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.

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.

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.

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.

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.

Screening for diabetes and hypertension in a rural low income setting in western Kenya utilizing home-based and community-based strategies.

BACKGROUND: The burdens of hypertension and diabetes are increasing in low- and middle-income countries (LMICs). It is important to identify patients with these conditions early in the disease process. The goal of this study, therefore, is to compare community- versus home-based screening for hypertension and diabetes in Kenya. METHODS: This was a feasibility study conducted by the Academic Model Providing Access to Healthcare (AMPATH) program in Webuye, a town in western Kenya. Home-based (door-to-door) screening occurred in March 2010 and community-based screening in November 2011. HIV counselors were trained to screen for diabetes and hypertension in the home-based screening with local district hospital based staff conducting the community-based screening. Participants >18 years old qualified for screening in both groups. Counselors referred all participants with a systolic blood pressure (SBP) ≥ 160 mmHg and/or a random blood glucose ≥ 7 mmol/L (126 mg/dL) to a local clinic for follow-up. Differences in likelihood of screening positive between the two strategies were compared using Fischer's Exact Test. Logistic regression models were used to identify factors associated with the likelihood of following-up after a positive screening. RESULTS: There were 236 participants in home-based screening: 13 (6%) had a SBP ≥ 160 mmHg, and 54 (23%) had a random glucose ≥ 7 mmol/L. There were 346 participants in community-based screening: 35 (10%) had a SBP ≥ 160 mmHg, and 27 (8%) had a random glucose ≥ 7 mmol/L. Participants in community-based screening were twice as likely to screen positive for hypertension compared to home-based screening (OR=1.93, P=0.06). In contrast, participants were 3.5 times more likely to screen positive for a random blood glucose ≥ 7 mmol/L with home-based screening (OR=3.51, P<0.01). Rates for following-up at the clinic after a positive screen were low for both groups with 31% of patients with an elevated SBP returning for confirmation in both the community-based and home-based group (P=1.0). Follow-up after a random glucose was also low with 23% returning in the home-based group and 22% in the community-based group (P=1.0). CONCLUSION: Community- or home-based screening for diabetes and hypertension in LMICs is feasible. Due to low rates of follow-up, screening efforts in rural settings should focus on linking cases to care.

Risk of Bleeding Associated With Outpatient Use of Rivaroxaban in VTE Management at a National Referral Hospital in Western Kenya.

There is limited data on the bleeding safety profile of direct oral anticoagulants, such as rivaroxaban, in low- and middle-income country settings like Kenya. In this prospective observational study, patients newly started on rivaroxaban or switching to rivaroxaban from warfarin for the management of venous thromboembolism (VTE) within the national referral hospital in western Kenya were assessed to determine the frequency of bleeding during treatment. Bleeding events were assessed at the 1- and 3-month visits, as well as at the end of follow-up. The International Society of Thrombosis and Hemostasis (ISTH) and the Bleeding Academic Research Consortium (BARC) criteria were used to categorize the bleeding events, and descriptive statistics were used to summarize categorical variables. Univariate and multivariate logistic regression model was used to calculate unadjusted and adjusted associations between patient characteristics and bleeding. The frequency of any type of bleeding was 14.4% (95% CI: 9.3%-20.8%) for an incidence rate of 30.9 bleeding events (95% CI: 20.1-45.6) per 100 patient-years of follow-up. The frequency of major bleeding was 1.9% while that of clinically relevant non-major bleeding was 13.8%. In the multivariate logistic regression model, being a beneficiary of the national insurance plan was associated with a lower risk of bleeding, while being unemployed was associated with a higher bleeding risk. The use of rivaroxaban in the management of VTE was associated with a higher frequency of bleeding. These findings warrant confirmation in larger and more targeted investigations in a similar population.

Changes in clinical markers observed from pharmacist-managed cardiovascular risk reduction clinics in federally qualified health centers: A retrospective cohort study.

BACKGROUND: Reductions in hemoglobin A1c (HbA1C) have been associated with improved cardiovascular outcomes and savings in medical expenditures. One public health approach has involved pharmacists within primary care settings. The objective was to assess change in HbA1C from baseline after 3-5 months of follow up in pharmacist-managed cardiovascular risk reduction (CVRR) clinics. METHODS: This retrospective cohort chart review occurred in eight pharmacist-managed CVRR federally qualified health clinics (FQHC) in Indiana, United States. Data were collected from patients seen by a CVRR pharmacist within the timeframe of January 1, 2015 through February 28, 2020. Data collected include: demographic characteristics and clinical markers between baseline and follow-up. HbA1C from baseline after 3 to 5 months was assessed with pared t-tests analysis. Other clinical variables were assessed and additional analysis were performed at 6-8 months. Additional results are reported between 9 months and 36 months of follow up. RESULTS: The primary outcome evaluation included 445 patients. Over 36 months of evaluation, 3,803 encounters were described. Compared to baseline, HbA1C was reduced by 1.6% (95%CI -1.8, -1.4, p<0.01) after 3-5 months of CVRR care. Reductions in HbA1C persisted at 6-8 months with a reduction of 1.8% ([95%CI -2.0, -1.5] p<0.01). The follow-up losses were 29.5% at 3-5 months and 93.2% at 33-36 months. CONCLUSIONS: Our study augments the existing literature by demonstrating the health improvement of pharmacist-managed CVRR clinics. The great proportion of loss to follow-up is a limitation of this study to be considered. Additional studies exploring the expansion of similar models may amplify the public health impact of pharmacist-managed CVRR services in primary care sites.

