Evaluation of cryoprotein investigation using a digital external quality assurance scheme.

Background: Robust preanalytical and analytical processes are critical for the detection of cryoproteins. There is significant variation in practice in the detection, analysis and reporting. Results: A survey in 2018 of 137 laboratories participating in the UK National External Quality Assessment Service (UK NEQAS) (6) quality control program showed significant variation in the laboratory processes which highlighted the need for standardisation of the detection, analysis and reporting of cryoglobulins.Conclusion: The first available EQA scheme aiming to harmonise practice for cryoprotein testing has been developed by UK NEQAS and laboratories should participate in an appropriate EQA scheme to fulfil requirements for ISO accreditation.

Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study.

BACKGROUND: The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9. METHODS: EQA sample results provided by 6 EQA providers (INSTAND [Germany], Korean Association of External Quality Assessment Service [KEQAS, South Korea], National Center for Clinical Laboratories [NCCL, China], United Kingdom National External Quality Assessment Service [UK NEQAS, United Kingdom], Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek [SKML, the Netherlands], and the Royal College of Pathologists of Australasia Quality Assurance Programs [RCPAQAP, Australia]) between 2020 and 2021 were used. The consensus means, calculated from the measurement procedures present in all EQA programs (Abbott Alinity, Beckman Coulter DxI, Roche Cobas, and Siemens Atellica), was used as reference values. Per measurement procedure, the relative difference between consensus mean for each EQA sample and the mean of all patient-pool-based EQA samples were calculated and compared to minimum, desirable, and optimal allowable bias criteria based on biological variation. RESULTS: Between 19040 (CA15-3) and 25398 (PSA) individual results and 56 (PSA) to 76 (AFP) unique EQA samples were included in the final analysis. The mean differences with the consensus mean of patient-pool-based EQA samples for all measurement procedures were within the optimum bias criterion for AFP, the desirable bias for PSA, and the minimum bias criterion for CEA. However, CEA results <8 µg/L exceeded the minimum bias criterion. For CA125, CA15-3, and CA19-9, the harmonization status was outside the minimum bias criterion, with systematic differences identified. CONCLUSIONS: This study provides relevant information about the current harmonization status of 6 tumor markers. A pilot harmonization investigation for CEA, CA125, CA15-3, and CA19-9 would be desirable.

Laboratory practice is central to earlier myeloma diagnosis: Utilizing a primary care diagnostic tool and laboratory guidelines integrated into haematology services.

Treatment advances have greatly improved survival, but myeloma is among the worst of all cancers for delayed diagnosis, causing serious morbidities and early deaths. This delay is largely because the symptom profile of myeloma has very low specificity, and in primary care, myeloma is rare. However, initiating the journey to diagnosis simply requires considering myeloma and sending blood to test for monoclonal immunoglobulin. Laboratory tests reliably detect monoclonal immunoglobulin, which is present in 99% of myeloma cases, so why do health care systems have such a problem with delayed diagnosis? The Myeloma UK early diagnosis programme has brought together diverse expertise to investigate this problem, and this article was prepared by the programme's working group for laboratory best practice. It reviews evidence for test requesting, analysis and reporting, for which there is large variation in practice across the United Kingdom. It presents a 'GP Myeloma diagnostic tool' and how it can be integrated into laboratory practice alongside a laboratory best practice tool. It proposes improved requesting and integration with haematology services for reporting and interpretation. Here the laboratory has a central role in creating efficient and cost-effective pathways for appropriate and timely bone marrow examination for myeloma diagnosis.

Clients in Uganda accessing preferred differentiated antiretroviral therapy models achieve higher viral suppression and are less likely to miss appointments: a cross-sectional analysis.

