Estimated health benefits, costs and cost-effectiveness of eliminating industrial trans-fatty acids in Nigeria: cost-effectiveness analysis.

INTRODUCTION: Nigeria is committed to reducing industrial trans-fatty acids (iTFA) from the food supply, but the potential health gains, costs and cost-effectiveness are unknown. METHODS: The effect on ischaemic heart disease (IHD) burden, costs and cost-effectiveness of a mandatory iTFA limit (≤2% of all fats) for foods in Nigeria were estimated using Markov cohort models. Data on demographics, IHD epidemiology and trans-fatty acid intake were derived from the 2019 Global Burden of Disease Study. Avoided IHD events and deaths; health-adjusted life years (HALYs) gained; and healthcare, policy implementation and net costs were estimated over 10 years and the population's lifetime. Incremental cost-effectiveness ratios using net costs and HALYs gained (both discounted at 3%) were used to assess cost-effectiveness. RESULTS: Over the first 10 years, a mandatory iTFA limit (assumed to eliminate iTFA intake) was estimated to prevent 9996 (95% uncertainty interval: 8870 to 11 118) IHD deaths and 66 569 (58 862 to 74 083) IHD events, and to save US$90 million (78 to 102) in healthcare costs. The corresponding lifetime estimates were 259 934 (228 736 to 290 191), 479 308 (95% UI 420 472 to 538 177) and 518 (450 to 587). Policy implementation costs were estimated at US$17 million (11 to 23) over the first 10 years, and US$26 million USD (19 to 33) over the population's lifetime. The intervention was estimated to be cost-saving, and findings were robust across several deterministic sensitivity analyses. CONCLUSION: Our findings support mandating a limit of iTFAs as a cost-saving strategy to reduce the IHD burden in Nigeria.

Evaluation of Primary Healthcare Centers' Service Availability and Readiness for Implementing Diabetes Care in Abuja, Nigeria: A Cross-Sectional, Formative Assessment.

Introduction: Noncommunicable diseases (NCDs) are associated with a high and rising burden of morbidity and mortality in sub-Saharan Africa, including Nigeria. Diabetes mellitus (DM) is among the leading causes of NCD-related deaths worldwide and is a foremost public health problem in Nigeria. As part of the National Multi-Sectoral Action Plan for the Prevention and Control of NCDs, Nigeria has committed to implementing the World Health Organization (WHO) Package of Essential NCD control interventions. Implementing the intervention requires the availability of essential elements, including guidelines, trained staff, health management information systems, equipment, and medications, in primary healthcare centers (PHCs). This study assessed the availability of the WHO package components and the readiness of PHCs to implement a DM screening, evaluation, and management program. Methods: This cross-sectional formative assessment adapted the WHO Service Availability and Readiness Assessment (SARA) tool to survey 30 PHCs selected by multistage sampling for readiness to deliver DM diagnosis and care in Abuja, Nigeria, between August 2021 and October 2021. The service availability and readiness indicator scores were calculated based on the proportion of PHCs with available DM care services, minimum staff requirement, diagnostic tests, equipment, medications, and national guidelines/protocols for DM care within the defined SARA domain. Results: All 30 PHCs reported the availability of at least two full-time staff (median [interquartile range] staff = 5 [4-9]), which were mostly community health extension workers (median [interquartile range]) = 3 [1-4]. At least one staff member was recently trained in DM care in only 11 (36%) of the PHCs. The study also reported high availability (100%) of paper-based health management information systems (HMIS) and DM screening services using a glucometer (87%), but low availability of DM treatment (23%), printed job aids (27%), and national guidelines/protocols (0%). Conclusion: This systematic assessment of PHCs' readiness to implement a DM screening, evaluation, and management program in Abuja demonstrated readiness to integrate DM care into PHCs in terms of equipment, paper-based HMIS, and nonphysician health workers' availability. However, strategies are needed to promote DM health workforce training, provide DM management guidelines, and ensure a reliable supply of essential DM medications.

Interventions and contextual factors to improve retention in care for patients with hypertension in primary care: Hermeneutic systematic review.

