"It is like an umbrella covering you, yet it does not protect you from the rain": a mixed methods study of insurance affordability, coverage, and financial protection in rural western Kenya.

Countries in Sub-Saharan Africa are increasingly adopting mandatory social health insurance programs. In Kenya, mandatory social health insurance is being implemented through the national health insurer, the National Hospital Insurance Fund (NHIF), but the level of coverage, affordability and financial risk protection provided by health insurance, especially for rural informal households, is unclear. This study provides as assessment of affordability of NHIF premiums, the need for financial risk protection, and the extent of financial protection provided by NHIF among rural informal workers in western Kenya.Methods We conducted a mixed methods study with a cross-sectional household survey (n = 1773), in-depth household interviews (n = 36), and 6 focus group discussions (FGDs) with community stakeholders in rural western Kenya. Health insurance status was self-reported and households were categorized into insured and uninsured. Using survey data, we calculated the affordability of health insurance (unaffordability was defined as the monthly premium being > 5% of total household expenditures), out of pocket expenditures (OOP) on healthcare and its impact on impoverishment, and incidence of catastrophic health expenditures (CHE). Logistic regression was used to assess household characteristics associated with CHE.Results Only 12% of households reported having health insurance and was unaffordable for the majority of households, both insured (60%) and uninsured (80%). Rural households spent an average of 12% of their household budget on OOP, with both insured and uninsured households reporting high OOP spending and similar levels of impoverishment due to OOP. Overall, 12% of households experienced CHE, with uninsured households more likely to experience CHE. Participants expressed concerns about value of health insurance given its cost, availability and quality of services, and financial protection relative to other social and economic household needs. Households resulted to borrowing, fundraising, taking short term loans and selling family assets to meet healthcare costs.Conclusion Health insurance coverage was low among rural informal sector households in western Kenya, with health insurance premiums being unaffordable to most households. Even among insured households, we found high levels of OOP and CHE. Our results suggest that significant reforms of NHIF and health system are required to provide adequate health services and financial risk protection for rural informal households in Kenya.

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.

Postpartum psychosis in peripartum cardiomyopathy: a case report.

BACKGROUND: This case report highlights the rare occurrence of postpartum psychosis in the setting of peripartum cardiomyopathy, which can have rare presentations like arrhythmias and pulmonary edema; and the challenges one should anticipate while managing these conditions together. Caution is advised whenever antipsychotic drugs are to be administered to a patient with a cardiac condition as these drugs potentially increase the risk of arrhythmias and sudden death. CASE PRESENTATION: A 35 year old grand multiparous woman who was 1 week into puerperium was admitted with severe difficulty in breathing at rest, chest congestion and pain. She also had easy fatigability, orthopnea, paroxysmal nocturnal dyspnea, edema, tachycardia, tachypnea, irregularly irregular heart rate with a pulse deficit, elevated jugular venous pressure, cardiomegaly, hepatomegaly and pulmonary crepitations. On the sixth day while improving on standard drugs for heart failure, she developed bizarre behavior and confusion. She also had auditory, visual and olfactory hallucinations; violence to the baby and the husband; and refusal to feed and take medication. There was no altered sensorium and the vital signs were normal. She was diagnosed with puerperal psychosis during the management of peripartum cardiomyopathy. CONCLUSION: In the rare occurrence of puerperal psychosis in the course of management of peripartum cardiomyopathy one must be acutely aware of the risk of sudden cardiac death occasioned by use of antipsychotics, either directly or due to arrhythmias. Continuous electrocardiogram (ECG) monitoring or use of alternative management modalities is thus highly advised.

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.

Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya.

