Community engagement to inform development of strategies to improve referral for hypertension: perspectives of patients, providers and local community members in western Kenya.

BACKGROUND: Hypertension is the leading cause of death and disability. Clinical care for patients with hypertension in Kenya leverages referral networks to provide basic and specialized healthcare services. However, referrals are characterized by non-adherence and delays in completion. An integrated health information technology (HIT) and peer-based support strategy to improve adherence to referrals and blood pressure control was proposed. A formative assessment gathered perspectives on barriers to referral completion and garnered thoughts on the proposed intervention. METHODS: We conducted a qualitative study in Kitale, Webuye, Kocholya, Turbo, Mosoriot and Burnt Forest areas of Western Kenya. We utilized the PRECEDE-PROCEED framework to understand the behavioral, environmental and ecological factors that would influence uptake and success of our intervention. We conducted four mabaraza (customary heterogenous community assemblies), eighteen key informant interviews, and twelve focus group discussions among clinicians, patients and community members. The data obtained was audio recorded alongside field note taking. Audio recordings were transcribed and translated for onward coding and thematic analysis using NVivo 12. RESULTS: Specific supply-side and demand-side barriers influenced completion of referral for hypertension. Key demand-side barriers included lack of money for care and inadequate referral knowledge. On the supply-side, long distance to health facilities, low availability of services, unaffordable services, and poor referral management were reported. All participants felt that the proposed strategies could improve delivery of care and expressed much enthusiasm for them. Participants appreciated benefits of the peer component, saying it would motivate positive patient behavior, and provide health education, psychosocial support, and assistance in navigating care. The HIT component was seen as reducing paper work, easing communication between providers, and facilitating tracking of patient information. Participants also shared concerns that could influence implementation of the two strategies including consent, confidentiality, and reduction in patient-provider interaction. CONCLUSIONS: Appreciation of local realities and patients' experiences is critical to development and implementation of sustainable strategies to improve effectiveness of hypertension referral networks. Incorporating concerns from patients, health care workers, and local leaders facilitates adaptation of interventions to respond to real needs. This approach is ethical and also allows research teams to harness benefits of participatory community-involved research. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03543787, Registered June 1, 2018. https://clinicaltrials.gov/ct2/show/NCT03543787.

Network characteristics of a referral system for patients with hypertension in Western Kenya: results from the Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) study.

BACKGROUND: Health system approaches to improve hypertension control require an effective referral network. A national referral strategy exists in Kenya; however, a number of barriers to referral completion persist. This paper is a baseline assessment of a hypertension referral network for a cluster-randomized trial to improve hypertension control and reduce cardiovascular disease risk. METHODS: We used sociometric network analysis to understand the relationships between providers within a network of nine geographic clusters in western Kenya, including primary, secondary, and tertiary care facilities. We conducted a survey which asked providers to nominate individuals and facilities to which they refer patients with controlled and uncontrolled hypertension. Degree centrality measures were used to identify providers in prominent positions, while mixed-effect regression models were used to determine provider characteristics related to the likelihood of receiving referrals. We calculated core-periphery correlation scores (CP) for each cluster (ideal CP score = 1.0). RESULTS: We surveyed 152 providers (physicians, nurses, medical officers, and clinical officers), range 10-36 per cluster. Median number of hypertensive patients seen per month was 40 (range 1-600). While 97% of providers reported referring patients up to a more specialized health facility, only 55% reported referring down to lower level facilities. Individuals were more likely to receive a referral if they had higher level of training, worked at a higher level facility, were male, or had more job experience. CP scores for provider networks range from 0.335 to 0.693, while the CP scores for the facility networks range from 0.707 to 0.949. CONCLUSIONS: This analysis highlights several points of weakness in this referral network including cluster variability, poor provider linkages, and the lack of down referrals. Facility networks were stronger than provider networks. These shortcomings represent opportunities to focus interventions to improve referral networks for hypertension. TRIAL REGISTRATION: Trial Registered on ClinicalTrials.gov NCT03543787 , June 1, 2018.

Supply-chain strategies for essential medicines in rural western Kenya during COVID-19.

