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.

Cost analysis of the WHO-HEARTS program for hypertension control and CVD prevention in primary health facilities in Ethiopia.

Background: In 2020, Ethiopia launched the Ethiopia Hypertension Control Initiative (EHCI) program to improve hypertension care using the approach described in the WHO HEARTS technical package. Objective: To estimate the costs of implementing the HEARTS program for hypertension control and cardiovascular disease (CVD) prevention in the primary care setting in Ethiopia for adult primary care users in the catchment area of five examined facilities. Study design: This study entails a program cost analysis using cross-sectional primary and secondary data. Methods: Micro-costing facility surveys were used to assess activity costs related to training, counselling, screening, lab diagnosis, medications, monitoring, and start-up costs at five selected health facilities. Cost data were obtained from primary and secondary sources, and expert opinion. Annual costs from the health system perspective were estimated using the Excel-based HEARTS costing tool under two intervention scenarios - hypertension-only control and a CVD risk management program, which addresses diabetes and hypercholesterolemia in addition to hypertension. Results: The estimated cost per adult primary care user was USD 5.3 for hypertension control and USD 19.3 for integrated CVD risk management. The estimated medication cost per person treated for hypertension was USD 9.0, whereas treating diabetes and high cholesterol would cost USD 15.4 and USD 15.3 per person treated, respectively. Medications were the major cost driver, accounting for 37% of the total cost in the hypertension control program. In the CVD risk management scenario, the proportions of medication and lab diagnostics of total costs were 18% and 64%, respectively. Conclusions: The results from this study can inform planning and budgeting for HEARTS scale-up to prevent CVD across Ethiopia.

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.

Real-time Feedback to Improve HIV Treatment Adherence in Pregnant and Postpartum Women in Uganda: A Randomized Controlled Trial.

We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394).

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.

High prevalence of undiagnosed hypertension among men in North Central Nigeria: Results from the Healthy Beginning Initiative.

BACKGROUND: The prevalence of hypertension in Nigeria is high and growing. The burden and risk factor distribution also vary by geographical zone. Information about prevalence, risk factors and disease status awareness are needed to guide evidence based public health response at the national and sub- national levels. PURPOSE: This paper describes the prevalence of hypertension and its correlates, as well as hypertension status awareness among men in North Central, Nigeria. METHODS: A cross sectional survey was administered to male partners of pregnant women participating in the Healthy Beginning Initiative program from 2016-2018. Information on socio-demographic characteristics, risk factors, physical measurement and blood pressure readings were collected using a standardized protocol. Data was analyzed with simple and multiple logistic regression. RESULTS: The 6,538 men had a median age of 31 years [IQR: 26-37]. The prevalence of hypertension was 23.3% (95% CI: 22.3%-24.4%), while 46.7% had prehypertension. The odds of hypertension was associated with increasing age (OR:1.02, CI:1.01-1.03), being overweight (aOR:1.5,CI:1.3-1.8), being obese (aOR:2.6,CI:2.0-3.3), living in an urban area (aOR:1.6,CI:1.2-2.1), and alcohol use in the 30 days prior (aOR:1.2,CI:1.1-1.4). Overall, 4.5% (297/6,528) of participants had ever been told they have hypertension. Among the 23.3% (1,527/6,528) with hypertension, 7.1% (109/1,527) were aware of their disease status. Men aged 41-50 years (aOR: 1.8, CI: 1.0-3.3), and > 50 years (aOR: 2.2, CI: 1.1-4.3), had higher odds disease status awareness. Living in an urban area was associated with lower odds (aOR: 0.2, CI: 0.03-0.7) of hypertension status awareness. CONCLUSION: This study showed that hypertension is already a significant public health burden in this population and that disease awareness level is very low. Alcohol use and obesity were associated with hypertension, highlighting some modifiable cardiovascular disease risk factors that are prevalent in the study population. Taken together, these findings can inform the design of interventions for primary and secondary cardiovascular disease prevention in Nigeria and similar settings.

A preprogram appraisal of factors influencing research productivity among faculty at college of medicine, University of Lagos.

