TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
1 other identifier
interventional
254
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Oct 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2019
CompletedFirst Posted
Study publicly available on registry
June 27, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
February 20, 2024
CompletedFebruary 20, 2024
February 1, 2024
2.6 years
March 16, 2019
June 6, 2023
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Condomless Intercourse Events
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.
9 Months
Condomless Intercourse Events While High on Drugs/Alcohol
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.
9 Months
Condomless Intercourse Events During Sex Work
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.
9 Months
HIV Seroconversion
HIV tests will be collected at each time point. Incident infections will be recorded.
9 Months
Incident STIs
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.
9 Months
Study Arms (3)
Text+Step
EXPERIMENTALThe 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.
WebApp+Step
EXPERIMENTALThe 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.
Information
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Friends Research Institute, Inc.lead
- San Diego State Universitycollaborator
- University of North Carolinacollaborator
- Emory Universitycollaborator
- Baylor College of Medicinecollaborator
- Children's Hospital of Philadelphiacollaborator
- The Fenway Institutecollaborator
- Hunter College of City University of New Yorkcollaborator
- Children's Hospital Los Angelescollaborator
Study Sites (5)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
The Fenway Institute
Boston, Massachusetts, 02215, United States
PRIDE Health Research Consortium at Hunter CUNY
New York, New York, 10018, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (2)
Reback CJ, Cain D, Rusow JA, Benkeser D, Schader L, Gwiazdowski BA, Skeen SJ, Hannah M, Belzer M, Castillo M, Mayer KH, Paul ME, Hill-Rorie J, Johnson ND, McAvoy-Banerjea J, Sanchez T, Hightow-Weidman LB, Sullivan PS, Horvath KJ. Technology-Based Interventions, with a Stepped Care Approach, for Reducing Sexual Risk Behaviors and Increasing PrEP Initiation Among Transgender and Gender Expansive Youth and Young Adults. AIDS Behav. 2024 Dec;28(12):3956-3969. doi: 10.1007/s10461-024-04513-w. Epub 2024 Sep 20.
PMID: 39304589DERIVEDReback 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.
PMID: 32788149DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathy Reback
- Organization
- Friends Research Institute, Inc.
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2019
First Posted
June 27, 2019
Study Start
October 18, 2019
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
February 20, 2024
Results First Posted
February 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the data set. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.