BACKGROUND: Regular engagement over time in hypertension care, or retention, is a crucial but understudied step in optimizing patient outcomes. This systematic review leverages a hermeneutic methodology to identify, evaluate, and quantify the effects of interventions and contextual factors for improving retention for patients with hypertension. METHODS: We searched for articles that were published between 2000 and 2022 from multiple electronic databases, including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and WHO International Trials Registry. We followed the latest version of the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline to report the findings for this review. We also synthesized the findings using a hermeneutic methodology for systematic reviews, which used an iterative process to review, integrate, analyze, and interpret evidence. RESULTS: From 4686 screened titles and abstracts, 18 unique studies from 9 countries were identified, including 10 (56%) randomized controlled trials (RCTs), 3 (17%) cluster RCTs, and 5 (28%) non-RCT studies. The number of participants ranged from 76 to 1562. The overall mean age range was 41-67 years, and the proportion of female participants ranged from 0% to 100%. Most (n = 17, 94%) studies used non-physician personnel to implement the proposed interventions. Fourteen studies (78%) implemented multilevel combinations of interventions. Education and training, team-based care, consultation, and Short Message Service reminders were the most common interventions tested. CONCLUSIONS: This review presents the most comprehensive findings on retention in hypertension care to date and fills the gaps in the literature, including the effectiveness of interventions, their components, and contextual factors. Adaptation of and implementing HIV care models, such differentiated service delivery, may be more effective and merit further study. REGISTRATION: CRD42021291368. PROTOCOL REGISTRATION: PROSPERO 2021 CRD42021291368. Available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=291368.

Formative Evaluation and Adaptation of a Hypertension Extension for Community Health Outcomes Program for Healthcare Workers within the Federal Capital Territory, Nigeria.

Background: The Extension for Community Health Outcomes (ECHO) model has been used extensively to link care providers in rural communities with experts with the aim of improving local patient care. Objective: The aim of this qualitative research study was to assess the feasibility, acceptability, perceived needs, and contextual factors to guide implementation of a hypertension focused ECHO program for Community Health Extension Workers (CHEWs) in the Federal Capital Territory, Nigeria. Methods: From September 2020 to December 2020, key informant interviews were performed with seven global organizations (hubs) providing ECHO training focused on cardiovascular disease or nephrology to identify contextual factors and implementation strategies used by each hub. In February 2022, seven focus group discussions were performed with 42 frontline healthcare workers in the Federal Capital Territory to inform local adaptation of a hypertension ECHO program. Directed content analysis identified major themes which were mapped to the Consolidated Framework for Implementation Research. Qualitative analyses were performed using Dedoose, and results were synthesized using the Implementation Research Logic Model. Results: We found both barriers and facilitators across the Consolidated Framework for Implementation Research domains that mapped to a number of constructs in each one. The results of these analyses confirmed that the core components of the ECHO model are a feasible and appropriate intervention for hypertension education of healthcare workers. However, implementing the ECHO program within the Federal Capital Territory may require strategies such as utilizing communications resources effectively, developing incentives to motivate initial participation, and providing rewards or recognition for ongoing engagement. Conclusions: These results provide valuable formative insights to guide implementation of our proposed hypertension ECHO program for CHEWs in the Federal Capital Territory, Nigeria. This information was used for key decisions around: 1) scope and content of training, 2) format and frequency, 3) selection of implementation strategies, and 4) building a community of practice.

Facilitators and barriers to optimal home blood pressure management in patients with hypertensive disorders of pregnancy in a tertiary care facility in Abuja, Nigeria: a qualitative research study.

BACKGROUND: Nigeria has one of the highest burdens of maternal deaths globally, and hypertensive disorders of pregnancy (HDP) are the leading cause of maternal morbidity and mortality in the country. There is a significant implementation gap in utilizing evidence-based practices for the management of HDP in Nigeria. This study evaluated facilitators and barriers to implementing a home blood pressure monitoring program to improve management of HDP. METHODS: From August 2022 to September 2022, we conducted 15 semi-structured, key informant interviews and 4 focus group discussions among patients, health care workers, and administrators at University of Abuja Teaching Hospital (UATH), a tertiary care centre in Nigeria. The study used the Consolidated Framework for Implementation Research to assess five domains: individual characteristics, inner and outer settings, intervention characteristics, and process of implementation. Audio files were transcribed, and data were analysed using a combination of inductive and deductive approaches. We also conducted 32 brief surveys on the participants to assess acceptability, appropriateness, and feasibility of a blood pressure monitoring program. RESULTS: The study sample consisted of healthcare workers (n=22) including specialists in cardiology, obstetrics and gynaecology, maternal-foetal medicine, nurses/midwives and resident doctors as well as patients (n=10). Mean (SD) age was 39.5 (10.9), and 78% were female. Participants identified facilitators including the perceived simplicity of home blood pressure monitoring program, high burden of HDP, and availability of a multi-disciplinary team of healthcare professionals with expertise in HDP management. Barriers identified were cost, limited knowledge of HDP amongst patients, limited transportation networks, inconsistent management protocols, and inadequate manpower and facilities. Survey results indicated that between 81% and 88% of participants reported that a blood pressure monitoring program would be acceptable, 56%-72% reported that it would be appropriate, and 47%-69% reported that it would be feasible. CONCLUSION: This study identified facilitators and barriers while highlighting key implementation strategies to leverage and effectively address these respectively to enable successful implementation of a home blood pressure monitoring program. It also demonstrated that a home blood pressure monitoring program was considered acceptable, appropriate and feasible among respondents interviewed at UATH.

