Comparison of 3 optimized delivery strategies for completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV in Uganda: A single-center randomized trial.

BACKGROUND: Expanding access to shorter regimens for tuberculosis (TB) prevention, such as once-weekly isoniazid and rifapentine taken for 3 months (3HP), is critical for reducing global TB burden among people living with HIV (PLHIV). Our coprimary hypotheses were that high levels of acceptance and completion of 3HP could be achieved with delivery strategies optimized to overcome well-contextualized barriers and that 3HP acceptance and completion would be highest when PLHIV were provided an informed choice between delivery strategies. METHODS AND FINDINGS: In a pragmatic, single-center, 3-arm, parallel-group randomized trial, PLHIV receiving care at a large urban HIV clinic in Kampala, Uganda, were randomly assigned (1:1:1) to receive 3HP by facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between facilitated DOT and facilitated SAT using a shared decision-making aid. We assessed the primary outcome of acceptance and completion (≥11 of 12 doses of 3HP) within 16 weeks of treatment initiation using proportions with exact binomial confidence intervals (CIs). We compared proportions between arms using Fisher's exact test (two-sided α = 0.025). Trial investigators were blinded to primary and secondary outcomes by study arm. Between July 13, 2020, and July 8, 2022, 1,656 PLHIV underwent randomization, with equal numbers allocated to each study arm. One participant was erroneously enrolled a second time and was excluded in the primary intention-to-treat analysis. Among the remaining 1,655 participants, the proportion who accepted and completed 3HP exceeded the prespecified 80% target in the DOT (0.94; 97.5% CI [0.91, 0.96] p < 0.001), SAT (0.92; 97.5% CI [0.89, 0.94] p < 0.001), and Choice (0.93; 97.5% CI [0.91, 0.96] p < 0.001) arms. There was no difference in acceptance and completion between any 2 arms overall or in prespecified subgroup analyses based on sex, age, time on antiretroviral therapy, and history of prior treatment for TB or TB infection. Only 14 (0.8%) participants experienced an adverse event prompting discontinuation of 3HP. The main limitation of the study is that it was conducted in a single center. Multicenter studies are now needed to confirm the feasibility and generalizability of the facilitated 3HP delivery strategies in other settings. CONCLUSIONS: Short-course TB preventive treatment was widely accepted by PLHIV in Uganda, and very high levels of treatment completion were achieved in a programmatic setting with delivery strategies tailored to address known barriers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

The Impact of a Student-Led Health Education Clinic on the Health Literacy and Behaviors of a Rural Community in the State of Pennsylvania, USA.

Rural populations experience a number of disparities that place them at increased risk of morbidity and mortality related to chronic disease, including lower health literacy and greater distance to medical care. Community-based free healthcare education can offer targeted preventive care to these vulnerable populations; however, limited quantitative research exists measuring their impact, specifically on health literacy and likelihood for behavior change. To investigate this, a student-led health education clinic was held in January 2023 in the rural community of Lykens, Pennsylvania by the Student-run and Collaborative Outreach Program for Health Equity (SCOPE). Fifty-five pre- and post-clinic surveys using Likert-style questions measured the knowledge and likelihood of behavioral change for several preventive health topics, including hypertension, diabetes mellitus, cancer screenings, childhood vaccinations, skin cancer, mental health, addiction, and nutrition. From pre- to post-clinic, there was a significant increase in knowledge of hypertension (p = 0.023) and diabetes (p = 0.014), likelihood of attending cancer screenings (p = 0.038), and confidence in identifying cancerous moles (p = < 0.001). There was a non-significant increase in understanding of mental health and nutrition, and no change in understanding of addiction or childhood vaccinations. It is likely that the level of interaction in education provided and relevance of information to participants contributed to effective uptake of information. The results demonstrate an immediate impact on health literacy and likelihood of behavioral change for several important preventive health topics, and advocate for the use of student-run healthcare interventions in addressing the prevalence of chronic disease in rural communities.