INTRODUCTION: The Uganda Ministry of Health recommends facility- and community-based differentiated antiretroviral therapy (DART) models to support person-centred care for eligible clients receiving antiretroviral therapy (ART). Healthcare workers assess client eligibility for one of six DART models upon initial enrolment; however, client circumstances evolve, and their preferences are not routinely adjusted. We developed a tool to understand the proportion of clients accessing preferred DART models and compared the outcomes of clients accessing preferred DART models to the outcomes of clients not receiving preferred DART models. METHODS: We conducted a cross-sectional study. A sample of 6376 clients was selected from 113 referrals, general hospitals and health centres purposely selected from 74 districts. Clients receiving ART accessing care from the sampled sites were eligible for inclusion. Healthcare workers interviewed clients (caretakers of clients under 18), over a 2-week period between January and February 2022 using a client preference tool to elicit whether clients were receiving DART services through their preferred model. Treatment outcomes of viral load test, viral load suppression and missed appointment date were extracted from clients' medical files before or immediately after the interview and de-identified. The descriptive analysis determined the interaction between client preferences and predefined treatment outcomes by comparing outcomes of clients whose care aligned with their preferences to outcomes of clients whose care misaligned with their preferences. RESULTS: Of 25% (1573/6376) of clients not accessing their preferred DART model, 56% were on facility-based individual management and 35% preferred fast-track drug refills model. Viral load coverage was 87% for clients accessing preferred DART models compared to 68% among clients not accessing their preferred model. Viral load suppression was higher among clients who accessed the preferred DART model (85%) compared to (68%) clients who did not access their preferred DART model. Missed appointments were lower at 29% for clients who accessed preferred DART models compared to 40% among clients not enrolled in the DART model of their choice. CONCLUSIONS: Clients who accessed their preferred DART model have better clinical outcomes. Preferences should be integrated throughout health systems, improvement interventions, policies and research efforts to ensure client-centred care and client autonomy.

Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP.

OBJECTIVES: Antinuclear antibodies (ANA) are important for the diagnosis of various autoimmune diseases. ANA are usually detected by indirect immunofluorescence assay (IFA) using HEp-2 cells (HEp-2 IFA). There are many variables influencing HEp-2 IFA results, such as subjective visual reading, serum screening dilution, substrate manufacturing, microscope components and conjugate. Newer developments on ANA testing that offer novel features adopted by some clinical laboratories include automated computer-assisted diagnosis (CAD) systems and solid phase assays (SPA). METHODS: A group of experts reviewed current literature and established recommendations on methodological aspects of ANA testing. This process was supported by a two round Delphi exercise. International expert groups that participated in this initiative included (i) the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group "Autoimmunity Testing"; (ii) the European Autoimmune Standardization Initiative (EASI); and (iii) the International Consensus on ANA Patterns (ICAP). RESULTS: In total, 35 recommendations/statements related to (i) ANA testing and reporting by HEp-2 IFA; (ii) HEp-2 IFA methodological aspects including substrate/conjugate selection and the application of CAD systems; (iii) quality assurance; (iv) HEp-2 IFA validation/verification approaches and (v) SPA were formulated. Globally, 95% of all submitted scores in the final Delphi round were above 6 (moderately agree, agree or strongly agree) and 85% above 7 (agree and strongly agree), indicating strong international support for the proposed recommendations. CONCLUSIONS: These recommendations are an important step to achieve high quality ANA testing.

Utilizing a church-based platform for mental health interventions: exploring the role of the clergy and the treatment preference of women with depression.

BACKGROUND: Training lay people to deliver mental health interventions in the community can be an effective strategy to mitigate mental health manpower shortages in low- and middle-income countries. The healthy beginning initiative (HBI) is a congregation-based platform that uses this approach to train church-based lay health advisors to conduct mental health screening in community churches and link people to care. This paper explores the potential for a clergy-delivered therapy for mental disorders on the HBI platform and identifies the treatment preferences of women diagnosed with depression. METHODS: We conducted focus group discussion and free-listing exercise with 13 catholic clergy in churches that participated in HBI in Enugu, Nigeria. These exercises, guided by the positive, existential, or negative (PEN-3) cultural model, explored their role in HBI, their beliefs about mental disorders, and their willingness to be trained to deliver therapy for mental disorders. We surveyed women diagnosed with depression in the same environment to understand their health-seeking behavior and treatment preferences. The development of the survey was guided by the health belief model. RESULTS: The clergy valued their role in HBI, expressed understanding of the bio-psycho-socio-spiritual model of mental disorders, and were willing to be trained to provide therapy for depression. Majority of the women surveyed preferred to receive therapy from trained clergy (92.9%), followed by a psychiatrist (89.3%), and psychologist (85.7%). CONCLUSION: These findings support a potential clergy-focused, faith-informed adaptation of therapy for common mental disorders anchored in community churches to increase access to treatment in a resource-limited setting.

