Windows of opportunity in integrating mental health into care of neglected tropical diseases: the Nigeria experience.

In this invited commentary, the Mental Health and the Neglected Tropical Diseases(NTDs) Program leads in the Nigerian Federal Ministry of Health and Social Welfare share the opportunities that have arisen from recent global progress in normative guidance and political interest in the intersection of mental health and NTDs. They describe the new collaboration that has taken place between their programs, e.g. contributing to the World Health Organization Essential Care Package for Mental Health, Stigma and NTDs and integration of mental health for the first time into the new National NTD Masterplan.

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.

Addressing the unmet mental health needs of people living with HIV: a scoping review of interventions in sub-Saharan Africa.

Some mental health interventions have addressed mental health among people living with HIV (PLWH) using a variety of approaches, but little is known about the details of such interventions in sub-Saharan Africa (SSA), a region that bears the largest burden of HIV in the world. The present study describes mental health interventions for PLWH in SSA regardless of the date and language of publication. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) reporting guidelines, we identified 54 peer-reviewed articles on interventions addressing adverse mental health conditions among PLWH in SSA. The studies were conducted in 11 different countries, with the highest number of studies in South Africa (33.3%), Uganda (18.5%), Kenya (9.26%), and Nigeria (7.41%). While only one study was conducted before the year 2000, there was a gradual increase in the number of studies in the subsequent years. The studies were mostly conducted in hospital settings (55.5%), were non-pharmacologic (88.9%), and interventions were mostly cognitive behavioural therapy (CBT) and counselling. Task shifting was the primary implementation strategy used in four studies. Interventions addressing the mental health needs of PLWH that incorporates the unique challenges and opportunities in SSA is highly recommended.

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.

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.

Stakeholder perspectives to inform adaptation of a hypertension treatment program in primary healthcare centers in the Federal Capital Territory, Nigeria: a qualitative study.

BACKGROUND: Implementing an evidence-based hypertension program in primary healthcare centers (PHCs) in the Federal Capital Territory, Nigeria is an opportunity to improve hypertension diagnosis, treatment, and control and reduce deaths from cardiovascular diseases. This qualitative research study was conducted in Nigerian PHCs with patients, non-physician health workers, administrators and primary care physicians to inform contextual adaptations of Kaiser Permanente Northern California's hypertension model and the World Health Organization's HEARTS technical package for the system-level, Hypertension Treatment in Nigeria (HTN) Program. METHODS: Purposive sampling in 8 PHCs identified patients (n = 8), non-physician health workers (n = 12), administrators (n = 3), and primary care physicians (n = 6) for focus group discussions and interviews. The Primary Health Care Performance Initiative (PHCPI) conceptual framework and Consolidated Framework for Implementation Research (CFIR) domains were used to develop semi-structured interviews (Appendix 1, Supplemental Materials) and coding guides. Content analysis identified multilevel factors that would influence program implementation. RESULTS: Participants perceived the need to strengthen four major health system inputs across CFIR domains for successful adaptation of the HTN Program components: (1) reliable drug supply and blood pressure measurement equipment, (2) enable and empower community healthcare workers to participate in team-based care through training and education, (3) information systems to track patients and medication supply chain, and (4) a primary healthcare system that could offer a broader package of health services to meet patient needs. Specific features of the PHCPI framework considered important included: accessible and person-centered care, provider availability and competence, coordination of care, and proactive community outreach. Participants also identified patient-level factors, such as knowledge and beliefs about hypertension, and financial and transportation barriers that could be addressed with better communication, home visits, and drug financing. Participants recommended using existing community structures, such as village health committees and popular opinion leaders, to improve knowledge and demand for the HTN Program. CONCLUSIONS: These results provide information on specific primary care and community contextual factors that can support or hinder implementation and sustainability of an evidence-based, system-level hypertension program in the Federal Capital Territory, Nigeria, with the ultimate aim of scaling it to other parts of the country.

Capacity and site readiness for hypertension control program implementation in the Federal Capital Territory of Nigeria: a cross-sectional study.

BACKGROUND: Nigeria faces an increase in the burden of non-communicable diseases (NCDs), including cardiovascular diseases (CVDs), leading to an estimated 29% of all deaths in the country. Nigeria has an estimated hypertension prevalence ranging from 25 to 40% of her adult population. Despite this high burden, awareness (14-30%), treatment (< 20%), and control (9%) rates of hypertension are low in Nigeria. Against this backdrop, we sought to perform capacity and readiness assessments of public Primary Healthcare Centers (PHCs) to inform Nigeria's system-level hypertension control program's implementation and adaptation strategies. METHODS: The study employed a multi-stage sampling to select 60 from the 243 PHCs in the Federal Capital Territory (FCT) of Nigeria. The World Health Organization (WHO) Service Availability and Readiness Assessment was adapted to focus on hypertension diagnosis and treatment and was administered to PHC staff from May 2019 - October 2019. Indicator scores for general and cardiovascular service readiness were calculated based on the proportion of sites with available amenities, equipment, diagnostic tests, and medications. RESULTS: Median (interquartile range [IQR]) number of full-time staff was 5 (3-8), and were predominantly community health extension workers (median = 3 [IQR 2-5]). Few sites (n = 8; 15%) received cardiovascular disease diagnosis and management training within the previous 2 years, though most had sufficient capacity for screening (n = 58; 97%), diagnosis (n = 56; 93%), and confirmation (n = 50; 83%) of hypertension. Few PHCs had guidelines (n = 7; 13%), treatment algorithms (n = 3; 5%), or information materials (n = 1; 2%) for hypertension. Most sites (n = 55; 92%) had one or more functional blood pressure apparatus. All sites relied on paper records, and few had a functional computer (n = 10; 17%) or access to internet (n = 5; 8%). Despite inclusion on Nigeria's essential medicines list, 35 (59%) PHCs had zero 30-day treatment regimens of any blood pressure-lowering medications in stock. CONCLUSIONS: This first systematic assessment of capacity and readiness for a system-level hypertension control program within the FCT of Nigeria demonstrated implementation feasibility based on the workforce, equipment, and paper-based information systems, but a critical need for essential medicine supply strengthening, health-worker training, and protocols for hypertension treatment and control in Nigeria.

