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NCT04077138 · ClinicalTrials.gov registry record

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

A clinical trial of HIV/AIDS and Behavior and Behavior Mechanisms, sponsored by Hektoen Institute for Medical Research.

Completed
Registry status
80
Enrollment target
3
Study locations

NCT04077138 is a study of HIV/AIDS and Behavior and Behavior Mechanisms that has completed, run by Hektoen Institute for Medical Research. The registered enrollment target is 80 participants, below the 33,179-participant average among 61 other HIV/AIDS trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT04077138, a study of HIV/AIDS and Behavior and Behavior Mechanisms, has completed, sponsored by Hektoen Institute for Medical Research.

COMPLETED
Registry status
80 participants
Enrollment target
3
Study locations

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.

Conditions Studied

HIV/AIDS Behavior and Behavior Mechanisms Gender

Study Locations (3)

Colorado

  • University of Colorado, Denver - Denver

Illinois

  • John H. Stroger, Jr. Hospital of Cook County - Chicago

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2019-01-01
Est. Completion 2023-11-30

Sponsor

Hektoen Institute for Medical Research

5 total trials

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What the Registry Record Tells You About NCT04077138

The ClinicalTrials.gov registry entry for NCT04077138 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 33,179-participant average among 61 other HIV/AIDS trials with a reported enrollment target (100% lower). The listed sponsor is Hektoen Institute for Medical Research, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with HIV/AIDS appearing as the primary indexed condition, and to 0 interventions.

NCT04077138 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Illinois, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04077138 about?

NCT04077138 is a clinical study titled "Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development". 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 NCT04077138?

This trial is currently completed. The enrollment target is 80 participants. The study started on 2019-01-01. Estimated completion is 2023-11-30.

What conditions does trial NCT04077138 study?

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

Who is sponsoring clinical trial NCT04077138?

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

Where is trial NCT04077138 being conducted?

This trial has 3 study locations across Colorado, Illinois, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.