Using a human-centered, mixed methods approach to understand the patient waiting experience and its impact on medically underserved Populations.

PURPOSE: To use a mixed methods approach to investigate the patient waiting experience for a medically underserved population at an outpatient surgical clinic. METHODS: We used lean methodology to perform 96 time-tracked observations of the patient journey in clinic, documenting the duration of activities from arrival to departure. We also used human-centered design (HCD) to perform and analyze 43 semi-structured interviews to understand patients' unmet needs. RESULTS: Patients spent an average of 68.5% of their total clinic visit waiting to be seen. While the average visit was 95.8 minutes, over a quarter of visits (27%) were over 2 hours. Patients waited an average of 24.4 minutes in the waiting room and 41.2 minutes in the exam room; and only spent 19.7% of their visit with an attending provider and 11.8% with a medical assistant. Interviews revealed that patients arrive to their visit already frustrated due to difficulties related to scheduling and attending their appointment. This is exacerbated during the visit due to long wait times, perceived information opacity, and an uncomfortable waiting room, resulting in frustration and anxiety. CONCLUSIONS: While time tracking demonstrated that patients spend a majority of their visit waiting to be seen, HCD revealed that patient frustrations span the waiting experience from accessing the appointment to visit completion. These combined findings are crucial for intervention design and implementation for medically underserved populations to improve the quality and experience with healthcare and also address system inefficiencies such as long wait times.

Completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness-implementation randomized trial.

BACKGROUND: Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid-rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization's (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. METHODS AND FINDINGS: The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness-implementation randomized trial comparing 3 optimized strategies for delivering 3HP-facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid-to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (≥11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. CONCLUSIONS: 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion. TRIAL REGISTRATION: ClinicalTrials.gov NCT03934931.

Digital adherence technology for tuberculosis treatment supervision: A stepped-wedge cluster-randomized trial in Uganda.

BACKGROUND: Adherence to and completion of tuberculosis (TB) treatment remain problematic in many high-burden countries. 99DOTS is a low-cost digital adherence technology that could increase TB treatment completion. METHODS AND FINDINGS: We conducted a pragmatic stepped-wedge cluster-randomized trial including all adults treated for drug-susceptible pulmonary TB at 18 health facilities across Uganda over 8 months (1 December 2018-31 July 2019). Facilities were randomized to switch from routine (control period) to 99DOTS-based (intervention period) TB treatment supervision in consecutive months. Patients were allocated to the control or intervention period based on which facility they attended and their treatment start date. Health facility staff and patients were not blinded to the intervention. The primary outcome was TB treatment completion. Due to the pragmatic nature of the trial, the primary analysis was done according to intention-to-treat (ITT) and per protocol (PP) principles. This trial is registered with the Pan African Clinical Trials Registry (PACTR201808609844917). Of 1,913 eligible patients at the 18 health facilities (1,022 and 891 during the control and intervention periods, respectively), 38.0% were women, mean (SD) age was 39.4 (14.4) years, 46.8% were HIV-infected, and most (91.4%) had newly diagnosed TB. In total, 463 (52.0%) patients were enrolled on 99DOTS during the intervention period. In the ITT analysis, the odds of treatment success were similar in the intervention and control periods (adjusted odds ratio [aOR] 1.04, 95% CI 0.68-1.58, p = 0.87). The odds of treatment success did not increase in the intervention period for either men (aOR 1.24, 95% CI 0.73-2.10) or women (aOR 0.67, 95% CI 0.35-1.29), or for either patients with HIV infection (aOR 1.51, 95% CI 0.81-2.85) or without HIV infection (aOR 0.78, 95% CI 0.46-1.32). In the PP analysis, the 99DOTS-based intervention increased the odds of treatment success (aOR 2.89, 95% CI 1.57-5.33, p = 0.001). The odds of completing the intensive phase of treatment and the odds of not being lost to follow-up were similarly improved in PP but not ITT analyses. Study limitations include the likelihood of selection bias in the PP analysis, inability to verify medication dosing in either arm, and incomplete implementation of some components of the intervention. CONCLUSIONS: 99DOTS-based treatment supervision did not improve treatment outcomes in the overall study population. However, similar treatment outcomes were achieved during the control and intervention periods, and those patients enrolled on 99DOTS achieved high treatment completion. 99DOTS-based treatment supervision could be a viable alternative to directly observed therapy for a substantial proportion of patients with TB. TRIAL REGISTRATION: Pan-African Clinical Trials Registry (PACTR201808609844917).

