Nigeria and London School of Hygiene & Tropical Medicine.DiscussionDefining access to services is complex, as it is not a single variable that can be measured directly and need for family planning is subjectively defined. Consequently, we have conceptualized ‘access to family planning’ based on a composite of beliefs about using services if needed.Trial registrationISRCTN registry ISRCTN12671153. Retrospectively registered on 17/04/2023.

Knowledge, Perception, and Uptake of Mandatory COVID-19 Vaccination among Nigerian Civil Servants: Implications for Evidence-Based Policies

Background: In 2021, some state governments in Nigeria made it compulsory for all civil servants to get vaccinated against COVID-19. Subsequently, the federal government adopted this policy which was met with mixed reactions. This study assessed knowledge, perception, willingness to be vaccinated, uptake, and determinants of full vaccination among Nigerian civil servants.
 Methods: A descriptive cross-sectional study was conducted among 622 civil servants from Ministries across the six geopolitical zones and the Federal Capital Territory using selfadministered structured questionnaires. Ethical approval was obtained from the National Health Research Ethics Committee and analyses done using IBM SPSS v.26.
 Results: The mean age of the respondents was 41.6 ± 9.1 years with most respondents (486; 78.1%) having good knowledge of COVID-19. Two-fifths (252; 40.5%) agreed that there should be no blanket policy for mandatory vaccination. Most of the respondents (463; 74.4%) had been vaccinated and about two-fifths (269; 43.2%) had been fully vaccinated while about a quarter 146 (23.5%) had not been vaccinated at all. Of those (n=159) who had not been vaccinated or were unwilling to disclose their status, the majority 116 (73.0%) were unwilling to be vaccinated. Respondents with a good knowledge of COVID-19 achieved full vaccination status (p = 0.007). 
 Conclusion: Since the majority of the respondents who are Nigerian civil servants had a good knowledge of COVID-19 and had been vaccinated, this study recommends that the government continues its health promotional campaigns towards improved uptake of vaccination against COVID-19 in the populace.

FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS

Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect. The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review. Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process. By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.

Improving Treatment Outcome for Cervical Cancer Using 2-Point Assessment of Quality of Life Among Nigerian Women: A Protocol for a Multi-Center Study.

Cervical cancer is the fourth most common cancer among women globally, with quality of life (QOL) being a major concern for patients with cervical cancer, especially in low- and middle-income countries (LMICs). This is largely due to the advanced nature of the disease at presentation. Although there are a higher number of studies focusing on the QOL of high-income countries, the QOL of cervical cancer patients in LMICs is not available. The aim of this study is to evaluate QOL among women with cervical cancer in Nigeria using a 2-point assessment. A multi-center prospective cohort study will be conducted in 6 tertiary health facilities randomly selected from the 6 geopolitical zones of Nigeria and consisting of a 2-point assessment of the QOL of participants at the time of diagnosis of cervical cancer and after treatment. Women who were recently diagnosed with histologically confirmed cervical cancer (treatment naïve) will be included. QOL will be assessed using Quality of Life Questionnaire domains (EORTC QLQ30) as developed by the European Organization for Research and Treatment of Cancer (EORTC). In addition to the QOL assessment, relevant and clinicopathological variables will be obtained using a self-structured data extraction sheet designed for this study. All data will be anonymized and will be analyzed using SPSS version 25. Levels of QOL will be calculated using EORTC QLQ30. Ethical approval was obtained from National Health Research Ethics Committee (NHREC/01/01/2007-08/11/2021). In view of the paucity of data on QOL in LMICs like Nigeria, where most women with cervical cancer present with advanced disease, this research was designed to help in formulating evidence-based interventions to improve the QOL and treatment outcomes provided to women with cervical cancer in Nigeria and other LMICs. The study is expected to fill these knowledge gaps.

