Femoral to abdomen tunneling at the bedside for medium/long term venous access.

BACKGROUND: Femoral to abdomen tunneling of small-bore central venous catheters is a bedside technique for patients with contraindications to a thoracic approach, or as an alternative to a lower extremity catheter exit site. METHOD: A femoral to abdomen tunneling technique was implemented for patients receiving medium and long-term intravenous treatments with contraindications to the thoracic venous approach or as an alternative to a lower extremity catheter exit site. All venous access devices were inserted with ultrasound guidance under local anesthesia, and catheter tip placement assessed by post procedural radiography. RESULTS: In this case series, from January 2020 to January 2023, a total of eight FTA-tunneled venous access devices were inserted. There were seven ambulatory patients and one bedbound patient. The median length of the subcutaneous tunnel was 20 cm, ranging from 15 to 27 cm. The median length of the intravenous catheter to the terminal tip was 31 cm, ranging from 23 to 40 cm. Tip location was confirmed by post-procedural abdominal radiograph. The catheter tip locations were interpreted to be at the level of T8-T9 (2), T12 (1), L4 (2), L2 (2), L1(1).No insertion or post insertion related complication was reported. Six patients completed the scheduled intravenous treatment. One patient was unable to be tracked due to transfer to an outside facility. One catheter initially demonstrated to be coiled over the left common iliac vessel was repositioned using a high flow flush technique. There was one reported catheter dislodgment by the nurse providing care and maintenance. The overall implant days were 961, with a median dwell time of 125 days ranging from 20 to 399 days. CONCLUSION: Femoral to abdomen tunneling provides an alternative exit site useful in select patients with complex intravenous access. The data of this small retrospective review suggests this a safe and minimally invasive bedside procedure.

Foot offloading associated with carbon fiber orthosis use: A pilot study.

BACKGROUND: Traumatic lower limb injuries can result in chronic pain. Orthotic interventions are a leading conservative approach to reduce pain, manage loading, and protect the foot. Robust carbon fiber custom dynamic orthoses (CDOs) designed for military service members have been shown to reduce foot loading. However, the effect of carbon fiber orthosis design, including designs widely used in the civilian sector, on foot loading is unknown. RESEARCH QUESTION: Determine if carbon fiber orthoses alter foot loading during gait. METHODS: Loadsol insoles were used to measure peak forces and force impulse acting on the forefoot, midfoot, hindfoot, and total foot. Nine healthy, able-bodied individuals participated. Force impulse was quantified as cumulative loading throughout stance phase. Participants walked without an orthosis and with three carbon fiber orthoses of differing designs: a Firm stiffness CDO, a Moderate stiffness CDO, and a medial and lateral strut orthosis (MLSO). RESULTS: There were significant main effects of orthosis condition on peak forefoot forces as well as forefoot and hindfoot force impulse. Peak forefoot forces were significantly lower in the Moderate and Firm CDOs compared to no orthosis and MLSO. Compared to walking without an orthosis, forefoot force impulse was significantly lower and hindfoot force impulse was significantly greater in all carbon fiber orthoses. Additionally, hindfoot force impulse in the Firm CDO was significantly higher than in the MLSO and Moderate CDO. SIGNIFICANCE: The three carbon fiber orthosis designs differed regarding foot loading, with more robust orthoses providing greater forefoot offloading. Orthosis-related changes in forefoot loading suggest that carbon fiber orthoses could reduce loading-associated pain during gait. However, increased hindfoot force impulse suggests caution should be used when considering carbon fiber orthoses for individuals at risk of skin breakdown with repetitive loading.

Factor structure of school readiness skills: conceptual vs. statistical distinctions.

Introduction: School readiness skills are a broad set of abilities that children develop in early childhood that support achievement once they enter formal schooling. Three components of school readiness skills are of focus in the current study: executive function (EF), language/literacy, and mathematics. The current study examines to what extent 13 direct assessments of these skills statistically align with theoretical models for distinct construct- and timepoint-specific latent factors. Methods: The sample included 684 children (52.34% male; 42% Black/African American; Mage = 4.80 years in the fall of prekindergarten) assessed in the fall and spring of the prekindergarten year. Results: Factor analyses revealed the most statistical support for a model with a latent random intercept across timepoints and constructs, along with timepoint-specific latent factors in the fall and spring of prekindergarten (independent of the random intercept). The timepoint-specific latent factors primarily consisted of early literacy and mathematics assessments. Discussion: These findings challenge commonly held practices of creating construct-specific latent factors in early childhood research and, to a lesser extent, timepoint-specific latent factors without consideration of the substantial shared variance across different constructs and timepoints. Implications for the factor structure and developmental theory of school readiness skills are considered, as well as practical considerations for future research.

Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment.

Background: Sarcoidosis is a chronic, multisystem inflammatory disorder characterized by non-caseating epithelioid granulomas; infiltration of mononuclear cells; and destruction of microarchitecture in the skin, eye, heart, and central nervous system, and the lung in >90% of cases. XTMAB-16 is a chimeric anti-tumor necrosis factor alpha (TNFα) antibody, distinct from other anti-TNF antibodies based on its molecular structure. The efficacy of XTMAB-16 has not been clinically demonstrated, and it is still undergoing clinical development as a potential treatment for sarcoidosis. The current study demonstrates the activity of XTMAB-16 in a well-established in vitro sarcoidosis granuloma model, although XTMAB-16 is not yet approved by the United States Food and Drug Administration (FDA) for treatment of sarcoidosis, or any other disease. Objective: To provide data to guide safe and efficacious dose selection for the ongoing clinical development of XTMAB-16 as a potential treatment for sarcoidosis. Methods: First, XTMAB-16 activity was evaluated in an established in vitro model of granuloma formation using peripheral blood mononuclear cells from patients with active pulmonary sarcoidosis to determine a potentially efficacious dose range. Second, data obtained from the first-in-human study of XTMAB-16 (NCT04971395) were used to develop a population pharmacokinetic (PPK) model to characterize the pharmacokinetics (PK) of XTMAB-16. Model simulations were performed to evaluate the sources of PK variability and to predict interstitial lung exposure based on concentrations in the in vitro granuloma model. Results: XTMAB-16 dose levels of 2 and 4 mg/kg, once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for up to 12 weeks, were supported by data from the non-clinical, in vitro secondary pharmacology; the Phase 1 clinical study; and the PPK model developed to guide dose level and frequency assumptions. XTMAB-16 inhibited granuloma formation and suppressed interleukin-1ß (IL-1ß) secretion in the in vitro granuloma model with a half maximal inhibitory concentration (IC50) of 5.2 and 3.5 µg/mL, respectively. Interstitial lung concentrations on average, following 2 or 4 mg/kg administered Q2W or Q4W, are anticipated to exceed the in vitro IC50 concentrations. Conclusion: The data presented in this report provide a rationale for dose selection and support the continued clinical development of XTMAB-16 for patients with pulmonary sarcoidosis.

The Role of Mistrust in Sexual Revictimization: An Analysis of Serial Indirect Effects.

A sample of 819 female college students completed measures of childhood sexual abuse (CSA), adult sexual victimization (ASV), mistrust, trauma-related symptoms, and drinking problems. Using a serial indirect effects model, we hypothesized that CSA would be associated with ASV through the indirect effects of mistrust → trauma-related symptoms → drinking problems. The results indicated that this serial indirect effects model was significant. When the order of the first two indirect effects was reversed, the model was not significant. These results highlight the importance of examining potential factors involved in sexual revictimization in tandem rather than in isolation.

Novel testing system to determine shoe mechanical properties.

BACKGROUND: Shoes play an important role in ankle foot orthosis (AFO) function and alignment. Despite this, shoe mechanical testing systems are rarely colocated with gait analysis systems, limiting their availability and use during AFO-related studies. OBJECTIVE: The purpose of this study was to evaluate a novel mechanical testing system used to measure shoe heel stiffness and change in height with loading using equipment available in most gait analysis laboratories. The novel testing system will allow for shoe assessment during AFO studies at little additional cost. STUDY DESIGN: Shoes were tested to determine initial stiffness, terminal stiffness, and total stiffness, and whether these measures changed with repeated compressions (early vs. late). TECHNIQUE: The novel testing system consists of a baseplate for counterweights, uprights that support a low-friction hinge, and a lever arm with a heel-shaped indenter to apply force to the shoe. Minimal detectable change values were calculated using the standard error of measurement. Intraclass correlation coefficients were calculated in SPSS using a (2, k) model. RESULTS: No significant differences in mean values, or interactions, were observed between rounds of testing and early and late compressions (P > .05). Intraclass correlation coefficient values were greater than 0.98, and minimal detectable change values were less than 20% of the average for each measure. CONCLUSIONS: The novel mechanical testing system, combined with pre-existing gait analysis equipment, can be used to reliably assess shoe stiffness and change in height.