Using human centered design to identify opportunities for reducing inequities in perinatal care.

BACKGROUND: Extreme disparities in access, experience, and outcomes highlight the need to transform how pregnancy care is designed and delivered in the United States, especially for low-income individuals and people of color. METHODS: We used human-centered design (HCD) to understand the challenges facing Medicaid-insured pregnant people and design interventions to address these challenges. The HCD method has three phases: Inspiration, Ideation, and Implementation. This study focused on the first and second. In the Inspiration phase we conducted semi-structured interviews with a purposeful sample of stakeholders who had either received or participated in the care of Medicaid-insured pregnant people within our community, with a specific emphasis on representation from marginalized communities. Using a general inductive approach to thematic analysis, we identified themes, which were then framed into design opportunities. In the Ideation phase, we conducted structured brainstorming sessions to generate potential prototypes of solutions, which were tested and iterated upon through a series of community events and engagement with a diverse community advisory group. RESULTS: We engaged a total of 171 stakeholders across both phases of the HCD methodology. In the Inspiration phase, interviews with 23 community members and an eight-person focus group revealed seven insights centered around two main themes: (1) racism and discrimination create major barriers to access, experience, and the ability to deliver high-value pregnancy care; (2) pregnancy care is overmedicalized and does not treat the pregnant person as an equal and informed partner. In the Ideation phase, 162 ideas were produced and translated into eight solution prototypes. Community scoring and feedback events with 140 stakeholders led to the progressive refinement and selection of three final prototypes: (1) implementing telemedicine (video visits) within the safety-net system, (2) integrating community-based peer support workers into healthcare teams, and (3) delivering co-located pregnancy-related care and services into high-need neighborhoods as a one-stop shop. CONCLUSIONS: Using HCD methodology and a collaborative community-health system approach, we identified gaps, opportunities, and solutions to address perinatal care inequities within our urban community. Given the urgent need for implementable and effective solutions, the design process was particularly well-suited because it focuses on understanding and centering the needs and values of stakeholders, is multi-disciplinary through all phases, and results in prototyping and iteration of real-world solutions.

Improving Efficiency and Meeting Expectations Without Compromising Care on Trauma Surgical Rounds.

BACKGROUND: Care teams on complex surgical services face a growing list of competing expectations. Approaches to quality improvement must use minimal resources and address both system and human requirements to meet expectations without compromising care. The purpose of this study was to demonstrate that iterative prototyping, combined with a rigorous quantitative evaluation approach, can effectively improve system and stakeholder efficiency on daily trauma surgical rounds at an academic safety-net hospital and level 1 trauma center. MATERIALS AND METHODS: This study occurred between May 2017 and October 2017 at the Zuckerberg San Francisco General Hospital and Trauma Center. Care team members rounding on the trauma service included attending trauma surgeons, fellows, residents, interns, nurse practitioners, pharmacists, and medical students. We used human-centered design to develop and test solutions to improve the surgical rounding process. Each prototype was evaluated using qualitative design research methods, which informed the next iteration. Time observations of rounding activities were adopted from the Lean methodology and tracked before and after implementation. Intern work hours, on-time operative starts, and discharge order times were also tracked before and after implementation. RESULTS: Four prototypes were designed and iteratively implemented, producing care team satisfaction by the end of the implementation period. Discharge order times decreased by a median of 58 min, intern work hours were decreased by 97 min/d, and first operative case on-time starts increased from 40% to 63% (P < 0.05). The time spent on clarifications decreased by 4.7% (P < 0.05), allowing for more time to discuss care plans with the patients themselves. CONCLUSIONS: Iterative prototyping as part of a human-centered design methodology is a powerful tool to address complex systems with diverse interests and competing priorities. Rapid, in-context prototyping is feasible on a complex trauma surgical service and can result in improved workflows and efficiency for the system and its stakeholders.