Study of CSF C-Reactive Protein for the Differentiation of Bacterial Meningitis from Aseptic Meningitis in Children

Background: Acute meningitis is a major cause of death, and disability worldwide. Differentiating bacterial from nonbacterial meningitis is very important in deciding on treatment. Bacterial meningitis is a life-threatening neurological condition, and needs prompt parenteral antibiotics, compared to viral, and aseptic meningitis which carries relatively better outcomes. Objective: To identify the importance of Cerebrospinal fluid C- reactive protein (CSF-CRP) to establish the diagnosis of ABM. Method: This study was conducted from 01 January 2017 to 30th June 2017 at the indoor department of Pediatric Medicine at Bangladesh Sishu Hospital & Institute (BSH & I) to the measure of CSF C-Reactive protein for the differentiation of bacterial meningitis from aseptic meningitis in children. One hundred patients had participated after meeting the inclusion, and exclusion criteria. Patients were selected by purposive sampling. Ethical clearance was obtained from the National Health Research Ethics Committee, BangladeshShishu Hospital& Institute, Dhaka. Results: Out of 57 cases of bacterial meningitis, 22 cases were culture-negative, and 35 cases were culture-positive. 22 cases (62.85%) out of 35 cases culture positive were Streptococcus Pneumoniae followed by 08 cases (22.85%) were Neisseria Meningitis, Haemophilus Influenza 3 cases (8.57%), E.coli were 02 cases (5.71%). WBC count & PMN (%) were increased significantly in bacterial meningitis, compared to aseptic meningitis. Protein and glucose levels in CSF were not significantly different between bacterial meningitis, and the aseptic meningitis group (Table 2). In the case of bacterial meningitis, in 51(89.47%) cases out of 57, the CSF CRP test was truly positive, mean±SD 21.7±10.9, and false negative were only 6 cases (10.52%). In aseptic meningitis 39 cases (90.69%) out of 43 cases, the CSF-CRP test was truly negative, and false positives were 04 cases (9.30%). (Table-4) shows outcome in the meningitis group showed .....

International Research and Philanthropy

International Research and Philanthropy

Assessment of whole school approach intervention to reduce violence affecting children in and around schools in Kenya and Tanzania: protocol for a before-and-after, mixed-methods pilot study

IntroductionNational violence against children (VAC) surveys in Tanzania and Kenya reported that approximately three-quarters of children in Tanzania experienced physical violence while 45.9% of women and 56.1% of men experienced...

Adolescent mental health research in Tanzania: a study protocol for a priority setting exercise and the development of an interinstitutional capacity strengthening programme

IntroductionPoor adolescent mental health is a barrier to achieving several sustainable development goals in Tanzania, where adolescent mental health infrastructure is weak. This is compounded by a lack of community...

Incidence Rate of COVID-19 Mortality and its Associated Factors During the First and Second Waves in Nigeria: A Retrospective Cohort Study

Background: COVID-19 mortality rate has not been formally assessed in Nigeria. We therefore aimed to address this gap and identify associated mortality risk factors during the first and second waves in Nigeria.Methods: We conducted a retrospective cohort study using the national surveillance database between February 27, 2020, and April 3, 2021. The outcome was deaths amongst persons with a laboratory diagnosis of COVID-19. Incidence rates of COVID-19 death per 100,000 person-days were estimated. Adjusted negative binomial regression was used to identify factors associated with COVID-19 death, and presented as adjusted Incidence Rate Ratios (aIRR) with 95% confidence intervals (CI). Results: The first wave included 65,790 COVID-19 patients, of whom 994 (1∙51%) died; the second wave included 91,089 patients, of whom 513 (0∙56%) died. The incidence rate of deaths related to COVID-19 was higher in the first wave [54∙25 (95% CI: 50∙98-57∙73)] than in the second wave [19∙19 (17∙60-20∙93)]. Factors independently associated with increased risk of death in both waves were: age ≥45 years, male gender [first wave aIRR 1∙65 (1∙35-2∙02) and second wave 1∙52 (1∙11-2∙06)], being symptomatic [aIRR 3∙17 (2∙59-3∙89) and 3∙04 (2∙20-4∙21)], and being hospitalised [aIRR 4∙19 (3∙26-5∙39) and 7∙84 (4∙90-12∙54)].Interpretation: The incidence rate of COVID-19 death in Nigeria was higher in the first wave, suggesting improved public health response and care during the second wave. Regional mortality differences suggest that policy makers focus on regional equity in access to testing and quality of care to mitigate the impact of another COVID-19 wave in Nigeria.Funding: None to declare. Declaration of Interest: None to declare. Ethical Approval: Ethical approval for the study was given by the Nigeria National Health Research Ethics Committee (NHREC/01/01/2007-22/06/2020).

