Transgender Youth Experiences with Implantable GnRH Agonists for Puberty Suppression.

This descriptive study reports caregiver experiences with GnRH agonist implants among a cohort of youth followed in a pediatric hospital-based gender clinic. We administered a survey to 36 of 55 eligible caregivers ascertaining demographics and satisfaction, with a medical record review of any surgical complications. The overwhelming majority (97.1%) reported satisfaction with the procedure and would undergo the implant procedure again (94.4%). The most frequent challenges noted were about affordability (39.8%) and insurance denials (39.8%). Implantable GnRH agonist can be used successfully in pediatric patients with gender dysphoria. Future policy should seek to address concerns regarding insurance approval and reimbursement.

Lyophilization Process Engineering and Thermostability of ID93 + GLA-SE, a Single-Vial Adjuvanted Subunit Tuberculosis Vaccine Candidate for Use in Clinical Studies.

Promising clinical efficacy results have generated considerable enthusiasm for the potential impact of adjuvant-containing subunit tuberculosis vaccines. The development of a thermostable tuberculosis vaccine formulation could have significant benefits on both the cost and feasibility of global vaccine distribution. The tuberculosis vaccine candidate ID93 + GLA-SE has reached Phase 2 clinical testing, demonstrating safety and immunogenicity as a two-vial point-of-care mixture. Earlier publications have detailed efforts to develop a lead candidate single-vial lyophilized thermostable ID93 + GLA-SE vaccine formulation. The present report describes the lyophilization process development and scale-up of the lead candidate thermostable ID93 + GLA-SE composition. The manufacture of three full-scale engineering batches was followed by one batch made and released under current Good Manufacturing Practices (cGMP). Up to 4.5 years of stability data were collected. The cGMP lyophilized ID93 + GLA-SE passed all manufacturing release test criteria and maintained stability for at least 3 months when stored at 37°C and up to 24 months when stored at 5°C. This work represents the first advancement of a thermostable adjuvant-containing subunit tuberculosis vaccine to clinical testing readiness.

Transition to adult services among behaviorally infected adolescents with HIV--a qualitative study.

OBJECTIVES: The present study aimed to describe the experiences of youth with behaviorally acquired HIV who transitioned to adult care, to identify difficulties encountered, and to explore areas for improvement. METHODS: Semi-structured interviews were conducted with 10 young adults ranging from 24 to 29 years old. Themes were derived from coding participant interviews. RESULTS: Participants experienced adolescent care providers as an important source of support, felt anxiety about transition, provided recommendations for improving the process, and described significant changes associated with adult HIV care. CONCLUSIONS: Findings support the development of a clear and structured transition process to address patients' fears and worries through early communication, planning, and coordination for adult healthcare, highlighting the need for future research in this area.

Experience of Chest Dysphoria and Masculinizing Chest Surgery in Transmasculine Youth.

OBJECTIVES: Transmasculine individuals, those assigned female sex at birth but who identify as masculine, have high rates of suicidal behavior and often suffer from chest dysphoria (discomfort and distress from unwanted breast development). Growing numbers of transmasculine youth are pursuing definitive treatment with masculinizing chest surgery (MCS), and adult studies reveal marked benefits of MCS, although little is known about the impact of chest dysphoria on transmasculine youth or the optimal timing of MCS. In this study, we aimed to explore youth experiences of chest dysphoria and the impact of MCS. METHODS: Transmasculine youth aged 13 to 21 were recruited from a pediatric hospital-based gender clinic. Participants completed a semistructured qualitative interview exploring the experience of chest dysphoria and thoughts about or experiences with MCS. Interview transcripts were coded by 3 investigators employing modified grounded theory, with the median interrater reliability at κ = 0.92. RESULTS: Subjects (N = 30) were a mean age of 17.5 years, and 47% had undergone MCS. Youth reported that chest dysphoria triggered strong negative emotions and suicidal ideation, caused a myriad of functional limitations, and was inadequately relieved by testosterone therapy alone. All post-MCS youth reported near or total resolution of chest dysphoria, lack of regret, and improved quality of life and functioning. CONCLUSIONS: We observed consensus that chest dysphoria is a major source of distress and can be functionally disabling to transmasculine youth. MCS performed during adolescence, including before age 18, can alleviate suffering and improve functioning. Additional research is needed to develop patient-reported outcome measures to assess the impact of chest dysphoria and MCS.

Posttraumatic stress and trauma history in adolescents and young adults with HIV.