Developing Virtual Reality Trauma Training Experiences Using 360-Degree Video: Tutorial.

Historically, medical trainees were educated in the hospital on real patients. Over the last decade, there has been a shift to practicing skills through simulations with mannequins or patient actors. Virtual reality (VR), and in particular, the use of 360-degree video and audio (cineVR), is the next-generation advancement in medical simulation that has novel applications to augment clinical skill practice, empathy building, and team training. In this paper, we describe methods to design and develop a cineVR medical education curriculum for trauma care training using real patient care scenarios at an urban, safety-net hospital and Level 1 trauma center. The purpose of this publication is to detail the process of finding a cineVR production partner; choosing the camera perspectives; maintaining patient, provider, and staff privacy; ensuring data security; executing the cineVR production process; and building the curriculum.

Why So Glum? Understanding the Challenges in Meeting User's Needs on Trauma Surgical Rounds.

BACKGROUND: Trauma patient rounds are complex, with a high volume of complicated patients in a dynamic environment with competing priorities and workflows. This presents challenges to quality improvement as single-method research approaches fail to comprehensively understand these complex systems. We used a mixed-methods approach to understand factors contributing to system inefficiency and user dissatisfaction on daily patient rounds at a safety-net teaching hospital and level 1 trauma center. MATERIALS AND METHODS: A human-centered design uses ethnographic observations and in-depth interviews to understand the challenges and needs facing users of a system. We performed in-context observations and 22 in-depth interviews with a cross-section of care team members, patients, and families. Using the lean methodology, we performed time observations of 15 rounds, tracking activities related to flow, and classified them as 'value added' and 'non-value added.' RESULTS: Lean time observations revealed that 34.2% of time was spent on 'non-value-added' activities. Qualitative interviews revealed that all users reported perceived inefficiency as their greatest challenge on rounds. Among these users, there were three distinct user groups: connectors, learners, and doers, and each group had a different set of needs and priorities for rounds which were not being met. CONCLUSIONS: To adequately address complex environments, we need to understand the strains on both the system and its users so that we can create sustainable quality-improvement programs. By mixing methods using lean and human-centered design processes, we were able to gain a more comprehensive understanding of the system- and human-centered factors affecting rounds on a trauma surgical service.

Managing sleep disturbances in children with atopic dermatitis.

Atopic dermatitis is a chronic, pruritic inflammatory disease that often disrupts sleep in severely affected children, but there are limited studies to guide clinical management of these sleep problems. Disease control is crucial in improving sleep, but additional sleep aids may sometimes be helpful in decreasing scratching during the night. This review discusses the benefits and limitations of potential therapeutic agents available to manage sleep disturbances in children with atopic dermatitis.

Cutaneous manifestations of metastatic Crohn's disease.

Metastatic Crohn's disease is a rare cutaneous complication of primary Crohn's disease. It is a granulomatous inflammatory process, similar to the pathogenic mechanism of Crohn's disease, that occurs in sites discontiguous from the gastrointestinal tract. Metastatic Crohn's disease can precede the development of Crohn's disease by months to years, and children are more likely to present with metastatic Crohn's disease in the absence of gastrointestinal symptoms. Given that approximately 30% of individuals with Crohn's disease present in childhood, early recognition of extraintestinal manifestations of Crohn's disease such as metastatic Crohn's disease can aid in timely diagnosis and management of bowel disease. We present data from two pediatric cases of metastatic Crohn's disease recently seen at our institution in addition to the 61 reported cases of pediatric metastatic Crohn's disease in the literature. This review article will focus on the epidemiology, pathogenesis, clinical features, and histology of and treatment options for pediatric metastatic Crohn's disease.