PROBLEM: The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide and threatened the supply of essential medicines. Especially affected are vulnerable patients in low- and middle-income countries who can only afford access to public health systems. APPROACH: Soon after physical distancing and curfew orders began on 15 March 2020 in Kenya, we rapidly implemented three supply-chain strategies to ensure a continuous supply of essential medicines while minimizing patients' COVID-19 exposure risks. We redistributed central stocks of medicines to peripheral health facilities to ensure local availability for several months. We equipped smaller, remote health facilities with medicine tackle boxes. We also made deliveries of medicines to patients with difficulty reaching facilities. LOCAL SETTING: Τo implement these strategies we leveraged our 30-year partnership with local health authorities in rural western Kenya and the existing revolving fund pharmacy scheme serving 85 peripheral health centres. RELEVANT CHANGES: In April 2020, stocks of essential chronic and non-chronic disease medicines redistributed to peripheral health facilities increased to 835 140 units, as compared with 316 330 units in April 2019. We provided medicine tackle boxes to an additional 46 health facilities. Our team successfully delivered medications to 264 out of 311 patients (84.9%) with noncommunicable diseases whom we were able to reach. LESSONS LEARNT: Our revolving fund pharmacy model has ensured that patients' access to essential medicines has not been interrupted during the pandemic. Success was built on a community approach to extend pharmaceutical services, adapting our current supply-chain infrastructure and working quickly in partnership with local health authorities.

Human-centered implementation research: a new approach to develop and evaluate implementation strategies for strengthening referral networks for hypertension in western Kenya.

BACKGROUND: Human-centered design (HCD) is an increasingly recognized approach for engaging stakeholders and developing contextually appropriate health interventions. As a component of the ongoing STRENGTHS study (Strengthening Referral Networks for Management of Hypertension Across the Health System), we report on the process and outcomes of utilizing HCD to develop the implementation strategy prior to a cluster-randomized controlled trial. METHODS: We organized a design team of 15 local stakeholders to participate in an HCD process to develop implementation strategies. We tested prototypes for acceptability, appropriateness, and feasibility through focus group discussions (FGDs) with various community stakeholder groups and a pilot study among patients with hypertension. FGD transcripts underwent content analysis, and pilot study data were analyzed for referral completion and reported barriers to referral. Based on this community feedback, the design team iteratively updated the implementation strategy. During each round of updates, the design team reflected on their experience through FGDs and a Likert-scale survey. RESULTS: The design team developed an implementation strategy consisting of a combined peer navigator and a health information technology (HIT) package. Overall, community participants felt that the strategy was acceptable, appropriate, and feasible. During the pilot study, 93% of referrals were completed. FGD participants felt that the implementation strategy facilitated referral completion through active peer engagement; enhanced communication between clinicians, patients, and health administrators; and integrated referral data into clinical records. Challenges included referral barriers that were not directly addressed by the strategy (e.g. transportation costs) and implementation of the HIT package across multiple health record systems. The design team reflected that all members contributed significantly to the design process, but emphasized the need for more transparency in how input from study investigators was incorporated into design team discussions. CONCLUSIONS: The adaptive process of co-creation, prototyping, community feedback, and iterative redesign aligned our implementation strategy with community stakeholder priorities. We propose a new framework of human-centered implementation research that promotes collaboration between community stakeholders, study investigators, and the design team to develop, implement, and evaluate HCD products for implementation research. Our experience provides a feasible and replicable approach for implementation research in other settings. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02501746 , registration date: July 17, 2015.

The Relationship Between Household Microfinance Group Participation and Vaccine Adherence Among Children in Rural Western Kenya.

INTRODUCTION: High childhood vaccine adherence is critical for disease prevention, and poverty is a key barrier to vaccine uptake. Interventions like microfinance programs that aim to lift individuals out of poverty could thus improve vaccine adherence of the children in the household. BIGPIC Family Program in rural Western Kenya provides group-based microfinance services while working to improve access to healthcare and health screenings for the local community. The aim of the present paper is to evaluate the association between household participation in BIGPIC's microfinance program and vaccine adherence among children in the household. We hypothesize that microfinance group participation will have a positive impact on vaccine adherence among children in the household. METHODS: From 2018 to 2019, we surveyed a sample of 300 participants from two rural communities in Western Kenya, some of whom were participants in the BIGPIC Family's microfinance program. The primary outcome of interest was vaccine adherence of children in the household. Log-binomial models were used to estimate the relationship between microfinance group participation and vaccine adherence, adjusted for key covariates. We also assessed whether the relationship differed by gender of the adult respondent. RESULTS: Microfinance group members were more likely to have all children in their households fully vaccinated [aPR (95% CI): 1.68 (1.20,2.35)] compared to non-microfinance group members. Further, the association was stronger when women were the microfinance members [PR (95% CI): 1.87 (1.27,2.76)] compared to men [PR (95% CI): 1.24 (0.81,1.90)]. CONCLUSIONS: Microfinance participation was associated with higher childhood vaccine adherence in rural Western Kenya. Microfinance interventions should be further explored as strategies to improve child health and well-being in low- and middle-income countries.

