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Background The benefit of primary and booster vaccination in people who experienced a prior Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection remains unclear. The objective of this study was to estimate the effectiveness of primary (two-dose series) and booster (third dose) mRNA vaccination against Omicron (lineage BA.1) infection among people with a prior documented infection. Methods and findings We conducted a test-negative case-control study of reverse transcription PCRs (RT-PCRs) analyzed with the TaqPath (Thermo Fisher Scientific) assay and recorded in the Yale New Haven Health system from November 1, 2021, to April 30, 2022. Overall, 11,307 cases (positive TaqPath analyzed RT-PCRs with S-gene target failure [SGTF]) and 130,041 controls (negative TaqPath analyzed RT-PCRs) were included (median age: cases: 35 years, controls: 39 years). Among cases and controls, 5.9% and 8.1% had a documented prior infection (positive SARS-CoV-2 test record [greater than or equal to]90 days prior to the included test), respectively. We estimated the effectiveness of primary and booster vaccination relative to SGTF-defined Omicron (lineage BA.1) variant infection using a logistic regression adjusted for date of test, age, sex, race/ethnicity, insurance, comorbidities, social venerability index, municipality, and healthcare utilization. The effectiveness of primary vaccination 14 to 149 days after the second dose was 41.0% (95% confidence interval (CI): 14.1% to 59.4%, p 0.006) and 27.1% (95% CI: 18.7% to 34.6%, p < 0.001) for people with and without a documented prior infection, respectively. The effectiveness of booster vaccination ([greater than or equal to]14 days after booster dose) was 47.1% (95% CI: 22.4% to 63.9%, p 0.001) and 54.1% (95% CI: 49.2% to 58.4%, p < 0.001) in people with and without a documented prior infection, respectively. To test whether booster vaccination reduced the risk of infection beyond that of the primary series, we compared the odds of infection among boosted ([greater than or equal to]14 days after booster dose) and booster-eligible people ([greater than or equal to]150 days after second dose). The odds ratio (OR) comparing boosted and booster-eligible people with a documented prior infection was 0.79 (95% CI: 0.54 to 1.16, p 0.222), whereas the OR comparing boosted and booster-eligible people without a documented prior infection was 0.54 (95% CI: 0.49 to 0.59, p < 0.001). This study's limitations include the risk of residual confounding, the use of data from a single system, and the reliance on TaqPath analyzed RT-PCR results. Conclusions In this study, we observed that primary vaccination provided significant but limited protection against Omicron (lineage BA.1) infection among people with and without a documented prior infection. While booster vaccination was associated with additional protection against Omicron BA.1 infection in people without a documented prior infection, it was not found to be associated with additional protection among people with a documented prior infection. These findings support primary vaccination in people regardless of documented prior infection status but suggest that infection history may impact the relative benefit of booster doses., Author(s): Margaret L. Lind 1,*, Alexander J. Robertson 1, Julio Silva 2, Frederick Warner 3,4, Andreas C. Coppi 3,4, Nathan Price 3,4, Chelsea Duckwall 1, Peri Sosensky 1, Erendira C. [...]

Background: The impact variant-specific immune evasion and waning protection have on declining COVID-19 vaccine effectiveness remains unclear. Using whole-genome-sequencing (WGS), we examined the contribution of these factors on the decline observed following the introduction of the Delta variant. Further, we evaluated the utility of calendar-period-based classification as an alternative to WGS.Methods: We conducted a test-negative-case-control study among people who received SARS-CoV-2 RT-PCR testing in the Yale New Haven Health System between April 1 and August 24, 2021. Variant classification was performed using WGS and calendar-period.Results: Overall, 2,029 cases (RT-PCR positive, sequenced samples [infections]) and 343,985 controls (negative RT-PCRs) were included. VE 14-89 days after 2nd dose was significantly higher against WGS-classified Alpha-infection (84.4%, CI: 75.6-90.0%) than Delta-infection (68.9%, CI: 58.0-77.1%, p-value = 0.013). The odds of WGS-classified Delta-infection were significantly higher 90-149 than 14-89 days after 2nd dose (p-value = 0.003). VE estimates against calendar-period-classified infections approximated estimates against WGS-classified infections, however, calendar-period-based classification was subject to outcome misclassification (35%: Alpha-period, 4%: Delta-period).Conclusions: Both waning protection and variant-specific immune evasion contributed to the lower effectiveness. While VE estimates against calendar-period-classified infections mirrored those against WGS-classified infections, our analysis highlights the need for WGS when variants are co-circulating and misclassification is likely. [ABSTRACT FROM AUTHOR]