Background: A defining feature of any university is its dedication to scholarly activities, leading to the generation of knowledge and ideas Research productivity is a measure of achievement of a scholar. The number of research publications in peer-reviewed journals is an important criterion for assessing productivity and prestige in the academia. Aims and Objectives: This cross-sectional descriptive study assessed the level of research productivity (RP) among junior faculty at the College of Medicine, University of Lagos, and investigated factors affecting their research output prior to the implementation of a 5-year training grant funded by the National Institutes of Health. Methods: Seventy junior faculty members attended a pre-program training, and the self-reported number of peer-reviewed publications (PRPs) was used as an indicator. Intrinsic and extrinsic factors influencing RP among the attendees were assessed and ranked. Results: The majority (42/70, 60%) of the respondents had <10 PRPs. The median (interquartile range) number of PRPs was 7 (3-18). A desire for the development of their personal skills, contribution to society, and personal research interests topped the list of intrinsic factors influencing RP. Work flexibility, research autonomy, and scholarly pursuits were the bottom three. A desire for promotion, respect from peers, and increased social standing were the top three extrinsic factors, while monetary incentives, employment opportunities, and the need to attend conferences were the lowest three. The top barriers to RP were lack of resources and lack of mentoring. Perceived older age, lack of time, and motivation were the lowest three barriers. Older age and professional cadre were associated with increased RP (P < 0.05). Conclusion: Among the participants, research output appears to be motivated primarily by a desire for personal development,promotion, and respect from peers. Lack of access to resources was the main barrier to increased RP. These factors may need to be considered when developing programs designed to promote RP.

RésuméContexte: Une caractéristique déterminante de toute université est son dévouement aux activités savantes, menant à la génération de connaissances et d'idées La productivité de la recherche est une mesure du rendement d'un chercheur. Le nombre de publications de recherche dans des revues à comité de lecture est un critère important pour évaluer la productivité et le prestige de l'académie. Buts et objectifs: Cette étude descriptive transversale a évalué le niveau de productivité de la recherche (RP) parmi les professeurs débutants du Collège de médecine de l'Université de Lagos et a examiné les facteurs affectant leurs résultats de recherche avant la mise en œuvre d'une subvention de formation de 5 ans. financé par les National Institutes of Health. Méthodes: Soixante-dix facultés juniors ont suivi une formation préalable au programme et le nombre autodéclaré de publications évaluées par des pairs a été utilisé comme indicateur. Les facteurs intrinsèques et extrinsèques influençant la RP chez les participants ont été évalués et classés. Résultats: La majorité (42/70, 60%) des répondants ont utilisé moins de 10 publications évaluées par des pairs. Le nombre médian (intervalle interquartile) de PRP était de 7 (3­18). Le désir de développer leurs compétences personnelles, leur contribution à la société et leurs intérêts personnels en recherche figuraient en tête de liste des facteurs intrinsèques influençant la productivité de la recherche. La flexibilité du travail, l'autonomie de recherche et les activités universitaires étaient les trois derniers. Un désir de promotion, le respect des pairs et une position sociale accrue étaient les trois principaux facteurs extrinsèques, tandis que les incitations monétaires, les possibilités d'emploi et la nécessité d'assister à des conférences étaient les trois plus faibles. Les principaux obstacles à la productivité de la recherche étaient le manque de ressources et le manque de mentorat. L'âge avancé perçu, le manque de temps et la motivation étaient les trois obstacles les plus bas. L'âge avancé et les cadres professionnels étaient associés à une augmentation de la RP (P <0,05). Conclusion: parmi les participants, les résultats de la recherche semblent être principalement motivés par un désir de développement personnel, de promotion et de respect de la part des pairs. Le manque d'accès aux ressources était le principal obstacle à l'augmentation de la productivité de la recherche. Ces facteurs peuvent devoir être pris en compte lors de l'élaboration de programmes conçus pour promouvoir la productivité de la recherche.

Effect of a multi-component intervention on providers' HPV vaccine communication.

