Clinical trial NCT04000724: TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Official title: TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Text Messaging
mHealth
HIV
AIDS
PrEP
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: University of North Carolina
name: Emory University
name: Baylor College of Medicine
name: Children's Hospital of Philadelphia
name: The Fenway Institute
name: Hunter College of City University of New York
name: Children's Hospital Los Angeles
First posted: 2019-06-27
Enrollment: 254
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Condomless Intercourse Events
timeFrame: 9 Months
measure: Condomless Intercourse Events While High on Drugs/Alcohol
timeFrame: 9 Months
measure: Condomless Intercourse Events During Sex Work
timeFrame: 9 Months
measure: HIV Seroconversion
timeFrame: 9 Months
measure: Incident STIs
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: New York
country: United States
facility: PRIDE Health Research Consortium at Hunter CUNY
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of North Carolina
name: Lisa Hightow-Wideman, MD, MPH
role: STUDY_CHAIR
affiliation: Emory University
name: Travis Sanchez, DVM, MPH
role: STUDY_CHAIR
affiliation: Friends Research Institute, Inc.
name: Cathy J Reback, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Keith J Horvath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reback CJ, Rusow JA, Cain D, Benkeser D, Arayasirikul S, Hightow-Weidman L, Horvath KJ. Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep). JMIR Res Protoc. 2020 Aug 13;9(8):e18326. doi: 10.2196/18326.