Description of the Mental Health and Psychosocial Support (MHPSS) Program Run by Médecins Sans Frontières – Spain (MSF) in Borno State, Nigeria

Introduction: Mental Health and psychosocial support (MHPSS) programs are essential during humanitarian crises. For the last 20 years and over 200 projects worldwide, Medecins Sans Frontieres (MSF) integrates MHPSS when responding to humanitarian crises. Here we describe an MSF-Spain MHPSS program, including patients’ clinical features, sociodemographic characteristics, and intervention outcomes. Methods: Retrospective study of 11,709 patients who attended MHPSS program in Pulka and Gwoza (Nigeria) during 2018 and 2019. Patients' information, symptoms, stressors, severity (CGI-S scale), and clinical improvement (CGI-I and MHGS scales) were assessed by patient and counselor during the intervention. Patients' characteristics and associations between symptoms, stressors, severity of illness and clinical improvement are presented.. Findings: Among patients, 78% were classified as of mild or moderate severity at enrollment. Anxiety and depression were the most common disorders. Sexual violence, torture, and other conflict/violence related stressors were strongly associated with posttraumatic stress disorder (PTSD). Being an unaccompanied minor was associated with higher severity. Most patients presented an improvement in outcome at discharge, either by counselor rating (92%, CGI-I) or self-rated (73%, MHGS). Patients who benefited from three to six sessions, according to severity, were more likely to present improvement. Interpretation: The number of sessions together with the most powerful potentially traumatic stressors identified were decisive factors associated with patient’s improvement. Therefore, the identification of patients’ stressors and severity to provide the most appropriate number of sessions, and the reduction of the drop-out rate, should be prioritized. Funding Information: Medicins sans Frontieres is the only funding source for this research by the corresponding salaries paid to their employees. Declaration of Interests: All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest other than Medecins Sans Frontieres, or non-financial interest in the subject discussed in this manuscript. Ethics Approval Statement: As this study utilized routine programmatic data and took the necessary steps to protect patient confidentiality, it was exempted from full review by the MSF Ethical Review Board and the National Health Research Ethics Committee of Nigeria (NHREC).