Pharmacotherapy Prescriptions for Relapse Prevention of Psychotic Depression After Electroconvulsive Therapy.

PURPOSE/BACKGROUND: Electroconvulsive therapy (ECT) is effective in the treatment of acute episodes of psychotic depression. However, no adequately powered studies have directly investigated the efficacy of antipsychotic pharmacotherapy in relapse prevention of psychotic depression after ECT. In the absence of such literature, we reviewed the clinical practice of 4 academic medical centers that have made research contributions in the treatment of psychotic depression over the past 20 years. METHODS/PROCEDURES: We reviewed medical records of patients with a diagnosis of psychotic depression who received 1 or more acute courses of ECT over the span of 3 years. Chi-square tests were used to compare pharmacotherapy prescribed at the time of completion of ECT. FINDINGS/RESULTS: A total of 163 patients received 176 courses of ECT for separate episodes of psychotic depression. The combination of an antidepressant plus an antipsychotic was the most common regimen, ranging from 61.9% to 85.5% of all prescriptions. One center added lithium in 45.5% of cases treated with the combination of an antidepressant plus an antipsychotic. An antipsychotic alone was prescribed in less than 10% of cases. An antidepressant alone or other drug combinations were rare. IMPLICATIONS/CONCLUSIONS: The combination of an antidepressant plus an antipsychotic was the most commonly prescribed regimen at the completion of ECT for relapse prevention in patients with psychotic depression acutely treated with ECT. Although this report offers a view of the clinical practice of 4 academic medical centers, it also points to the need of randomized controlled trials on continuation pharmacotherapy after treatment of psychotic depression with ECT.

Hepatitis B infection and risk factors among pregnant women and their male partners in the Baby Shower Programme in Nigeria: a cross-sectional study.

OBJECTIVES: To determine the population prevalence and determinants of hepatitis B (Hep B) status, and status discordance, among pregnant women and their male partners in Nigeria. METHODS: Cross-sectional study assessing the seroprevalence of Hep B virus in a cohort of 16 920 pregnant women and their male partners in northcentral Nigeria. Rapid HBsAg antibody test was used for Hep B diagnosis. Demographic, socio-economic and behavioural information was collected through interviewer-administered questionnaires and evaluated as determinants of Hep B status and couple status discordance using logistic regression. RESULTS: Of 16 920 participants who had a Hep B test result, 6750 couples and 1316 discordant couples were identified. The prevalence of Hep B among all participants was 10.9%, with lower prevalence among pregnant women (10.2%) than their male partners (11.9%), P < 0.001. The prevalence of Hep B sero-discordance among couples was 19.5% (1316/6750). Younger age, prior Hep B testing and a prior positive Hep B test increased the odds of Hep B infection while being a woman decreased the odds of Hep B among all participants, and among couples. Furthermore, polygamy (adjusted odds ratio [AOR]: 1.49, 95% confidence interval [CI]: 1.19-1.87), prior Hep B testing (AOR: 2.38, 95% CI: 1.14-4.97) and a prior positive Hep B test result were significant determinants of status discordance among the participating couples. CONCLUSION: The prevalence of Hep B among pregnant women and their male partners in northcentral Nigeria is high. A large-scale intervention is required to reduce Hep B prevalence in this setting.

