TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission

NCT04000724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2024-02-20

Study results available
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Summary

TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake. Participants are randomized into one of three conditions for a 6-month intervention: Group 1: culturally relevant theory-based text messages (Text+Step); or, Group 2: culturally relevant mobile-enhanced website (WebApp+Step); or, Group 3: informational website control condition with no theoretically based text messages or WebApp.

Conditions

Interventions

BEHAVIORAL

Text Messaging (Text+Step)

Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.

BEHAVIORAL

WebApp (App+Step)

Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.

BEHAVIORAL

Information/No Step

Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.

Sponsors & Collaborators

  • San Diego State University

    collaborator OTHER
  • University of North Carolina

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • Baylor College of Medicine

    collaborator OTHER
  • Children's Hospital of Philadelphia

    collaborator OTHER
  • The Fenway Institute

    collaborator OTHER
  • Hunter College of City University of New York

    collaborator OTHER
  • Children's Hospital Los Angeles

    collaborator OTHER
  • Friends Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Lisa Hightow-Wideman, MD, MPH · University of North Carolina

  • Travis Sanchez, DVM, MPH · Emory University

  • Cathy J Reback, PhD · Friends Research Institute, Inc.

  • Keith J Horvath, PhD · San Diego State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000724 on ClinicalTrials.gov