Pyridoxal 5 phosphate for neuroleptic-induced tardive dyskinesia.

BACKGROUND: Tardive dyskinesia is a chronic and disabling abnormal movement disorder affecting the muscles of the face, neck, tongue and the limbs. It is a common side effect of long-term antipsychotic medication use in individuals with schizophrenia and other related psychotic disorders. While there are no known effective treatments for tardive dyskinesia to date, some reports suggest that pyridoxal 5 phosphate may be effective in reducing the severity of tardive dyskinesia symptoms. OBJECTIVES: To determine the effectiveness of pyridoxal 5 phosphate (vitamin B6 or Pyridoxine or Pyridoxal phosphate) in the treatment of neuroleptic-induced tardive dyskinesia among people with schizophrenia and other related psychotic disorders. SEARCH METHODS: The Cochrane schizophrenia group's register of clinical trials was searched (January 2013) using the phrase: [*Pyridoxal* OR *Pyridoxine* OR *P5P* OR *PLP* OR *tardoxal* OR *Vitamin B6* O *Vitamin B 6* R in title, abstract or index terms of REFERENCE, or interventions of STUDY. References of relevant identified studies were handsearched and where necessary, the first authors of relevant studies were contacted. SELECTION CRITERIA: Studies described as randomised controlled trials comparing the effectiveness pyridoxal 5 phosphate with placebo in the treatment of neuroleptic-induced tardive dyskinesia among patients with schizophrenia. DATA COLLECTION AND ANALYSIS: The review authors independently extracted data from each selected study. For dichotomous data, we calculated risk ratios (RR) and their 95% confidence intervals (CIs) on an intention-to-treat basis based on a fixed-effect model. For continuous data, we calculated mean differences (MD) with 95% CIs, again based on a fixed-effect model. We assessed risk of bias for each included study and used GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to rate quality of evidence. MAIN RESULTS: Of the 12 records retrieved by the search, three trials published in 2001, 2003 and 2007, involving 80 inpatients with schizophrenia, aged 18 to 71 years, admitted in a psychiatric facility and followed up for a period nine weeks to 26 weeks, were included. Overall, pyridoxal 5 phosphate produced a significant improvement in tardive dyskinesia symptoms when compared with placebo, assessed by a change in Extrapyramidal Symptoms Rating Scale (ESRS) scores from baseline to the end of the first phase of the included studies (2 RCTs n = 65, RR 19.97, CI 2.87 to 139.19, low quality evidence). The endpoint tardive dyskinesia score (a measure of its severity) assessed with the ESRS, was significantly lower among participants on pyridoxal 5 phosphate compared to those on placebo (2 RCTs n = 60, MD -4.07, CI -6.36 to -1.79, low quality evidence).It was unclear whether pyridoxal 5 phosphate led to more side effects (n = 65, 2 RCTs, RR 3.97, CI 0.20 to 78.59, low quality evidence) or caused deterioration in tardive dyskinesia symptoms when compared to placebo (n = 65, 2 RCTs, RR 0.16, CI 0.01 to 3.14, low quality evidence). Five participants taking pyridoxal 5 phosphate withdrew from the study because they were not willing to take more medications while none of the participants taking placebo discontinued their medications (n = 65, 2 RCTs, RR 8.72, CI 0.51 to 149.75, low quality evidence).There was no significant difference in the endpoint positive and negative psychiatric symptoms scores, measured using the Positive and Negative symptoms Scale (PANSS) between participants taking pyridoxal 5 phosphate and those taking placebo. For the positive symptoms: (n = 15, 1 RCT, MD -1.50, CI -4.80 to 1.80, low quality evidence). For negative the symptoms: (n = 15, 1 RCT, MD -1.10, CI -5.92 to 3.72, low quality evidence). AUTHORS' CONCLUSIONS: Pyridoxal 5 phosphate may have some benefits in reducing the severity of tardive dyskinesia symptoms among individuals with schizophrenia. However, the quality of evidence supporting the effectiveness of pyridoxal 5 phosphate in treating tardive dyskinesia is low, based on few studies, short follow-up periods, small sample sizes and inadequate adherence to standardised reporting guidelines for randomised controlled trials among the included studies.