OBJECTIFS: Déterminer la prévalence dans la population et les déterminants du statut de l'hépatite B (Hep B) et de la discordance de statut chez les femmes enceintes et leurs partenaires masculins au Nigéria. MÉTHODES: Etude transversale évaluant la séroprévalence du virus Hep B dans une cohorte de 16.920 femmes enceintes et leurs partenaires masculins dans le centre-nord du Nigéria. Un test rapide des anticorps anti-HBsAg a été utilisé pour le diagnostic de l'Hep B. Des informations démographiques, socio-économiques et comportementales ont été recueillies au moyen de questionnaires administrés par les intervieweurs et évaluées en tant que déterminants du statut Hep B et de la discordance du statut de couple à l'aide de la régression logistique. RÉSULTATS: Sur 16.920 participants qui avaient un résultat de dépistage de l'Hep B, 6.750 couples et 1.316 couples discordants ont été identifiés. La prévalence de l'Hep B chez tous les participants était de 10,9%, avec une prévalence plus faible chez les femmes enceintes (10,2%) que chez leurs partenaires masculins (11,9%), p <0,001. La prévalence de la séro-discordance de l'Hep B chez les couples était de 19,5% (1.316/6.750). Un âge plus jeune, un dépistage antérieur de l'Hep B et un test Hep B positif antérieur augmentaient les risques d'infection à l'Hep B alors que le sexe féminin diminuait les risques d'Hep B chez tous les participants et parmi les couples. De plus, la polygamie (rapport de cotes ajusté [AOR]: 1,49, intervalle de confiance [IC] à 95%: 1,19-1,87), un dépistage antérieur de l'Hep B (AOR: 2,38 ; IC95%: 1,14-4,97) et un test hépatique B positif antérieur résultat étaient des déterminants significatifs de la discordance de statut parmi les couples participants. CONCLUSION: La prévalence de l'Hep B chez les femmes enceintes et leurs partenaires masculins dans le centre-nord du Nigéria est élevée. Une intervention à grande échelle est nécessaire pour réduire la prévalence de l'Hep B dans cette région.

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.

Current laboratory and clinical practices in reporting and interpreting anti-nuclear antibody indirect immunofluorescence (ANA IIF) patterns: results of an international survey.

BACKGROUND: The International Consensus on Antinuclear Antibody (ANA) Patterns (ICAP) has recently proposed nomenclature in order to harmonize ANA indirect immunofluorescence (IIF) pattern reporting. ICAP distinguishes competent-level from expert-level patterns. A survey was organized to evaluate reporting, familiarity, and considered clinical value of ANA IIF patterns. METHODS: Two surveys were distributed by European Autoimmunity Standardization Initiative (EASI) working groups, the International Consensus on ANA Patterns (ICAP) and UK NEQAS to laboratory professionals and clinicians. RESULTS: 438 laboratory professionals and 248 clinicians from 67 countries responded. Except for dense fine speckled (DFS), the nuclear competent patterns were reported by > 85% of the laboratories. Except for rods and rings, the cytoplasmic competent patterns were reported by > 72% of laboratories. Cytoplasmic IIF staining was considered ANA positive by 55% of clinicians and 62% of laboratory professionals, with geographical and expertise-related differences. Quantification of fluorescence intensity was considered clinically relevant for nuclear patterns, but less so for cytoplasmic and mitotic patterns. Combining IIF with specific extractable nuclear antigens (ENA)/dsDNA antibody testing was considered most informative. Of the nuclear competent patterns, the centromere and homogeneous pattern obtained the highest scores for clinical relevance and the DFS pattern the lowest. Of the cytoplasmic patterns, the reticular/mitochondria-like pattern obtained the highest scores for clinical relevance and the polar/Golgi-like and rods and rings patterns the lowest. CONCLUSION: This survey confirms that the major nuclear and cytoplasmic ANA IIF patterns are considered clinically important. There is no unanimity on classifying DFS, rods and rings and polar/Golgi-like as a competent pattern and on reporting cytoplasmic patterns as ANA IIF positive.

Opportunities and challenges to integrating mental health into HIV programs in a low- and middle-income country: insights from the Nigeria implementation science Alliance.

