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

Sponsor

Hektoen Institute for Medical Research (Other)

Overall Status

Unknown status

CT.gov ID

NCT04077151

Collaborator

National Institute of Mental Health (NIMH) (NIH)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Gender Behavior and Behavior Mechanisms	Behavioral: PrEP Demonstration Project	N/A

Detailed Description

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, investigators will conduct a PK study exploring the interactions of cs-HT for both TW and TM on TDF/FTC. Simultaneously, in Phase 2, 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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

May 30, 2020

Anticipated Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care PrEP prescribed with no intervention
Experimental: Intervention Recipients PrEP Demonstration Project intervention will be given	Behavioral: PrEP Demonstration Project 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.

Arm

Intervention/Treatment

No Intervention: Standard of Care

PrEP prescribed with no intervention

Experimental: Intervention Recipients

PrEP Demonstration Project intervention will be given

Behavioral: PrEP Demonstration Project

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.

Outcome Measures

Primary Outcome Measures

PrEP Acceptability Questionnaire [48 weeks]
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.
Tenofovir diphosphate levels [48 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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