Executive Function Mediates the Relationship Between Conscious Discipline Fidelity and Kindergarten Readiness.

Conscious Discipline is a classroom management program that targets relationship building and socio-emotional learning to improve students' academic performance, as well as executive function (EF) and social skills. Past studies evaluating the effectiveness of this program, however, are limited and have yielded mixed results. The purpose of this study was to examine the relationship between preschool teachers' Conscious Discipline fidelity and students' kindergarten readiness and social skill development. This study included 873 preschool-aged students from 146 classrooms that used the Conscious Discipline program. We found that Conscious Discipline fidelity was significantly associated with students' EF skill gains, which in turn predicted outcomes on students' overall kindergarten readiness scores as well as their scores on evaluations of their language and literacy, math, social foundations, and physical development specifically. Results suggest that EF skill development mediates the relationship between preschool teachers' Conscious Discipline fidelity and students' kindergarten readiness scores.

Maternal use of corporal punishment and behavior problems in early childhood: A sibling comparison analysis.

BACKGROUND: Previous research demonstrates that there are environmental and genetic factors associated with the use of corporal punishment (CP) and children's behavior problems. Thus, it is difficult to disentangle whether CP has a causal effect on children's developmental outcomes. OBJECTIVE: This study explored the relationship between maternal use of CP at ages 3-4 years and symptoms of internalizing and externalizing behavior problems between the ages of 6 and 9 years using a sibling comparison design. In doing so, we were able to control for shared environmental factors and partially control for genetic factors that could explain the relationship between CP and behavior problems. METHODS: This study analyzed data from 11,506 children from the United States. We used generalized linear models to assess the relationship between the use of CP and behavior problems among biological siblings raised in the same home. RESULTS: At the population level, CP was significantly associated with the development of internalizing behavior problems (ß = 0.134, SE = 0.03, p < .001). When comparing siblings, this relationship was no longer significant. In contrast, CP was significantly associated with externalizing behavior problems at both the population (ß = 0.233, SE = 0.02, p < .001) and sibling comparison level (ß = 0.107, SE = 0.03, p < .001). CONCLUSION: We did not find evidence to suggest that the association between CP and externalizing behavior problems is due to environmental and genetic factors exclusively. Corroborating previous research, these results suggest that CP may increase the likelihood of externalizing behavior problems.

Strategic, feasibility, economic, and cultural aspects of phase 0 approaches: Is it time to change the drug development process in order to increase productivity?

Research conducted over the past 2 decades has enhanced the validity and expanded the applications of microdosing and other phase 0 approaches in drug development. Phase 0 approaches can accelerate drug development timelines and reduce attrition in clinical development by increasing the quality of candidates entering clinical development and by reducing the time to "go-no-go" decisions. This can be done by adding clinical trial data (both healthy volunteers and patients) to preclinical candidate selection, and by applying methodological and operational advantages that phase 0 have over traditional approaches. The main feature of phase 0 approaches is the limited, subtherapeutic exposure to the test article. This means a reduced risk to research volunteers, and reduced regulatory requirements, timelines, and costs of first-in-human (FIH) testing. Whereas many operational aspects of phase 0 approaches are similar to those of other early phase clinical development programs, they have some unique strategic, regulatory, ethical, feasibility, economic, and cultural aspects. Here, we provide a guidance to these operational aspects and include case studies to highlight their potential impact in a range of clinical development scenarios.

HLA-A Locus is Associated With Sepsis and Septic Shock After Traumatic Injury.

