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

NCT03652623 | Completed Phase 1 FDA Drug

• 2 other identifiers: R01MH114753-1R01MH114753
• Study Type: interventional
• Target: 49
• 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. The 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 (3)

• Change in Tenofovir Levels

  Tenofovir levels in a cohort of transgender youth on cs-HT

  Baseline and Weeks 0, 1, 2, 3 & 4

• Change in Estradiol Levels

  Estradiol levels in a cohort of transgender youth on cs-HT

  Baseline and Weeks 0, 1, 2, 3 & 4

• Change in Testosterone Levels

  Testosterone levels in a cohort of transgender youth on cs-HT

  Baseline and Weeks 0, 1, 2, 3 & 4

Study Arms (1)

TDF/FTC and cs-HT

EXPERIMENTAL

Transgender youth will simultaneously take TDF/FTC and cs-HT. TW will take oral estradiol +/- spironolactone and TM will take subcutaneous testosterone. In order to ensure adherence to TDF/FTC, daily DOT procedures will be employed.

Drug: TDF/FTC

Interventions

TDF/FTC DRUG

In Phase 1, a PK study will be conducted 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 transgender women taking estradiol and transgender men taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily TDF/FTC adherence and maximize drug exposure.

TDF/FTC and cs-HT

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)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Yager J, Brooks KM, Brothers J, Mulligan K, Landovitz R, Reirden D, Glenny C, Malhotra M, Anderson PL, Hosek S. Pharmacokinetics of Emtricitabine/Tenofovir Disoproxil Fumarate Among Transgender Adolescents and Young Adults Without HIV Receiving Gender Affirming Hormones. AIDS Res Hum Retroviruses. 2022 Nov;38(11):840-846. doi: 10.1089/AID.2022.0043. Epub 2022 Sep 7.

  PMID: 35943868 DERIVED

• Yager J, Brooks KM, Brothers J, Mulligan K, Landovitz RJ, Reirden D, Malhotra M, Glenny C, Harding P, Powell T, Anderson PL, Hosek S. Gender-Affirming Hormone Pharmacokinetics Among Adolescent and Young Adult Transgender Persons Receiving Daily Emtricitabine/Tenofovir Disoproxil Fumarate. AIDS Res Hum Retroviruses. 2022 Dec;38(12):939-943. doi: 10.1089/AID.2022.0044. Epub 2022 Aug 9.

  PMID: 35815468 DERIVED

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: phase 1
• 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: August 29, 2018
• Study Start: July 23, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)