Comparative cardiac effects of antimalarial drug halofantrine with or without concomitant administration of kolanut or fluconazole in healthy volunteers.

Background: There is rekindled interest in the cardiotoxicity of antimalarial medicines. Halofantrine is associated with QT interval prolongation. Fluconazole and kolanut alter the pharmacokinetics of halofantrine. Objectives: The study assessed the electrocardiographic changes of concomitant administration of kolanut or fluconazole with halofantrine and the effects on the QTc interval. Methods: Eighteen healthy volunteers received a single oral dose of halofantrine, halofantrine with kolanut or halofantrine with fluconazole in a crossover study. Twelve lead electrocardiography (ECG) was performed to measure the PR and QT interval (QTc). Statistical analysis was with SPSS at 5% level of significance. Results: PR intervals were shortened by halofantrine alone and halofantrine with kolanut (169.29 28.67 to 165.29 28.007 and 172.73 29.843 to 163.00 18.336ms) but was prolonged by halofantrine with fluconazole (177.70 27.394 to 186.59 44.434ms). There was prolongation of QTc (384.76 21.727 to 394.12 21.525; 381.36 22.29 to 388.30 17.26 and 382.35 20.08 to 390.84 21.97) in all the three treatment groups at 6 hours, p>0.05. One subject on halofantrine and fluconazole had QTc >440ms. Pre-treatment PR interval (PR0) correlated well with post-treatment PR6, and with PR14 r= 0.519, p= 0.014; r=0.664, p=0.013. Conclusion: Concomitant intake of kolanut with halofantrine was significantly decrease cardiac effect of halofantrine.

The Pandemic of Coronary Artery Disease in the Sub-Saharan Africa: What Clinicians Need to Know.

PURPOSE OF REVIEW: Cardiovascular diseases (CVDs) are a leading cause of morbidity and mortality globally with an accelerated increase in CVD­related death in Africa and other low­middle­income countries. This review is aimed at highlighting the burden of coronary artery disease CAD, its peculiarities as well as challenges of management in sub-Saharan Africa. RECENT FINDINGS: Recent data revealed a shift from high incidence of CVDs associated with poverty and malnutrition (such as rheumatic heart disease) initially, which are now falling, to rising incidence of other non-communicable CVDs (such as hypertension, coronary artery disease (CAD), and heart failure). Africa disproportionately bears the brunt of CVD burden and has one of the highest risks of dying from non-communicable diseases (NCDs) worldwide, which is projected to supersede communicable diseases in the future. Previous studies have shown that CAD was rare among Africans. Those studies conducted in Africa in the 1940s-1960s reported that Black Africans were almost immune to developing CAD and were even thought to have specific genetic make-up protecting them from CAD. However, the continent is now experiencing a steady rise in the prevalence of CAD associated with severe disease burden, compared to other regions of the world. The changes seen have been attributed to the current epidemiological transition with increase in CVD risk factors that are poorly controlled, lack of awareness as well as the poor health facilities to tackle the menace of the disease. The Global Burden of Disease (GBD) estimates have also shown that over the past three decades the highest contribution to CVD burden in Africa is attributed to atherosclerotic diseases, with 71.4, 37.7, and 154% increases in the burden of ischemic heart disease, stroke, and peripheral artery disease respectively. There is a steady increase of CAD prevalence in Africa as a result of increase in CV risk factors. Hypertension, obesity, diabetes, dyslipidemia, and cigarette smoking are the rapidly rising risk factors for CAD on the continent. Africa also faces challenges in diagnosis and management of CAD. There is need for increased public and health personnel awareness on prevention and control of commonly identifiable risk factors, provision of prehospital emergency services, and provision of modern therapeutic facilities for treatment of CAD including reperfusion therapy. These are priority areas where efforts could be intensified in the future with potential to improve the current rate of progress of the disease on the continent.

Elevated blood pressure among adolescents in sub-Saharan Africa: a systematic review and meta-analysis.

