Increasing access to pediatric surgical care: Assessing district hospital readiness in rural Rwanda.

Introduction/Background: Safe and quality surgery is crucial for child health. In Rwanda, district hospitals serve as primary entry points for pediatric patients needing surgical care. This paper reports on the organizational readiness and facility capacity to provide pediatric surgery in three district hospitals in rural Rwanda. Methods: We administered the Children's Surgical Assessment Tool (CSAT), adapted for a Rwandan district hospital, to assess facility readiness across 5 domains (infrastructure, workforce, service delivery, financing, and training) at three Partners in Health supported district hospitals (Kirehe, Rwinkwavu, and Butaro District Hospitals). We used the Safe Surgery Organizational Readiness Tool (SSORT) to measure perceived individual and team readiness to implement surgical quality improvement interventions across 14 domains. Results: None of the facilities had a dedicated pediatric surgeon, and the most common barriers to pediatric surgery were lack of surgeon (68%), lack of physician anesthesiologists (19%), and inadequate infrastructure (17%). There were gaps in operating and recovery room infrastructure, and information management for pediatric outpatients and referrals. In SSORT interviews (n=47), the highest barriers to increasing pediatric surgery capacity were facility capacity (mean score=2.6 out of 5), psychological safety (median score=3.0 out of 5), and resistance to change (mean score=1.5 out of 5 with 5=no resistance). Conclusions: This study highlights challenges in providing safe and high-quality surgical care to pediatric patients in three rural district hospitals in Rwanda. It underscores the need for targeted interventions to address facility and organizational barriers prior to implementing interventions to expand pediatric surgical capacity.

Implementation and Cost Analysis of a Novel Silicosis Case-Finding Program For Mine Workers in Rural Rwanda.

Little is known about the burden of silicosis in Africa, despite extensive mining and construction operations in the region putting numerous people at risk. The implementation experience and costs of case-finding for occupational lung disease in resource-limited settings are also currently unknown. We describe the first-ever silicosis case-finding project in rural Rwanda using chest X-ray, symptom questionnaires, and spirometry. This was coupled with routine noncommunicable disease case-finding for diabetes and hypertension. We performed an ingredient-based analysis of the costs of all case-finding activities. In 2022, over 25 days, 1,032 mine workers were included in the program, of which 1,014 (98.3%) completed silicosis case-finding activities. The total cost of the program was estimated to be US$38,656, representing a cost of US$37.49 per person. We conclude that conducting large-scale occupational lung disease case-finding is clinically and economically feasible in resource-limited settings and can be effectively integrated with routine noncommunicable disease case-finding.

Functional recovery after cesarean delivery: a prospective cohort study in rural Rwanda.

INTRODUCTION: Women who deliver via cesarean section (c-section) experience short- and long-term disability that may affect their physical health and their ability to function normally. While clinical complications are assessed, postpartum functional outcomes are not well understood from a patient's perspective or well-characterized by previous studies. In Rwanda, 11% of rural women deliver via c-section. This study explores the functional recovery of rural Rwandan women after c-section and assesses factors that predict poor functionality at postoperative day (POD) 30. METHODS: Data were collected prospectively on POD 3, 11, and 30 from women delivering at Kirehe District Hospital between October 2019 and March 2020. Functionality was measured by self-reported overall health, energy level, mobility, self-care ability, and ability to perform usual activities; and each domain was rated on a 4-point likert scale, lower scores reflecting higher level of difficulties. Using the four functionality domains, we computed composite mean scores with a maximum score of 4.0 and we defined poor functionality as composite score of ≤ 2.0. We assessed functionality with descriptive statistics and logistic regression. RESULTS: Of 617 patients, 54.0%, 25.9%, and 26.8% reported poor functional status at POD3, POD11, and POD30, respectively. At POD30, the most self-reported poor functionality dimensions were poor or very poor overall health (48.1%), and inability to perform usual activities (15.6%). In the adjusted model, women whose surgery lasted 30-45 min had higher odds of poor functionality (aOR = 1.85, p = 0.01), as did women who experienced intraoperative complications (aOR = 4.12, 95% CI (1.09, 25.57), p = 0.037). High income patients had incrementally lower significant odds of poor physical functionality (aOR = 0.62 for every US$1 increase in monthly income, 95% CI (0.40, 0.96) p = 0.04). CONCLUSION: We found a high proportion of poor physical functionality 30 days post-c-section in this Rwandan cohort. Surgery lasting > 30 min and intra-operative complications were associated with poor functionality, whereas a reported higher income status was associated with lower odds of poor functionality. Functional status assessments, monitoring and support should be included in post-partum care for women who delivered via c-section. Effective risk mitigating intervention should be implemented to recover functionality after c-section, particularly among low-income women and those undergoing longer surgical procedures or those with intraoperative complications.