OBJECTIVE: Determine whether variation in the HLA region is associated with the development of post-traumatic sepsis and septic shock. BACKGROUND: Sepsis-related deaths remain a major source of mortality after traumatic injury. Genetic characteristics may contribute to susceptibility to adverse outcomes including sepsis and septic shock. Recent advances in next-generation sequencing technology now allow comprehensive genotyping of the HLA region. METHODS: White adult trauma patients requiring more than 2 days of mechanical ventilation underwent HLA genotyping, and were followed for the development of sepsis and septic shock. Odds ratios (OR) for the associations between our outcomes and HLA variants were estimated, a correction for multiple comparisons was applied, and significant variants were included in regression models adjusting for potential confounders. RESULTS: A total of 1184 patients were included. Patients were severely injured (median injury severity score 33); 33% developed sepsis, 6% septic shock, and in-hospital mortality was 14%. An amino acid variant (156Q) within the HLA-A peptide-binding groove was associated with greater odds of sepsis [OR 1.50, (1.18-1.89)]. HLA-A∗02:01 was associated with lower odds of septic shock [OR 0.52, (0.32-0.82)]. These associations remained significant after adjusting for potential confounders. CONCLUSIONS: This is the first study to apply next-generation sequencing techniques to evaluate associations between immunogenetic factors and post-traumatic sepsis and septic shock. Associations with class I HLA variants are novel as they implicate adaptive immunity in post-traumatic sepsis. These findings are a step towards developing a panel of genetic markers assessing risk of infection-related complications as we move towards more personalized medicine.

Carbon Fiber-Based Twisted and Coiled Artificial Muscles (TCAMs) for Powered Ankle-Foot Orthoses.

Ankle foot orthoses (AFOs) control the position and motion of the ankle, compensate for weakness, and correct deformities. AFOs can be classified as passive or powered. Powered AFOs overcome the limitations of passive AFOs by adapting their performance to meet a variety of requirements. However, the actuators currently used to power AFOs are typically heavy, bulky, expensive, or limited to laboratory settings. Thus, there is a strong need for lightweight, inexpensive, and flexible actuators for powering AFOs. In this technical brief, carbon fiber/silicone rubber (CF/SR) twisted and coiled artificial muscles (TCAMs) are proposed as novel actuators for powered AFOs. CF/SR TCAMs can lift to 12,600 times their weight with an input power of only 0.025 W cm-1 and are fabricated from inexpensive materials through a low-cost manufacturing process. Additionally, they can provide a specific work of 758 J kg-1 when an input voltage of 1.64 V cm-1 is applied. Mechanical characterization of CF/SR TCAMs in terms of length/tension, tension/velocity, and active-passive length/tension is presented, and results are compared with the performance of skeletal muscles. A gait analysis demonstrates that CF/SR TCAMs can provide the performance required to supplement lower limb musculature and replicate the gait cycle of a healthy subject. Therefore, the preliminary results provided in this brief are a stepping stone for a dynamic AFO powered by CF/SR TCAMs.

Exploration of pharmacist comfort with harm reduction behaviors: Cross-sectional latent class analysis.

BACKGROUND: Pharmacists are positioned to play important roles in implementing evidence-based prevention and harm reduction approaches for opioid misuse and related health care outcomes such as human immunodeficiency virus (HIV) and hepatitis C. More research is needed to understand how best to facilitate harm reduction practices among pharmacists. OBJECTIVES: This hypothesis-generating study investigated (1) whether subgroups (latent classes) were observable among pharmacists based on self-reported comfort with specific harm reduction behaviors, (2) whether having reported expertise in key content areas was associated with any latent classes that might be identified, and (3) whether comfort and training were associated with actually having dispensed syringes for likely nonprescription drug use. METHODS: This was a statewide census of community managing pharmacists in Arizona conducted from December 2018 to May 2019. Participants reported their degree of comfort with 10 harm reduction behaviors, their expertise (e.g., recent continuing pharmacy education or specialization) in selected content areas, and their syringe dispensing behavior. Additional sociodemographic information was also collected. Subgroups related to harm reduction were computed using latent class analysis, and associations between study variables were assessed using the Fisher's exact tests. RESULTS: Data suggested the existence of 4 latent, comfort-based harm reduction classes: high comfort, moderate comfort, and clinical comfort, and opioid prevention only. Reported expertise in pre-exposure prophylaxis for HIV was likely associated with harm reduction class. However, class membership was not associated with reporting having dispensed nonprescription syringes, although the single comfort item for syringe dispensing, by itself, was associated therewith. CONCLUSION: Comfort with harm reduction likely clusters, so pharmacists may be broadly comfortable with topics or methods of harm reduction; however, comfort with a specific harm reduction pharmacy practice may be a better predictor of engaging in that behavior than harm reduction comfort class. In contrast, strategies to improve comfort, such as intervention development, might successfully be informed by pharmacists' latent class.