Objective: To evaluate the effect of a multi-component intervention including communication training on provider beliefs and recommendation practices around the human papillomavirus (HPV) vaccine using both self-reports and audio-recordings of clinical interactions. Methods: We conducted a mixed method study at five family medicine and pediatric practices. Providers self-reported beliefs and practices about HPV vaccination via surveys and qualitative interviews conducted pre- and post-intervention. We also assessed provider recommendation style using audio-recordings of clinical interactions pre- and post-intervention. Content analysis was used to identify themes in qualitative interviews. Matched pre- and post-intervention surveys were analyzed for changes in provider beliefs and attitudes. Pre- and post-intervention audio recordings of clinical interactions were analyzed for observed differences in recommendation styles. Bivariate analyses of quantitative data used Chi-square and Fisher's exact tests; t-tests were used for continuous variables. Results: Providers reported in interviews that the intervention led to communication changes by increasing their knowledge, reframing the HPV vaccine as a routine vaccination, and providing tools for engaging with parents. Surveys indicated that the proportion of providers reporting that the HPV vaccine is one of the most important adolescent vaccines increased from 71% pre-intervention to 100% post-intervention (p = .03). Audio-recording analysis demonstrated that use of an indicated (presumptive) recommendation style increased from 62.5% pre-intervention to 79.6% post-intervention (p = .047). Conclusions: Educating providers about HPV vaccination and giving them tools to facilitate communication with parents can reframe HPV as a routine adolescent vaccination and motivate providers to routinely use effective recommendation styles in practice.

Epidemiologic and viral predictors of antiretroviral drug resistance among persons living with HIV in a large treatment program in Nigeria.

BACKGROUND: Expanded access to combination antiretroviral therapy (cART) throughout sub-Saharan Africa over the last decade has remarkably improved the prognosis of persons living with HIV (PLWH). However, some PLWH experience virologic rebound after a period of viral suppression, usually followed by selection of drug resistant virus. Determining factors associated with drug resistance can inform patient management and healthcare policies, particularly in resource-limited settings where drug resistance testing is not routine. METHODS: A case-control study was conducted using data captured from an electronic medical record in a large treatment program in Nigeria. Cases PLWH receiving cART who developed acquired drug resistance (ADR) and controls were those without ADR between 2004 and 2011. Each case was matched to up to 2 controls by sex, age, and education. Logistic regression was used estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors associated with ADR. RESULTS: We evaluated 159 cases with ADR and 299 controls without ADR. In a multivariate model, factors associated with ADR included older age (OR = 2.35 [age 30-40 years 95% CI 1.29, 4.27], age 41 + years OR = 2.31 [95% CI 1.11, 4.84], compared to age 17-30), higher education level (secondary OR 2.14 [95% CI 1.1.11-4.13]), compared to primary and tertiary), non-adherence to care (OR = 2.48 [95% CI 1.50-4.00]), longer treatment duration (OR = 1.80 [95% CI 1.37-2.35]), lower CD4 count((OR = 0.95 [95% CI 0.95-0.97]) and higher viral load (OR = 1.97 [95% CI 1.44-2.54]). CONCLUSIONS: Understanding these predictors may guide programs in developing interventions to identify patients at risk of developing ADR and implementing prevention strategies.

A preprogram appraisal of factors influencing research productivity among faculty at college of medicine, University of Lagos

A defining feature of any university is its dedication to scholarly activities, leading to the generation of knowledge and ideas Research productivity is a measure of achievement of a scholar. The number of research publications in peer-reviewed journals is an important criterion for assessing productivity and prestige in the academia. Aims and Objectives: This cross-sectional descriptive study assessed the level of research productivity (RP) among junior faculty at the College of Medicine, University of Lagos, and investigated factors affecting their research output prior to the implementation of a 5-year training grant funded by the National Institutes of Health. Methods: Seventy junior faculty members attended a pre-program training, and the self-reported number of peer-reviewed publications (PRPs) was used as an indicator. Intrinsic and extrinsic factors influencing RP among the attendees were assessed and ranked. Results: The majority (42/70, 60%) of the respondents had <10 PRPs. The median (interquartile range) number of PRPs was 7 (3­18). A desire for the development of their personal skills, contribution to society, and personal research interests topped the list of intrinsic factors influencing RP. Work flexibility, research autonomy, and scholarly pursuits were the bottom three. A desire for promotion, respect from peers, and increased social standing were the top three extrinsic factors, while monetary incentives, employment opportunities, and the need to attend conferences were the lowest three. The top barriers to RP were lack of resources and lack of mentoring. Perceived older age, lack of time, and motivation were the lowest three barriers. Older age and professional cadre were associated with increased RP (P < 0.05). Conclusion: Among the participants, research output appears to be motivated primarily by a desire for personal development,promotion, and respect from peers. Lack of access to resources was the main barrier to increased RP. These factors may need to be considered when developing programs designed to promote RP

Effect of PEPFAR funding policy change on HIV service delivery in a large HIV care and treatment network in Nigeria.

