Abstract Purpose Family support is protective against health risks in sexual minority individuals. However, few studies have focused specifically on transgender youth, who often experience rejection, ...marginalization, and victimization that place them at risk for poor mental health. This study investigated the relationships among parental support, quality of life, and depression in transgender adolescents. Methods A total of 66 transgender youth presenting for care at Children's Hospital Los Angeles completed a survey assessing parental support (defined as help, advice, and confidante support), quality of life, and depression. Regression analyses assessed the associations between parental support and mental health outcomes. Results Parental support was significantly associated with higher life satisfaction, lower perceived burden of being transgender, and fewer depressive symptoms. Conclusions Parental support is associated with higher quality of life and is protective against depression in transgender adolescents. Interventions that promote parental support may significantly affect the mental health of transgender youth.
The purpose of this study was to examine the physiologic impact of hormones on youth with gender dysphoria. These data represent follow-up data in youth ages 12–23 years over a two-year time period ...of hormone administration.
This prospective, longitudinal study initially enrolled 101 youth with gender dysphoria at baseline from those presenting consecutively for care between February 2011 and June 2013. Physiologic data at baseline and follow-up were abstracted from medical charts. Data were analyzed by descriptive statistics.
Of the initial 101 participants, 59 youth had follow-up physiologic data collected between 21 and 31 months after initiation of hormones available for analysis. Metabolic parameters changes were not clinically significant, with the exception of sex steroid levels, intended to be the target of intervention.
Although the impact of hormones on some historically concerning physiologic parameters, including lipids, potassium, hemoglobin, and prolactin, were statistically significant, clinical significance was not observed. Hormone levels physiologically concordant with gender of identity were achieved with feminizing and masculinizing medication regimens. Extensive and frequent laboratory examination in transgender adolescents may be unnecessary. The use of hormones in transgender youth appears to be safe over a treatment course of approximately two years.
Abstract Purpose The purpose of this study was to describe baseline characteristics of participants in a prospective observational study of transgender youth (aged 12–24 years) seeking care for ...gender dysphoria at a large, urban transgender youth clinic. Methods Eligible participants presented consecutively for care at between February 2011 and June 2013 and completed a computer-assisted survey at their initial study visit. Physiologic data were abstracted from medical charts. Data were analyzed by descriptive statistics, with limited comparisons between transmasculine and transfeminine participants. Results A total of 101 youth were evaluated for physiologic parameters, 96 completed surveys assessing psychosocial parameters. About half (50.5%) of the youth were assigned a male sex at birth. Baseline physiologic values were within normal ranges for assigned sex at birth. Youth recognized gender incongruence at a mean age of 8.3 years (standard deviation = 4.5), yet disclosed to their family much later (mean = 17.1; standard deviation = 4.2). Gender dysphoria was high among all participants. Thirty-five percent of the participants reported depression symptoms in the clinical range. More than half of the youth reported having thought about suicide at least once in their lifetime, and nearly a third had made at least one attempt. Conclusions Baseline physiologic parameters were within normal ranges for assigned sex at birth. Transgender youth are aware of the incongruence between their internal gender identity and their assigned sex at early ages. Prevalence of depression and suicidality demonstrates that youth may benefit from timely and appropriate intervention. Evaluation of these youth over time will help determine the impact of medical intervention and mental health therapy.
This randomized behavioral trial examined whether youth living with HIV (YLH) receiving cell-phone support with study funded phone plans, demonstrated improved adherence and viral control during the ...24 week intervention and 24 weeks post-intervention compared to controls. Monday through Friday phone calls confirmed medications were taken, provided problem-solving support, and referred to services to address adherence barriers. Of 37 participants (ages 15–24), 62 % were male and 70 % were African American. Self-reported adherence was significantly higher in the intervention group compared to the control at 24 and 48 weeks for the past month (
P
= 0.007) and log 10 HIV VL was significantly lower at both 24 weeks (2.82 versus 4.52
P
= 0.002) and 48 weeks (3.23 versus 4.23
P
= 0.043). Adherence and viral load showed medium to large effect sizes across the 48 week study. This is the first study to demonstrate sustained clinically significant reductions in HIV VL using youth friendly technology.
A pilot randomized clinical trial of youth ages 15-24 nonadherent to antiretroviral therapy (ART) utilizing daily cell phone support was found to have significant improvement in self-reported ...adherence and HIV RNA. Understanding acceptability and feasibility is critical for future implementation in clinic settings. Exit interviews were obtained from participants and adherence facilitators (AF). Acceptability was assessed from content analysis of exit interviews. Feasibility was assessed via intervention retention and study retention rates. Thirty-seven eligible youth were enrolled with 19 assigned to the intervention. Seven (37%) discontinued the intervention either due to missing over 20% of calls for two consecutive months (N=5) or missing 10 consecutive calls (N=2). Sixteen participants completed exit interviews, 15 reported the call length was just right, 13 reported they would have liked to continue calls after the 24-week intervention, and all participants reported they would recommend the intervention to friends. Scheduling and making calls required less than 1 h per week per participant. Providing cell phone support to youth nonadherent to ART was acceptable and feasible. While the cost is low compared to the price of ART, healthcare systems will need to explore how to cover the cost of providing cell phones (incentive).
