A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial.

BACKGROUND: The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in Wuhan, Hubei, China, in December 2019. It was recognized as a pandemic by the World Health Organization on 11 March 2020. Outbreak forecasting and mathematical modelling suggest that these numbers will continue to rise. Early identification of effective remedies that can shorten the duration and severity of illness is critical for Lagos State, which is the epi-centre of the disease in Nigeria. METHODS: This is a multi-centre, randomized, double-blind placebo-controlled superiority trial. The study investigates the efficacy of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard of care compared to standard of care only in patients with COVID-19 disease. The primary outcome is the clinical status of patients measured using a 7-point ordinal scale at day 15. Research participants and clinicians will be blinded to the allocated intervention. Outcome measures will be directly assessed by clinicians. Statistical analysis will be done by a team blinded to the identity and allocation of research participants. Data analysis will follow intention-to-treat methods, using R software. DISCUSSION: The current study is of strategic importance for Lagos State in potentially curbing the health, social and economic burden of COVID-19 disease. Should the current study demonstrate that either of the three intervention drugs is more efficacious than standard therapy alone, the State Ministry of Health will develop an evidence-based guideline for the management of COVID-19 in Lagos State. The findings will also be shared nationally and with other states which may lead to a standardized national guideline for the treatment of COVID-19 in Nigeria. TRIAL REGISTRATION: Pan African Clinical Trials Register PACTR202004801273802 . Registered prospectively on April 2, 2020.

Tuberculosis infection prevention and control measures in DOTS centres in Lagos State, Nigeria.

Nigeria is a high tuberculosis (TB) burden country. However, there is limited evidence on implementation of tuberculous infection prevention and control (TBIC) practices in Nigeria. To assess TBIC practices, and barriers to their implementation, in TB-DOTS centres in Lagos State, Nigeria. A descriptive cross-sectional study was used to assess 112 TB-DOTS centres in primary and secondary health facilities in Lagos State using mixed methods. Quantitative data comprised a survey and measurement of the air exchange rate in a subsample of centres. The qualitative aspect comprised focus-group discussions to highlight health care workers' (HCWs') perceptions of TBIC guidelines and barriers to their implementation. The majority of the DOTS centres had a dedicated TBIC officer, while a fifth (21%) had documented TBIC plans. About 57% of DOTS centres had staff that had been trained on TBIC and 37% provided some form of personal respiratory protection (face masks/tissue papers) for staff or patients. The air exchange rate was adequate in 21% of centres. The HCWs' perception of being at risk of contracting TB was reported to affect the way they relate to TB patients. The key barrier to implementing TBIC was the design of DOTS centres. TBIC measures at study centres were inadequate. Institutional commitment, renovation of existing and appropriate design of new DOTS centres in the future to improve TBIC implementation is recommended. .

Assessment of the knowledge of teachers about asthma and the availability of facilities for asthma care in public secondary schools in Lagos, Nigeria.

BACKGROUND: Asthma is a common chronic illness affecting young people. Asthma management at schools may be influenced by teachers' knowledge of the condition and the availability of treatment facilities. OBJECTIVES: To assess the knowledge of secondary school teachers in Lagos, Nigeria, regarding asthma and to evaluate management options available at schools. METHODS: A descriptive cross-sectional study was conducted. Schools were selected by proportional sampling of the educational districts, followed by stratified single-stage cluster sampling. All consenting teachers in the 54 selected schools were recruited. A self-administered questionnaire was used for data collection. A composite score was calculated, with 32 as the maximum possible. Knowledge was regarded as poor if scores were <16, fair for scores between 16 and 21, and good if scores were ≥22. RESULTS: Results show that 475 (48.1%) of the respondents had poor knowledge, 414 (41.9%) had fair knowledge, and only 99 (10%) had good knowledge. Better knowledge about asthma was associated with personal experience (χ² =16.466; p=0.001) or history of a family member with the condition (χ² =6.412; p=0.04). Of the 54 schools surveyed, only 9 (16%) had a school clinic, while a school nurse was available at only 4 (7.41%) of the schools. None of the schools had access to a nebuliser in case of an asthma emergency. CONCLUSION: Teachers in secondary schools in Lagos have unsatisfactory knowledge about asthma and are not equipped to support affected students during an asthma episode.

Antihypertensive use, prescription patterns, and cost of medications in a Teaching Hospital in Lagos, Nigeria.

INTRODUCTION: Hypertension has been reported as the strongest modifiable risk factor for cardiovascular morbidity and mortality. AIMS: The aim of the study was to identify the most prescribed antihypertensive drugs, its patterns, comorbidities, cost of medications, and laboratory investigations. SETTINGS AND DESIGN: This study was a cross-sectional, descriptive study of hypertensive patients conducted at the Lagos State University Teaching Hospital, Ikeja. SUBJECTS AND METHODS: A total of 200 case notes were retrieved from the medical records unit over a period of 8 weeks. Information on antihypertensive prescriptions and comorbidities was retrieved. The average cost of medications and laboratory investigations was calculated. Statistical Analysis Tool Used: SPSS software version 16. RESULTS: The mean age of the patients was 58.44 ± 12.65 years. Of the 200 patients, 5 (2.5%) were on monotherapy and 195 (97.5%) were on combination therapy. One hundred and twenty (60%) patients had comorbidities which included congestive heart failure 55 (27.5%), diabetes mellitus 22 (11%), hyperlipidemia 15 (7.5%), and cardiovascular disease 13 (6.5%). The various classes of antihypertensive drugs prescribed were diuretics 128 (64.0%), beta-blockers 126 (63.0%), calcium channel blockers 106 (53.0%), angiotensin-converting enzymes inhibitors 103 (51.5%), angiotensin receptor blockers 33 (16.5%), alpha blockers 9 (4.5%), and fixed drug combinations 2 (1.0%). The average cost per month of the antihypertensive medications was ₦ 2045 (US$10.2). CONCLUSIONS: Antihypertensive prescription pattern was in accordance with the seventh report of Joint National Committee on Prevention, Detection, Evaluation, and Treatment of high blood pressure. Community-based insurance scheme should be encouraged and effective implementation of integrated noncommunicable diseases screening into the primary health care services would be helpful.