BACKGROUND: More people from sub-Saharan Africa aged between 20 years and 60 years are affected by end-organ damage due to underlying hypertension than people in high-income countries. However, there is a paucity of data on the pattern of elevated blood pressure among adolescents aged 10-19 years in sub-Saharan Africa. We aimed to provide pooled estimates of high blood pressure prevalence and mean levels in adolescents aged 10-19 years across sub-Saharan Africa. METHODS: In this systematic review and meta-analysis, we searched PubMed, Google Scholar, African Index Medicus, and Embase to identify studies published from Jan 1, 2010, to Dec 31, 2021. To be included, primary studies had to be observational studies of adolescents aged 10-19 years residing in sub-Saharan African countries reporting the pooled prevalence of elevated blood pressure or with enough data to compute these estimates. We excluded studies on non-systemic hypertension, in African people not living in sub-Saharan Africa, with participant selection based on the presence of hypertension, and with adult cohorts in which we could not disaggregate data for adolescents. We independently extracted relevant data from individual studies using a standard data extraction form. We used a random-effects model to estimate the pooled prevalence of elevated blood pressure and mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels overall and on a sex-specific basis. This study is registered with PROSPERO (CRD42022297948). FINDINGS: We identified 2559 studies, and assessed 81 full-text studies for eligibility, of which 36 studies comprising 37 926 participants aged 10-19 years from ten (20%) of 49 sub-Saharan African countries were eligible. A pooled sample of 29 696 adolescents informed meta-analyses of elevated blood pressure and 27 155 adolescents informed meta-analyses of mean blood pressure. Sex data were available from 26 818 adolescents (14 369 [53·6%] were female and 12 449 [46·4%] were male) for the prevalence of elevated blood pressure and 23 777 adolescents (12 864 [54·1%] were female and 10 913 [45·9%] were male) for mean blood pressure. Study quality was high, with no low-quality studies. The reported prevalence of elevated blood pressure ranged from 4 (0·2%) of 1727 to 1755 (25·1%) of 6980 (pooled prevalence 9·9%, 95% CI 7·3-12·5; I?=99·2%, pheterogeneity<0·0001). Mean SBP was 111 mm Hg (95% CI 108-114) and mean DBP was 68 mm Hg (66-70). 13·4% (95% CI 12·9-13·9; pheterogeneity<0·0001) of male participants had elevated blood pressure compared with 11·9% (11·3-12·4; pheterogeneity<0·0001) of female participants (odds ratio 1·04, 95% CI 0·81-1·34; pheterogeneity<0·0001). INTERPRETATION: To our knowledge, this systematic review and meta-analysis is the first systematic synthesis of blood pressure data specifically derived from adolescents in sub-Saharan Africa. Although many low-income countries were not represented in our study, our findings suggest that approximately one in ten adolescents have elevated blood pressure across sub-Saharan Africa. Accordingly, there is an urgent need to improve preventive heart-health programmes in the region. FUNDING: None.

Clinical characteristics and treatment patterns of pregnant women with hypertension in primary care in the Federal Capital Territory of Nigeria: cross-sectional results from the hypertension treatment in Nigeria Program.

BACKGROUND: Hypertensive disorders of pregnancy, including hypertension, are a leading cause of maternal mortality in Nigeria. However, there is a paucity of data on pregnant women with hypertension who receive care in primary health care facilities. This study presents the results from a cross-sectional analysis of pregnant women enrolled in the Hypertension Treatment in Nigeria Program which is aimed at integrating and strengthening hypertension care in primary health care centres. METHODS: A descriptive analysis of the baseline results from the Hypertension Treatment in Nigeria Program was performed. Baseline blood pressures, treatment and control rates of pregnant women were analysed and compared to other adult women of reproductive age. A complete case analysis was performed, and a two-sided p value < 0.05 was considered statistically significant. RESULTS: Between January 2020 to October 2022, 5972 women of reproductive age were enrolled in the 60 primary healthcare centres participating in the Hypertension Treatment in Nigeria Program and 112 (2%) were pregnant. Overall mean age (SD) was 39.6 years (6.3). Co-morbidities were rare in both groups, and blood pressures were similar amongst pregnant and non-pregnant women (overall mean (SD) first systolic and diastolic blood pressures were 157.4 (20.6)/100.7 (13.6) mm Hg and overall mean (SD) second systolic and diastolic blood pressures were 151.7 (20.1)/98.4 (13.5) mm Hg). However, compared to non-pregnant women, pregnant women had a higher rate of newly diagnosed hypertension (65.2% versus 54.4% p = 0.02) and lower baseline walk-in treatment (32.1% versus 42.1%, p = 0.03). The control rate was numerically lower among pregnant patients (6.3% versus 10.2%, p = 0.17), but was not statistically significant. Some pregnant patients (8.3%) were on medications contraindicated in pregnancy, and none of the pregnant women were on aspirin for primary prevention of preeclampsia. CONCLUSIONS: These findings indicate significant gaps in care and important areas for future studies to improve the quality of care and outcomes for pregnant women with hypertension in Nigeria, a country with the highest burden of maternal mortality globally.