Pitch and Rhythm Perception and Verbal Short-Term Memory in Acute Traumatic Brain Injury.

Music perception deficits are common following acquired brain injury due to stroke, epilepsy surgeries, and aneurysmal clipping. Few studies have examined these deficits following traumatic brain injury (TBI), resulting in an under-diagnosis in this population. We aimed to (1) compare TBI patients to controls on pitch and rhythm perception during the acute phase; (2) determine whether pitch and rhythm perception disorders co-occur; (3) examine lateralization of injury in the context of pitch and rhythm perception; and (4) determine the relationship between verbal short-term memory (STM) and pitch and rhythm perception. Music perception was examined using the Scale and Rhythm tests of the Montreal Battery of Evaluation of Amusia, in association with CT scans to identify lesion laterality. Verbal short-term memory was examined using Digit Span Forward. TBI patients had greater impairment than controls, with 43% demonstrating deficits in pitch perception, and 40% in rhythm perception. Deficits were greater with right hemisphere damage than left. Pitch and rhythm deficits co-occurred 31% of the time, suggesting partly dissociable networks. There was a dissociation between performance on verbal STM and pitch and rhythm perception 39 to 42% of the time (respectively), with most individuals (92%) demonstrating intact verbal STM, with impaired pitch or rhythm perception. The clinical implications of music perception deficits following TBI are discussed.

Is metformin effective for reducing weight in obese or overweight adolescents?

YES, TO SOME DEGREE-BUT IT IS OF UNCERTAIN CLINICAL SIGNIFICANCE. OVER A PERIOD OF 6 MONTHS, METFORMIN MODESTLY REDUCED WEIGHT (-2.1 KG) AND BODY FAT MASS (-1.9%), BUT NOT BODY MASS INDEX (BMI) OR LEAN BODY MASS, IN ADOLESCENTS WHO WERE OVERWEIGHT OR OBESE. THIS IS COMPARABLE TO LIFESTYLE INTERVENTIONS (DIET AND EXERCISE) SUPPORTED WITH > 26 HOURS OF COUNSELING, WHICH MODESTLY IMPROVED BMI BUT NOT WEIGHT. (STRENGTH OF RECOMMENDATION [SOR]: A, BASED ON A LARGE META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS [RCTS] OF VARIABLE QUALITY).

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report.

OBJECTIVE: Partial foot amputation is often associated with decreased mobility and function. Recent advances in custom carbon-fiber dynamic ankle-foot orthoses (CDOs) have improved gait, pain, and function following musculoskeletal trauma and can benefit individuals with partial foot amputation. However, limited information is available related to CDO use outside the military. The purpose of this case report is to describe the course of care and outcomes of a civilian provided with CDOs after bilateral transmetatarsal amputation. CASE DESCRIPTION: A 72-year-old man had a blood-borne bacterial infection (septicemia) of unknown origin at 68 years of age, developed limb-threatening necrosis of the hands and feet, and received bilateral transmetatarsal amputations with skin grafting. The patient initially used foam toe fillers and cushioned shoes but was functionally limited and experienced recurrent ulceration. He was fitted with bilateral CDOs 39 months after amputation and completed device-specific training with a physical therapist. RESULTS: After 1 week with the CDOs, ankle range of motion during gait was reduced, but greater than 40% increases were observed in bilateral ankle plantarflexor moments and ankle plantarflexion push-off power compared with the toe fillers. With additional therapist-directed training focused on gait and activity performance, ankle plantarflexor moments and plantarflexion push-off power further increased when compared with results after 1 week of CDO use. The patient reported marked improvement in quality of life with the CDOs due to improved walking ability on level and uneven terrain, marked improvement in confidence, and reduced pain. CONCLUSION: This case reflects the lessons learned and outcomes of a civilian using bilateral CDOs after bilateral transmetatarsal amputation and with poor skin quality. The results from this case study suggest that carbon-fiber CDOs and focused training by a physical therapist can result in improved gait biomechanics, mobility, and quality of life.