Long travel times from health center to hospital reduce caesarean section access: a study from Kirehe District, Rwanda.

Introduction: timely access to safe cesarean section (c-section) delivery can save the lives of mothers and neonates. This paper explores how distance affects c-section access in rural sub-Saharan Africa, where women in labor present to health centers before being referred to district hospitals for surgical care. Methods: this study included all adult women delivering via c-section between April 2017 and March 2018 in Kirehe District, Rwanda. We assessed the association between travel times and village-level c-section rates. Results: the estimated travel time from home-to-health center was 26 minutes (IQR: 13, 41) and from health center-to-hospital was 43 minutes (IQR: 2, 59). There was no significant association between travel time from home-to-health center and c-section rates (RR=1.01, p=0.42), but the association was significant for health center-to-hospital travel times (RR=0.96, p=0.01); for every 15-minute increase in travel time, there was a 4% decrease in c-sections for a health center catchment area. Conclusion: in the context of decentralized health services, minimizing health center to hospital referral barriers is of utmost importance for improving c-section access in rural sub-Saharan Africa.

Late and Persistent Symptoms Suggestive of Surgical Site Infections After Cesarean Section: Results from a Prospective Cohort Study in Rural Rwanda.

Background: Women in low-resource settings will likely develop late surgical site infections (SSIs), diagnosed after post-operative day (POD) 10. We measured SSI prevalence and predictors of late and persistent SSIs-suggestive symptoms among women who delivered via cesarean section (c-section). Patients and Methods: Women who underwent c-sections at Kirehe District Hospital (KDH) between September 2019 and February 2020 were prospectively enrolled. Data were collected on POD1, POD11, and POD30. Logistic regression identified factors associated with persistent and late SSI symptoms. Results: In total, 808 women were study enrolled. Of these, 646 women physically attended the POD11 clinic visit follow-up, while 671 received the POD30 telephone-based follow-up review. Thirty-three (5.0%) women were diagnosed with an SSI on POD11, and 39 (5.3%) had an SSI diagnosis during POD11 to POD30, giving a cumulative prevalence of 10.3% late SSI rate. Of 671, 400 (59.9%) reported at least one SSI-associated symptom between POD11 and POD30. The reported symptoms included pain (56.6%), fever (19.4%), or incision drainage (16.6%). Of these, 200 women reported still having at least one of these symptoms on POD30. Of the 400 women with late SSI symptoms, 232 (58.0%) did not seek care, and of these, 80 (48.5%), 59 (35.8%), and 15 (8.9%) could not afford transport fare, did not believe symptoms were severe for a medical visit, and were not able to travel, respectively. Lower odds of late SSI-suggestive symptoms were reported among women with health insurance (adjusted odds ratio [aOR], 0.06; p = 0.013), whereas higher late SSI-suggestive symptoms odds were among women with wealthier socioeconomic status (aOR, 2.88; p = 0.004). Conclusions: Women in rural Rwanda are at risk of late and persistent SSI-suggestive symptoms. Financial barriers and the perception that their symptoms were not serious enough for the medical visit need education on early care seeking and interventions to mitigate financial barriers for optimizing perinatal care.

Safe recovery after cesarean in rural Africa: Technical consensus guidelines for post-discharge care.

Despite increasing cesarean rates in Africa, there remain extensive gaps in the standard provision of care after cesarean birth. We present recommendations for discharge instructions to be provided to women following cesarean delivery in Rwanda, particularly rural Rwanda, and with consideration of adaptable guidelines for sub-Saharan Africa, to support recovery during the postpartum period. These guidelines were developed by a Technical Advisory Group comprised of clinical, program, policy, and research experts with extensive knowledge of cesarean care in Africa. The final instructions delineate between normal and abnormal recovery symptoms and advise when to seek care. The instructions align with global postpartum care guidelines, with additional emphasis on care practices more common in the region and address barriers that women delivering via cesarean may encounter in Africa. The recommended timeline of postpartum visits and visit activities reflect the World Health Organization protocols and provide additional activities to support women who give birth via cesarean. These guidelines aim to standardize communication with women at the time of discharge after cesarean birth in Africa, with the goal of improved confidence and clinical outcomes among these individuals.

