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Supplemental Digital Content is Available in the Text., Background: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. Setting: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. Methods: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER

Background We projected the clinical and economic impact of alternative testing strategies on coronavirus disease 2019 (COVID-19) incidence and mortality in Massachusetts using a microsimulation model. Methods We compared 4 testing strategies: (1) hospitalized: polymerase chain reaction (PCR) testing only for patients with severe/critical symptoms warranting hospitalization; (2) symptomatic: PCR for any COVID-19–consistent symptoms, with self-isolation if positive; (3) symptomatic + asymptomatic once: symptomatic and 1-time PCR for the entire population; and (4) symptomatic + asymptomatic monthly: symptomatic with monthly retesting for the entire population. We examined effective reproduction numbers (Re = 0.9–2.0) at which policy conclusions would change. We assumed homogeneous mixing among the Massachusetts population (excluding those residing in long-term care facilities). We used published data on disease progression and mortality, transmission, PCR sensitivity/specificity (70%/100%), and costs. Model-projected outcomes included infections, deaths, tests performed, hospital-days, and costs over 180 days, as well as incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year [QALY]). Results At Re = 0.9, symptomatic + asymptomatic monthly vs hospitalized resulted in a 64% reduction in infections and a 46% reduction in deaths, but required >66-fold more tests/day with 5-fold higher costs. Symptomatic + asymptomatic monthly had an ICER Conclusions Testing people with any COVID-19–consistent symptoms would be cost-saving compared to testing only those whose symptoms warrant hospital care. Expanding PCR testing to asymptomatic people would decrease infections, deaths, and hospitalizations. Despite modest sensitivity, low-cost, repeat screening of the entire population could be cost-effective in all epidemic settings.

ImportanceApproximately 356,000 people stay in homeless shelters nightly in the US. These individuals are at high risk for COVID-19.ObjectiveTo assess clinical outcomes, costs, and cost-effectiveness of strategies for COVID-19 prevention and management among sheltered homeless adults.DesignWe developed a dynamic microsimulation model of COVID-19. We modeled sheltered homeless adults in Boston, Massachusetts, using cohort characteristics and costs from Boston Health Care for the Homeless Program. Disease progression, transmission, and clinical outcomes data were from published literature and national databases. We examined surging, growing, and slowing epidemics (effective reproduction numbers [Re] 2.6, 1.3, and 0.9). Costs were from a health care sector perspective; time horizon was 4 months.Setting & ParticipantsSimulated cohort of 2,258 adults residing in homeless shelters in Boston.InterventionsWe assessed combinations of daily symptom screening with same-day polymerase chain reaction (PCR) testing of screen-positive individuals, universal PCR testing every 2 weeks, hospital-based COVID-19 care, alternate care sites [ACSs] for mild/moderate COVID-19 management, and moving people from shelters to temporary housing, compared to no intervention.Main OutcomesInfections, hospital-days, costs, and cost-effectiveness.ResultsCompared to no intervention, daily symptom screening with ACSs for those with pending tests or confirmed COVID-19 and mild/moderate disease leads to 37% fewer infections and 46% lower costs when Re=2.6, 75% fewer infections and 72% lower costs when Re=1.3, and 51% fewer infections and 51% lower costs when Re=0.9. Adding universal PCR testing every 2 weeks further decreases infections in all epidemic scenarios, with incremental cost per case prevented of $1,000 (Re=2.6), $27,000 (Re=1.3), and $71,000 (Re=0.9). In all scenarios, moving shelter residents to temporary housing with universal PCR testing every 2 weeks is most effective but substantially more costly than other options. Results are most sensitive to the cost and sensitivity of PCR testing and the efficacy of ACSs in preventing transmission.Conclusions & RelevanceDaily symptom screening and ACSs for sheltered homeless adults will substantially decrease COVID-19 cases and reduce costs compared to no intervention. In a surging epidemic, adding universal PCR testing every 2 weeks further decreases cases at modest incremental cost and should be considered.Key PointsQuestionWhat are the projected clinical outcomes and costs of strategies for reducing COVID-19 infections among people experiencing sheltered homelessness?FindingsIn this microsimulation modeling study, daily symptom screening with polymerase chain reaction (PCR) testing of screen-positive individuals, paired with non-hospital care site management of people with mild to moderate COVID-19, substantially reduces infections and lowers costs over 4 months compared to no intervention, across a wide range of epidemic scenarios. In a surging epidemic, adding periodic universal PCR testing to symptom screening and non-hospital care site management improves clinical outcomes at modestly increased costs. Periodic universal PCR testing paired with temporary housing further reduces infections but at much higher cost.MeaningDaily symptom screening with PCR testing of screen-positive individuals and use of alternate care sites for COVID-19 management among sheltered homeless people will substantially prevent new cases and reduce costs compared to other strategies.

Background: Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management. Objective: The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer. Methods: We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial. Results: We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps. Conclusions: To our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management. Clinical Trial: ClinicalTrials.gov NCT02157519; https://clinicaltrials.gov/ct2/show/NCT02157519 (Archived by WebCite at http://www.webcitation.org/6prj3xfKA) [JMIR Res Protoc 2017;6(4):e62]

BackgroundThe widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole. These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use. Therefore, we developed ChemOtheRapy Assistant, CORA, a personalized mobile phone–based self-management application to help cancer patients on oral anti-cancer medications. ObjectiveOur objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinically relevant outcomes in the management of patients with renal and prostate cancer. MethodsThe study will be implemented as a 2-parallel group randomized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period. The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual. Medication adherence will be measured objectively by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken. We will also assess the effect of the intervention on cancer-related symptoms measured by the MD Anderson Symptom Inventory and unplanned hospital utilizations. Other outcomes that will be measured at study start, midpoint, and endpoint are health-related quality of life, cancer-related fatigue, and anxiety. Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed. Logistic regression will be used to identify potential predictors of adherence. ResultsWe expect to have results for this study before the end of 2016. ConclusionsThis novel mobile phone–enabled, multimodal self-management and educational intervention could lead to improvements in clinical outcomes and serve as a foundation for future mHealth research in improving outcomes for patients on oral anti-cancer medications.

The transition to parenthood marks a major milestone in family development that is especially difficult for roughly 10% of postpartum women who develop clinical depressions serious enough to interfere with daily functioning. Relatively little is known about the course of postpartum depression, the factors associated with its onset or severity, or its impact on the quality of mother-infant interaction. We studied 70 depressed women and 59 demographically matched nondepressed women delivering their first child and then followed them longitudinally through 24 months. Although the majority of depressions had remitted by 6 months postpartum, some women were depressed throughout the follow-up period, and others continued to evidence subclinical symptoms, indicating that depression in postpartum women can be relatively chronic. Depressed women differed from comparison women on measures of personal and family history, their adaptation to pregnancy, and minor pregnancy and delivery complications. They also perceived their infants as more difficult to care for and their husbands as less supportive. A combination of these variables accounted for 49% of the variance in depression severity scores at 2 months. Depressed women also showed less positive engagement and more negative affect when observed with their infants at 2 months. Spouse support and maternal positive engagement with the baby at 2 months differentiated between those with more chronic versus short-lived depressions. The implications of these findings for the woman's and her infant's development are discussed.