Tuberculosis infection control measures in health care facilities offering tb services in Ikeja local government area, Lagos, South West, Nigeria.

BACKGROUND: Tuberculosis infection among health care workers is capable of worsening the existing health human resource problems of low--and middle-income countries. Tuberculosis infection control is often weakly implemented in these parts of the world therefore, understanding the reasons for poor implementation of tuberculosis infection control guidelines are important. This study was aimed at assessing tuberculosis infection control practices and barriers to its implementation in Ikeja, Nigeria. METHODS: A cross-sectional study in 20 tuberculosis care facilities (16 public and 4 private) in Ikeja, Lagos was conducted. The study included a facility survey to assess the availability of tuberculosis infection control guidelines, the adequacy of facilities to prevent transmission of tuberculosis and observations of practices to assess the implementation of tuberculosis infection control guidelines. Four focus group discussions were carried out to highlight HCWs' perceptions on tuberculosis infection control guidelines and barriers to its implementation. RESULTS: The observational study showed that none of the clinics had a tuberculosis infection control plan. No clinic was consistently screening patients for cough. Twelve facilities (60%) consistently provided masks to patients who were coughing. Ventilation in the waiting areas was assessed to be adequate in 60% of the clinics while four clinics (20%) possessed N-95 respirators. Findings from the focus group discussions showed weak managerial support, poor funding, under-staffing, lack of space and not wanting to be seen as stigmatizing against tuberculosis patients as barriers that hindered the implementation of TB infection control measures. CONCLUSION: Tuberculosis infection control measures were not adequately implemented in health facilities in Ikeja, Nigeria. A multi-pronged approach is required to address the identified barriers to the implementation of tuberculosis infection control guidelines.

Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial.

AIMS AND OBJECTIVES: The immunogenicity, reactogenicity and safety of the 10- valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in a cohort of Nigerian infants included in a study conducted in Mali and Nigeria (ClinicalTrials.gov identifier: NCT00678301). SUBJECTS AND METHODS: In this open, randomised, controlled study, 119 healthy infants received combined diphtheria-tetanus-whole-cell pertussis-hepatitis B/ Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) and oral poliovirus vaccine (OPV) co-administered with PHiD-CV (PHiD-CV group) or without PHiD-CV (control group) at 6-10-14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity were measured and adverse events were recorded. RESULTS: One month post-dose 3, for each of the vaccine pneumococcal serotypes, e"90.1% of PHiD-CV recipients had an antibody concentration e"0.2 ug/mL compared to < 9 % (except for serotypes 14 [32.4%] and 19F [27.8%]) in the control group. For each of the vaccine pneumococcal serotypes, e"90.6% of infants in the PHiD-CV group had an OPA titre e"8, compared to % 18% (except for serotype 7F [60.0%]) in the control group. Anti-protein D antibody geometric mean antibody concentrations were 2949.7 EL.U/mL in the PHiD-CV group and 68.9 EL.U/mL in the control group. For each DTPw-HBV/Hib antigen antibody seroprotection/seropositivity rates were e"94.4%. Tolerability was generally comparable between the PHiD-CV and control vaccination groups. CONCLUSIONS: PHiD-CV co-administered with routine vaccines was immunogenic for all vaccine pneumococcal serotypes and protein D in Nigerian infants. Vaccine tolerability was generally comparable between the PHiD-CV and control groups. These results suggest PHiD-CV can be co-administered with other vaccines included in the National Programme on Immunisation.

Community education on cervical cancer amongst market women in an urban area of Lagos, Nigeria.

BACKGROUND: Cervical cancer is one of the most common forms of carcinoma among women worldwide, accounting for about 12% of all cancers. Tragically, studies have shown generally low awareness levels on its symptoms, risk factors and prevention. This study evaluated the effect of a health education program on knowledge of cervical cancer amongst women at risk in Africa. METHOD: This study was conducted in the city of Lagos, Nigeria, using a multistage sampling technique. Two model markets were chosen by simple random sampling method from a total of 10 local governments with model markets. One was designated the intervention/experimental group while the other was the control. Systematic sampling method was used in selecting 350 women comprising of 175 participants from each model market. A baseline survey on cervical cancer awareness and screening practices was carried out in both sample groups with the aid of interviewer-administered, structured and pre-tested questionnaires. Thereafter, respondents in the intervention group received sessions of community-based educational messages on cervical cancer and its prevention. Subsequently, participants in both groups were reassessed to evaluate the effect of the educational program. Data analysis was conducted with Epi-info statistical software. RESULTS: Knowledge level was low on cervical cancer at baseline; only about 15% and 6.9% of participants in the intervention and control groups respectively had heard of cervical cancer. The most common sources of information were friends and media prior to the intervention. Significant increase in proportions were found in the intervention/experimental group on awareness of cervical cancer (61.7%), associated symptoms and risk factors such as early sexual debut, promiscuity and smoking. CONCLUSION: It is apparent that efforts must be put in place by all stakeholders in reaching women at risk of cervical cancer through well organized educational campaigns using culturally sensitive information, education and communication.