BACKGROUND: More than half of artemisinin combination therapies (ACTs) consumed globally are dispensed in the retail sector, where diagnostic testing is uncommon, leading to overconsumption and poor targeting. In many malaria-endemic countries, ACTs sold over the counter are available at heavily subsidized prices, further contributing to their misuse. Inappropriate use of ACTs can have serious implications for the spread of drug resistance and leads to poor outcomes for nonmalaria patients treated with incorrect drugs. We evaluated the public health impact of an innovative strategy that targets ACT subsidies to confirmed malaria cases by coupling free diagnostic testing with a diagnosis-dependent ACT subsidy. METHODS AND FINDINGS: We conducted a cluster-randomized controlled trial in 32 community clusters in western Kenya (population approximately 160,000). Eligible clusters had retail outlets selling ACTs and existing community health worker (CHW) programs and were randomly assigned 1:1 to control and intervention arms. In intervention areas, CHWs were available in their villages to perform malaria rapid diagnostic tests (RDTs) on demand for any individual >1 year of age experiencing a malaria-like illness. Malaria RDT-positive individuals received a voucher for a discount on a quality-assured ACT, redeemable at a participating retail medicine outlet. In control areas, CHWs offered a standard package of health education, prevention, and referral services. We conducted 4 population-based surveys-at baseline, 6 months, 12 months, and 18 months-of a random sample of households with fever in the last 4 weeks to evaluate predefined, individual-level outcomes. The primary outcome was uptake of malaria diagnostic testing at 12 months. The main secondary outcome was rational ACT use, defined as the proportion of ACTs used by test-positive individuals. Analyses followed the intention-to-treat principle using generalized estimating equations (GEEs) to account for clustering with prespecified adjustment for gender, age, education, and wealth. All descriptive statistics and regressions were weighted to account for sampling design. Between July 2015 and May 2017, 32,404 participants were tested for malaria, and 10,870 vouchers were issued. A total of 7,416 randomly selected participants with recent fever from all 32 clusters were surveyed. The majority of recent fevers were in children under 18 years (62.9%, n = 4,653). The gender of enrolled participants was balanced in children (49.8%, n = 2,318 boys versus 50.2%, n = 2,335 girls), but more adult women were enrolled than men (78.0%, n = 2,139 versus 22.0%, n = 604). At baseline, 67.6% (n = 1,362) of participants took an ACT for their illness, and 40.3% (n = 810) of all participants took an ACT purchased from a retail outlet. At 12 months, 50.5% (n = 454) in the intervention arm and 43.4% (n = 389) in the control arm had a malaria diagnostic test for their recent fever (adjusted risk difference [RD] = 9 percentage points [pp]; 95% CI 2-15 pp; p = 0.015; adjusted risk ratio [RR] = 1.20; 95% CI 1.05-1.38; p = 0.015). By 18 months, the ARR had increased to 1.25 (95% CI 1.09-1.44; p = 0.005). Rational use of ACTs in the intervention area increased from 41.7% (n = 279) at baseline to 59.6% (n = 403) and was 40% higher in the intervention arm at 18 months (ARR 1.40; 95% CI 1.19-1.64; p < 0.001). While intervention effects increased between 12 and 18 months, we were not able to estimate longer-term impact of the intervention and could not independently evaluate the effects of the free testing and the voucher on uptake of testing. CONCLUSIONS: Diagnosis-dependent ACT subsidies and community-based interventions that include the private sector can have an important impact on diagnostic testing and population-wide rational use of ACTs. Targeting of the ACT subsidy itself to those with a positive malaria diagnostic test may also improve sustainability and reduce the cost of retail-sector ACT subsidies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02461628.

Evaluation of malaria rapid diagnostic test (RDT) use by community health workers: a longitudinal study in western Kenya.

BACKGROUND: Malaria rapid diagnostic tests (RDTs) are a simple, point-of-care technology that can improve the diagnosis and subsequent treatment of malaria. They are an increasingly common diagnostic tool, but concerns remain about their use by community health workers (CHWs). These concerns regard the long-term trends relating to infection prevention measures, the interpretation of test results and adherence to treatment protocols. This study assessed whether CHWs maintained their competency at conducting RDTs over a 12-month timeframe, and if this competency varied with specific CHW characteristics. METHODS: From June to September, 2015, CHWs (n = 271) were trained to conduct RDTs using a 3-day validated curriculum and a baseline assessment was completed. Between June and August, 2016, CHWs (n = 105) were randomly selected and recruited for follow-up assessments using a 20-step checklist that classified steps as relating to safety, accuracy, and treatment; 103 CHWs participated in follow-up assessments. Poisson regressions were used to test for associations between error count data at follow-up and Poisson regression models fit using generalized estimating equations were used to compare data across time-points. RESULTS: At both baseline and follow-up observations, at least 80% of CHWs correctly completed 17 of the 20 steps. CHWs being 50 years of age or older was associated with increased total errors and safety errors at baseline and follow-up. At follow-up, prior experience conducting RDTs was associated with fewer errors. Performance, as it related to the correct completion of all checklist steps and safety steps, did not decline over the 12 months and performance of accuracy steps improved (mean error ratio: 0.51; 95% CI 0.40-0.63). Visual interpretation of RDT results yielded a CHW sensitivity of 92.0% and a specificity of 97.3% when compared to interpretation by the research team. None of the characteristics investigated was found to be significantly associated with RDT interpretation. CONCLUSIONS: With training, most CHWs performing RDTs maintain diagnostic testing competency over at least 12 months. CHWs generally perform RDTs safely and accurately interpret results. Younger age and prior experiences with RDTs were associated with better testing performance. Future research should investigate the mode by which CHW characteristics impact RDT procedures.

