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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:15 - 24
Updated:8/31/2018
Start Date:July 23, 2018
End Date:November 30, 2020
Contact:Sybil Hosek, PhD
Email:shosek@cookcountyhhs.org
Phone:3128648030

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

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.

Transgender women (TW) are one of the most vulnerable populations for acquiring HIV
infection, and the scant available data on transgender men (TM) suggests they are also at
risk. TW have accounted for only 0.2% of all participants in bio-behavioral HIV prevention
trials using pre-exposure prophylaxis (PrEP), and TM have typically not been included. TW and
TM adolescents have received even less attention in PrEP trials.

Although tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), the FDA-approved PrEP drug,
would not be expected to interact with cross-sex hormone therapy (cs-HT; estradiol and
testosterone) based on known mechanisms and data from studies with hormonal contraceptives,
there are no data that prove this. Given this lack of data, TW and TM youth on cs-HT have
decreased PrEP uptake and adherence due to concerns that PrEP may reduce the effectiveness of
cs-HT. To address these critical scientific gaps in PrEP safety for transgender youth and to
plan for appropriate implementation, the investigators propose the following study in 3
integrated phases. In Phase 1, the investigators will conduct a PK study exploring the
interactions of cs-HT for both TW and TM on TDF/FTC. Simultaneously, in Phase 2, the
investigators will collect ethnographic data via focus groups and in-depth interviews to
inform the development of a tailored gender-affirmative intervention to improve uptake and
adherence to PrEP in transgender youth. In Phase 3, the investigators will conduct a small
demonstration trial of PrEP use in TW and TM youth, utilizing the ethnographically developed
intervention to improve uptake and adherence, while also monitoring renal and bone safety
outcomes.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 720-777-4971
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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