Impact of COVID-19 on access to cancer care in Rwanda: a retrospective time-series study using electronic medical records data.

INTRODUCTION: The COVID-19 pandemic has caused disruptions in access to routine healthcare services worldwide, with a particularly high impact on chronic care patients and low and middle-income countries. In this study, we used routinely collected electronic medical records data to assess the impact of the COVID-19 pandemic on access to cancer care at the Butaro Cancer Center of Excellence (BCCOE) in rural Rwanda. METHODS: We conducted a retrospective time-series study among all Rwandan patients who received cancer care at the BCCOE between 1 January 2016 and 31 July 2021. The primary outcomes of interest included a comparison of the number of patients who were predicted based on time-series models of pre-COVID-19 trends versus the actual number of patients who presented during the COVID-19 period (between March 2020 and July 2021) across four key indicators: the number of new patients, number of scheduled appointments, number of clinical visits attended and the proportion of scheduled appointments completed on time. RESULTS: In total, 8970 patients (7140 patients enrolled before COVID-19 and 1830 patients enrolled during COVID-19) were included in this study. During the COVID-19 period, enrolment of new patients dropped by 21.7% (95% prediction interval (PI): -31.3%, -11.7%) compared with the pre-COVID-19 period. Similarly, the number of clinical visits was 25.0% (95% PI: -31.1%, -19.1%) lower than expected and the proportion of scheduled visits completed on time was 27.9% (95% PI: -39.8%, -14.1%) lower than expected. However, the number of scheduled visits did not deviate significantly from expected. CONCLUSION: Although scheduling procedures for visits continued as expected, our findings reveal that the COVID-19 pandemic interrupted patients' ability to access cancer care and attend scheduled appointments at the BCCOE. This interruption in care suggests delayed diagnosis and loss to follow-up, potentially resulting in a higher rate of negative health outcomes among cancer patients in Rwanda.

Feasibility and effectiveness of self-monitoring of blood glucose among insulin-dependent patients with type 2 diabetes: open randomized control trial in three rural districts in Rwanda.

BACKGROUND: The prevalence of type 2 diabetes in sub Saharan Africa (SSA) has been on the rise. Effective control of blood glucose is key towards reducing the risk of diabetes complications. Findings mainly from high-income countries have demonstrated the effectiveness of self-monitoring of blood-glucose (SMBG) in controlling blood glucose levels. However, there are limited studies describing the implementation of SMBG in rural SSA. This study explores the feasibility and effectiveness of implementing SMBG among patients diagnosed with insulin-dependent type 2 diabetes in rural Rwanda. METHODS: Participants were randomized into intervention (n = 42) and control (n = 38) groups. The intervention group received a glucose-meter, blood test-strips, log-book, waste management box and training on SMBG in addition to usual care. The control group continued with their usual care consisting of, routine monthly medical consultation and health education. The primary outcomes were adherence to the implementation of SMBG (testing schedule and recording data in the log-book) and change in hemoglobin A1c. Descriptive statistics and a paired t-test were used to analyze the primary outcomes. RESULTS: In both the intervention and control arms, majority of the participants were female (59.5% vs 52.6%) and married (71.4% vs 73.7%). Most had at most a primary level education (83.3% vs. 89.4%) and were farmers (54.8% vs. 50.0%). Among those in the intervention group, 63.4% showed good adherence to implementing SMBG based on the number of tests recorded in the glucose meter. Only 20.3% demonstrated accurate recording of the glucose level tests in log-books. The mean difference of the HbA1C from baseline to six months post-intervention was significantly better among the intervention group -0.94% (95% CI -1.46, -0.41) compared to the control group 0.73% (95% CI -0.09, 1.54) p < 0.001. CONCLUSION: Our study showed that among patients with insulin-dependent type 2 diabetes residing in rural Rwanda, SMBG was feasible and demonstrated positive outcomes in improving blood glucose control. However, there is need for strategies to enhance accuracy in recording blood glucose test results in the log-book. TRIAL REGISTRATION: The trial was registered retrospectively on the Pan African Clinical Trial Registry, on 17th May 2019. The registration number is PACTR201905538846394.

mHealth-community health worker telemedicine intervention for surgical site infection diagnosis: a prospective study among women delivering via caesarean section in rural Rwanda.