BACKGROUND: In Nigeria, there is an estimated 1.9 million people living with HIV (PLHIV), 53% of whom utilize HIV care and services. With decreasing HIV-related deaths and increasing new infections, HIV with its associated comorbidities continue to be a key public health challenge in Nigeria. Untreated, comorbid mental disorders are a critical but potentially modifiable determinant of optimal HIV treatment outcomes. This study aimed to identify the challenges and opportunities related to integrating mental health care into existing HIV programs in Nigeria. METHOD: Attendees at the Nigeria Implementation Science Alliance (NISA)'s 2019 conference participated in nominal group technique (NGT) exercise informed by the "Exploration, Preparation, Implementation, and Sustainment (EPIS)" framework. The NGT process was conducted among the nominal groups in two major sessions of 30-min phases followed by a 30-min plenary session. Data analysis proceeded in four steps: transcription, collation, theming and content analysis. RESULTS: The two major theoretical themes from the study were - opportunities and challenges of integrating mental health treatment into HIV services. Three sub-themes emerged on opportunities: building on health care facilities for HIV services (screening, counseling, task-sharing monitoring and evaluation frameworks), utilizing existing human resources or workforce in HIV programs (in-service training and including mental health in education curriculum) and the role of social and cultural structures (leveraging existing community, traditional and faith-based infrastructures). Four sub-themes emerged for challenges: double burden of stigma and the problems of early detection (HIV and mental health stigma, lack of awareness), existing policy gaps and structural challenges (fragmented health system), limited human resources for mental health care in Nigeria (knowledge gap and burnout) and dearth of data/evidence for planning and action (research gaps). CONCLUSIONS: Potential for integrating treatments for mental disorders into HIV programs and services exist in Nigeria. These include opportunities for clinicians' training and capacity building as well as community partnerships. Multiple barriers and challenges such as stigma, policy and research gaps would need to be addressed to leverage these opportunities. Our findings serve as a useful guide for government agencies, policy makers and research organizations to address co-morbid mental disorders among PLHIV in Nigeria.

Successful pregnancy following chemotherapy in a survivor of small cell carcinoma of the ovary, hypercalcemic type (SCCOHT): A case report and review of literature.

•Small cell carcinoma of the ovary hypercalcemic type (SCCOHT) is a rare neoplasm that mostly affects young women.•The chances of future fertility in women are limited due to the aggressive nature of SCCOHT and need for adjuvant therapy.•We report the case of a 26y woman with stage IA SCCOHT who had a successful pregnancy following surgery and chemotherapy.

Continued provision of WHO International Standards for total and free PSA: Content and commutability of replacement preparations.

OBJECTIVES: Replacements are required for the WHO International Standards (IS) for free PSA, coded 96/668 and total PSA (90:10), coded 96/670, which were established in 1999 to support efforts to harmonise PSA assays and address non-equimolarity. An important consideration is that the introduction of the replacements should have minimal impact on PSA measurements. DESIGN AND METHODS: We report the development of a replacement strategy, informed by field assessment of preparations through an external quality assessment scheme and the subsequent evaluation of the candidate ISs in worldwide collaborative studies. RESULTS: By immunoassay, data from participants confirmed the value assigned to the current standards. Robust geometric mean estimates of the free PSA content of the candidate replacement for 96/668 coded 17/102 was 0.533 µg/ampoule (n = 21). The ratio of the content estimates of 17/102:96/668 was 0.516 (GCV 12.5%, n = 21). Robust geometric mean estimates of the total PSA content of the candidate replacement for 96/670, coded 17/100, was 0.505 µg/ampoule (n = 22). The ratio of the content estimates of 17/100:96/670 was 0.490 (GCV 5.3%, n = 22). Through concomitant measurement of a panel of 15 representative patient samples, the candidate ISs were shown to exhibit commutability with patient samples that was comparable with that of the current ISs. CONCLUSION: On the basis of these results, the preparations coded 17/102 and 17/100 were established by the WHO Expert Committee on Biological Standardization as the 2nd ISs for free and total PSA (PSA-ACT+free PSA) respectively, with assigned contents of 0.53 µg/ampoule and 0.50 µg/ampoule.

