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NCT04077151 · ClinicalTrials.gov registry record · NA
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project
A NA study, sponsored by Hektoen Institute for Medical Research.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT04077151: Completed NA study, sponsored by Hektoen Institute for Medical Research.
NCT04077151 is a NA study that has completed, run by Hektoen Institute for Medical Research. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04077151, a NA study, has completed, sponsored by Hektoen Institute for Medical Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL PrEP Demonstration Project
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2023-11-30 |
| Phase | NA |
What the finished NCT04077151 record still lists
NCT04077151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which PrEP Demonstration Project is the first listed.
NCT04077151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04077151 about?
NCT04077151 is a clinical study titled "Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project". 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 ...
What is the current status of trial NCT04077151?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2022-03-14. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT04077151?
The interventions under investigation include: PrEP Demonstration Project (BEHAVIORAL).
Who is sponsoring clinical trial NCT04077151?
This trial is sponsored by Hektoen Institute for Medical Research, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04077151's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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