Nigeria healthcare worker SARS-CoV-2 serology study: Results from a prospective, longitudinal cohort.

Healthcare workers, both globally and in Nigeria, have an increased risk for SARS-CoV-2 infection compared with the general population due to higher risk contacts, including occupational exposures. In addition, primary healthcare workers represent an important group for estimating prior infection to SARS-CoV-2 because they work at the first point-of-contact for most patients yet have not been included in prior COVID-19 seroepidemiology research in Nigeria. We sought to evaluate baseline seroprevalence, rates of seroconversion (IgG- to IgG+) and seroreversion (IgG+ to IgG-), change in IgG concentration at 3- and 6-month follow-up, and factors associated with seropositivity. From June 2020 to December 2020, we conducted a longitudinal seroepidemiology study among frontline health care workers in Nigeria using a validated dried blood spot assay. Among 525 participants, mean (SD) age was 39.1 (9.7) years, 61.0% were female, and 45.1% were community health workers. The six-month follow-up rate was 93.5%. Seropositivity rates increased from 31% (95% CI: 27%, 35%) at baseline to 45% (95% CI: 40%, 49%) at 3-month follow-up, and 70% (95% CI: 66%, 74%) at 6-month follow-up. There was a corresponding increase in IgG levels from baseline (median = 0.18 ug/mL) to 3-month (median = 0.35 ug/mL) and 6-month follow-up (median = 0.59 ug/mL, Ptrend < .0001). A minority of participants reported symptoms from February 2020 until baseline (12.2%) or during 3-month (6.6%) or 6-month (7.5%) follow-up. only 1 participant was hospitalized. This study demonstrated high baseline, 3-month and 6-month follow-up prevalence of IgG antibodies to SARS-CoV-2 during the first two waves of the COVID-19 pandemic in Nigeria among a cohort of unvaccinated frontline healthcare workers, including primary healthcare workers despite low symptomatology. These results may have implications in state- and national-level disease pandemic modeling. Trial registration: NCT04158154.

Prevalence and risk factors for subclinical atherosclerosis amongst adults living with HIV in University of Abuja Teaching Hospital, Gwagwalada.

Background: Subclinical atherosclerosis characterizes cardiovascular diseases (CVD), and Human Immunodeficiency Virus (HIV) infection and antiretroviral therapy (ART) are identified risk factors for atherosclerosis. Meanwhile, data on HIV and atherosclerosis in Nigeria are limited. Objectives: We sought to estimate the prevalence of subclinical atherosclerosis and associated risk factors amongst adult persons living with HIV/AIDS (PLHIV) enrolled at University of Abuja Teaching Hospital, Gwagwalada, Abuja (UATH). Methods: This was a cross-sectional study of 277 consecutively selected PLHIV ≥18 years enrolled for HIV care and treatment at UATH. Pretested structured questionnaire was used to collect data from consenting ART-experienced and ART-naïve patients on risk factors of atherosclerosis. Carotid intima media thickness (CIMT) ≥0.71 mm as measured by Doppler ultrasonography was used to identify patients with sub-clinical atherosclerosis. Two logistic regression models with (Model-A) and without (Model-B) traditional risk factors were fitted to identify risk factors of subclinical atherosclerosis. Results: Participants' mean age was 39.44 ± 10.71 years with female preponderance (64.26%). Overall prevalence of subclinical atherosclerosis was 43.32% (62.25% in ART-experienced). Model-A identified male sex [AOR 4.33(1.74-10.76), p = 0.002], advancing age [30-39 years AOR 5.95(1.31-26.96), p = 0.021]; ≥40 years AOR 19.51(4.30-88.56), p ≤ 0.001), advancing HIV infection [≥WHO stage II AOR 4.19(1.11-15.92), p = 0.035], hypercholesterolemia [AOR 3.88(1.47-10.25), p ≤ 0.001] and ≥5 year duration on ART [AOR 9.05(3.16-25.92), p ≤ 0.001] as risk factors of subclinical atherosclerosis. In Model-B (excluding traditional risk factors) on the other hand, advancing HIV infection [≥WHO stage II AOR 3.93(1.19-13.042), p = 0.025] and duration on ART [≥5 years AOR 11.43(4.62-28.29), p = 0.001] were found as risk factors of subclinical atherosclerosis. Conclusion: Subclinical atherosclerosis was higher in ART-experienced patients, and this was irrespective of presence or absence of traditional risk factors. And advancing HIV disease and duration on ART were found as significant risk factors for subclinical atherosclerosis. We therefore recommend routine CVD risk screening in PLHIV.