Scalp-to-toes application of permethrin for patients with scabies.

Scabies is an infestation of Sarcoptes scabiei resulting in intensely pruritic erythematous papules tipped with hemorrhagic crusts. Current guidelines and medication labels instruct application of topical permethrin 5% cream from neck down for treatment of adult patients with scabies. Although scalp and head involvement are observed in infants, it is rare in older children and adults. Herein, we present a case of an 11-month-old patient who had scalp involvement, and required a scalp-to-toes application of permethrin. We also present a 77-year-old patient with scabies involving the head, who failed initial treatment when permethrin was applied neck down, but had subsequent resolution when it was applied scalp-to-toes. These cases provide impetus for review of current guidelines to reflect application of topical permethrin 5% cream to all external surfaces of the body including the scalp and head.

"X" Marks the Spot: An Injection Technique for Alopecia Areata.

Children with alopecia areata often have multiple patches of hair loss. When administering intralesional steroid injections, it can be difficult to monitor which areas have already been treated. Additionally, patients and their parents may worry that we did not treat all of the affected areas. We describe a simple technique to keep track of which areas have been treated.

Lymphoplasmacytic Plaque in Children: A Demonstrative Case of an Emerging Clinicopathologic Entity.

Lymphoplasmacytic plaque in children is a rare but increasingly reported clinicopathologic entity characterized by extratruncal erythematous solitary plaques, most often in children and Caucasian girls, that are thought to be a reactive or pseudolymphomatous process. We report a demonstrative case of lymphoplasmacytic plaque in a 3-year-old girl and discuss the clinical and pathologic experience with this entity.

Serious Complications from Staphylococcal aureus in Atopic Dermatitis.

Colonization with Staphylococcal aureus is markedly more frequent in individuals with atopic dermatitis (AD) than in unaffected individuals. Chronic scratching leads to worsening of an existing defect in the epidermal barrier, which can allow S. aureus invasion into the bloodstream and subsequent systemic infections. We report two unusual cases of systemic illness in individuals with AD. One developed infective endocarditis followed by a stroke and the other developed septic arthritis and osteomyelitis. We performed an extensive literature review of reported systemic complications caused by S. aureus in patients with AD. Although reports are rare, practitioners should be aware of these important, albeit unlikely, complications of staphylococcal superinfections in individuals with AD.

Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial.

Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We conducted an inductive thematic analysis and aligned the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as required enabled acceptance for patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, and collaboration among HCPs enabled, whereas initial concerns about 3HP safety among HCPs delayed 3HP adoption and implementation. SAT was maintained post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up.

Religious objection to cantharidin use in Jain patients.

We report a case of a Jain family that was upset with the use of cantharidin for treatment of molluscum contagiosum for religious reasons.

Fever, irritability, and ulcerations in an infant.

A young infant with fever and oral ulcerations is presented herein. Extensive infectious, nutritional, immunodeficiency and autoimmune work up was performed. Pertinent maternal history suggested the potential diagnosis of neonatal Behçet's, and treatment for this condition resulted in rapid and sustained clinical improvement.

Facilitating Integrated Perinatal Care for Families Affected by Substance Use.

Families of newborns are frequently referred to child protection systems because of parental substance use, yet many families face barriers to accessing prenatal care and substance use treatment services. Although federal legislation requires states to develop Plans of Safe Care to address families' health and substance use treatment needs, few have developed comprehensive and systematic approaches to provide perinatal support to parents and infants. In this commentary, we describe the development and initial testing of a Plan of Safe Care that engages patients and their providers in perinatal care coordination. Developed out of an in-depth analysis of current care workflows at an urban safety net health system, the Plan of Safe Care facilitates conversations with clients around delivery planning and aligns resources to support families with substance use disorders.