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

NCT04077138 | Completed

• 2 other identifiers: R01MH114753-2R01MH114753
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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 (1)

• Qualitative Interviews

  Focus groups and in-depth interviews with young transgender women and transgender men will combine with PK data from phase 1 to inform the development of a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth.

  Year 2

Study Arms (2)

Focus Groups

Ten focus groups with transgender women and transgender men will be conducted. . The structure of the focus groups will utilize an interactive "Rapid Approach", which differs from traditional focus groups by asking fewer questions and tightly focusing on specific areas of inquiry.

In-Depth Interviews

Participants for the IDIs, 10-15 TW and TM, will be selected from among Phase 1 participants. We will create a purposive sample that represents a range of experiences that occurred during Phase 1.

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)
• Sampling Method: Non-Probability Sample

Study Population

Transgender women youth and transgender men youth at high-risk of acquiring HIV

You may qualify if:

• HIV uninfected
• Able to provide informed consent in English
• Self-reports HIV transmission risk behavior including one or more of the following: a) condomless anal or vaginal intercourse, b) 3 or more sexual partners in the past 3 months, c) any diagnosis by self-report of a STI in the past 12 months, and e) any history of transactional sex work

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 (3)

University of Colorado, Denver

Denver, Colorado, 80045, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, 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: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: September 4, 2019
• Study Start: January 1, 2019
• 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 (3)