Challenges and Strategies for Improving Training of Mid-Level Research Personnel in Nigeria.

BACKGROUND: Contextual research evidence is needed to reduce morbidity and mortality due to chronic but preventable diseases in low- and middle-income countries. Nigeria, Africa's most populous country, is particularly burdened by these diseases despite its academic and research infrastructure. A major impediment to developing robust evidence on sustainable disease prevention and treatment strategies is the lack of skilled research personnel. OBJECTIVE: This study aimed to identify (1) training barriers for research assistants and coordinators and (2) potential strategies to counter these barriers using a Nominal Group Technique (NGT) exercise conducted at the 2017 conference of the Nigeria Implementation Science Alliance (NISA). METHOD: A one-hour NGT exercise was conducted with 26 groups of 2-9 persons each (N = 134) drawn from conference attendees. Group members were presented with questions related to the two objectives. Each member was asked to generate, list, discuss and vote on ideas that were eventually ranked by the group. Qualitative Thematic Analysis (QTA) was conducted for the collated responses. FINDINGS: The QTA identified 166 training gaps and 147 potential solutions, out of which 104 were ranked. Themes that emerged for gaps included: 1) inadequate mentorship; 2) inadequate training/ lack of organized curriculum; 3) limited access to opportunities for training and employment; 4) lack of government funding; 5) lack of interest, motivation; and 6) lack of research culture. Themes for potential strategies to address the gaps were: 1) trainings/curriculum development; 2) research modules implemented in secondary and tertiary institutions; 3) creating a sustainable forum for research-related questions and answers; and 4) advocating for and accessing more government funding for research training. CONCLUSION: This study identified actionable strategies that reflect practical realities in implementation research in Nigeria, which can guide government agencies, policy makers, research organizations, and local foundations as they work together to increase research capacity in Nigeria.

"PSYCH-PASS": the Development, Adaptation, and Implementation of a Psychiatric Handoff.

OBJECTIVE: The primary purpose of the study was to develop and implement a psychiatry mnemonic PSYCH-PASS for transitions of care in residency training programs. METHODS: The authors examined areas of improvement in the handoff system with residency training administration, service directors, and psychiatry residents to create PSYCH-PASS, a novel mnemonic that could be integrated in the electronic medical record (EMR). The components of PSYCH-PASS are Patient summary, Situational awareness, "whY" is the patient here, Comorbidities, Hemodynamics, Pharmacology/PRNs, Action list, Specifics, and Synthesis. The authors developed a 14 question pre- and post-survey with a 4-point Likert scale measuring five categories. RESULTS: Pre-survey and post-surveys completed by post-graduate year 2 and 3 residents at Montefiore Medical Center (n = 24) noted increased satisfaction, handoff efficiency, handoff efficiency, accessibility, accuracy, communication, awareness, and adherence to PSYCH-PASS, along with a decrease in frequency of errors. CONCLUSIONS: With promising results across a range of metrics indicating resident-reported positive impacts on patient care, further research on the implementation of PSYCH-PASS and its integration into EMR systems is merited. Future directions include gathering objective data from Epic and expansion of the initiative to other psychiatric services and institutions.

Targeted HIV testing for male partners of HIV-positive pregnant women in a high prevalence setting in Nigeria.