The transition to PEPFAR 2.0 with its focus on country ownership was accompanied by substantial funding cuts. We describe the impact of this transition on HIV care in a large network of HIV clinics in Nigeria. We surveyed 30 comprehensive HIV treatment clinics to assess services supported before (October 2013-September 2014) and after (October 2014-September 2015) the PEPFAR funding policy change, the impact of these policy changes on service delivery areas, and response of clinics to the change. We compared differences in support for staffing, laboratory services, and clinical operations pre- and post-policy change using paired t-tests. We used framework analysis to assess answers to open ended questions describing responses to the policy change. Most sites (83%, n = 25) completed the survey. The majority were public (60%, n = 15) and secondary (68%, n = 17) facilities. Clinics had a median of 989 patients in care (IQR: 543-3326). All clinics continued to receive support for first and second line antiretrovirals and CD4 testing after the policy change, while no clinics received support for other routine drug monitoring labs. We found statistically significant reductions in support for viral load testing, staff employment, defaulter tracking, and prevention services (92% vs. 64%, p = 0.02; 80% vs. 20%, 100% vs. 44%, 84% vs. 16%, respectively, p<0.01 for all) after the policy change. Service delivery was hampered by interrupted laboratory services and reduced wages and staff positions leading to reduced provider morale, and compromised quality of care. Almost all sites (96%) introduced user fees to address funding shortages. Clinics in Nigeria are experiencing major challenges in providing routine HIV services as a result of PEPFAR's policy changes. Funding cutbacks have been associated with compromised quality of care, staff shortages, and reliance on fee-based care for historically free services. Sustainable HIV services funding models are urgently needed.

High Medication Possession Ratios Associated With Greater Risk of Virologic Failure Among Youth Compared With Adults in a Nigerian Cohort.

BACKGROUND: Medication possession ratio (MPR) is widely used as a measure of adherence to antiretroviral therapy (ART). Many adolescents and young adults (AYA) experience ART adherence challenges. Our objective was to determine whether the relationship between MPR and virologic failure (VF) is consistent between AYA and older adults in Nigeria. METHODS: We conducted a retrospective study of AYA (aged 15-25 years) and adults (aged >25 years) who initiated ART between January 2009 and December 2012 at 10 university-affiliated HIV clinics in Nigeria. We used multivariate generalized linear models to assess the relationship between age, MPR (ART doses dispensed)/(days since ART initiation), and risk of VF (HIV RNA >1000 copies/mL) in the 1st year on ART. RESULTS: The cohort included 1508 AYA and 11,376 older adults. VF was more common in AYA than older adults (30% vs. 24% P < 0.01). Overall, 74% of patients had optimal, 16% suboptimal, and 9% poor adherence (MPR >94%, 80%-94%, and <80%, respectively). AYA attended fewer pharmacy-only visits than older adults (5 vs. 6, P < 0.001). Higher MPR was associated with decreased rate of VF (80%-94%, accounting rate of return 0.57; >94% accounting rate of return 0.43, P < 0.001 vs. MPR <80%). Among those with optimal adherence by MPR, 26% of AYA had VF, a risk that was 20% higher than for older adults with optimal adherence (P < 0.001). CONCLUSIONS: In this Nigerian cohort, MPRs were high overall, and there was a strong association between low MPR and risk of VF. Nonetheless, 26% of AYA with high MPRs still had VF. Understanding the discrepancy between MPR and viral suppression in AYA is an important priority.

The patient-centered medical home: a reality for HIV care in Nigeria.

OBJECTIVE: HIV care delivery in resource-limited settings (RLS) may serve as a paradigm for chronic disease care, but comprehensive measurement frameworks are lacking. Our objective was to adapt the patient-centered medical home (PCMH) framework for use in RLS, and evaluate the performance of HIV treatment programs within this framework. DESIGN AND SETTING: Cross-sectional survey administered within the AIDS Prevention Initiative in Nigeria (APIN) network. PARTICIPANTS: Medical directors at APIN clinics. MAIN OUTCOME MEASURES: We adapted the 2011 US National Committee on Quality Assurance's PCMH standard to develop a survey measuring five domains of HIV care: (i) enhancing access and continuity, (ii) identifying and managing patient populations, (iii) planning and managing care, (iv) promoting self-care and support and (v) measuring and improving performance. RESULTS: Thirty-three of 36 clinics completed the survey. Most were public (73%) and urban/semi-urban (64%); 52% had >500 patients in care. On a 0-100 scale, clinics scored highest in self-care and support, 91% (63-100%); managing patient populations, 80% (72-81%) and improving performance, 72% (44-78%). Clinics scored lowest with the most variability in planning/managing care, 65% (22-89%), and access and continuity, 61% (33-80%). Average score across all domains was 72% (58-81%). CONCLUSIONS: Our findings suggest that the modified PCMH tool is feasible, and likely has sufficient performance variation to discriminate among clinics. Consistent with extant literature, clinics showed greatest room for improvement on access and continuity, supporting the tool's face validity. The modified PCMH tool may provide a powerful framework for evaluating chronic HIV care in RLS.