Satisfaction with ankle foot orthoses in individuals with Charcot-Marie-Tooth disease.

BACKGROUND: Ankle foot orthoses (AFOs) are commonly prescribed to individuals with Charcot-Marie-Tooth disease (CMT). The aim of this study was to evaluate patient reported satisfaction with orthotic devices and services in individuals with CMT to provide preliminary data for advancing AFO development and improving clinical care. METHODS: The Orthotics and Prosthetics Users Survey was distributed via e-mail through the Inherited Neuropathy Consortium (INC) Contact Registry and includes 11 device-specific questions and 10 service-related questions. Participants were also asked open-ended questions about their experiences with AFOs. RESULTS: Three hundred and fourteen individuals completed the survey. Over one-third of participants provided negative responses, including dislike of AFO appearance, discomfort, abrasions or irritations, and pain. Ratings of orthotic services were generally positive. CONCLUSIONS: Lower scores related to discomfort, abrasions and pain identified areas for AFO improvement. Continued research in these areas will be beneficial to informing and advancing AFO development and improving clinical care.

Killer Cell Immunoglobulin-like Receptor Variants Are Associated with Protection from Symptoms Associated with More Severe Course in Parkinson Disease.

Immune dysfunction plays a role in the development of Parkinson disease (PD). NK cells regulate immune functions and are modulated by killer cell immunoglobulin-like receptors (KIR). KIR are expressed on the surface of NK cells and interact with HLA class I ligands on the surface of all nucleated cells. We investigated KIR-allelic polymorphism to interrogate the role of NK cells in PD. We sequenced KIR genes from 1314 PD patients and 1978 controls using next-generation methods and identified KIR genotypes using custom bioinformatics. We examined associations of KIR with PD susceptibility and disease features, including age at disease onset and clinical symptoms. We identified two KIR3DL1 alleles encoding highly expressed inhibitory receptors associated with protection from PD clinical features in the presence of their cognate ligand: KIR3DL1*015/HLA-Bw4 from rigidity (p c = 0.02, odds ratio [OR] = 0.39, 95% confidence interval [CI] 0.23-0.69) and KIR3DL1*002/HLA-Bw4i from gait difficulties (p c = 0.05, OR = 0.62, 95% CI 0.44-0.88), as well as composite symptoms associated with more severe disease. We also developed a KIR3DL1/HLA interaction strength metric and found that weak KIR3DL1/HLA interactions were associated with rigidity (pc = 0.05, OR = 9.73, 95% CI 2.13-172.5). Highly expressed KIR3DL1 variants protect against more debilitating symptoms of PD, strongly implying a role of NK cells in PD progression and manifestation.

A Sexual Health Promotion App for Transgender Women (Trans Women Connected): Development and Usability Study.

BACKGROUND: HIV severely impacts the transgender communities in the United States, and transgender women have the highest HIV incidence rates among any identified risk group. Guided by formative research with transgender women and by an expert advisory panel of transgender women, we designed a prototype mobile app to promote HIV prevention among transgender women. OBJECTIVE: This study aimed to develop and test the usability and acceptability of the prototype Trans Women Connected mobile app. METHODS: We engaged in a 3-phase prototype development process. After conducting formative research about the health needs of this population, we outlined a theory-based app framework and developed three prototype activities (ie, a vision board, a pre-exposure prophylaxis [PrEP] education activity, and an interactive map). We then tested the usability and acceptability of the mobile app and activities with 16 transgender women using pre- and posttests, think-aloud protocols, and open-ended questions. RESULTS: Participants reported high acceptability for the mobile app; the mean rating across all usability and likability questions was 5.9 out of 7. Service utilization intention, goal setting, and social support increased at posttest compared with pretest. Increases in self-efficacy in finding lesbian, gay, bisexual, transgender, and queer-friendly services; intention to seek online social support; and PrEP knowledge were statistically significant. Participants described the app as attractive and useful and perceived all three activities positively. CONCLUSIONS: This study describes the development and usability and acceptability evaluation of a prototype mobile app designed for and with transgender women for HIV prevention. The usability testing findings provided important insights toward refining and the further development of the Trans Women Connected mobile app. The results suggest that a mobile health intervention can support positive changes. The remaining development and efficacy randomized trial of the Trans Women Connected mobile app is currently underway.