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.

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.

Q Fever, Scrub Typhus, and Rickettsial Diseases in Children, Kenya, 2011-2012.

To increase knowledge of undifferentiated fevers in Kenya, we tested paired serum samples from febrile children in western Kenya for antibodies against pathogens increasingly recognized to cause febrile illness in Africa. Of patients assessed, 8.9%, 22.4%, 1.1%, and 3.6% had enhanced seroreactivity to Coxiella burnetii, spotted fever group rickettsiae, typhus group rickettsiae, and scrub typhus group orientiae, respectively.

A cluster-randomized trial of client and provider-directed financial interventions to align incentives with appropriate case management in retail medicine outlets: Results of the TESTsmART Trial in western Kenya.

ACTs are responsible for a substantial proportion of the global reduction in malaria mortality over the last ten years, made possible by publicly-funded subsidies making these drugs accessible and affordable in the private sector. However, inexpensive ACTs available in retail outlets have contributed substantially to overconsumption. We test an innovative, scalable strategy to target ACT-subsidies to clients with a confirmatory diagnosis. We supported malaria testing(mRDTs) in 39 medicine outlets in western Kenya, randomized to three study arms; control arm offering subsidized mRDT testing (0.4USD), client-directed intervention where all clients who received a positive RDT at the outlet were eligible for a free (fully-subsidized) ACT, and a combined client and provider directed intervention where clients with a positive RDT were eligible for free ACT and outlets received 0.1USD for every RDT performed. Our primary outcome was the proportion of ACT dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients tested at the outlet and adherence to diagnostic test results. 43% of clients chose to test at the outlet. Test results informed treatment decisions, resulting in targeting of ACTs to confirmed malaria cases- 25.3% of test-negative clients purchased an ACT compared to 75% of untested clients. Client-directed and client+provider-directed interventions did not offer further improvements, compared to the control arm, in testing rates(RD = 0.09, 95%CI:-0.08,0.26) or dispensing of ACTs to test-positive clients(RD = 0.01,95% CI:-0.14, 0.16). Clients were often unaware of the price they paid for the ACT leading to uncertainty in whether the ACT subsidy was passed on to the client. This uncertainty undermines our ability to definitively conclude that client-directed subsidies are not effective for improving testing and appropriate treatment. We conclude that mRDTs could reduce ACT overconsumption in the private retail sector, but incentive structures are difficult to scale and their value to private providers is uncertain. Trial registration: ClinicalTrials.gov NCT04428307.

A cluster-randomized trial of client and provider directed financial interventions to align incentives with appropriate case management in private medicine retailers: Results of the TESTsmART trial in Lagos, Nigeria.

Malaria remains a major health priority in Nigeria. Among children with fever who seek care, less than a quarter gets tested for malaria, leading to inappropriate use of the recommended treatment for malaria; Artemisinin-based Combination Therapy (ACT). Here we test an innovative strategy to target ACT subsidies to clients seeking care in Nigeria's private retail health sector who have a confirmed malaria diagnosis. We supported point-of-care malaria testing (mRDTs) in 48 Private Medicine Retailers (PMRs) in the city of Lagos, Nigeria and randomized them to two study arms; a control arm offering subsidized mRDT testing for USD $0.66, and an intervention arm where, in addition to access to subsidized testing as in the control arm, clients who received a positive mRDT at the PMR were eligible for a free (fully subsidized) first-line ACT and PMRs received USD $0.2 for every mRDT performed. Our primary outcome was the proportion of ACTs dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients who were tested at the PMR and adherence to diagnostic test results. Overall, 23% of clients chose to test at the PMR. Test results seemed to inform treatment decisions and resulted in enhanced targeting of ACTs to confirmed malaria cases with only 26% of test-negative clients purchasing an ACT compared to 58% of untested clients. However, the intervention did not offer further improvements, compared to the control arm, in testing rates or dispensing of ACTs to test-positive clients. We found that ACT subsidies were not passed on to clients testing positive in the intervention arm. We conclude that mRDTs could reduce ACT overconsumption in Nigeria's private retail health sector, but PMR-oriented incentive structures are difficult to implement and may need to be complemented with interventions targeting clients of PMRs to increase test uptake and adherence. Trials registration: Clinical Trials Registration Number: NCT04428307. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816435/ Correction: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9476591/.