Interruptions to HIV Care Delivery During Pandemics and Natural Disasters: A Qualitative Study of Challenges and Opportunities From Frontline Healthcare Providers in Western Kenya.

During public health crises, people living with HIV (PLWH) may become disengaged from care. The goal of this study was to understand the impact of the COVID-19 pandemic and recent flooding disasters on HIV care delivery in western Kenya. We conducted ten individual in-depth interviews with HIV providers across four health facilities. We used an iterative and integrated inductive and deductive data analysis approach to generate four themes. First, increased structural interruptions created exacerbating strain on health facilities. Second, there was increased physical and psychosocial burnout among providers. Third, patient uptake of services along the HIV continuum decreased, particularly among vulnerable patients. Finally, existing community-based programs and teleconsultations could be adapted to provide differentiated HIV care. Community-centric care programs, with an emphasis on overcoming the social, economic, and structural barriers will be crucial to ensure optimal care and limit the impact of public health disruptions on HIV care globally.

How health systems can adapt to a population ageing with HIV and comorbid disease.

As people age with HIV, their needs increase beyond solely managing HIV care. Ageing people with HIV, defined as people with HIV who are 50 years or older, face increased risk of both age-regulated comorbidities and ageing-related issues. Globally, health-care systems have struggled to meet these changing needs of ageing people with HIV. We argue that health systems need to rethink care strategies to meet the growing needs of this population and propose models of care that meet these needs using the WHO health system building blocks. We focus on care provision for ageing people with HIV in the three different funding mechanisms: President's Emergency Plan for AIDS Relief and Global Fund funded nations, the USA, and single-payer government health-care systems. Although our categorisation is necessarily incomplete, our efforts provide a valuable contribution to the debate on health systems strengthening as the need for integrated, people-centred, health services increase.

Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya.

BACKGROUND: The Harambee study is a cluster randomized trial in Western Kenya that tests the effect, mechanisms, and cost-effectiveness of integrating community-based HIV and non-communicable disease care within microfinance groups on chronic disease treatment outcomes. This paper documents the stages of our feasibility study conducted in preparation for the Harambee trial, which include (1) characterizing the target population and gauging recruitment capacity, (2) determining community acceptability of the integrated intervention and study procedures, and (3) identifying key implementation considerations prior to study start. METHODS: Feasibility research took place between November 2019 and February 2020 in Western Kenya. Mixed methods data collection included surveys administered to 115 leaders of 105 community-based microfinance groups, 7 in-person meetings and two workshops with stakeholders from multiple sectors of the health system, and ascertainment of field notes and geographic coordinates for group meeting locations and HIV healthcare facilities. Quantitative survey data were analyzed using STATA IC/13. Longitude and latitude coordinates were mapped to county boundaries using Esri ArcMap. Qualitative data obtained from stakeholder meetings and field notes were analyzed thematically. RESULTS: Of the 105 surveyed microfinance groups, 77 met eligibility criteria. Eligible groups had been in existence from 6 months to 18 years and had an average of 22 members. The majority (64%) of groups had at least one member who owned a smartphone. The definition of "active" membership and model of saving and lending differed across groups. Stakeholders perceived the community-based intervention and trial procedures to be acceptable given the minimal risks to participants and the potential to improve HIV treatment outcomes while facilitating care integration. Potential challenges identified by stakeholders included possible conflicts between the trial and existing community-based interventions, fear of group disintegration prior to trial end, clinicians' inability to draw blood for viral load testing in the community, and deviations from standard care protocols. CONCLUSIONS: This study revealed that it was feasible to recruit the number of microfinance groups necessary to ensure that our clinical trial was sufficient powered. Elicitation of stakeholder feedback confirmed that the planned intervention was largely acceptable and was critical to identifying challenges prior to implementation. TRIAL REGISTRATION: The original trial was prospectively registered with ClinicalTrials.gov (NCT04417127) on 4 June 2020.

Community-based medication delivery program for antihypertensive medications improves adherence and reduces blood pressure.