Impact of Unplanned Care Interruption on CD4 Response Early After ART Initiation in a Nigerian Cohort.

The authors conducted a retrospective cohort study of unplanned care interruption (UCI) among adults initiating antiretroviral therapy (ART) from 2009 to 2011 in a Nigerian clinic. The authors used repeated measures regression to model the impact of UCI on CD4 count upon return to care and rate of CD4 change on ART. Among 2496 patients, 83% had 0, 15% had 1, and 2% had ≥2 UCIs. Mean baseline CD4 for those with 0, 1, or ≥2 UCIs was 228/cells/mm3, 355/cells/mm3, and 392/cells/mm3 ( P < .0001), respectively. The UCI was associated with a 62 CD4 cells/mm3 decrease (95% confidence interval [CI]: -78 to -45) at next measurement. In months 1 to 6 on ART, patients with 0 UCI gained 10 cells/µL/mo (95% CI: 7-4). Those with 1 and ≥2 UCIs lost 2 and 5 cells/µL/mo (95% CI: -18 to 13 and -26 to 16). Patients with UCI did not recover from early CD4 losses associated with UCI. Preventing UCI is critical to maximize benefits of ART.

Long-Term Outcomes on Antiretroviral Therapy in a Large Scale-Up Program in Nigeria.

BACKGROUND: While there has been a rapid global scale-up of antiretroviral therapy programs over the past decade, there are limited data on long-term outcomes from large cohorts in resource-constrained settings. Our objective in this evaluation was to measure multiple outcomes during first-line antiretroviral therapy in a large treatment program in Nigeria. METHODS: We conducted a retrospective multi-site program evaluation of adult patients (age ≥15 years) initiating antiretroviral therapy between June 2004 and February 2012 in Nigeria. The baseline characteristics of patients were described and longitudinal analyses using primary endpoints of immunologic recovery, virologic rebound, treatment failure and long-term adherence patterns were conducted. RESULTS: Of 70,002 patients, 65.2% were female and median age was 35 (IQR: 29-41) years; 54.7% were started on a zidovudine-containing and 40% on a tenofovir-containing first-line regimen. Median CD4+ cell counts for the cohort started at 149 cells/mm3 (IQR: 78-220) and increased over duration of ART. Of the 70,002 patients, 1.8% were reported as having died, 30.1% were lost to follow-up, and 0.1% withdrew from treatment. Overall, of those patients retained and with viral load data, 85.4% achieved viral suppression, with 69.3% achieving suppression by month 6. Of 30,792 patients evaluated for virologic failure, 24.4% met criteria for failure and of 45,130 evaluated for immunologic failure, 34.0% met criteria for immunologic failure, with immunologic criteria poorly predicting virologic failure. In adjusted analyses, older age, ART regimen, lower CD4+ cell count, higher viral load, and inadequate adherence were all predictors of virologic failure. Predictors of immunologic failure differed slightly, with age no longer predictive, but female sex as protective; additionally, higher baseline CD4+ cell count was also predictive of failure. Evaluation of long-term adherence patterns revealed that the majority of patients retained through 84 months maintained ≥95% adherence. CONCLUSION: While improved access to HIV care and treatment remains a challenge in Nigeria, our study shows that a high quality of care was achieved as evidenced by strong long-term clinical, immunologic and virologic outcomes.

Age Matters: Increased Risk of Inconsistent HIV Care and Viremia Among Adolescents and Young Adults on Antiretroviral Therapy in Nigeria.