The relationship between a microfinance-based healthcare delivery platform, health insurance coverage, health screenings, and disease management in rural Western Kenya.

BACKGROUND: Structural barriers often prevent rural Kenyans from receiving healthcare and diagnostic testing. The Bridging Income Generation through grouP Integrated Care (BIGPIC) Family intervention facilitates microfinance groups, provides health screenings and treatment, and delivers education about health insurance coverage to address some of these barriers. This study evaluated the association between participation in BIGPIC microfinance groups and health screening/disease management outcomes. METHODS: From November 2018 to March 2019, we interviewed a sample of 300 members of two rural communities in Western Kenya, 100 of whom were BIGPIC microfinance members. We queried participants about their experiences with health screening and disease management for HIV, diabetes, hypertension, tuberculosis, and cervical cancer. We used log-binomial regression models to estimate the association between microfinance membership and each health outcome, adjusting for key covariates. RESULTS: Microfinance members were more likely to be screened for most of the health conditions we queried, including those provided by BIGPIC [e.g. diabetes: aPR (95% CI): 3.46 (2.60, 4.60)] and those not provided [e.g. cervical cancer: aPR (95% CI): 2.43 (1.21, 4.86)]. Microfinance membership was not significantly associated with health insurance uptake and disease management outcomes. CONCLUSIONS: In rural Kenya, a microfinance program integrated with healthcare delivery may be effective at increasing health screening. Interventions designed to thoughtfully and sustainably address structural barriers to healthcare will be critical to improving the health of those living in low-resource settings.

Correction to: Human-centered design as a guide to intervention planning for non-communicable diseases: the BIGPIC study from Western Kenya.

An amendment to this paper has been published and can be accessed via the original article.

Human-centered design as a guide to intervention planning for non-communicable diseases: the BIGPIC study from Western Kenya.

BACKGROUND: Non-communicable disease (NCD) care in Sub-Saharan Africa is challenging due to barriers including poverty and insufficient health system resources. Local culture and context can impact the success of interventions and should be integrated early in intervention design. Human-centered design (HCD) is a methodology that can be used to engage stakeholders in intervention design and evaluation to tailor-make interventions to meet their specific needs. METHODS: We created a Design Team of health professionals, patients, microfinance officers, community health workers, and village leaders. Over 6 weeks, the Design Team utilized a four-step approach of synthesis, idea generation, prototyping, and creation to develop an integrated microfinance-group medical visit model for NCD. We tested the intervention with a 6-month pilot and conducted a feasibility evaluation using focus group discussions with pilot participants and community members. RESULTS: Using human-centered design methodology, we designed a model for NCD delivery that consisted of microfinance coupled with monthly group medical visits led by a community health educator and a rural clinician. Benefits of the intervention included medication availability, financial resources, peer support, and reduced caregiver burden. Critical concerns elicited through iterative feedback informed subsequent modifications that resulted in an intervention model tailored to the local context. CONCLUSIONS: Contextualized interventions are important in settings with multiple barriers to care. We demonstrate the use of HCD to guide the development and evaluation of an innovative care delivery model for NCDs in rural Kenya. HCD can be used as a framework to engage local stakeholders to optimize intervention design and implementation. This approach can facilitate the development of contextually relevant interventions in other low-resource settings. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02501746, registration date: July 17, 2015.

C - reactive protein and interleukin - 6 levels among human immunodeficiency virus -infected patients with dysglycemia in Tanzania.

