TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
NCT ID: NCT04000724
Last Updated: 2024-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
254 participants
INTERVENTIONAL
2019-10-18
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
24 Years
ALL
Yes
Sponsors
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San Diego State University
OTHER
University of North Carolina
OTHER
Emory University
OTHER
Baylor College of Medicine
OTHER
Children's Hospital of Philadelphia
OTHER
The Fenway Institute
OTHER
Hunter College of City University of New York
OTHER
Children's Hospital Los Angeles
OTHER
Friends Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Lisa Hightow-Wideman, MD, MPH
Role: STUDY_CHAIR
University of North Carolina
Travis Sanchez, DVM, MPH
Role: STUDY_CHAIR
Emory University
Cathy J Reback, PhD
Role: PRINCIPAL_INVESTIGATOR
Friends Research Institute, Inc.
Keith J Horvath, PhD
Role: PRINCIPAL_INVESTIGATOR
San Diego State University
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
The Fenway Institute
Boston, Massachusetts, United States
PRIDE Health Research Consortium at Hunter CUNY
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ATN160
Identifier Type: -
Identifier Source: org_study_id
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