Non-adherence to antihypertensive medications is a major cause of uncontrolled hypertension, leading to cardiovascular morbidity and mortality. Ensuring consistent medication possession is crucial in addressing non-adherence. Community-based medication delivery is a strategy that may improve medication possession, adherence, and blood pressure (BP) reduction. Our program in Kenya piloted a community medication delivery program, coupled with blood pressure monitoring and adherence evaluation. Between September 2019 and March 2020, patients who received hypertension care from our chronic disease management program also received community-based delivery of antihypertensive medications. We calculated number of days during which each patient had possession of medications and analyzed the relationship between successful medication delivery and self-reported medication adherence and BP. A total of 128 patient records (80.5% female) were reviewed. At baseline, mean systolic blood pressure (SBP) was 155.7 mmHg and mean self-reported adherence score was 2.7. Sixty-eight (53.1%) patients received at least 1 successful medication delivery. Our pharmacy dispensing records demonstrated that medication possession was greater among patients receiving medication deliveries. Change in self-reported medication adherence from baseline worsened in patients who did not receive any medication delivery (+0.5), but improved in patients receiving 1 delivery (-0.3) and 2 or more deliveries (-0.8). There was an SBP reduction of 1.9, 6.1, and 15.5 mmHg among patients who did not receive any deliveries, those who received 1 delivery, and those who received 2 or more medication deliveries, respectively. Adjusted mixed-effect model estimates revealed that mean SBP reduction and self-reported medication adherence were improved among individuals who successfully received medication deliveries, compared to those who did not. A community medication delivery program in western Kenya was shown to be implementable and enhanced medication possession, reduced SBP, and significantly improved self-reported adherence. This is a promising strategy to improve health outcomes for patients with uncontrolled hypertension that warrants further investigation.

Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial.

PURPOSE: Evaluate the effectiveness of compression while receiving chemotherapy compared with chemotherapy alone in the treatment of HIV-associated Kaposi sarcoma (KS) lymphedema. METHODS: A randomized controlled trial was conducted in a single oncology clinic in western Kenya (NCT03404297). A computer-generated randomization schedule was used to allocate treatment arms. Randomized block design was used for stratification by lymphedema stage. Participants were HIV positive adults age ≥ 18 years on antiretroviral therapy with biopsy-proven KS associated with leg lymphedema and being initiated on chemotherapy. The intervention was 10 weeks of weekly clinic-based application of two-component paste compression bandages. The primary outcome was change in the Lower Extremity Lymphedema Index (LELI) score from week 0 to week 14. The secondary outcomes were change in the Lymphedema Quality of Life measure (LYMQOL) and change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score from week 0 to week 14. Blinded outcome assessments were conducted. RESULTS: Of 30 participants randomly assigned, 25 eligible patients (chemotherapy [control], n = 13; compression plus chemotherapy [intervention], n = 12) returned at week 14. Change in LELI, LYMQOL, and EORTC QLQ-C30 scores between week 14 and week 0 did not significantly differ by arm. The mean (standard deviation) change in LELI score was -25.9 (34.6) for the control arm compared with -13.3 (29.5) for the intervention arm, P = .340. The difference (95% CI) in the change in LELI score was -12.6 (-39.3 to 14.1). CONCLUSION: Future studies evaluating a 14-week change in LELI for KS lymphedema should assume a standard deviation of approximately 30. Lessons learned from this pilot trial should inform the development of a larger, multicenter trial to evaluate the effectiveness of compression for KS lymphedema.

The evolution of diabetes care in the rural, resource-constrained setting of western Kenya.

BACKGROUND: The initial focused effort on addressing the HIV pandemic in sub-Saharan Africa has helped set the groundwork for addressing many of the other areas of the health-care system requiring support in resource-constrained settings. With the growing prevalence of diabetes in this setting, the US Agency for International Development-Academic Model Providing Access to Healthcare Partnership (USAID-AMPATH) has begun developing infrastructure to meet the growing need for diabetes care. OBJECTIVE: To describe the evolution of diabetes care in the rural, resource-constrained setting of western Kenya and to analyze preliminary data on the current status of glucose control of patients. METHODS: Through partnerships, USAID-AMPATH has facilitated the provision of basic modalities of diabetes care, including reliable stocks of insulin, hemoglobin A(1c) (A1C) testing, and point-of-care glucose-testing supplies. RESULTS: Through the introduction of A1C testing, the poor quality of diabetes care was revealed, as the average A1C for the clinic population was 10.4%, with insulin-dependent patients constituting the majority of individuals with markedly elevated A1C levels. To address this, a contextualized electronic medical record and a cell phone-based home glucose monitoring program were created to improve glycemic control, which has led to significant reductions in A1C levels. CONCLUSIONS: Through the inclusion of clinical data within the electronic medical record, there is an ongoing effort to research various aspects of diabetes care in this understudied population, with the goal of addressing many of the unanswered questions surrounding diabetes care in sub-Saharan Africa. The lessons learned from this pilot program will be used to create sustainable infrastructure for diabetes care in partnership with the Kenyan government and will serve as a model for similar programs.