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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2022

Detailed 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. Transgender youth and young adults are enrolled for 9 months in the RCT. During the RCT, 250 participants will be enrolled and randomized to either: (1) text messaging (n=83), (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.

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.

Arms, Groups and Cohorts

  • Experimental: Text+Step
    • The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
  • Experimental: WebApp+Step
    • The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
  • Experimental: Information
    • The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.

Clinical Trial Outcome Measures

Primary Measures

  • Condomless Intercourse Events
    • Time Frame: 9 Months
    • Participants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
  • Condomless Intercourse Events While High on Drugs/Alcohol
    • Time Frame: 9 Months
    • Participants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol during their three most recent sexual encounters in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
  • Condomless Intercourse Events During Sex Work
    • Time Frame: 9 Months
    • Participants will report the number of exchange partners in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
  • HIV Seroconversion
    • Time Frame: 9 Months
    • HIV tests will be collected at each time point. Incident infections will be recorded.
  • Incident STIs
    • Time Frame: 9 Months
    • Participants will be tested for gonorrhea and chlamydia via throat, rectal, and urogenital swab specimen collection, as well as via urine samples at each time point. Incident STIs will be recorded.

Participating in This Clinical Trial

Inclusion Criteria

  • Report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months; – Confirmed negative HIV test; – Availability to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston – Have a mobile device with short messaging service (SMS; i.e. "texting") and Internet access capabilities; and – Read and speak English (since the intervention is built in English) Exclusion Criteria:

  • Does not report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months; – Reactive or indeterminate HIV test; – Unable to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston – Does not have a mobile device with SMS and Internet access capabilities; – Unable to read and speak English (since the intervention is built and delivered in English) – Unwilling or unable to comply with protocol requirements; – Unable to understand the Informed Consent/Assent Form.

Gender Eligibility: All

Participants will include youth and young adults who are self-identified trans feminine, trans masculine or gender non-conforming OR whose birth sex and current gender differ

Minimum Age: 15 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Friends Research Institute, Inc.
  • Collaborator
    • San Diego State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lisa Hightow-Wideman, MD, MPH, Study Chair, University of North Carolina
    • Travis Sanchez, DVM, MPH, Study Chair, Emory University
    • Cathy J Reback, PhD, Principal Investigator, Friends Research Institute, Inc.
    • Keith J Horvath, PhD, Principal Investigator, San Diego State University

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