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HIV/AIDSPhase 1/2NCT03652623

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

A Phase 1/2 study testing TDF/FTC in people with HIV/AIDS and Gender, run by Hektoen Institute for Medical Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS, Gender, Behavior and Behavior Mechanisms
What is being tested?
TDF/FTC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
23 Jul 2018to 30 Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado, Denver

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: 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:

Read more

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.

Read the 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, 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.

Being tested
TDF/FTC
Keywords
Transgender, Pre-exposure Prophylaxis (PrEP), HIV Prevention, Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), Cross-sex Hormone Therapy, Adherence, Behavior Change, Gender Affirmation
Medical subject headings
Acquired Immunodeficiency Syndrome, Coitus, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDF/FTCDrug

    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.

Study groups in NCT03652623
Study groupRoleWhat they receive
TDF/FTC and cs-HTExperimentalTransgender 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.
Receives: Drug: TDF/FTC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Tenofovir Levels

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

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

  2. Change in Estradiol Levels

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

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

  3. Change in Testosterone Levels

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start23 Jul 2018
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03652623
Sponsor's protocol ID
R01MH114753-1
Other IDs
R01MH114753
Status last verified
Mar 2024
First submitted
25 Jun 2018
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35943868

  • 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.

    PubMed 35815468

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TDF/FTC in people with HIV/AIDS and Gender, run by Hektoen Institute for Medical Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tenofovir Levels (time frame: Baseline and Weeks 0, 1, 2, 3 & 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03652623, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.

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