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NCT03652623 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HIV/AIDS and Behavior and Behavior Mechanisms, sponsored by Hektoen Institute for Medical Research.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target
1
Study location

NCT03652623: Completed Phase 1 study of HIV/AIDS and Behavior and Behavior Mechanisms, sponsored by Hektoen Institute for Medical Research.

NCT03652623 is a Phase 1 study of HIV/AIDS and Behavior and Behavior Mechanisms that has completed, run by Hektoen Institute for Medical Research. The registered enrollment target is 49 participants, below the 33,180-participant average among 61 other HIV/AIDS trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03652623, a Phase 1 study of HIV/AIDS and Behavior and Behavior Mechanisms, has completed, sponsored by Hektoen Institute for Medical Research.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target
1
Study location

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. 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.

Primary Outcome

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

Conditions Studied

HIV/AIDS Behavior and Behavior Mechanisms Gender

Interventions

  • DRUG TDF/FTC

Study Locations (1)

Colorado

  • University of Colorado, Denver - Aurora

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2018-07-23
Est. Completion 2023-11-30
Phase Phase 1
Hektoen Institute for Medical Research

5 total trials

What the finished NCT03652623 record still lists

NCT03652623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 33,180-participant average among 61 other HIV/AIDS trials with a reported enrollment target (100% lower).

The record links to 3 conditions, with HIV/AIDS appearing as the primary indexed condition, and to 1 intervention - of which TDF/FTC is the first listed.

NCT03652623 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT03652623 about?

NCT03652623 is a clinical study titled "Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study". 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 NCT03652623?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2018-07-23. Estimated completion is 2023-11-30.

What conditions does trial NCT03652623 study?

This clinical trial studies the following conditions: HIV/AIDS, Behavior and Behavior Mechanisms, Gender.

What interventions are being tested in trial NCT03652623?

The interventions under investigation include: TDF/FTC (DRUG).

Who is sponsoring clinical trial NCT03652623?

This trial is sponsored by Hektoen Institute for Medical Research, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03652623 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV/AIDS

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03652623's enrollment target sits among peer trials

49 45th of 61 higher than 17 of 61 other HIV/AIDS trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV/AIDS 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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Related registry views

Source: ClinicalTrials.gov NCT03652623, the US trial registry maintained by the National Library of Medicine. NCT03652623 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.