PURPOSE: Interruptions in HIV care are a major cause of morbidity and mortality, particularly in resource-limited settings. We compared engagement in care and virologic outcomes between HIV-infected adolescents and young adults (AYA) and older adults (OA) one year after starting antiretroviral therapy (ART) in Nigeria. METHODS: We conducted a retrospective cohort study of AYA (15-24 years) and OA (>24 years) who initiated ART from 2009-2011. We used negative binomial regression to model the risk of inconsistent care and viremia (HIV RNA >1,000 copies/mL) among AYA and OA in the first year on ART. Regular care included monthly ART pickup and 3-monthly clinical visits. Patients with ≤3 months between consecutive visits were considered in care. Those with inconsistent care had >3 months between consecutive visits. RESULTS: The cohort included 354 AYA and 2,140 OA. More AYA than OA were female (89% vs. 65%, p < .001). Median baseline CD4 was 252/µL in AYA and 204/µL in OA (p = .002). More AYA had inconsistent care than OA (55% vs. 47%, p = .001). Adjusting for sex, baseline CD4, and education, AYA had a greater risk of inconsistent care than OA (Relative Risk [RR]: 1.15, p = .008). Among those in care after one year on ART, viremia was more common in AYA than OA (40% vs. 26% p = .003, RR: 1.53, p = .002). CONCLUSIONS: In a Nigerian cohort, AYA were at increased risk for inconsistent HIV care. Of patients remaining in care, youth was the only independent predictor of viremia at 1 year. Youth-friendly models of HIV care are needed to optimize health outcomes.

Putting Institutions at the Center of Primary Health Care Reforms: Experience from Implementation in Three States in Nigeria.

Abstract-Within the last two decades, the Nigerian government has committed to strengthening its primary health care system, through reforms addressing institutional restructuring, deepening decentralized governance, and the incorporation of an alternative health care financing strategy. One of these reforms prescribed the establishment of state primary health care agencies/boards (SPHCDBs) as an integral part of the national health system, with the principal responsibility "for the coordination of planning, budgeting, provision and monitoring of all primary health care services that affect residents of the state." Central to this reform is the integration of primary health care (PHC) governance and management, popularly called primary health care under one roof. Another reform, piloting results-based financing, has been implemented since 2011 in three states under the Nigeria State Health Investment Project. This study assesses the implementation of the Primary Health Care Under One Roof (PHCUOR) policy as part of the broader PHC reforms, with a specific focus on how this policy has been strengthened through the Nigeria State Health Investment Project (NSHIP) in Adamawa, Nasarawa, and Ondo states, documenting the evolution of SPHCDB and PHC service delivery, with a focus on management, accountability, and incentives. The study shows that, in the above-mentioned states, significant milestones were achieved in the establishment of the SPHCDB, the strengthening of PHC systems, the improvement of accountability linkages, and an increase in service utilization. The authors therefore argue that integrated PHC systems through SPHCDBs, as enshrined in the PHCUOR guidelines, are a panacea for effective provision of primary health care and a potential game changer for health outcomes, especially when reinforced with a results-based financing approach.

High rates of unplanned interruptions from HIV care early after antiretroviral therapy initiation in Nigeria.

BACKGROUND: Unplanned care interruption (UCI) challenges effective HIV treatment. We determined the frequency and risk factors for UCI in Nigeria. METHODS: We conducted a retrospective-cohort study of adults initiating antiretroviral therapy (ART) between January 2009 and December 2011. At censor, patients were defined as in care, UCI, or inactive. Associations between baseline factors and UCI rates were quantified using Poisson regression. RESULTS: Among 2,496 patients, 44 % remained in care, 35 % had ≥1 UCI, and 21 % became inactive. UCI rates were higher in the first year on ART (39/100PY), than the second (19/100PY), third (16/100PY), and fourth (14/100PY) years (p < 0.001). In multivariate analysis, baseline CD4 > 350/uL (IRR 3.21, p < 0.0001), being a student (IRR 1.95, p < 0.0001), and less education (IRR 1.58, p = 0.001) increased risk for UCI. Fifty-five percent of patients with UCI and viral load data had HIV viral load > 1,000 copies/ml upon return to care. DISCUSSION: UCI were observed in over one-third of patients treated, and were most common in the first year on ART. High baseline CD4 count at ART initiation was the greatest predictor of subsequent UCI. CONCLUSIONS: Interventions focused on the first year on ART are needed to improve continuity of HIV care.