Sero-Epidemiological Survey and Profile of SARS-CoV-2 Infection in Cape Verde

Background: The pandemic caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2), the etiological agent of COVID-19, affected, until July 15, 2020, more than fourteen million people and caused more than six hundred thousand deaths in the world, constituting a worldwide public health concern, especially in small island states. In Cape Verde, the first confirmed case of infection by SARS-CoV-2 was recorded on the island of Boa Vista on March 19, 2020. Since then, the pandemic has spread to several islands, and by July, 2020, only two of the nine inhabited islands had not yet been affected. The general objective of this study was to analyze the seroprevalence and the profile of SARS-CoV-2 infection in the Cape Verdean population.Methods: 1184 households were surveyed, corresponding to a total of 5348 individuals from 10 to 80 years old, stratified at the level of municipalities. A questionnaire containing information on sociodemographic characteristics, living conditions, behavior and symptoms related to COVID-19 was applied to all respondents, and they were all subjected to a rapid test (TDR) to detect total antibodies.Findings: Seroprevalence was 0.4%, being higher in females, 86%, and in the younger age group (10 to 20 years). The counties where positive TDR results were detected were Sal 66%, Maio 15%, Praia 10%, São Domingos 5% and Ribeira Brava de São Nicolau 5%.Other risk factors associated with any significance found were: (i) taking trips outside the municipalities of origin, during the state of emergency, in public transport and (ii) failure to comply with the correct use of a mask whenever one is in place with crowds of people Interpretation: The results of this study allow us to conclude that the Cape Verdean population is susceptible to the virus and, in the near future, there may be an increase in cases of COVID-19.Funding: Ministry of Health and Social Security of Cape Verde, National Institute of Public Health, and Bureau of the World Health Organization in Cape Verde.Declaration of Interests: The authors declare no conflict of interest.Ethics Approval Statement: The study was submitted to the Cape Verde National Health Research Ethics Committee and the National Data Protection Commission. It received approval from both institutions, and is therefore bound by a code of ethics and strict laws that protect participants' confidentiality.

The Burden of HIV, Hepatitis B and Hepatitis C by Armed Conflict Setting the Nigeria Aids Indicator and Impact Survey, 2018

Background: Against a background of security challenges, Nigeria conducted recently the largest population-based HIV survey in the world to ascertain the burden of the HIV disease in the country. We evaluated the main outcomes of the survey and the level of success using participation/response indicators. Methods: The survey was conducted from July 2018 to December 2018 by over 6,000 field staff across Nigeria in six consecutive webs, using two-stage cluster sampling. This analysis was restricted to adults (15-64 years old) from randomly selected households. We estimated the prevalence of HIV, hepatitis B and hepatitis C in the entire country and by conflict zone status. Adjusted odds ratios (OR) and 95% confidence intervals (CI) from survey logistic regression models were used to compare the likelihood of test positivity for the three infections between zones. Findings: A total of 186,405 adults were interviewed from 97,250 households in 3,848 census enumeration areas. Although household response rate was lower in conflict compared to non-conflict areas (68·76% versus 89·83%; p < 0·01), rates of interview response (92·43% versus 91·61%) and blood draw acceptance (94·71% versus 92·91%) were higher in conflict zones. The overall HIV, hepatitis B and hepatitis C positivity rates were 1·55%, 7·63% and 1·73%, respectively. The prevalence of HIV, hepatitis B and C infection was significantly greater in conflict than non-conflict zones (HIV: 1·75% versus 1·0%; hepatitis B: 9·9% versus 7·3%; and hepatitis C: 3·2% versus 0·3%; p < 0·01 in all cases). Individuals living in conflict zones were about three times as likely to test positive for HIV (OR = 2·80, 95% CI = 2·08,3·60) and nearly six times as likely to test positive for hepatitis C (OR = 5·90, 95% CI = 2·17,16·67). Interpretation: Large population-based surveys are feasible, even in armed conflict settings. The burden of HIV, hepatitis B and hepatitis C was significantly higher in areas of conflict in Nigeria, highlighting the need for reinforced public health control measures in these settings in order to attain UNAIDS’ 95-95-95 targets of controlling the HIV epidemic in sub-Saharan Africa by 2030. Funding Statement: President’s Emergency Plan for AIDS Relief (PEPFAR), The US Centers for Disease Control and Prevention, The Global Fund. Declaration of Interests: All authors attest that there is no conflict of interest to be declared Ethics Approval Statement: The protocol for the survey was approved by the Nigeria National Health Research Ethics Committee (NHREC) and the Institutional Review Boards at the CDC and the University of Maryland.