Randomized clinical trials (RCTs) enrolling pediatric populations often struggle with recruitment. Engaging healthcare providers in the recruitment process may increase patients' and caregivers' ...willingness to participate in research. The purpose of this study was to understand the perspectives of pediatric subspecialty healthcare providers considering recruiting patients to participate in an mobile health (mHealth) RCT.
We conducted 9 semi-structured interviews and 1 focus group with a total of N = 11 providers from various disciplines before the initiation of an mHealth RCT addressing medication nonadherence. Then, we conducted 5 follow-up interviews and 1 follow-up focus group with a total of 8 of these providers several months later. We used thematic analysis to generate themes describing providers' views of the RCT and patient recruitment.
Providers indicated that they were willing to recruit for this study because they believed that the intervention sought to address a significant problem. They also thought it made sense to intervene using technology for this age group. However, many providers thought that certain patients (e.g., those with mild, shorter-lasting adherence difficulties) were the most appropriate to recruit. They described how keeping the trial front of mind facilitated recruitment, and they advised researchers to use strategies to promote their ongoing awareness of the study if conducting similar research in the future.
Pediatric healthcare providers are important stakeholders in mHealth intervention research. Engaging them in participant recruitment is a complex endeavor that might promote patient enrollment, but their views of research and demanding clinical roles are important to understand when designing study procedures.
Digital strategies and broadened eligibility criteria may optimize the enrollment of youth living with HIV in mobile health adaptive interventions. Prior research suggests that digital recruitment ...strategies are more efficient than traditional methods for overcoming enrollment challenges of youth living with HIV in the United States.
This study highlights the challenges and strategies that explain screening and enrollment milestones in a national web-based adherence protocol for youth living with HIV.
Baseline data from a national web-based HIV adherence protocol for youth living with HIV, collected from July 2018 to February 2021, were analyzed. A centralized recruitment procedure was developed, which used web-based recruitment via Online Master Screener; paid targeted advertisements on social media platforms (eg, Facebook and Reddit) and geosocial networking dating apps (eg, Grindr and Jack'd); and site and provider referrals from Subject Recruitment Venues and other AIDS service organizations, website referrals, and text-in recruitment.
A total of 3 distinct cohorts of youth living with HIV were identified, marked by changes in recruitment strategies. Overall, 3270 individuals consented to screening, 2721 completed screening, 581 were eligible, and 83 completed enrollment. We examined sociodemographic and behavioral differences in completing milestones from eligibility to full enrollment (ie, submitting antiretroviral therapy and viral load data and completing the baseline web-based survey). Those with the most recent viral load tests >6 months ago were half as likely to enroll (odds ratio 0.45, 95% CI 0.21-0.94). Moreover, eligible participants with self-reported antiretroviral therapy adherence (SRA) between 50% and 80% were statistically significant (P<.001 to P=.03) and more likely to enroll than those with SRA >80%.
The findings add to our knowledge on the use of digital technologies for youth living with HIV before and during the COVID-19 pandemic and provide insight into the impact of expanding eligibility criteria on enrollment. As the COVID-19 pandemic continues and the use of and engagement with social media and dating apps among youth living with HIV changes, these platforms should continue to be investigated as potential recruitment tools. Using a wide variety of recruitment strategies such as using social media and dating apps as well as provider referral mechanisms, increasing compensation amounts, and including SRA in enrollment criteria should continue to be studied with respect to their ability to successfully recruit and enroll eligible participants.
RR2-10.2196/11183.
Abstract
Introduction
Adolescents and young adults (AYA) living with chronic medical conditions often struggle to develop medication adherence skills. This pilot trial evaluated the impact of a ...mobile health coaching intervention, Cell Phone Support (CPS), on medication adherence.
Methods
Interventions in this randomized trial were CPS delivered by phone calls (CPS-C), CPS delivered by text messages (CPS-T), or automated text message reminders (ATR). Participants were AYA with different chronic medical conditions (i.e., sickle cell disease, solid organ transplant, type 2 diabetes), aged 15–20 years (
N
= 34). We examined the feasibility, acceptability, and preliminary efficacy of each intervention.
Results
We examined the feasibility, acceptability, and preliminary efficacy of both CPS interventions. CPS was feasible and acceptable. There was evidence that participants found CPS to be more useful than ATR. In this pilot trial, participants receiving CPS reported relatively stronger increases in adherence, compared to those assigned to ATR. CPS-C slightly outperformed CPS-T.
Conclusions
Providing coaching to AYA struggling with illness self-management via their cell phones may promote their acquisition of medication adherence skills. Although larger studies are needed to confirm the results of this pilot study, phone calls and text messages are both promising modalities for delivering human cell phone support.
Trial registration
This trial was registered prospectively at ClinicalTrials.gov (NCT04241627) on 1/27/2020.
Youth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to ...antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this.
This study (ATN Adolescent Trials Network 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al.
This study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives.
Data collection for this study is projected to begin in August 2018 and last until June 2020.
This is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs.
ClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z).
PRR1-10.2196/11183.
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