Loss to Follow-Up within the Prevention of Mother-to-Child Transmission Care Cascade in a Large ART Program in Nigeria.

BACKGROUND: The 2013 WHO guidelines incorporated simplified and more effective antiretroviral regimens for the purposes of preventing mother-to-child transmission of HIV. With ideal implementation of these recommendations, perinatal HIV transmission could be reduced to less than 2%. However, loss to follow-up (LTFU) has the potential to erode the success of programs and a number of studies report high rates of LTFU within the prevention of mother-to-child transmission (PMTCT) care cascade. We evaluated the timing and magnitude of LTFU in a large programmatic PMTCT cohort in Nigeria in order to focus future efforts to reduce loss in this high burden setting. METHODS: From 2004-2014, the APIN/Harvard PEPFAR program supported antenatal HIV screening for nearly one million pregnant women and provided PMTCT care to over 30,000 women. The care cascade for women enrolling in the PMTCT program includes antenatal, delivery, and infant follow-up services through 12-18 months of life. In this retrospective cohort analysis, we examined data collected between 2004-2014 from 31 clinical sites in Nigeria and assessed the numbers of mothers and infants enrolled and LTFU at various points along the care cascade. RESULTS: Among 31,504 women (median age 30, IQR: 27-34) entering PMTCT care during the antenatal period, 20,679 (66%) completed the entire cascade of services including antenatal, delivery, and at least one infant follow-up visit. The median gestational age at presentation for antenatal care services was 23 weeks (IQR: 17-29). The median infant age at last follow-up visit was 12 months (IQR: 5-18). The greatest loss in the PMTCT care cascade occurred prior to delivery care (21%), with a further 16% lost prior to first infant visit. Of the 38,223 women who entered at any point along the PMTCT cascade, an HIV DNA PCR was available for 20,202 (53%) of their infants. Among infants for whom DNA PCR results were available, the rate of HIV transmission for infants whose mothers received any antenatal and/or delivery care was 2.8% versus 20.0% if their mother received none. CONCLUSION: In this large cohort analysis, the proportion of women LTFU in the PMTCT care cascade was lower than that reported in previous cohort analyses. Nevertheless, this proportion remains unacceptably high and inhibits the program from maximally achieving the goals of PMTCT care. We also provide the largest analysis to date on rates of perinatal HIV transmission, with low rates among women receiving NNRTI- or PI-based regimens, approaching that reported in clinical trials. However, among mothers who received any antenatal care, infant outcomes were unknown for 48%, and women presented later in pregnancy than that recommended by current guidelines. Implementation research to evaluate ways to improve integration of services, particularly transitions from antenatal to delivery and pediatric care, are critically needed to reduce LTFU within PMTCT programs and achieve the ultimate goal of eliminating pediatric HIV infection.

Scale-up of networked HIV treatment in Nigeria: creation of an integrated electronic medical records system.

OBJECTIVES: The implementation of PEPFAR programs in resource-limited settings was accompanied by the need to document patient care on a scale unprecedented in environments where paper-based records were the norm. We describe the development of an electronic medical records system (EMRS) put in place at the beginning of a large HIV/AIDS care and treatment program in Nigeria. METHODS: Databases were created to record laboratory results, medications prescribed and dispensed, and clinical assessments, using a relational database program. A collection of stand-alone files recorded different elements of patient care, linked together by utilities that aggregated data on national standard indicators and assessed patient care for quality improvement, tracked patients requiring follow-up, generated counts of ART regimens dispensed, and provided 'snapshots' of a patient's response to treatment. A secure server was used to store patient files for backup and transfer. RESULTS: By February 2012, when the program transitioned to local in-country management by APIN, the EMRS was used in 33 hospitals across the country, with 4,947,433 adult, pediatric and PMTCT records that had been created and continued to be available for use in patient care. Ongoing trainings for data managers, along with an iterative process of implementing changes to the databases and forms based on user feedback, were needed. As the program scaled up and the volume of laboratory tests increased, results were produced in a digital format, wherever possible, that could be automatically transferred to the EMRS. Many larger clinics began to link some or all of the databases to local area networks, making them available to a larger group of staff members, or providing the ability to enter information simultaneously where needed. CONCLUSIONS: The EMRS improved patient care, enabled efficient reporting to the Government of Nigeria and to U.S. funding agencies, and allowed program managers and staff to conduct quality control audits.