Prevalence, seroconversion and mother-to-child transmission of dual and triplex infections of HIV, hepatitis B and C viruses among pregnant women in Nigeria: study protocol

BackgroundNigeria contributes significantly to the global burden of HIV, Hepatitis B and C infections, either singly or in combinations, despite progress in HIV care regionally and globally. Although some limited data on mono infection of HIV, Hepatitis B and C virus infections do exists, that of dual and triplex infections, including seroconversion and mother-to-child transmission (MTCT) rates necessary for planning to address the scourge of infections in pregnancy are not available.ObjectivesTo determine the seroprevalence, rate of new infections, MTCT of dual and triple infections of HIV, Hepatitis B and C viruses and associated factors, among pregnant women in Nigeria.MethodA multicenter prospective cohort study will be conducted in six tertiary health facilities randomly selected from the six geopolitical zones of Nigeria. All eligible pregnant women are to be tested at enrollment after informed consent for HIV, Hepatitis B and C virus infections. While those positive for at least two of the infections in any combination will be enrolled into the study and followed up to 6 weeks post-delivery, those negative for the three infections or positive for only one of the infections at enrolment will be retested at delivery using a rapid diagnostic test. On enrolment into the study relevant information, will be obtained, and laboratory test of CD4 count, liver function test and full blood counts, and prenatal ultrasonography will also be obtained/performed. Management of mother-newborns pairs will be according to appropriate national guidelines. All exposed newborns will be tested for HIV, HBV or HCV infection at birth and 6 weeks using PCR technique. The study data will be documented on the study case record forms. Data will be managed with SPSS for windows version 23. Ethical approval was obtained from National Health Research Ethics Committee (NHREC) (NHREC/01/01/2007–23/01/2020).ConclusionPregnant women with multiple of HIV, HBV and HCV infections are at increased risk of hepatotoxicity, maternal and perinatal morbidity and mortality. Additionally, infected pregnant women transmit the virus to their unborn baby even when asymptomatic. Children born with any of the infection have significantly poorer quality of life and lower five-year survival rate. Unfortunately, the seroconversion and MTCT rates of dual or triplex infections among pregnant women in Nigeria have not been studied making planning for prevention and subsequent elimination of the viruses difficult. The study is expected to fill this knowledge gaps. Nigeria joining the rest of the world to eliminate the triple infection among children rest on the availability of adequate and reliable data generated from appropriately designed, and powered study using representative population sample. The establishment of the three-in-one study of prevalence, rate of new infection, rate and risk factor for MTCT of dual and triple infection of HIV, Hepatitis B and C viruses among pregnant women in Nigeria is urgently needed for policy development and planning for the improvement of the quality of life of mothers and the elimination of childhood triplex infection.

OC 8716 ENHANCING RESEARCH ETHICS REVIEW CAPACITY IN SUDAN

BackgroundIn Sudan, there is an increase in health research in a situation of scarce resources and limited counteractive quality assurance in research ethics. The aim of this project was to enhance the ethical review system in Sudan.MethodsOur framework for enhancing the ethical review capacity was based on the context of Sudan with emphasis on governance, coordination, feasibility, efficiency and sustainability. Activities conducted to achieve our goals included reviewing the guidelines that govern human subjects research, enhancing the governance of national authorities (National Health Research Ethics Committee and National Medicine and Poisons Board), improving coordination between the national authorities by developing a consensus clarifying their roles and functions, capacity building for the oversight bodies and institutional ethical review committees (RECs) as well as establishing a network of research ethics committees.ResultsThe guidelines that govern human subjects research in Sudan were reviewed and updated. In addition, a consensus document was endorsed to clarify the roles of the national regulatory authorities creating channels of coordination and cooperation between them and institutional RECs. Thirty-nine RECs from different parts of Sudan have been trained and the results of the pre/post test have shown an increase in the knowledge score among trainees (p&lt;0.05). The project has also provided a platform for sharing experiences and maintaining partnerships with regional and international institutes in addition to provision of technical support for newly established RECs.ConclusionWe believe that the array of activities conducted through this project had enhanced the governance, coordination, feasibility and, efficiency of the ethical review system in Sudan.