This study examined trauma history and posttraumatic stress in a sample of 30 adolescents and young adults with HIV/AIDS, recruited from December 14, 2004 through May 3, 2005. Overall, participants reported a mean of 5.63 traumatic events, with 93% of the sample reporting that receiving a diagnosis of HIV was experienced as traumatic. Of these, 13.3% met criteria for posttraumatic stress disorder in response to HIV diagnosis, while an additional 20% showed significant post-traumatic stress symptoms. Even greater rates of posttraumatic stress were reported in response to other trauma, with 47% of youth surveyed reporting symptoms of posttraumatic stress in response to such traumatic events as being a victim of a personal attack, sexual abuse, or being abandoned by a caregiver. These findings may inform professionals about the potential impact of the HIV diagnosis on adolescents and young adults, particularly as this may impact participation in medical care and need for mental health support.

Creating Welcoming Spaces for Lesbian, Gay, Bisexual, and Transgender (LGBT) Patients: An Evaluation of the Health Care Environment.

Health outcomes are affected by patient, provider, and environmental factors. Previous studies have evaluated patient-level factors; few focusing on environment. Safe clinical spaces are important for lesbian, gay, bisexual, and transgender (LGBT) communities. This study evaluates current models of LGBT health care delivery, identifies strengths and weaknesses, and makes recommendations for LGBT spaces. Models are divided into LGBT-specific and LGBT-embedded care delivery. Advantages to both models exist, and they provide LGBT patients different options of healthcare. Yet certain commonalities must be met: a clean and confidential system. Once met, LGBT-competent environments and providers can advocate for appropriate care for LGBT communities, creating environments where they would want to seek care.

Policy Perspective: Ensuring Comprehensive Care and Support for Gender Nonconforming Children and Adolescents.

Despite recent notable advances in societal equality for lesbian, gay, bisexual, and transgender (LGBT) individuals, youth who identify as trans* or gender nonconforming, in particular, continue to experience significant challenges accessing the services they need to grow into healthy adults. This policy perspective first offers background information describing this population, their unique healthcare needs, and obstacles when seeking care, including case study examples. The authors then provide recommendations for medical education, health systems, and insurance payers, as well as recommendations for school systems and broader public policy changes to improve the health and well-being of gender nonconforming youth.

Effective Treatment of Depressive Disorders in Medical Clinics for Adolescents and Young Adults Living With HIV: A Controlled Trial.

OBJECTIVE: Preliminary test of a manualized, measurement-guided treatment for depression for adolescents and young adults in care at 4 sites of the Adolescent Trials Network for HIV/AIDS Interventions. DESIGN: The US sites were randomly assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB) tailored for youth living with HIV (YLWH) or to treatment as usual (TAU). METHODS: Youth at TAU sites had access to therapists and medication management as needed. COMB-site clinicians were trained in the manualized intervention and participated in supervision calls to monitor intervention fidelity. RESULTS: Over the course of the study with 44 participants, those in COMB, compared with those in TAU, reported fewer depressive symptoms, P < 0.01 (as measured by the Quick Inventory for Depression symptoms) and were more likely to be in remission, P < 0.001 (65% vs. 10% at week 24, end of treatment, and 71% vs. 7% at week 48, final follow-up). A greater proportion of COMB participants received psychotherapy (95% vs. 45%, P < 0.001) and attended more sessions (12.6 vs. 5, P < 0.001) than those in TAU. Viral load decreased in both groups and was associated (P < 0.05) with reduction in depressive symptoms. CONCLUSIONS: A 24-week manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH was more effective in achieving and sustaining remission from depression than TAU at HIV care clinic sites. Given observed treatment efficacy, this structured combination treatment could be disseminated to medical clinics to successfully treat YLWH, who are at particular risk for depression.

Optimal driving conditions are the most common injury conditions for child pedestrians.

OBJECTIVES: Motor vehicle-pedestrian crashes are one of the leading causes of serious injury in children. Prior studies have focused on child and traffic factors contributing to these crashes. The objective of the current study was to examine the role of driving conditions on the occurrence of motor vehicle crashes involving child pedestrians. METHODS: Detailed information was abstracted for the period January 1994 to December 1999 from the Philadelphia Police Department accident reports for all pediatric (age <18 years) pedestrian crashes in a single, urban county. Data included pedestrian age, road and weather conditions, illumination, pedestrian location, and intent, time of day, and date of incident. RESULTS: For the 6-year period of review, there were 3823 children under 18 years of age struck by motor vehicles (range 518 to 726 crashes per year), representing an average of 1.7 per day and a rate of 181 crashes per 100,000 children per year. The mean age was 7.9 years +/- 3.9 (range 1 to 17 years). Crashes occurred when the street was dry (>90%), with no adverse weather conditions (>90%), and during daylight hours or under streetlights (>92%). The most frequent day of the week was Friday (18.1%). The most common time of day was 3:00 to 6:00 PM (38.7%). The spring months (39.1%) predominated, with May (14.0%) being the most common month and January the least. When the circumstances were known, children were struck crossing in midblock 87.9% of cases and crossing behind a vehicle 38.8% of the time; only 4.8% were struck while playing in the street. Injuries as reported by the police exceeded minor in 32.3% with an overall fatality rate of 0.7%. CONCLUSIONS: Urban pediatric pedestrian crashes are common and occur most frequently during optimal driving conditions (good lighting, a dry road, and good weather). The data also suggest that pedestrian crashes are related to the saturation of the streets with children (optimal play conditions) compounded by poor street-crossing technique. Prevention efforts should reinforce the fact that optimal driving conditions are also likely to represent optimal conditions for child play and may increase the risk for pediatric pedestrian injuries through increased exposure.