Given the high rates of mental health problems and poor service access among youth in war-affected countries throughout Sub-Saharan Africa, incorporating evidence-based mental health interventions into alternative delivery platforms could improve service access in these settings. We conducted a randomized controlled pilot study with high-risk Sierra Leonean youth to investigate the feasibility of implementing the Youth Readiness Intervention (YRI), a cognitive behavioral and interpersonal therapy-based group intervention, within an employment promotion program (EPP) and preliminary effects of the YRI on mental health outcomes. Participants were 175 youth (females = 62%) ages 18–30 recruited via flyers and radio announcements. Participants were assigned to geographic clusters stratified by gender; clusters were randomized into YRI+EPP (n = 58) or EPP-only (n = 57). Statistically matched controls were recruited from comparable chiefdoms (n = 60). The 12-session YRI was delivered bi-weekly, following EPP completion. Qualitative findings indicated that the YRI was highly feasible and acceptable as integrated into the EPP. Mixed linear effects models showed promising trends. Compared with controls, both YRI+EPP and EPP-only males reported significantly reduced post-traumatic stress symptoms, and YRI+EPP reported marginally significantly reduced emotional regulation difficulties. EPP-only females reported significantly reduced functional impairment compared to controls. Findings suggest that the YRI can be feasibly implemented within an EPP. Integrating the YRI into existing delivery platforms may help increase access to mental health care in Sierra Leone and provide a leverage point for scaling up evidence-based mental health interventions in other low-resource settings globally. [Clinicaltrials.gov; NCT0360361; 5/18/18] [ABSTRACT FROM AUTHOR]

Purpose: Low- and middle-income countries account for 86% of all cervical cancer cases and 88% of cervical cancer mortality globally. Successful management of cervical cancer requires resources that are scarce in sub-Saharan Africa, especially in rural settings. Here, we describe the early clinical outcomes and implementation lessons learned from the Rwanda Ministry of Health's first national cancer referral center, the Butaro Cancer Center of Excellence (BCCOE). We hypothesize that those patients presenting at earlier stage and receiving treatment will have higher rates of being alive. Methods: The implementation of cervical cancer services included developing partnerships, clinical protocols, pathology services, and tools for monitoring and evaluation. We conducted a retrospective study of patients with cervical cancer who presented at BCCOE between July 1, 2012, and June 30, 2015. Data were collected from the electronic medical record system and by manually reviewing medical records. Descriptive, bivariable and multivariable statistical analyses were conducted to describe patient demographics, disease profiles, treatment, and clinical outcomes. Results: In all, 373 patients met the study inclusion criteria. The median age was 53 years (interquartile rage, 45 to 60 years), and 98% were residents of Rwanda. Eighty-nine percent of patients had a documented disease stage: 3% were stage I, 48% were stage II, 29% were stage III, and 8% were stage IV at presentation. Fifty percent of patients were planned to be treated with a curative intent, and 54% were referred to chemoradiotherapy in Uganda. Forty percent of patients who received chemoradiotherapy were in remission. Overall, 25% were lost to follow-up. Conclusion: BCCOE illustrates the feasibility and challenges of implementing effective cervical cancer treatment services in a rural setting in a low-income country. [ABSTRACT FROM AUTHOR]

