Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project

NCT04077151 | Completed

• 2 other identifiers: R01MH114753-3R01MH114753
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

Conditions

HIV/AIDS; Gender; Behavior and Behavior Mechanisms

Keywords

Transgender; Pre-exposure Prophylaxis (PrEP); HIV Prevention; Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC); Cross-sex Hormone Therapy; Adherence; Behavior Change; Gender Affirmation

Outcome Measures

Primary Outcomes (2)

• PrEP Acceptability Questionnaire

  Acceptability and feasibility of PrEP among TM and TW youth will be measured; details unavailable at the current time as specific study has yet to be developed.

  48 weeks

• Tenofovir diphosphate levels

  Adherence to PrEP among TM and TW youth will be measured; details unavailable at the current time as specific study has yet to be developed.

  48 weeks

Study Arms (1)

Intervention Recipients

EXPERIMENTAL

PrEP Demonstration Project intervention will be given

Behavioral: PrEP Demonstration Project

Interventions

PrEP Demonstration Project BEHAVIORAL

In phase 2, a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth will be developed by incorporates the PK data from phase 1 and data gathered from focus groups and in-depth interviews with young transgender women and transgender men. During phase 3, this intervention will be given to the experimental arm and tested versus a standard-of-care control group.

Intervention Recipients

Eligibility Criteria

• Age: 15 Years - 24 Years
• Gender Eligibility Details: Self-identification as a transgender individual
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Self-identification as a transgender individual \[As determined by the two-step process of gender identification whereby potential participants will be asked their gender identity and sex assigned at birth\]
• HIV-uninfected by EIA and viral load within 7 days of study entry
• Creatinine clearance ≥ 60 mL/min by Cockroft Gault for ages ≥18 years (Schwartz equation for those \<18)
• Willing to comply with all study procedures
• On a stable dose of cs-HT for at least 2 months verified by clinical chart review and willing to not change doses for duration of PK study

You may not qualify if:

• Hospitalization within 30 days of study entry (elective procedures okay with team approval)
• Condition (medical, psychological, or social) that, in the opinion of the study investigators, would preclude the participant from completing study-required procedures
• Previous participation in an HIV vaccine study, unless the participant can document placebo arm assignment
• Use of TDF/FTC in the past 3 months

Sponsors & Collaborators

• Hektoen Institute for Medical Research: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Coitus; Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexual Behavior

Study Officials

• Sybil Hosek, PhD

  Cook County Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: September 4, 2019
• Study Start: March 14, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)