BACKGROUND: Surgical site infections (SSIs) cause a significant global public health burden in low and middle-income countries. Most SSIs develop after patient discharge and may go undetected. We assessed the feasibility and diagnostic accuracy of an mHealth-community health worker (CHW) home-based telemedicine intervention to diagnose SSIs in women who delivered via caesarean section in rural Rwanda. METHODS: This prospective cohort study included women who underwent a caesarean section at Kirehe District Hospital between September 2019 and March 2020. At postoperative day 10 (±3 days), a trained CHW visited the woman at home, provided wound care and transmitted a photo of the wound to a remote general practitioner (GP) via WhatsApp. The GP reviewed the photo and made an SSI diagnosis. The next day, the woman returned to the hospital for physical examination by an independent GP, whose SSI diagnosis was considered the gold standard for our analysis. We describe the intervention process indicators and report the sensitivity and specificity of the telemedicine-based diagnosis. RESULTS: Of 787 women included in the study, 91.4% (n=719) were located at their home by the CHW and all of them (n=719, 100%) accepted the intervention. The full intervention was completed, including receipt of GP telemedicine diagnosis within 1 hour, for 79.0% (n=623). The GPs diagnosed 30 SSIs (4.2%) through telemedicine and 38 SSIs (5.4%) through physical examination. The telemedicine sensitivity was 36.8% and specificity was 97.6%. The negative predictive value was 96.4%. CONCLUSIONS: Implementation of an mHealth-CHW home-based intervention in rural Rwanda and similar settings is feasible. Patients' acceptance of the intervention was key to its success. The telemedicine-based SSI diagnosis had a high negative predictive value but a low sensitivity. Further studies must explore strategies to improve accuracy, such as accompanying wound images with clinical data or developing algorithms using machine learning.

Telemedicine for Surgical Site Infection Diagnosis in Rural Rwanda: Concordance and Accuracy of Image Reviews.

BACKGROUND: In rural Africa where access to medical personnel is limited, telemedicine can be leveraged to empower community health workers (CHWs) to support effective postpartum home-based care after cesarean section (c-section). As a first step toward telemedicine, we assessed the sensitivity, specificity, and interrater reliability of image-based diagnosis of surgical site infections (SSIs) among women delivering via c-section at a rural Rwandan Hospital. METHODS: Women ≥18 years who underwent c-section from March to October 2017 at Kirehe District Hospital (KDH) were enrolled. On postoperative day 10 at KDH, participants underwent a physical examination by a general practitioner, who provided a diagnosis of SSI or no SSI. Trained CHWs photographed patients' incisions and the collected images were shown to six physicians, who upon review, assigned one of the following diagnoses to each image: definite SSI, suspected SSI, suspected no SSI, and definite no SSI, which were compared with the diagnoses based on physical exam. We report the sensitivity and specificity and assessed reviewer agreement using Gwet's AC1. RESULTS: 569 images were included, with 61 women (10.7%) diagnosed with an SSI. Of the 3414 image-reviews, 49 (1.4%) could not be assigned diagnoses due to image quality. The median sensitivity and specificity were 0.83 and 0.69, respectively. The Gwet's AC1 estimate for binary classification was 0.46. CONCLUSIONS: We demonstrate decent accuracy but only moderate consistency for photograph-based SSI diagnosis. Strategies to improve overall agreement include providing clinical information to accompany photographs, providing a baseline photograph for comparison, and implementing photograph-taking processes aimed at improving image quality.

Does community-based health insurance protect women from financial catastrophe after cesarean section? A prospective study from a rural hospital in Rwanda.

BACKGROUND: The implementation of community-based health insurance in (CBHI) in Rwanda has reduced out of pocket (OOP) spending for the > 79% of citizens who enroll in it but the effect for surgical patients is not well described. For all but the poorest citizens who are completely subsidized, the OOP (out of pocket) payment at time of service is 10%. However, 55.5% of the population is below the international poverty line meaning that even this copay can have a significant impact on a family's financial health. The aim of this study was to estimate the burden of OOP payments for cesarean sections in the context of CBHI and determine if having it reduces catastrophic health expenditure (CHE). METHODS: This study is nested in a larger randomized controlled trial of women undergoing cesarean section at a district hospital in Rwanda. Eligible patients were surveyed at discharge to quantify household income and routine monthly expenditures and direct and indirect spending related to the hospitalization. This was used in conjunction with hospital billing records to calculate the rate of catastrophic expenditure by insurance group. RESULTS: About 94% of the 340 women met the World Bank definition of extreme poverty. Of the 330 (97.1%) with any type of health insurance, the majority (n = 310, 91.2%) have CBHI. The average OOP expenditure for a cesarean section and hospitalization was $9.36. The average cost adding transportation to the hospital was $19.29. 164 (48.2%) had to borrow money and 43 (12.7%) had to sell possessions. The hospital bill alone was a CHE for 5.3% of patients. However, when including transportation costs, 15.4% incurred a CHE and including lost wages, 22.6%. CONCLUSION: To ensure universal health coverage (UHC), essential surgical care must be affordable. Despite enrollment in universal health insurance, cesarean section still impoverishes households in rural Rwanda, the majority of whom already lie below the poverty line. Although CBHI protects against CHE from the cost of healthcare, when adding in the cost of transportation, lost wages and caregivers, cesarean section is still often a catastrophic financial event. Further innovation in financial risk protection is needed to provide equitable UHC.