Purpose: Low- and middle-income countries disproportionately comprise 65% of cancer deaths. Cancer care delivery in resource-limited settings, especially low-income countries in sub-Saharan Africa, is exceedingly complex, requiring multiple modalities of diagnosis and treatment. Given the vast human, technical, and financial resources required, access to radiotherapy remains limited in sub-Saharan Africa. Through 2017, Rwanda has not had in-country radiotherapy services. The aim of this study was to describe the implementation and early outcomes of the radiotherapy referral program at the Butaro Cancer Centre of Excellence and to identify both successful pathways and barriers to care. Methods: Butaro District Hospital is located in a rural area of the Northern Province and is home to the Butaro Cancer Centre of Excellence. We performed a retrospective study from routinely collected data of all patients with a diagnosis of cervical, head and neck, or rectal cancer between July 2012 and June 2015. Results: Between 2012 and 2015, 580 patients were identified with these diagnoses and were potential candidates for radiation. Two hundred eight (36%) were referred for radiotherapy treatment in Uganda. Of those referred, 160 (77%) had cervical cancer, 31 (15%) had head and neck cancer, and 17 (8%) had rectal cancer. At the time of data collection, 101 radiotherapy patients (49%) were alive and had completed treatment with no evidence of recurrence, 11 (5%) were alive and continuing treatment, and 12 (6%) were alive and had completed treatment with evidence of recurrence. Conclusion: This study demonstrates the feasibility of a rural cancer facility to successfully conduct out-of-country radiotherapy referrals with promising early outcomes. The results of this study also highlight the many challenges and lessons learned in providing comprehensive cancer care in resource-limited settings. [ABSTRACT FROM AUTHOR]

Purpose: Improvements in childhood survival rates have been achieved in low- and middle- income countries that have made a commitment to improve access to cancer care. Accurate data on the costs of delivering cancer treatment in these settings will allow ministries of health and donors to accurately assess and plan for expansions of access to care. This study assessed the financial cost of treating two common pediatric cancers, nephroblastoma and Hodgkin lymphoma, at the Butaro Cancer Center of Excellence in rural Rwanda. Methods: A microcosting approach was used to calculate the per-patient cost for Hodgkin lymphoma and nephroblastoma diagnosis and treatment. Costs were analyzed retrospectively from the provider perspective for the 2014 fiscal year. The cost per patient was determined using an idealized patient receiving a full course of treatment, follow-up, and recommended social support in accordance with the national treatment protocol for each cancer. Results: The cost for a full course of treatment, follow-up, and social support was determined to be between $1,490 and $2,093 for a patient with nephroblastoma and between $1,140 and $1,793 for a pediatric patient with Hodgkin lymphoma. Conclusion: Task shifting, reduced labor costs, and locally adapted protocols contributed to significantly lower costs than those seen in middle- or high-income countries. [ABSTRACT FROM AUTHOR]

Purpose: The cost of providing cancer care in low-income countries remains largely unknown, which creates a significant barrier to effective planning and resource allocation. This study examines the cost of providing comprehensive cancer care at the Butaro Cancer Center of Excellence (BCCOE) in Rwanda. Methods: A retrospective costing analysis was conducted from the provider perspective by using secondary data from the administrative systems of the BCCOE. We identified the start-up funds necessary to begin initial implementation and determined the fiscal year 2013-2014 operating cost of the cancer program, including capital expenditures and fixed and variable costs. Results: A total of $556,105 US dollars was assessed as necessary start-up funding to implement the program. The annual operating cost of the cancer program was found to be $957,203 US dollars. Radiotherapy, labor, and chemotherapy were the most significant cost drivers. Radiotherapy services, which require sending patients out of country because there are no radiation units in Rwanda, comprised 25% of program costs, labor accounted for 21%, and chemotherapy, supportive medications, and consumables accounted for 15%. Overhead, training, computed tomography scans, surgeries, blood products, pathology, and social services accounted for less than 10% of the total. Conclusion: This study is one of the first to examine operating costs for implementing a cancer center in a low-income country. Having a strong commitment to cancer care, adapting clinical protocols to the local setting, shifting tasks, and creating collaborative partnerships make it possible for BCCOE to provide quality cancer care at a fraction of the cost seen in middle- and high-income countries, which has saved many lives and improved survival. Not all therapies, though, were available because of limited financial resources. [ABSTRACT FROM AUTHOR]