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.

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.

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.

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.

Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial.

In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care.

Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial

In a three-arm, randomised, controlled trial among 60 Nigerian adults with hypertension, community health worker support and home blood pressure monitoring led to greater reductions in systolic blood pressure at four weeks compared to the usual care

Left ventricular mass estimation by different partition values in a large population of black hypertensive subjects.

AIMS: Our aim is to compare the impact of the 2 most widely used methods of indexing left ventricular mass (LVM) on the distribution of abnormal left ventricular (LV) geometric patterns, in a large sample of untreated asymptomatic black hypertensive subjects. METHODS AND RESULTS: All patients with hypertension referred to the Cardiology unit of University of Abuja Teaching Hospital, Abuja, Nigeria from 2006 to 2013, who gave informed consent, and underwent physical examination and echocardiography. LVM indexation was classified into 4 geometric patterns after echocardiography: normal geometry, concentric hypertrophy, concentric remodeling, and eccentric hypertrophy. Concentric hypertrophy was the commonest geometric pattern and was detected in 33.6% to 39.5% of the patients. LVM/height2.7 was a better method to detect abnormal geometric pattern than LVM/BSA (P < 0.0001). CONCLUSION: In a large cohort of hypertensive subjects with no clinical evidence of cardiovascular disease, abnormal LV geometry was found in greater than four-fifths of the population. In addition, LVM indexed for height 2.7 was found to be a better method for detecting LVH than LVM indexed for BSA, as the highest prevalence of abnormal geometry was diagnosed when LVM was indexed for height2.7.

Risk-Factor Profile and Comorbidities in 2398 Patients With Newly Diagnosed Hypertension From the Abuja Heart Study.

Risk factors, comorbidities, and end-organ damage in newly diagnosed hypertension (HT) are poorly described in larger cohorts of urban African patients undergoing epidemiological transition. We therefore decided to characterize a large cohort of hypertensive subjects presenting to a tertiary health center in sub-Saharan Africa. It is an observational cross-sectional study. We prospectively collected detailed clinical, biochemical, electrocardiography, and echocardiography data of all subjects with HT as the primary diagnosis in patients presenting at the Cardiology Unit of the University of Abuja Teaching Hospital over an 8-year period. Of 2398 subjects, 1187 patients (49.4%) were female with a mean age of 51 ± 12.8 years. Presenting symptoms and signs were most commonly palpitation in 691 (28.8%) followed by dyspnoea on exertion in 541 (22.6%), orthopnea in 532 (22.2%), pedal oedema in 468 (19.5%), paroxysmal nocturnal dyspnoea in 332 (13.8%), whereas only 31 (1.3%) presented with chest pain. Risk factors were obesity in 671 (28%); 523 (21.8%) had total cholesterol >5.2 mmol/L, diabetes mellitus was present in 201 (8.4%) and 187 (7.8%) were smokers. End-organ damage was present in form of echocardiographic left ventricular hypertrophy in 1336 (55.7%) followed by heart failure in 542 (22.6%). Arrhythmias occurred in 110 (4.6%) of cases, cerebrovascular accident in 103 (4.3%), chronic kidney disease in 26 (1.1%), hypertensive encephalopathy in 10 (0.4%), and coronary artery disease in 6 (0.26%). There were marked differences in sex as women were more obese and men presented with more advanced disease. The burden of HT and its complications in this carefully characterized African cohort is quite enormous with more than three-fourth having one form of complication. The need of effective primary and secondary preventive measures to be mapped out to tackle this problem cannot be overemphasized.