BACKGROUND: Partner HIV testing during pregnancy has remained abysmally low in sub-Saharan Africa, particularly in Nigeria. Males rarely attend antenatal clinics with their female partners, limiting the few opportunities available to offer them HIV testing. In this study, we evaluated the scale-up of the Healthy Beginning Initiative (HBI), a community-driven evidenced-based intervention to increase HIV testing among pregnant women and their male partners. Our objectives were to determine the: (1) male partner participation rate; (2) prevalence of HIV among male partners of pregnant women; (3) factors associated with HIV positivity among male partners of HIV-positive pregnant women. METHODS: We reviewed program data of expectant parents enrolled in HBI in Benue State, north-central Nigeria. During HBI, trained lay health workers provided educational and counseling sessions, and offered free onsite integrated testing for HIV, hepatitis B virus and sickle cell genotype to pregnant women and their male partners who participated in incentivized, church-organized baby showers. Each participant completed an interviewer-administered questionnaire on demographics, lifestyle habits, and HIV testing history. Chi-square test was used to compare the characteristics of HIV-positive and HIV-negative male partners. Simple and multivariable logistic regression models were used to determine the association between participants' characteristics and HIV positivity among male partners of HIV-positive women. RESULTS: Male partner participation rate was 57% (5264/9231). Overall HIV prevalence was 6.1% (891/14495) with significantly higher rates in women (7.4%, 681/9231) compared to men (4.0%, 210/5264). Among the 681 HIV-positive women, 289 male partners received HIV testing; 37.7% (109/289) were found to be HIV-positive. In multivariate analysis, older age (adjusted odds ratio [aOR]: 2.45, 95% confidence interval [CI]: 1.27-4.72 for age 30-39 years vs. <30 years; aOR: 2.39, CI: 1.18-4.82 for age ≥40 years vs. <30 years) and self-reported daily alcohol intake (vs. never (aOR: 0.35, CI: 0.13-0.96)) were associated with HIV positivity in male partners of HIV-positive women. CONCLUSION: The community-based congregational approach is a potential strategy to increase male partner HIV testing towards achieving the UNAIDS goal of 90% HIV screening. Targeting male partners of HIV-positive women for screening may provide a higher yield of HIV diagnosis and the opportunity to engage known positives in care in this population.

Developing a Theoretical Framework for a Complex Maternal-Child Health Intervention: Health Beginning Initiative.

A theoretical framework serves as a roadmap for the implementation and application of a complex, health promotion intervention; is used to test hypotheses; and guides analysis and evaluation of the intervention. The purpose of this article is to demonstrate how a theoretical framework was developed and used to guide the implementation of Healthy Beginning Initiative (HBI) to promote uptake of HIV services in a low-income country. We used the guide for developing a theoretical framework published in Health Promotion Practice. Developing the theoretical framework included seven steps: (1) identifying the essential elements of the intervention; (2) identifying the variables and the context; (3) listing the postulated mechanisms, mediating variables, and postulated outcomes; (4) identifying existing theoretical models supporting the theoretical framework underdevelopment; (5) scripting the theoretical framework into either a figure or sets of statements; (6) conducting content and face validation of the theoretical framework; and (7) revising the theoretical framework. The theoretical framework was developed and used to evaluate HBI's impact on HIV testing, linkage to care and retention in care for pregnant women, their male partners, and newborns. The theoretical framework will also be adapted for other screenings and other settings while remaining true to the essential elements of HBI.

Determinants of Infant Mortality in Southeast Nigeria: Results from the Healthy Beginning Initiative, 2013-2014.

BACKGROUND: Neonatal mortality due to preventable factors occurs at high rates throughout sub-Saharan Africa. Community-based interventions increase opportunities for prenatal screening and access to antenatal care services (ANC) services. The Healthy Beginning Initiative (HBI) provided congregation-based prenatal screening and health counseling for 3,047 women in Enugu State. The purpose of this study was to identify determinants for infant mortality among this cohort. METHODS: This was a prospective cohort study of post-delivery outcomes at 40 churches in Enugu State, Nigeria between 2013 and 2014. Risk factors for infant mortality were assessed using chi square, odds ratios, and multiple logistic regression. RESULTS: There were 2,436 live births from the 2,379 women who delivered (55 sets of twins and one set of triplets), and 99 cases of neonatal/early postneonatal mortality. The neonatal mortality rate was 40.6 per 1,000 live births. Risk factors associated with neonatal mortality were lack of access to ANC services [OR= 8.81], maternal mortality [OR= 15.28], caesarian section [OR= 2.47], syphilis infection [OR= 6.46], HIV-positive status [OR= 3.87], and preterm birth [OR= 14.14]. CONCLUSIONS AND GLOBAL HEALTH IMPLICATIONS: These results signify that culturally-acceptable community-based interventions targeted to increase access to ANC services, post-delivery services for preterm births, and HIV and syphilis screening for expectant mothers are needed to reduce infant mortality in resource-limited settings.