Presence of trans-Fatty Acids Containing Ingredients in Pre-Packaged Foods and the Availability of Reported trans-Fat Levels in Kenya and Nigeria.

In most African countries, the prevalence of industrially produced trans-fatty acids (iTFA) in the food supply is unknown. We estimated the number and proportion of products containing specific (any hydrogenated edible oils) and non-specific (vegetable fat, margarine, and vegetable cream) ingredients potentially indicative of iTFAs among pre-packaged foods collected in Kenya and Nigeria. We also summarized the number and proportion of products that reported trans-fatty acids levels and the range of reported trans-fatty acids levels. In total, 99 out of 5668 (1.7%) products in Kenya and 310 out of 6316 (4.9%) products in Nigeria contained specific ingredients indicative of iTFAs. Bread and bakery products and confectioneries in both countries had the most foods that contained iTFAs-indicative ingredients. A total of 656 products (12%) in Kenya and 624 products (10%) in Nigeria contained non-specific ingredients that may indicate the presence of iTFAs. The reporting of levels of trans-fatty acids was low in both Kenya and Nigeria (11% versus 26%, respectively, p < 0.001). With the increasing burden of ischemic heart disease in Kenya and Nigeria, the rapid adoption of WHO best-practice policies and the mandatory declaration of trans-fatty acids are important for eliminating iTFAs.

Fixed-dose combination therapy-based protocol compared with free pill combination protocol: Results of a cluster randomized trial.

Fixed-dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster-randomized trial evaluates effectiveness and safety of a treatment protocol that used two-drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6-month follow-up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6-months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster-adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6-months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates.

Stakeholder perspectives on Nigeria's national sodium reduction program: Lessons for implementation and scale-up.

BACKGROUND: To reduce excess dietary sodium consumption, Nigeria's 2019 National Multi-sectoral Action Plan (NMSAP) for the Prevention and Control of Non-communicable Diseases includes policies based on the World Health Organization SHAKE package. Priority actions and strategies include mandatory sodium limits in processed foods, advertising restrictions, mass-media campaigns, school-based interventions, and improved front-of-package labeling. We conducted a formative qualitative evaluation of stakeholders' knowledge, and potential barriers as well as effective strategies to implement these NMSAP priority actions. METHODS: From January 2021 to February 2021, key informant interviews (n = 23) and focus group discussions (n = 5) were conducted with regulators, food producers, consumers, food retailers and restaurant managers, academia, and healthcare workers in Nigeria. Building on RE-AIM and the Consolidated Framework for Implementation Research, we conducted directed content qualitative analysis to identify anticipated implementation outcomes, barriers, and facilitators to implementation of the NMSAP sodium reduction priority actions. RESULTS: Most stakeholders reported high appropriateness of the NMSAP because excess dietary sodium consumption is common in Nigeria and associated with high hypertension prevalence. Participants identified multiple barriers to adoption and acceptability of implementing the priority actions (e.g., poor population knowledge on the impact of excess salt intake on health, potential profit loss, resistance to change in taste) as well as facilitators to implementation (e.g., learning from favorable existing smoking reduction and advertising strategies). Key strategies to strengthen NMSAP implementation included consumer education, mandatory and improved front-of-package labeling, legislative initiatives to establish maximum sodium content limits in foods and ingredients, strengthening regulation and enforcement of food advertising restrictions, and integrating nutrition education into school curriculum. CONCLUSION: We found that implementation and scale-up of the Nigeria NMSAP priority actions are feasible and will require several implementation strategies ranging from community-focused education to strengthening current and planned regulation and enforcement, and improvement of front-of-package labeling quality, consistency, and use.

Characteristics and Patterns of Retention in Hypertension Care in Primary Care Settings From the Hypertension Treatment in Nigeria Program.