Community-Based Control of Malaria Vectors Using Bacillus thuringiensis var. Israelensis (Bti) in Rwanda.

Larval source management (LSM) programs for control of malaria vectors are often vertically organized, while there is much potential for involving local communities in program implementation. To address this, we evaluated the entomological impact of community-based application of Bacillus thuringiensis var. israelensis (Bti) in a rice irrigation scheme in Ruhuha, Rwanda. A non-randomized trial with control compared a Bti implementation program that was supervised by the project team (ES) with a program that was led and carried out by local rice farming communities (CB). One other area served as a control to assess mosquito populations without Bti application. Entomological surveys were carried out every two weeks and assessed the presence and abundance of the larval, pupal, and adult stages of Anopheles mosquitoes. In ES, the per round reduction in Anopheles larval habitats was estimated at 49%. This reduction was less in CB (28%) and control (22%) although the per round reduction in CB was still significantly higher than in control. Pupal production was almost completely prevented from round 5 (out of 10) onwards in both CB (average habitat occupancy 0.43%) and ES intervention arms (average habitat occupancy 0.27%), whereas pupal occupancy rates were on average 12.8% from round 5 onwards in the control. Emergence of adult mosquitoes from rice fields was thus prevented although this was not directly noticeable in adult An. gambiae populations in houses nearby the rice fields. Together with our earlier work on the willingness to financially contribute to the LSM program and the high perceived safety and acceptance of the Bti product, the current study demonstrates that, in an environment with limited resources, communities could become more engaged in LSM program implementation and contribute directly to malaria vector control in their environment.

The Effect and Feasibility of mHealth-Supported Surgical Site Infection Diagnosis by Community Health Workers After Cesarean Section in Rural Rwanda: Randomized Controlled Trial.

BACKGROUND: The development of a surgical site infection (SSI) after cesarean section (c-section) is a significant cause of morbidity and mortality in low- and middle-income countries, including Rwanda. Rwanda relies on a robust community health worker (CHW)-led, home-based paradigm for delivering follow-up care for women after childbirth. However, this program does not currently include postoperative care for women after c-section, such as SSI screenings. OBJECTIVE: This trial assesses whether CHW's use of a mobile health (mHealth)-facilitated checklist administered in person or via phone call improved rates of return to care among women who develop an SSI following c-section at a rural Rwandan district hospital. A secondary objective was to assess the feasibility of implementing the CHW-led mHealth intervention in this rural district. METHODS: A total of 1025 women aged ≥18 years who underwent a c-section between November 2017 and September 2018 at Kirehe District Hospital were randomized into the three following postoperative care arms: (1) home visit intervention (n=335, 32.7%), (2) phone call intervention (n=334, 32.6%), and (3) standard of care (n=356, 34.7%). A CHW-led, mHealth-supported SSI diagnostic protocol was delivered in the two intervention arms, while patients in the standard of care arm were instructed to adhere to routine health center follow-up. We assessed intervention completion in each intervention arm and used logistic regression to assess the odds of returning to care. RESULTS: The majority of women in Arm 1 (n=295, 88.1%) and Arm 2 (n=226, 67.7%) returned to care and were assessed for an SSI at their local health clinic. There were no significant differences in the rates of returning to clinic within 30 days (P=.21), with high rates found consistently across all three arms (Arm 1: 99.7%, Arm 2: 98.4%, and Arm 3: 99.7%, respectively). CONCLUSIONS: Home-based post-c-section follow-up is feasible in rural Africa when performed by mHealth-supported CHWs. In this study, we found no difference in return to care rates between the intervention arms and standard of care. However, given our previous study findings describing the significant patient-incurred financial burden posed by traveling to a health center, we believe this intervention has the potential to reduce this burden by limiting patient travel to the health center when an SSI is ruled out at home. Further studies are needed (1) to determine the acceptability of this intervention by CHWs and patients as a new standard of care after c-section and (2) to assess whether an app supplementing the mHealth screening checklist with image-based machine learning could improve CHW diagnostic accuracy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03311399; https://clinicaltrials.gov/ct2/show/NCT03311399.