BACKGROUND: Chronic inflammation has been associated with dysglycemia among people living with HIV (PLHIV). There is however, limited data regarding this phenomenon in sub-Sahara Africa (SSA). Therefore we assessed the levels of C-reactive protein (CRP) and Interleukin 6 (IL-6) on a cohort of PLHIV and its associations with dysglycemia in Tanzania. METHODS: We conducted a cross-sectional study at the Infectious Disease Clinic (IDC) in Tanzania from March to May 2018. Purposive sampling was used to identify participants who had an undetectable viral load, were on 1st line anti-retroviral therapy (ART) and had an overnight fast. The WHO stepwise approach for non-communicable disease (NCD) surveillance was used to collect data. Fasting blood glucose and blood glucose after 75 g oral glucose load was measured, and Enzyme-linked immunosorbent assay (ELISA) was used to test for inflammatory markers (IL-6 and CRP). Associations were explored using the Chi square test and binary logistic regression was performed to estimate the odds ratios. A p-value less than 0.05 was considered statistically significant. RESULTS: A total of 240 participants were enrolled. Forty two percent were overweight/obese (> 25 kg/m2), 89% had a high waist to height ratio. The median ART duration was 8(5-10) years. The prevalence of dysglycemia among our cohort of PLHIV was 32%. High CRP was associated with a 2.05 increased odds of having dysglycemia OR 2.05 (1.15-3.65) (p = 0.01). Taking stavudine was associated with a 1.99 odds of having dysglycemia OR 1.99 (1.04-3.82) (p = 0.03).We did not find a significant association between IL-6 and dysglycemia. CONCLUSION: High CRP and taking stavudine were significantly associated with dysglycemia among PLHIV with undetectable viral load.

Retrospective assessment of the quality of diabetes care in a rural diabetes clinic in Western Kenya.

BACKGROUND: Sub-Saharan Africa continues to face the highest rate of mortality from diabetes in the world due to limited access to quality diabetes care. We assessed the quality of diabetes care in a rural diabetes clinic in western Kenya. METHODS: To provide a comprehensive assessment, a set of clinical outcomes, process, and structure metrics were evaluated to assess the quality of diabetes care provided in the outpatient clinic at Webuye District Hospital. The primary clinical outcome measures were the change in HbA1c and point of care blood glucose. In assessing process metrics, the primary measure was the percentage of patients who were lost to follow up. The structure metrics were assessed by evaluating different facets of the operation of the clinic and their accordance with the International Diabetes Federation (IDF) guidelines. RESULTS: A total of 524 patients were enrolled into the diabetes clinic during the predefined period of evaluation. The overall clinic population demonstrated a statistically significant reduction in HbA1c and point of care blood glucose at all time points of evaluation after baseline. Patients had a mean baseline HbA1C of 10.2% which decreased to 8.4% amongst the patients who remained in care after 18 months. In terms of process measures, 38 patients (7.3%) were characterized as being lost to follow up as they missed clinic visits for more than 6 months. Through the assessment of structural metrics, the clinic met at least the minimal standards of care for 14 out of the 19 domains recommended by the IDF. CONCLUSION: This analysis illustrates the gains made in various elements of diabetes care quality which can be used by other programs to guide diabetes care scale up across the region.

Leveraging the power of partnerships: spreading the vision for a population health care delivery model in western Kenya.

BACKGROUND: The Academic Model Providing Access to Healthcare (AMPATH) has been a model academic partnership in global health for nearly three decades, leveraging the power of a public-sector academic medical center and the tripartite academic mission - service, education, and research - to the challenges of delivering health care in a low-income setting. Drawing our mandate from the health needs of the population, we have scaled up service delivery for HIV care, and over the last decade, expanded our focus on non-communicable chronic diseases, health system strengthening, and population health more broadly. Success of such a transformative endeavor requires new partnerships, as well as a unification of vision and alignment of strategy among all partners involved. Leveraging the Power of Partnerships and Spreading the Vision for Population Health. We describe how AMPATH built on its collective experience as an academic partnership to support the public-sector health care system, with a major focus on scaling up HIV care in western Kenya, to a system poised to take responsibility for the health of an entire population. We highlight global trends and local contextual factors that led to the genesis of this new vision, and then describe the key tenets of AMPATH's population health care delivery model: comprehensive, integrated, community-centered, and financially sustainable with a path to universal health coverage. Finally, we share how AMPATH partnered with strategic planning and change management experts from the private sector to use a novel approach called a 'Learning Map®' to collaboratively develop and share a vision of population health, and achieve strategic alignment with key stakeholders at all levels of the public-sector health system in western Kenya. CONCLUSION: We describe how AMPATH has leveraged the power of partnerships to move beyond the traditional disease-specific silos in global health to a model focused on health systems strengthening and population health. Furthermore, we highlight a novel, collaborative tool to communicate our vision and achieve strategic alignment among stakeholders at all levels of the health system. We hope this paper can serve as a roadmap for other global health partners to develop and share transformative visions for improving population health globally.