Background: More than 1.2 billion adults worldwide have hypertension. High retention in clinical care is essential for long-term management of hypertension, but 1-year retention rates are less than 50% in many resource-limited settings. Objective: To evaluate short-term retention rates and associated factors among patients with hypertension in primary health care centers in the Federal Capital Territory of Nigeria. Design, Setting, and Participants: In this cohort study, data were collected by trained study staff from adults aged 18 years or older at 60 public, primary health care centers in Nigeria between January 2020 and July 2021 as part of the Hypertension Treatment in Nigeria (HTN) Program. Patients with hypertension were registered. Exposures: Follow-up visit for hypertension care within 37 days of the registration visit. Main Outcomes and Measures: The main outcome was the 3-month rolling average 37-day retention rate in hypertension care, calculated by dividing the number of patients who had a follow-up visit within 37 days of their first (ie, registration) visit in the program by the total number of registered patients with hypertension during multiple consecutive 3-month periods. Interrupted time series analyses evaluated trends in retention rates before and after the intervention phase of the HTN Program. Mixed-effects, multivariable regression models evaluated associations between patient-, site-, and area council-level factors, hypertension treatment and control status, and 37-day retention rate. Results: In total, 10 686 patients (68.3% female; mean [SD] age, 48.8 [12.7] years) were included in the analysis. During the study period, the 3-month rolling average 37-day retention rate was 41% (95% CI, 37%-46%), with wide variability among sites. The retention rate was higher among patients who were older (adjusted odds ratio [aOR], 1.01 per year; 95% CI, 1.01-1.02 per year), were female (aOR, 1.11; 95% CI, 1.01-1.23), had a higher body mass index (aOR, 1.01; 95% CI, 1.00-1.02), were in the Kuje vs the Abaji area council (aOR, 2.25; 95% CI, 1.25-4.04), received hypertension treatment at the registration visit (aOR, 1.27; 95% CI, 1.07-1.50), and were registered during the postintervention period (aOR, 1.16; 95% CI, 1.06-1.26). Conclusions and Relevance: The findings suggest that retention in hypertension care is suboptimal in primary health care centers in Nigeria, although large variability among sites was found. Potentially modifiable and nonmodifiable factors associated with retention were identified and may inform multilevel, contextualized implementation strategies to improve retention.

Effect of 3, 2-Drug Combinations of Antihypertensive Therapies on Blood Pressure Variability in Black African Patients: Secondary Analyses of the CREOLE Trial.

BACKGROUND: The effect of 3 commonly recommended combinations of anti-hypertensive agents-amlodipine plus hydrochlorothiazide (calcium channel blocker [CCB]+thiazide), amlodipine plus perindopril (CCB+ACE [angiotensin-converting enzyme]-inhibitor), and perindopril plus hydrochlorothiazide (ACE-inhibitor+thiazide) on blood pressure variability (V) are unknown. METHODS: We calculated the blood pressure variability (BPV) in 405 patients (130, 146, and 129 randomized to ACE-inhibitor+thiazide, CCB+thiazide, and CCB+ACE-inhibitor, respectively) who underwent ambulatory blood pressure monitoring after 6 months of treatment in the Comparisons of Three Combinations Therapies in Lowering Blood Pressure in Black Africans trial (CREOLE) of Black African patients. BPV was calculated using the SD of 30-minute interval values for 24-hour ambulatory BPs and for confirmation using the coefficient of variation. Linear mixed model regression was used to calculate mean differences in BPV between treatment arms. Within-clinic BPV was also calculated from the mean SD and coefficient of variation of 3 readings at clinic visits. RESULTS: Baseline distributions of age, sex, and blood pressure parameters were similar across treatment groups. Participants were predominately male (62.2%) with mean age 50.4 years. Those taking CCB+thiazide had significantly reduced ambulatory systolic and diastolic BPV compared with those taking ACE-inhibitor+thiazide. The CCB+thiazide and CCB+ACE-inhibitor groups showed similar BPV. Similar patterns of BPV were apparent among groups using within-clinic blood pressures and when assessed by coefficient of variation. CONCLUSIONS: Compared with CCB-containing combinations, ACE-inhibitor plus thiazide was associated with higher levels, generally significant, of ambulatory and within-clinic systolic and diastolic BPV. These results supplement the differential ambulatory blood pressure-lowering effects of these therapies in the CREOLE trial.

Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial.

BACKGROUND: Hypertension is the most common cardiovascular disease in Nigeria and contributes to a large non-communicable disease burden. Our aim was to implement and evaluate a large-scale hypertension treatment and control program, adapted from the Kaiser Permanent Northern California and World Health Organization HEARTS models, within public primary healthcare centers in the Federal Capital Territory, Nigeria. METHODS: A type 2 hybrid, interrupted time series design was used to generate novel information on large-scale implementation and effectiveness of a multi-level hypertension control program within 60 primary healthcare centers in the Federal Capital Territory, Nigeria. During the formative phase, baseline qualitative assessments were held with patients, health workers, and administrators to inform implementation package adaptation. The package includes a hypertension patient registry with empanelment, performance and quality reporting, simplified treatment guideline emphasizing fixed-dose combination therapy, reliable access to quality essential medicines and technology, team-based care, and health coaching and home blood pressure monitoring. Strategies to implement and adapt the package were identified based on barriers and facilitators mapped in the formative phase, previous implementation experience, mid-term qualitative evaluation, and ongoing stakeholder and site feedback. The control phase included 11 months of sequential registration of hypertensive patients at participating primary healthcare centers, followed by implementation of the remainder of the package components and evaluation over 37 subsequent, consecutive months of the intervention phase. The formative phase was completed between April 2019 and August 2019, followed by initiation of the control phase in January 2020. The control phase included 11 months (January 2020 to November 2020) of sequential registration and empanelment of hypertensive patients at participating primary healthcare centers. After completion of the control phase in November 2020, the intervention phase commenced in December 2020 and will be completed in December 2023. DISCUSSION: This trial will provide robust evidence for implementation and effectiveness of a multi-level implementation package more broadly throughout the Federal Capital Territory, which may inform hypertension systems of care throughout Nigeria and in other low- and middle-income countries. Implementation outcome results will be important to understand what system-, site-, personnel-, and patient-level factors are necessary for successful implementation of this intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04158154 . The trial was prospectively registered on November 8, 2019.