Malaria in Pregnancy: Key Points for the Neonatologist.

In malaria-endemic regions, infection with the malaria parasite Plasmodium during pregnancy has been identified as a key modifiable factor in preterm birth, the delivery of low-birthweight infants, and stillbirth. Compared with their nonpregnant peers, pregnant persons are at higher risk for malaria infection. Malaria infection can occur at any time during pregnancy, with negative effects for the pregnant person and the fetus, depending on the trimester in which the infection is contracted. Pregnant patients who are younger, in their first or second pregnancy, and those coinfected with human immunodeficiency virus are at increased risk for malaria. Common infection prevention measures during pregnancy include the use of insecticide-treated bed nets and the use of intermittent preventive treatment with monthly doses of antimalarials, beginning in the second trimester in pregnant patients in endemic areas. In all trimesters, artemisinin-combination therapies are the first-line treatment for uncomplicated falciparum malaria, similar to treatment in nonpregnant adults. The World Health Organization recently revised its recommendations, now listing the specific medication artemether-lumefantrine as first-line treatment for uncomplicated malaria in the first trimester. While strong prevention and detection methods exist, use of these techniques remains below global targets. Ongoing work on approaches to treatment and prevention of malaria during pregnancy remains at the forefront of global maternal child health research.

Supply-side and demand-side factors influencing uptake of malaria testing services in the community: lessons for scale-up from a post-hoc analysis of a cluster randomised, community-based trial in western Kenya.

OBJECTIVES: Maximising the impact of community-based programmes requires understanding how supply of, and demand for, the intervention interact at the point of delivery. DESIGN: Post-hoc analysis from a large-scale community health worker (CHW) study designed to increase the uptake of malaria diagnostic testing. SETTING: Respondents were identified during a household survey in western Kenya between July 2016 and April 2017. PARTICIPANTS: Household members with fever in the last 4 weeks were interviewed at 12 and 18 months post-implementation. We collected monthly testing data from 244 participating CHWs and conducted semistructured interviews with a random sample of 70 CHWs. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure was diagnostic testing before treatment for a recent fever. The secondary outcomes were receiving a test from a CHW and tests done per month by each CHW. RESULTS: 55% (n=948 of 1738) reported having a malaria diagnostic test for their recent illness, of which 38.4% were tested by a CHW. Being aware of a local CHW (adjusted OR=1.50, 95% CI: 1.10 to 2.04) and belonging to the wealthiest households (vs least wealthy) were associated with higher testing (adjusted OR=1.53, 95% CI: 1.14 to 2.06). Wealthier households were less likely to receive their test from a CHW compared with poorer households (adjusted OR=0.32, 95% CI: 0.17 to 0.62). Confidence in artemether-lumefantrine to cure malaria (adjusted OR=2.75, 95% CI: 1.54 to 4.92) and perceived accuracy of a malaria rapid diagnostic test (adjusted OR=2.43, 95% CI: 1.12 to 5.27) were positively associated with testing by a CHW. Specific CHW attributes were associated with performing a higher monthly number of tests including formal employment, serving more than 50 households (vs <50) and serving areas with a higher test positivity. On demand side, confidence of the respondent in a test performed by a CHW was strongly associated with seeking a test from a CHW. CONCLUSION: Scale-up of community-based malaria testing is feasible and effective in increasing uptake among the poorest households. To maximise impact, it is important to recognise factors that may restrict delivery and demand for such services. TRIAL REGISTRATION NUMBER: NCT02461628; Post-results.

