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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077151
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hektoen Institute for Medical Research

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. PrEP Acceptability Questionnaire [ Time Frame: 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.

  2. Tenofovir diphosphate levels [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identification as a transgender individual
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077151


Contacts
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Contact: Sybil Hosek, PhD 3128648030 shosek@cookcountyhhs.org
Contact: Jennifer Brothers, MPH 3128648008 jbrothers@cookcountyhhs.org

Locations
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United States, Illinois
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
Contact: Sybil Hosek, PhD    312-864-8030    shosek@cookcountyhhs.org   
Contact: Jennifer Brothers, MPH    3128648008    jbrothers@cookcountyhhs.org   
Principal Investigator: Sybil Hosek, PhD         
Sponsors and Collaborators
Hektoen Institute for Medical Research
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sybil Hosek, PhD John H. Stroger Hospital

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Responsible Party: Hektoen Institute for Medical Research
ClinicalTrials.gov Identifier: NCT04077151    
Other Study ID Numbers: R01MH114753-3
R01MH114753 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hektoen Institute for Medical Research:
Transgender
Pre-exposure Prophylaxis (PrEP)
HIV Prevention
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
Cross-sex Hormone Therapy
Adherence
Behavior Change
Gender Affirmation