A Differential Response to Antihypertensive Therapy in African Men and Women: Insights From the CREOLE Trial.

BACKGROUND: We sought to address the paucity of data to support the evidence-based management of hypertension to achieve optimal blood pressure (BP) control on a sex-specific basis in Africa. METHODS: We undertook a post hoc analysis of the multicenter, randomized CREOLE (Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans) Trial to test the hypothesis that there would be clinically important differences in office BP control between African men and women. We compared the BP levels of 397 and 238 hypertensive women (63%, 50.9 ± 10.5 years) and men (51.2 ± 11.3 years) from 10 sites across sub-Saharan Africa who completed baseline and 6-month profiling according to their randomly allocated antihypertensive treatment. RESULTS: Overall, 442/635 (69.6%) participants achieved an office BP target of <140/90 mm Hg at 6 months; comprising more women (286/72.0%) than men (156/65.5%) (adjusted odds ratio [OR] 1.59, 95% confidence interval [CI] 1.07-2.39; P = 0.023). Women randomized to amlodipine-hydrochlorothiazide (HCTZ) (adjusted OR 3.03, 95% CI 1.71-5.35; P < 0.001) or amlodipine-perindopril (adjusted OR 2.62, 95% CI 1.49-4.58; P = 0.01) were more likely to achieve this target compared with perindopril-HCTZ. Among men, there were no equivalent treatment differences-amlodipine-HCTZ (OR 1.54, 95% CI 0.76-3.12; P = 0.23) or amlodipine-perindopril (OR 1.32, 95% CI 0.65-2.67; P = 0.44) vs. perindopril-HCTZ. Among the 613 participants (97%) with 24-hour ambulatory BP monitoring, women had significantly lower systolic (124.1 ± 18.1 vs. 127.3 ± 16.9; P = 0.028) and diastolic (72.7 ± 10.4 vs. 75.1 ± 10.5; P = 0.007) BP levels at 6 months compared with men. CONCLUSIONS: These data suggest clinically important differences in the therapeutic response to antihypertensive combination therapy among African women compared with African men.

Characteristics, treatment, and control of hypertension in public primary healthcare centers in Nigeria: baseline results from the Hypertension Treatment in Nigeria Program.

BACKGROUND: There are limited data on large-scale, multilevel implementation research studies to improve hypertension diagnosis, treatment, and control rates at the primary healthcare (PHC) level in Africa. We describe the characteristics, treatment, and control rates of patients with hypertension in public PHC centers in the Hypertension Treatment in Nigeria Program. METHODS: Data were collected from adults at least 18 years at 60 public PHC centers between January 2020 and November 2020. Hypertension treatment rates were calculated at registration and upon completion of the initial visit. Hypertension control rates were calculated based on SBP and DBPs less than 140/90 mmHg. Regression models were created to evaluate factors associated with hypertension treatment and control status. RESULTS: Four thousand, nine hundred and twenty-seven individuals [66.7% women, mean (SD) age = 48.2 (12.9) years] were included. Mean (SD) SBP was higher in men compared with women [152.9 (20.0) mmHg versus 150.8 (21) mmHg, P = 0.001]. Most (58.3%) patients were on treatment at the time of registration, and by the end of the baseline visit, 89.2% of patients were on treatment. The baseline hypertension control rate was 13.1%, and control was more common among patients who were older [adjusted OR (95% CI) 1.01 [1.01 -1.02)], women [adjusted OR (95% CI) 1.30 (1.05- 1.62)], who used fixed dose combination therapy [adjusted OR (95% CI) 1.83 (1.49 -2.26)], and had higher education levels. CONCLUSION: This baseline report of the largest facility-based hypertension study in Africa demonstrates high hypertension treatment rates but low control rates.