The true costs of cesarean delivery for patients in rural Rwanda: Accounting for post-discharge expenses in estimated health expenditures.

INTRODUCTION: While it is recognized that there are costs associated with postoperative patient follow-up, risk assessments of catastrophic health expenditures (CHEs) due to surgery in sub-Saharan Africa rarely include expenses after discharge. We describe patient-level costs for cesarean section (c-section) and follow-up care up to postoperative day (POD) 30 and evaluate the contribution of follow-up to CHEs in rural Rwanda. METHODS: We interviewed women who delivered via c-section at Kirehe District Hospital between September 2019 and February 2020. Expenditure details were captured on an adapted surgical indicator financial survey tool and extracted from the hospital billing system. CHE was defined as health expenditure of ≥ 10% of annual household expenditure. We report the cost of c-section up to 30 days after discharge, the rate of CHE among c-section patients stratified by in-hospital costs and post-discharge follow-up costs, and the main contributors to c-section follow-up costs. We performed a multivariate logistic regression using a backward stepwise process to determine independent predictors of CHE at POD30 at α ≤ 0.05. RESULTS: Of the 479 participants in this study, 90% were classified as impoverished before surgery and an additional 6.4% were impoverished by the c-section. The median out-of-pocket costs up to POD30 was US$122.16 (IQR: $102.94, $148.11); 63% of these expenditures were attributed to post-discharge expenses or lost opportunity costs (US$77.50; IQR: $67.70, $95.60). To afford c-section care, 64.4% borrowed money and 18.4% sold possessions. The CHE rate was 27% when only considering direct and indirect costs up to the time of discharge and 77% when including the reported expenses up to POD30. Transportation and lost household wages were the largest contributors to post-discharge costs. Further, CHE at POD30 was independently predicted by membership in community-based health insurance (aOR = 3.40, 95% CI: 1.21,9.60), being a farmer (aOR = 2.25, 95% CI:1.00,3.03), primary school education (aOR = 2.35, 95% CI:1.91,4.66), and small household sizes had 0.22 lower odds of experiencing CHE compared to large households (aOR = 0.78, 95% CI:0.66,0.91). CONCLUSION: Costs associated with surgical follow-up are often neglected in financial risk calculations but contribute significantly to the risk of CHE in rural Rwanda. Insurance coverage for direct medical costs is insufficient to protect against CHE. Innovative follow-up solutions to reduce costs of patient transport and compensate for household lost wages need to be considered.

Implementation of Refugees' Inclusion in National Viral Hepatitis B and Hepatitis C Screening Campaign in Mahama Refugee Camp, Rwanda.

INTRODUCTION: The World Health Organization has called for the elimination of hepatitis B virus (HBV) and hepatitis C virus (HCV) as public health threats by 2030. In response to the United Nations High Commissioner for Refugees requests, Rwanda became the first country to include refugees in its national viral hepatitis prevention and management program in 2019. We used secondary data to describe the implementation of the first HBV and HCV screening program among refugees in Rwanda. METHODS: Rapid diagnostic tests were used to screen for HBV surface antigen (HBsAg) and HCV antibody (anti-HCV). We used routine data collected during the HBV and HCV mass screening campaign among Burundian refugees living in Mahama camp and program records to estimate the screening coverage, the prevalence of HBV and HCV, and the cost of the campaign. RESULTS: Over 28 days in February and March 2020, 26,498 unique individuals were screened for HBV and HCV, reflecting a screening coverage of 77.9% (95% confidence interval [CI]=76.5%, 78.4%). Coverage was greater than 90% among women aged 30-64 years, but younger age groups and men were less likely to be screened. On average, 946 clients were screened per day. The prevalence of anti-HCV was 1.1% (95% CI=1.0%, 1.3%), and the prevalence of HBsAg was 3.8% (95% CI=3.6%, 4.0%). We estimate that the total cost of the campaign was US$177,336.60, reflecting a per-person-screened cost of US$6.69. CONCLUSION: Conducting a mass screening was a feasible and effective strategy to achieve high screening coverage and identify refugees who were eligible for HBV and HCV treatment. This screening program in the Mahama refugee camp can serve as a reference for other refugee camps in Rwanda and elsewhere.

