Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate.

Purpose: Minor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents' willingness to participate (WTP) in biomedical HIV prevention research.

Instituting Sexual Orientation and Gender Identity Training and Documentation to Increase Inclusivity at a Pediatric Health System.

In this mixed-methods quality improvement project, we implemented and evaluated sexual orientation and gender identity (SOGI) form rollout in the electronic medical record. Families in our gender diversity program completed a baseline survey in 2017 (55/328 responded) and follow-up in 2020 (180/721 responded) to evaluate the frequency of affirmed name and pronoun use in the hospital. Survey feedback informed system-wide inclusivity efforts and training.

Pharmacokinetics of Emtricitabine/Tenofovir Disoproxil Fumarate Among Transgender Adolescents and Young Adults Without HIV Receiving Gender Affirming Hormones.

The transgender community has expressed concerns regarding drug-drug interactions between HIV-pre-exposure prophylaxis (PrEP) and gender-affirming hormones. In this study, we evaluated emtricitabine (F, FTC)/tenofovir (TFV) disoporoxil fumarate (TDF) pharmacokinetics (PK) among adolescent and young adult transgender persons receiving gender-affirming hormone therapy (GAHT). This was a prospective, observational study among transgender women (TW) and men (TM) without HIV, 15-24 years of age, receiving GAHT (estradiol with/without spironolactone, or testosterone).

Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate.

Transgender persons have an increased vulnerability to HIV infection yet have not been well-represented in past clinical trials for pre-exposure prophylaxis (PrEP). Because of this, there are few data available to understand whether gender-affirming hormone concentrations are influenced by PrEP agents in transgender men (TM) and transgender women (TW). The objective of this study was to compare gender-affirming hormone concentrations with versus without emtricitabine (F, FTC)-tenofovir disoproxil fumarate (TDF).

Behavioral Health Diagnoses in Youth with Gender Dysphoria Compared with Controls: A PEDSnet Study.

Objective: To assess the odds of a psychiatric or neurodevelopmental diagnosis among youth with a diagnosis of gender dysphoria compared with matched controls in a large electronic health record dataset from 6 pediatric health systems, PEDSnet. We hypothesized that youth with gender dysphoria would have higher odds of having psychiatric and neurodevelopmental diagnoses than controls.

Study Design: All youth with a diagnosis of gender dysphoria (n = 4173 age at last visit 16.

High Prevalence of Anal High-Grade Squamous Intraepithelial Lesions, and Prevention Through Human Papillomavirus Vaccination, in Young Men Who Have Sex With Men Living With Human Immunodeficiency Virus.

Background: Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV)-related anal cancer. Little is known about the prevalence of low-grade squamous intraepithelial lesions (LSILs) and the anal cancer precursor, high-grade squamous intraepithelial lesions (HSILs), among young MSM with HIV (MSMLWH). HPV vaccination is recommended in this group, but its safety, immunogenicity, and protection against vaccine-type HPV infection and associated LSILs/HSILs have not been studied.

Body Composition and Markers of Cardiometabolic Health in Transgender Youth on Gonadotropin-Releasing Hormone Agonists.

Up to 1.8% of youth identify as transgender; many will be treated with a gonadotropin-releasing hormone agonist (GnRHa). The impact of GnRHa on insulin sensitivity and body composition in transgender youth is understudied.

Qualitative Study on the Acceptability of and Adherence to a Vaginal Ring for HIV Prophylaxis Among Adolescent Girls.

Objective: This study aims to assess the product-related, relationship-related, and sex-related factors that act as facilitators and barriers to the acceptability of a vaginal ring (VR) for HIV prevention among adolescent girls.

Design: Qualitative study.

Methods: Ninety-six girls aged 15-17 years from 6 urban US sites were enrolled in MTN-023/IPM 030, a 24-week randomized controlled trial, for assessing the safety and acceptability of a dapivirine VR for HIV prevention.

Perceptions of quality and safety in cannabis acquisition amongst young gay and bisexual men living with HIV/AIDS who use cannabis: Impact of legalisation and dispensaries.

Background: Upwards of 35% of young gay and bisexual men living with HIV report daily use of cannabis in the U.S. The effects of legalisation of recreational and medical cannabis on the acquisition of cannabis products amongst a group with such high prevalence of use is largely unknown.

Medical, therapeutic, and recreational use of cannabis among young men who have sex with men living with HIV.

Cannabis plays a role in symptoms management in HIV, especially the alleviation of pain and nausea and stimulation of appetite, and prevalence of cannabis use in HIV-positive populations exceeds that of the general U.S. population.

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?

Purpose: One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear.

Innovative Approaches to Obtain Minors' Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives.

Background: Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents-as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment.

Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women.

Background: Young women aged 15-24 years are disproportionately affected by the HIV epidemic. Two phase III trials of a vaginal ring containing 25-mg dapivirine demonstrated HIV-1 risk reduction in adult women older than 21 years but not in those aged 18-21 years. Lack of protection was correlated with low adherence.

Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men.

The aims of this study were to: 1) determine prevalence of anogenital and oral HPV, 2) determine concordance between HPV at anal, perianal, scrotal/penile, and oral sites; and 3) describe factors associated with anogenital HPV types targeted by the 9-valent vaccine. Data were collected from 2012 to 2015 among men who have sex with men 18-26 years of age enrolled in a vaccine trial (N = 145). Penile/scrotal, perianal, anal, and oral samples were tested for 61 HPV types.

Pharmacologic Considerations for Preexposure Prophylaxis in Transgender Women.

Studies of tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC)-based preexposure prophylaxis (PrEP) have not focused on transgendered women who are at disproportionate risk of HIV acquisition. Concerns exist for drug interactions between cross-sex therapy (estradiol, progestins, and spironolactone) with tenofovir disoproxil fumarate-emtricitabine. This review assessed the experimental and theoretical risk for such drug interactions.

Engagement-in-care during the first 5 years after HIV diagnosis: data from a cohort of newly HIV-diagnosed individuals in a large US city.

Initial descriptions of the HIV engagement continuum are limited by short-term follow-up and incomplete data. We evaluated engagement in a newly HIV-diagnosed cohort. Our goals were to assess long-term engagement-in-care, evaluate the effects of out-of-state migration on engagement estimates, and determine whether engagement has improved in more recently diagnosed individuals.

Initial linkage and subsequent retention in HIV care for a newly diagnosed HIV-infected cohort in Denver, Colorado.

This is a retrospective cohort study of 352 newly diagnosed HIV-infected individuals in Denver, from 2005 to 2007. Utilizing data from 3 health care systems, 2 clinical trials units, and statewide Colorado HIV laboratory reporting databases, we tracked initial linkage to HIV care, retention in care, loss to follow-up, and transitions between HIV care providers. After more than 2.