TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Condition: HIV
Study type: Interventional

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.
    

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.
    

Intervention name(s): Text Messaging (Text+Step); WebApp (App+Step); Information/No Step
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Text Messaging; mHealth; HIV; AIDS; PrEP