A Global Health Reciprocal Innovation grant programme: 5-year review with lessons learnt.

Unilateral approaches to global health innovations can be transformed into cocreative, uniquely collaborative relationships between low-income and middle-income countries (LMICs) and high-income countries (HIC), constituted as 'reciprocal innovation' (RI). Since 2018, the Indiana Clinical and Translational Sciences Institute (CTSI) and Indiana University (IU) Center for Global Health Equity have led a grants programme sculpted from the core elements of RI, a concept informed by a 30-year partnership started between IU (Indiana) and Moi University (Kenya), which leverages knowledge sharing, transformational learning and translational innovations to address shared health challenges. In this paper, we describe the evolution and implementation of an RI grants programme, as well as the challenges faced. We aim to share the successes of our RI engagement and encourage further funding opportunities to promote innovations grounded in the RI core elements. From the complex series of challenges encountered, three major lessons have been learnt: dedicating extensive time and resources to bring different settings together; establishing local linkages across investigators; and addressing longstanding inequities in global health research. We describe our efforts to address these challenges through educational materials and an online library of resources for RI projects. Using perspectives from RI investigators funded by this programme, we offer future directions resulting from our 5-year experience in applying this RI-focused approach. As the understanding and implementation of RI grow, global health investigators can share resources, knowledge and innovations that have the potential to significantly change the face of collaborative international research and address long-standing health inequities across diverse settings.

Associations between Antenatal Syphilis Test Results and Adverse Pregnancy Outcomes in Western Kenya.

Maternal syphilis remains a major contributor to poor pregnancy outcomes. Syphilis point-of-care (POC) tests are now used for pregnancy screening; the effect of screening on outcomes is unclear. We enrolled women presenting to antenatal care (ANC) in a matched cohort study at a single site in Kenya tested by either a syphilis-only or an HIV/syphilis dual POC test. Syphilis POC-positive women (patients) were matched 1:2 with POC-negative women (control subjects) on gravidity, gestational age, and HIV status, and were monitored through delivery. Syphilis serum testing was performed every 8 weeks. Pregnancy outcomes were assessed up to 1 month after delivery and compared using prevalence ratios. A total of 151 women were enrolled (51 patients and 100 control subjects) at a mean of 22 weeks gestation; 24% were HIV positive and 40% were paucigravid. A positive Treponema pallidum hemagglutination test was more common among patients (64.7%) than control subjects (11.1%, P < 0.001). Only two women met the definition for incident syphilis. Pregnancy outcomes were available for 147 women. The prevalence of low birthweight (LBW) was greater among patients (15.2%) than control subjects (5.4%, P = 0.052). Of the 109 women with concordant syphilis POC and Treponema pallidum hemagglutination test results at ANC enrollment, LBW prevalence was significantly greater among test-positive (25%) than test-negative (4.9%) women (adjusted prevalence ratio, 5.84; 95% CI, 1.08-31.5). Despite treatment with penicillin, latent syphilis at ANC enrollment was associated with a more than 5-fold increased risk of LBW. Alternate implementation strategies for syphilis POC testing may be necessary to realize the potential of ANC syphilis screening to improve pregnancy outcomes.

How do malaria testing and treatment subsidies affect drug shop client expenditures? A cross-sectional analysis in Western Kenya.

OBJECTIVES: To examine how drug shop clients' expenditures are affected by subsidies for malaria diagnostic testing and for malaria treatment, and also to examine how expenditures vary by clients' malaria test result and by the number of medications they purchased. DESIGN: Secondary cross-sectional analysis of survey responses from a randomised controlled trial. SETTING: The study was conducted in twelve private drug shops in Western Kenya. PARTICIPANTS: We surveyed 836 clients who visited the drug shops between March 2018 and October 2019 for a malaria-like illness. This included children >1 year of age if they were physically present and accompanied by a parent or legal guardian. INTERVENTIONS: Subsidies for malaria diagnostic testing and for malaria treatment (conditional on a positive malaria test result). PRIMARY AND SECONDARY OUTCOME MEASURES: Expenditures at the drug shop in Kenya shillings (Ksh). RESULTS: Clients who were randomised to a 50% subsidy for malaria rapid diagnostic tests (RDTs) spent approximately Ksh23 less than those who were randomised to no RDT subsidy (95% CI (-34.6 to -10.7), p=0.002), which corresponds approximately to the value of the subsidy (Ksh20). However, clients randomised to receive free treatment (artemisinin combination therapies (ACTs)) if they tested positive for malaria had similar spending levels as those randomised to a 67% ACT subsidy conditional on a positive test. Expenditures were also similar by test result, however, those who tested positive for malaria bought more medications than those who tested negative for malaria while spending approximately Ksh15 less per medication (95% CI (-34.7 to 3.6), p=0.102). CONCLUSIONS: Our results suggest that subsidies for diagnostic health products may result in larger household savings than subsidies on curative health products. A better understanding of how people adjust their behaviours and expenditures in response to subsidies could improve the design and implementation of subsidies for health products. TRIAL REGISTRATION NUMBER: NCT03810014.