Stigma and sexual health risk in HIV-positive African American young men who have sex with men.

Understanding the multiple forms of stigma experienced by young HIV-positive African American men who have sex with men and how they relate to sexual risk behaviors is essential to design effective HIV prevention programs. This study of 40 African American young MSM found that 90% of those surveyed experienced sexual minority stigma, 88% experienced HIV stigma, and 78% experienced dual stigma. Sexual minority stigma was characterized by experiences of social avoidance, and HIV stigma, by shame. Individuals with high HIV stigma were significantly more likely to engage in unprotected sex while high or intoxicated. Associations between stigma and sexual practices were examined; youth endorsing higher levels of sexual minority stigma engaged in less insertive anal intercourse. Individuals endorsing more HIV stigma reported more receptive anal intercourse. These findings support the development of stigma-informed secondary prevention interventions for African American HIV-positive young MSM.

Description of a novel pediatric emergency department-based HIV screening program for adolescents.

Several emergency department (ED)-based HIV screening programs have been described. However, the majority of these programs have been aimed at adults and older adolescents, and few have taken place in a dedicated pediatric ED. Given that many adolescents seek care in hospital EDs, and that the ED may be an adolescent's only contact with the health care system, we decided to implement an HIV-counseling and testing program in the ED of an urban children's hospital. The program included a dedicated health educator who provided sexual health counseling in a 30-minute session as well as optional HIV testing and test results to patients aged 14-24 years, and arranged necessary follow-up care for adolescents who tested positive for HIV. We collected aggregate data on the number of youth counseled, tested, and followed up. A total of 1287 patients were approached for potential counseling and testing during the first 3 years of the project. Of these, 643 (50.0%) agreed to meet with the health educator and were counseled. Three hundred eighteen (49.5%) of these patients agreed to HIV testing. One hundred eighty-seven (58.8%) patients returned for follow-up. Two patients (0.6%) whose previous HIV status was unknown tested positive for HIV; both of these patients were successfully linked to care. Fifty-six health care providers (17.3% of ED providers) were surveyed about their opinions of the program; although 93% were supportive of the program, several respondents were concerned about the appropriateness of HIV testing in the ED setting. This project suggests that, if appropriate resources are available, a dedicated HIV counseling and testing program can be successfully implemented in a busy, urban, pediatric ED. Providing access to these services to high-risk adolescents has the potential to significantly impact their health.

A randomized, clinical trial of a home safety intervention based in an emergency department setting.

OBJECTIVE: To assess the effectiveness of an emergency department (ED)-based home safety intervention on caregivers' behaviors and practices related to home safety. METHODS: We conducted a randomized, clinical trial of 96 consecutive caregivers of children who were younger than 5 years and presented to an urban pediatric ED for evaluation of an acute unintentional injury sustained in the home. After completing a structured home safety questionnaire via face-to-face interview, caregivers were randomly assigned to receive either comprehensive home safety education and free safety devices or focused, injury-specific ED discharge instructions. Participants were contacted by telephone 2 months after the initial ED visit for repeat administration of the safety questionnaire. The pretest and posttest questionnaires were scored such that the accrual of points correlated with reporting of safer practices. Scores were then normalized to a 100-point scale. The overall safety score reflected performance on the entire questionnaire, and the 8 category safety scores reflected performance in single areas of home injury prevention (fire, burn, poison, near-drowning, aspiration, cuts/piercings, falls, and safety device use). The main outcome was degree of improvement in safety practices as assessed by improvement in safety scores. RESULTS: The intervention group demonstrated a significantly higher average overall safety score at follow-up than the control group (73.3% +/- 8.4% vs 66.8% +/-11.1) and significant improvements in poison, cut/piercing, and burns category scores. Caregivers in the intervention group also demonstrated greater improvement in reported use of the distributed safety devices. CONCLUSIONS: This educational and device disbursement intervention was effective in improving the home safety practices of caregivers of young children. Moreover, the ED was used effectively to disseminate home injury prevention information.