Gaps and strategies in developing health research capacity: experience from the Nigeria Implementation Science Alliance.

BACKGROUND: Despite being disproportionately burdened by preventable diseases than more advanced countries, low- and middle-income countries (LMICs) continue to trail behind other parts of the world in the number, quality and impact of scholarly activities by their health researchers. Our strategy at the Nigerian Implementation Science Alliance (NISA) is to utilise innovative platforms that catalyse collaboration, enhance communication between different stakeholders, and promote the uptake of evidence-based interventions in improving healthcare delivery. This article reports on findings from a structured group exercise conducted at the 2016 NISA Conference to identify (1) gaps in developing research capacity and (2) potential strategies to address these gaps. METHODS: A 1-hour structured group exercise was conducted with 15 groups of 2-9 individuals (n = 94) to brainstorm gaps for implementation, strategies to address gaps and to rank their top 3 in each category. Qualitative thematic analysis was used. First, duplicate responses were merged and analyses identified emerging themes. Each of the gaps and strategies identified were categorised as falling into the purview of policy-makers, researchers, implementing partners or multiple groups. RESULTS: Participating stakeholders identified 98 gaps and 91 strategies related to increasing research capacity in Nigeria. A total of 45 gaps and an equal number of strategies were ranked; 39 gaps and 43 strategies were then analysed, from which 8 recurring themes emerged for gaps (lack of sufficient funding, poor research focus in education, inadequate mentorship and training, inadequate research infrastructure, lack of collaboration between researchers, research-policy dissonance, lack of motivation for research, lack of leadership buy-in for research) and 7 themes emerged for strategies (increased funding for research, improved research education, improved mentorship and training, improved infrastructure for research, increased collaboration between academic/research institutions, greater engagement between researchers and policy-makers, greater leadership buy-in for research). CONCLUSIONS: The gaps and strategies identified in this study represent pathways judged to be important in increasing research and implementation science capacity in Nigeria. The inclusion of perspectives and involvement of stakeholders who play different roles in policy, research and implementation activities makes these findings comprehensive, relevant and actionable, not only in Nigeria but in other similar LMICs.

A Patient-Held Smartcard With a Unique Identifier and an mHealth Platform to Improve the Availability of Prenatal Test Results in Rural Nigeria: Demonstration Study.

BACKGROUND: Community-based strategies to test for HIV, hepatitis B virus (HBV), and sickle cell disease (SCD) have expanded opportunities to increase the proportion of pregnant women who are aware of their diagnosis. In order to use this information to implement evidence-based interventions, these results have to be available to skilled health providers at the point of delivery. Most electronic health platforms are dependent on the availability of reliable Internet connectivity and, thus, have limited use in many rural and resource-limited settings. OBJECTIVE: Here we describe our work on the development and deployment of an integrated mHealth platform that is able to capture medical information, including test results, and encrypt it into a patient-held smartcard that can be read at the point of delivery without the need for an Internet connection. METHODS: We engaged a team of implementation scientists, public health experts, and information technology specialists in a requirement-gathering process to inform the design of a prototype for a platform that uses smartcard technology, database deployment, and mobile phone app development. Key design decisions focused on usability, scalability, and security. RESULTS: We successfully designed an integrated mHealth platform and deployed it in 4 health facilities across Benue State, Nigeria. We developed the Vitira Health platform to store test results of HIV, HBV, and SCD in a database, and securely encrypt the results on a Quick Response code embedded on a smartcard. We used a mobile app to read the contents on the smartcard without the need for Internet connectivity. CONCLUSIONS: Our findings indicate that it is possible to develop a patient-held smartcard and an mHealth platform that contains vital health information that can be read at the point of delivery using a mobile phone-based app without an Internet connection. TRIAL REGISTRATION: ClinicalTrials.gov NCT03027258; https://clinicaltrials.gov/ct2/show/NCT03027258 (Archived by WebCite at http://www.webcitation.org/6owR2D0kE).