Community-Based Malaria Testing Reduces Polypharmacy in a Population-Based Survey of Febrile Illness in Western Kenya.

Objective: The objective was to describe the relationship between the location of care, the malaria test result, and the type of medicine consumed for the fever, and to determine whether community-based access to malaria testing reduced polypharmacy. Methods: This is a secondary analysis of a cluster-randomized trial of an intervention designed to increase diagnostic testing and targeting of Artemesinin Combined Therapies (ACTs). Data collected at baseline, 12, and 18 months were analyzed to determine the impact of diagnostic testing on drug consumption patterns among febrile individuals. Results: Of the 5,756 participants analyzed, 60.1% were female, 42% were aged 5-17 years, and 58.1% sought care for fever in a retail outlet. Consumption of both ACT and antibiotics was 22.1% (n = 443/2008) at baseline. At endline, dual consumption had declined to 16.6%. There was reduced antibiotic consumption among those testing positive for malaria (39.5%-26.5%) and those testing negative (63.4%-55.1%), accompanied by a substantial decline in ACT use among malaria-negative participants. Conclusion: Diagnostic testing for malaria reduces dual consumption of ACTs and antibiotics, especially among those testing outside the formal healthcare sector.

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.

Incentivizing appropriate malaria case management in the private sector: a study protocol for two linked cluster randomized controlled trials to evaluate provider- and client-focused interventions in western Kenya and Lagos, Nigeria.

BACKGROUND: A large proportion of artemisinin-combination therapy (ACT) anti-malarial medicines is consumed by individuals that do not have malaria. The over-consumption of ACTs is largely driven by retail sales in high malaria-endemic countries to clients who have not received a confirmatory diagnosis. This study aims to target ACT sales to clients receiving a confirmatory diagnosis using malaria rapid diagnostic tests (mRDTs) at retail outlets in Kenya and Nigeria. METHODS: This study comprises two linked four-arm 2 × 2 factorial cluster randomized controlled trials focused on malaria diagnostic testing and conditional ACT subsidies with the goal to evaluate provider-directed and client-directed interventions. The linked trials will be conducted at two contrasting study sites: a rural region around Webuye in western Kenya and the urban center of Lagos, Nigeria. Clusters are 41 and 48 participating retail outlets in Kenya and Nigeria, respectively. Clients seeking care at participating outlets across all arms will be given the option of paying for a mRDT-at a study-recommended price-to be conducted at the outlet. In the provider-directed intervention arm, the outlet owner receives a small monetary incentive to perform the mRDT. In the client-directed intervention arm, the client receives a free ACT if they purchase an mRDT and receive a positive test result. Finally, the fourth study arm combines both the provider- and client-directed interventions. The diagnosis and treatment choices made during each transaction will be captured using a mobile phone app. Study outcomes will be collected through exit interviews with clients, who sought care for febrile illness, at each of the enrolled retail outlets. RESULTS: The primary outcome measure is the proportion of all ACTs that are sold to malaria test-positive clients in each study arm. For all secondary outcomes, we will evaluate the degree to which the interventions affect purchasing behavior among people seeking care for a febrile illness at the retail outlet. CONCLUSIONS: If our study demonstrates that malaria case management can be improved in the retail sector, it could reduce overconsumption of ACTs and enhance targeting of publicly funded treatment reimbursements, lowering the economic barrier to appropriate diagnosis and treatment for patients with malaria. TRIAL REGISTRATION: ClinicalTrials.gov NCT04428307 , registered June 9, 2020, and NCT04428385 , registered June 9, 2020.