Leveraging peer-based support to facilitate HIV care in Kenya.

Rakhi Karwa and colleagues discuss a program in which peer navigators support care for people with HIV at a Kenyan hospital.

Bridging Income Generation with Group Integrated Care for cardiovascular risk reduction: Rationale and design of the BIGPIC study.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with >80% of CVD deaths occurring in low and middle income countries (LMICs). Diabetes mellitus and pre-diabetes are risk factors for CVD, and CVD is the major cause of morbidity and mortality among individuals with DM. There is a critical period now during which reducing CVD risk among individuals with diabetes and pre-diabetes may have a major impact. Cost-effective, culturally appropriate, and context-specific approaches are required. Two promising strategies to improve health outcomes are group medical visits and microfinance. METHODS/DESIGN: This study tests whether group medical visits integrated into microfinance groups are effective and cost-effective in reducing CVD risk among individuals with diabetes or at increased risk for diabetes in western Kenya. An initial phase of qualitative inquiry will assess contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance for CVD risk reduction. Subsequently, we will conduct a four-arm cluster randomized trial comparing: (1) usual clinical care, (2) usual clinical care plus microfinance groups only, (3) group medical visits only, and (4) group medical visits integrated into microfinance groups. The primary outcome measure will be 1-year change in systolic blood pressure, and a key secondary outcome measure is 1-year change in overall CVD risk as measured by the QRISK2 score. We will conduct mediation analysis to evaluate the influence of changes in social network characteristics on intervention outcomes, as well as moderation analysis to evaluate the influence of baseline social network characteristics on effectiveness of the interventions. Cost-effectiveness analysis will be conducted in terms of cost per unit change in systolic blood pressure, percent change in CVD risk score, and per disability-adjusted life year saved. DISCUSSION: This study will provide evidence regarding effectiveness and cost-effectiveness of interventions to reduce CVD risk. We aim to produce generalizable methods and results that can provide a model for adoption in low-resource settings worldwide.

Impact of Bridging Income Generation with Group Integrated Care (BIGPIC) on Hypertension and Diabetes in Rural Western Kenya.

BACKGROUND: Rural settings in Sub-Saharan Africa (SSA) consistently report low participation in non-communicable disease (NCD) treatment programs and poor outcomes. OBJECTIVE: The objective of this study is to assess the impact of the implementation of a patient-centered rural NCD care delivery model called Bridging Income Generation through grouP Integrated Care (BIGPIC). DESIGN: The study prospectively tracked participation and health outcomes for participants in a screening event and compared linkage frequencies to a historical comparison group. PARTICIPANTS: Rural Kenyan participants attending a voluntary NCD screening event were included within the BIGPIC model of care. INTERVENTIONS: The BIGPIC model utilizes a contextualized care delivery model designed to address the unique barriers faced in rural settings. This model emphasizes the following steps: (1) find patients in the community, (2) link to peer/microfinance groups, (3) integrate education, (4) treat in the community, (5) enhance economic sustainability and (6) generate demand for care through incentives. MAIN MEASURES: The primary outcome is the linkage frequency, which measures the percentage of patients who return for care after screening positive for either hypertension and/or diabetes. Secondary measures include retention frequencies defined as the percentage of patients remaining engaged in care throughout the 9-month follow-up period and changes in systolic (SBP) and diastolic blood pressure (DBP) and blood sugar over 12 months. KEY RESULTS: Of the 879 individuals who were screened, 14.2 % were confirmed to have hypertension, while only 1.4 % were confirmed to have diabetes. The implementation of a comprehensive microfinance-linked, community-based, group care model resulted in 72.4 % of screen-positive participants returning for subsequent care, of which 70.3 % remained in care through the 12 months of the evaluation period. Patients remaining in care demonstrated a statistically significant mean decline of 21 mmHg in SBP [95 % CI (13.9 to 28.4), P < 0.01] and 5 mmHg drop in DBP [95 % CI (1.4 to 7.6), P < 0.01]. CONCLUSIONS: The implementation of a contextualized care delivery model built around the unique needs of rural SSA participants led to statistically significant improvements in linkage to care and blood pressure reduction.

