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 the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: a qualitative study.

OBJECTIVES: Although substandard and falsified (SF) blood pressure (BP) lowering medications are a global problem, qualitative research exploring factors driving this in Nigeria has not been reported. This study provides information on factors driving demand for and supply of low-quality BP lowering medications in Nigeria and potential strategies to address these factors. METHODS: This was a cross-sectional qualitative study. Between August 2020 and September 2020, we conducted 11 in-depth interviews and 7 focus group discussions with administrators of health facilities, major manufacturers and distributors of BP lowering medications, pharmacists, drug regulators, patients and primary care physicians purposively sampled from the Federal Capital Territory, Nigeria. Data were analysed using directed content analysis, with the aid of Dedoose. RESULTS: We found that demand for SF BP lowering medications in Nigeria was driven by high out-of-pocket expenditure and stockouts of quality-assured BP lowering medications. Supply of low-quality BP lowering medications was driven by limited in-country manufacturing capacity, non-adherence to good manufacturing and distribution practices, under-resourced drug regulatory systems, ineffective healthcare facility operations, poor distribution practices, limited number of trained pharmacists and the COVID-19 pandemic which led to stockouts. Central medicine store procurement procedures, active pharmaceutical ingredient quality check and availability of trained pharmacists were existing strategies perceived to lower the risk of supply and demand of SF BP lowering medications. CONCLUSION: Our findings suggest that demand for and supply of SF BP lowering medications in Nigeria are driven by multi-level, interrelated factors. Multi-pronged strategies need to target stakeholders and systems involved in drug production, distribution, prescription, consumption, regulation and pricing.

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.