Rwanda's community health workers at the front line: a mixed-method study on perceived needs and challenges for community-based healthcare delivery during COVID-19 pandemic.

OBJECTIVE: During the COVID-19 pandemic, community health workers (CHWs) served as front-line workers in the COVID-19 response while maintaining community health services. We aimed to understand challenges faced by Rwanda's CHWs during a nationwide COVID-19 lockdown that occurred between March and May 2020 by assessing the availability of trainings, supplies and supervision while exploring perceived needs and challenges. DESIGN AND SETTING: This study was a mixed-method study conducted in three Rwandan districts: Burera, Kirehe and Kayonza. MAIN OUTCOME AND MEASURE: Using data collected via telephone, we assessed the availability of trainings, supplies and supervision during the first national lockdown, while exploring perceived needs and challenges of CHWs who were engaged in COVID-19 response, in addition to their existing duties of delivering health services in the community. RESULTS: Among the 292 quantitative survey participants, CHWs were responsible for a median of 55 households (IQR: 42-79) and visited a median of 30 households (IQR: 11-52) in the month prior to the survey (July 2020). In the previous 12 months, only 164 (56.2%) CHWs reported being trained on any health topic. Gaps in supply availability, particularly for commodities, existed at the start of the lockdown and worsened over the course of the lockdown. Supervision during the lockdown was low, with nearly 10% of CHWs never receiving supervision and only 24% receiving at least three supervision visits during the 3-month lockdown. In qualitative interviews, CHWs additionally described increases in workload, lack of personal protective equipment and COVID-specific training, fear of COVID-19, and difficult working conditions. CONCLUSION: Many challenges faced by CHWs during the lockdown predated COVID-19 and persisted or were exacerbated during the pandemic. To promote the resilience of Rwanda's CHW system, we recommend increased access to PPE; investment in training, supervision and supply chain management; and financial compensation for CHWs.

Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial.

BACKGROUND: Hepatitis C virus (HCV) genotype 4 non-a/d subtypes, which frequently have NS5A resistance-associated substitutions, are highly prevalent in sub-Saharan Africa. These subtypes, particularly genotype 4r, have been associated with higher rates of failure of treatment regimens containing the NS5A inhibitors ledipasvir or daclatasvir, which are the most accessible direct-acting antivirals in low-income countries. Clinical evidence regarding the efficacy of re-treatment options for these subtypes is limited. We aimed to evaluate the safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for the treatment of adults in Rwanda with chronic HCV infection, predominantly of genotype 4, and a history of direct-acting antiviral treatment failure. METHODS: In this single-arm prospective trial, we enrolled adults (aged ≥18 years) with a HCV RNA titre of at least 1000 IU/mL, and a documented history of direct-acting antiviral failure. Patients were assessed for eligibility at a single study site after referral from hospitals with HCV treatment programmes throughout Rwanda, and participants for whom sofosbuvir-ledipasvir treatment had failed in the previous SHARED trial were also included. Participants with decompensated liver disease or hepatitis B virus co-infection were excluded. Participants were treated once daily with an oral fixed-dose combination tablet containing sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg) for 12 weeks. The primary endpoint was the proportion of participants with a sustained virological response 12 weeks after completion of treatment (SVR12) in the intention-to-treat population. Viral sequencing of NS3, NS5A, and NS5B genes was done at baseline in all participants and at end of follow-up (week 24) in participants with treatment failure. The study is registered with ClinicalTrials.gov (NCT03888729) and is completed. FINDINGS: Between Sept 23, 2019, and Jan 10, 2020, 49 individuals were screened and 40 participants were enrolled. 20 (50%) were female, 20 (50%) were male, median age was 63 years (IQR 56-68), and median HCV viral load was 6·2 log10 IU/mL (5·8-6·5) at baseline. The genotype subtypes identified were 4r (18 [45%] participants), 4k (six [15%]), 4b (five [13%]), 4q (four [10%]), 4l (two [5%]), 4a (one [3%]), 4m (one [3%]), and 3h (one [3%]). One (3%) genotype 4 isolate could not be subtyped, and one (3%) isolate was of unknown genotype. All successfully sequenced isolates (33 [83%]) had at least two NS5A resistance-associated substitutions and 25 (63%) had three or more. 39 (98% [95% CI 87-100]) participants had SVR12. Seven (18%) participants had a total of ten grade 3, 4, or 5 adverse events, including three (8%) cases of hypertension, and one (3%) case each of cataract, diabetes, gastrointestinal bleeding, joint pain, low back pain, vaginal cancer, and sudden death. Four of these events were categorised as serious adverse events resulting in hospitalisation. The one sudden death occurred at home from an unknown cause 4 weeks after the completion of treatment. No serious adverse event was determined to be related to the study drug or resulted in treatment discontinuation. INTERPRETATION: A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment. Improved affordability and access to sofosbuvir-velpatasvir-voxilaprevir in regions with these subtypes is crucial. FUNDING: Gilead Sciences.

Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial.

BACKGROUND: Hepatitis C virus (HCV) genotype 4 is the predominant type of HCV found in sub-Saharan Africa. Various genotype 4 subtypes, such as 4r, frequently have resistance-associated substitutions that can increase rates of treatment failure with common direct-acting antiviral regimens. In-vitro studies suggest that the NS5A inhibitor velpatasvir is effective against viral isolates containing such resistance-associated substitutions, but its clinical efficacy against genotype 4 non-a/d subtypes in sub-Saharan Africa remains to be confirmed. We aimed to evaluate the safety and efficacy of sofosbuvir-velpatasvir among adults chronically infected with HCV and naive to direct-acting antiviral treatment in Rwanda, where genotype 4 non-a/d subtypes predominate. METHODS: In this single-arm prospective trial, we enrolled adults (age ≥18 years) in Rwanda who had chronic HCV infection and a plasma HCV RNA titre of at least 1000 IU/mL. Patients were referred from hospitals with HCV treatment programmes throughout Rwanda and were sequentially enrolled and assessed for eligibility at a single study site. Individuals with decompensated liver disease or hepatitis B virus co-infection were excluded. Participants were given an oral fixed-dose combination tablet of sofosbuvir (400 mg) and velpatasvir (100 mg) once-daily for 12 weeks. The primary endpoint was the proportion of participants with a sustained virological response 12 weeks after completion of treatment (SVR12) in the intention-to-treat population. Viral sequencing of the NS5A and NS5B genes was done at baseline for all participants and end of follow-up (week 24) for participants who did not have SVR12. This study is registered with ClinicalTrials.gov (NCT03888729) and is completed. FINDINGS: Between Sept 23, 2019, and Jan 10, 2020, 73 individuals were screened for eligibility, of whom 12 (16%) were excluded and 61 (84%) were enrolled. 40 (66%) participants were female, 21 (34%) were male, median age was 64 years (IQR 51-74), and median baseline HCV viral load was 5·7 log10 IU/mL (5·2-6·2). The genotypes identified among the participants were 4k (28 [46%] participants), 4r (11 [18%]), 4v (eight [13%]), 4q (five [8%]), 4l (three [5%]), 4b (one [2%]), 4c (one [2%]), and one undetermined genotype 4 subtype. Three isolates could not be sequenced and were of indeterminate genotype. Of the 55 HCV isolates that were successfully sequenced, all had at least two NS5A resistance-associated substitutions. 59 (97% [95% CI 89-99]) participants had SVR12. 18 (30%) participants had grade 3 adverse events (including 12 [20%] with hypertension), and none had grade 4 adverse events. Four (7%) participants had serious adverse events, including one asthma exacerbation, one abscess, one uterine myoma, and one pelvic fracture related to a motor vehicle accident. No serious adverse events were attributed to the study drug and no adverse event resulted in discontinuation of the study drug. INTERPRETATION: A 12-week regimen of sofosbuvir-velpatasvir is safe and efficacious in treating chronic HCV genotype 4 infection in patients in Rwanda. This regimen could be an effective treatment option in regions known to have a high prevalence of HCV genotype 4 of diverse non-a/d subtypes. FUNDING: Gilead Sciences.

Retreatment of Chronic Hepatitis C Infection: Real-World Regimens and Outcomes From National Treatment Programs in Three Low- and Middle-Income Countries.

Access to recommended second-line treatments is limited for patients who fail initial hepatitis C virus (HCV) therapy in low- and middle-income countries. Alternative regimens and associated outcomes are not well understood. Through a pooled analysis of national program data in Egypt, Georgia, and Myanmar, we observed SVR rates >90% for alternative retreatment regimens.