Venous Thromboembolism Requiring Extended Anticoagulation Among HIV-Infected Patients in a Rural, Resource-Constrained Setting in Western Kenya.

BACKGROUND: HIV-infected patients are at an increased risk of developing venous thromboembolism (VTE), and minimal data are available to describe the need for extended treatment. OBJECTIVE: To evaluate the frequency of and determine predictive risk factors for extended anticoagulation of VTE in HIV-infected patients in rural, western Kenya. METHODS: A retrospective chart review was conducted at the Anticoagulation Monitoring Service affiliated with Moi Teaching and Referral Hospital and the Academic Model Providing Access to Healthcare. Data were collected on patients who were HIV-infected and receiving anticoagulation for lower-limb deep vein thrombosis. The need for extended anticoagulation, defined as receiving ≥7 months of warfarin therapy, was established based on patient symptoms or Doppler ultrasound-confirmed diagnosis. Evaluation of the secondary outcomes utilized a univariate analysis to identify risk factors associated with extended anticoagulation. RESULTS: A total of 71 patients were included in the analysis; 27 patients (38%) required extended anticoagulation. The univariate analysis showed a statistically significant association between the need for extended anticoagulation and achieving a therapeutic international normalized ratio within 21 days in both the unadjusted and adjusted analysis. Patients with a history of opportunistic infections required an extended duration of anticoagulation in the adjusted analysis: odds ratio = 3.42; 95% CI = 1.04-11.32; P = 0.04. CONCLUSIONS: This study shows that there may be a need for increased duration of anticoagulation in HIV-infected patients, with a need to address the issue of long-term management. Guideline recommendations are needed to address the complexity of treatment issues in this population.

Prevalence of gestational diabetes mellitus based on various screening strategies in western Kenya: a prospective comparison of point of care diagnostic methods.

BACKGROUND: Early diagnosis of gestational diabetes mellitus (GDM) is crucial to prevent short term delivery risks and long term effects such as cardiovascular and metabolic diseases in the mother and infant. Diagnosing GDM in Sub-Saharan Africa (SSA) however, remains sub-optimal due to associated logistical and cost barriers for resource-constrained populations. A cost-effective strategy to screen for GDM in such settings are therefore urgently required. We conducted this study to determine the prevalence of gestational diabetes mellitus (GDM) and assess utility of various GDM point of care (POC) screening strategies in a resource-constrained setting. METHODS: Eligible women aged ≥18 years, and between 24 and 32 weeks of a singleton pregnancy, prospectively underwent testing over two days. On day 1, a POC 1-h 50 g glucose challenge test (GCT) and a POC glycated hemoglobin (HbA1c) was assessed. On day 2, fasting blood glucose, 1-h and 2-h 75 g oral glucose tolerance test (OGTT) were determined using both venous and POC tests, along with a venous HbA1c. The International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria was used to diagnose GDM. GDM prevalence was reported with 95% confidence interval (CI). Specificity, sensitivity, positive predictive value, and negative predictive value of the various POC testing strategies were determined using IADPSG testing as the standard reference. RESULTS: Six hundred-sixteen eligible women completed testing procedures. GDM was diagnosed in 18 women, a prevalence of 2.9% (95% CI, 1.57% - 4.23%). Compared to IADPSG testing, POC IADPSG had a sensitivity and specificity of 55.6% and 90.6% respectively while that of POC 1-h 50 g GCT (using a diagnostic cut-off of ≥7.2 mmol/L [129.6 mg/dL]) was 55.6% and 63.9%. All other POC tests assessed showed poor sensitivity. CONCLUSIONS: POC screening strategies though feasible, showed poor sensitivity for GDM detection in our resource-constrained population of low GDM prevalence. Studies to identify sensitive and specific POC GDM screening strategies using adverse pregnancy outcomes as end points are required. TRIALS REGISTRATION: Clinical trials.gov : NCT02978807 , Registered 29 November 2016.

