Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
250

Summary

Conditions
HIV
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 15 years and 24 years
Gender
Both males and females

Description

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 PrEP uptake. Transge...

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 PrEP uptake. Transgender youth and young adults are enrolled for 9 months in the RCT. During the RCT, 275 participants will be enrolled and randomized to either: (1) text messaging (n=108), (2) WebApp (n=83), or (3) an informational website control (n=83) condition. Participants will include HIV-negative youth and young adults (ages 15-24) who are self-identified transgender feminine, transgender masculine or gender non-conforming. Participants will be recruited from venues in Boston, Houston, Los Angeles, New York, and Philadelphia. There will be four data collection time points: baseline, 3-, 6-, and 9-month. Visits will be conducted in-person at the venues, online, or some combination of in person or online. An ACASI will be completed using online survey tools. An HIV test, sexually transmitted infection (STI) panel, urine screen for recent illicit drug use, and blood microsampling or dried blood spot, for those who report PrEP uptake, to verify PrEP adherence will be collected in-person at the participants local venue, or via mailed self-collection kits. Process data of each participant activity at each step of the intervention, as well as the control intervention, will be collected. The study aims to measure the effects of the information-only (Info) arm compared to a text messaging intervention (Text+Step) to a WebApp intervention (WebApp+Step) for reducing sexual risk behaviors and increasing PrEP uptake.

Tracking Information

NCT #
NCT04000724
Collaborators
  • San Diego State University
  • University of North Carolina
  • Emory University
  • Baylor College of Medicine
  • Children's Hospital of Philadelphia
  • The Fenway Institute
  • Hunter College of City University of New York
  • Children's Hospital Los Angeles
Investigators
Study Chair: Lisa Hightow-Wideman, MD, MPH University of North Carolina Study Chair: Travis Sanchez, DVM, MPH Emory University Principal Investigator: Cathy J Reback, PhD Friends Research Institute, Inc. Principal Investigator: Keith J Horvath, PhD San Diego State University