Assessing the accuracy of a point-of-care analyzer for hyperlipidaemia in western Kenya.

OBJECTIVES: The prevalence of hyperlipidaemia, along with other non-communicable diseases, is on the rise in low- and middle-income countries. CardioChek PA is a point-of-care lipid measuring device, which seeks to overcome laboratory-based diagnostic barriers by providing immediate results without dependency on significant laboratory infrastructure. However, it has not been validated in Kenya. In this study, we assess the accuracy of CardioChek PA with respect to the gold standard laboratory-based testing. METHODS: In Webuye, Kenya, two blood samples were collected from 246 subjects to simultaneously measure the lipid levels via both CardioChek PA and the gold standard. All subjects were adults, and geographic stratified sampling methods were applied. Statistical analysis of the device's accuracy was based on per cent bias parameters, as established by the United States National Institutes of Health (NIH). The NIH recommends that per cent bias be ≤±3% for low-density lipoprotein (LDL) cholesterol, ≤±5% for high-density lipoprotein (HDL) cholesterol, ≤±5% for total cholesterol (TC) and ≤±4% for triglycerides (TG). Risk group misclassification rates were also analysed. RESULTS: The CardioChek PA analyzer was substantially inaccurate for LDL cholesterol (-25.9% bias), HDL cholesterol (-8.2% bias) and TC (-15.9% bias). Moreover, those patients at higher risk of complications from hyperlipidaemia were most likely to be misclassified into a lower risk category. CONCLUSION: CardioChek PA is inaccurate and not suitable for our clinical setting. Furthermore, our findings highlight the need to validate new diagnostic tools in the appropriate setting prior to scale up regardless of their potential for novel utility.

Social determinants of health-based strategies to address vaccination disparities through a university-public health partnership.

A decline in routine vaccinations, attributed to vaccine hesitancy, undermines preventative healthcare, impacting health and exacerbating vaccine disparities. University-public health partnerships can improve vaccination services. This study describes and evaluates a university-public health use case employing social determinants of health (SDoH)-based strategies to address vaccination disparities. Guided by the Translational Science Benefits Logic Model, the partnership offered no-cost preventative vaccines at community-based organization (CBO) sites, collected CBO clientele's vaccination interest, hesitancy, and demographic data, and conducted descriptive analyses. One hundred seven vaccination events were held, administering 3,021 vaccines. This partnership enhanced health outcomes by addressing disparities through co-located vaccination and SDoH services.

Cost-effectiveness of group medical visits and microfinance interventions versus usual care to manage hypertension in Kenya: a secondary modelling analysis of data from the Bridging Income Generation with Group Integrated Care (BIGPIC) trial.

BACKGROUND: The Bridging Income Generation with Group Integrated Care (BIGPIC) trial in rural Kenya showed that integrating usual care with group medical visits or microfinance interventions reduced systolic blood pressure and cardiovascular risk in participants. We aimed to estimate the incremental cost-effectiveness of three BIGPIC interventions for a modelled cohort and by sex, as well as the cost of implementing these interventions. METHODS: For this analysis, we used data collected during the BIGPIC trial, a four-group, cluster-randomised trial conducted in the western Kenyan catchment area of the Academic Model Providing Access to Healthcare. BIGPIC enrolled participants from 24 rural health facilities in rural western Kenya aged 35 years or older with either increased blood pressure or diabetes. Participants were assigned to receive either usual care, group medical visits, microfinance, or a combination of group medical visits and microfinance (GMV-MF). Our model estimated the incremental cost-effectiveness of the three BIGPIC interventions via seven health states (ie, a hypertensive state, five chronic cardiovascular-disease states, and a death state) by simulating transitions between health states for a hypothetical cohort of individuals with hypertension on the basis of QRISK3 scores. In every cycle, participants accrued costs and disability-adjusted life-years (DALYs) associated with their health state. Incremental cost-effectiveness ratios (ICERs) were calculated for the entire modelled cohort and by sex by dividing the incremental cost by the incremental effectiveness of the next most expensive intervention. The main outcome of this analysis was ICERs for each intervention evaluated. This analysis is registered at ClinicalTrials.gov (NCT02501746). FINDINGS: Between Feb 6, 2017, and Dec 29, 2019, 2890 people were recruited to the BIGPIC trial. 2020 (69·9%) of 2890 participants were female and 870 (30·1%) were male. At baseline, mean QRISK3 score was 11·5 (95% CI 11·1-11·9) for the trial population, 11·9 (11·5-12·2) for male participants, and 11·3 (11·0-11·6) for female participants. For the population of Kenya, group medical visits were estimated to cost US$7 more per individual than usual care and result in 0·005 more DALYs averted (ICER $1455 per DALY averted). Microfinance was estimated to cost $19 more than group medical visits but was only estimated to avert 0·001 more DALYs. Relative to group medical visits, GMV-MF was estimated to cost $29 more and avert 0·009 more DALYs ($3235 per DALY averted). Relative to usual care, GMV-MF was estimated to cost $37 more and avert 0·014 more DALYs ($2601 per DALY averted). In the first year of the intervention, usual care was estimated to be the least expensive intervention to implement ($87 per participant; $10 238 per health-facility catchment area [HFCA]), then group medical visits ($99 per participant; $12 268 per HFCA), then microfinance ($120 per participant; $14 172 per HFCA), with GMV-MF estimated to be the most expensive intervention to implement ($139 per participant; $16 913 per HFCA). INTERPRETATION: Group medical visits and GMV-MF were estimated to be cost-effective strategies to improve blood-pressure control in rural Kenya. However, which intervention to pursue depends on resource availability. Policy makers should consider these factors, in addition to sex differences in programme effectiveness, when selecting optimal implementation strategies. FUNDING: US National Institutes of Health.

Early pregnancy HbA1c as the first screening test for gestational diabetes: results from three prospective cohorts.

BACKGROUND: More than 90% of gestational diabetes cases are estimated to occur in low-income and middle-income countries (LMICs). Most current guidelines recommend an oral glucose tolerance test (OGTT) at 24-28 weeks of gestation. The OGTT is burdensome, especially in LMICs, resulting in a high proportion of women not being screened. We aimed to develop a simple and effective screening strategy for gestational diabetes. METHODS: STRiDE, a prospective cohort study, was set up in seven centres in south India and seven centres in western Kenya, and included pregnant women aged 18-50 years of age and at less than 16 weeks of gestation (<20 weeks in Kenya), confirmed by dating ultrasound. We assessed the efficacy of early pregnancy HbA1c (venous and capillary point-of-care), either alone or as part of a composite risk score with age, BMI, and family history of diabetes, in predicting gestational diabetes at 24-28 weeks of gestation, in two LMICs (India and Kenya) and in a UK multi-ethnic population from the PRiDE study. A key secondary outcome was to assess whether an early pregnancy composite risk score can reduce the need for OGTTs. Gestational diabetes was diagnosed using current WHO criteria. FINDINGS: Between Feb 15, 2016, Dec 13, 2019, we enrolled 3070 participants in India and 4104 in Kenya. 4320 participants were included from the PRiDE cohort. Gestational diabetes prevalence by OGTT at 24-28 weeks was 19·2% in India, 3·0% in Kenya, and 14·5% in the UK. Early pregnancy HbA1c was independently associated with incidence of gestational diabetes at 24-28 weeks of gestation. Adjusted risk ratios were 1·60 (95% CI 1·19-2·16) in India, 3·49 (2·8-4·34) in Kenya, and 4·72 (3·82-5·82) in the UK. Composite risk score models that combined venous or point-of-care HbA1c with age, BMI, and family history of diabetes best predicted testing positive for gestational diabetes. A population-specific, two-threshold screening strategy of rule-in and rule-out gestational diabetes using early pregnancy composite risk score could reduce the requirement of OGTTs by 50-64%. For the HbA1c-alone model, the thresholds were 5·4% (rule in) and 4·9% (rule out) in India, 6·0% (rule in) and 5·2% (rule out) in Kenya, and 5·6% (rule in) and 5·2% (rule out) in the UK. INTERPRETATION: Early pregnancy HbA1c offers a simple screening test for gestational diabetes, allowing those at highest risk to receive early intervention and greatly reduce the need for OGTTs. This can also be carried out using point-of-care HbA1c in LMICs. FUNDING: UK Medical Research Council and the Indian Department of Biotechnology.