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Trial record 1 of 1 for:    transgender techstep | HIV/AIDS
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TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000724
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
San Diego State University
University of North Carolina
Emory University
Baylor College of Medicine
Children's Hospital of Philadelphia
The Fenway Institute
Hunter College of City University of New York
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Tracking Information
First Submitted Date  ICMJE March 16, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE October 18, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • 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.
  • PrEP Adherence [ Time Frame: 9 Months ]
    Mitra blood microsamples (10-30 µL) or dried blood spots will be collected at each time point to verify PrEP uptake and adherence.
  • 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.
  • Incident Syphilis [ Time Frame: 9 Months ]
    Participants will be tested for syphilis via a blood draw by a trained phlebotomist or via mailed self-collection kit at each time point. Incident syphilis cases will be recorded.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Change in Condomless Intercourse Events [ Time Frame: 3 Months ]
    Participants will report the number of condomless sexual intercourse events they have engaged in for the past 30 days both at baseline and at 3-month follow-up. The value of interest is the difference between these two values.
  • Change in Condomless Intercourse Events while High on Drugs/Alcohol [ Time Frame: 3 Months ]
    Participants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol for the past 30 days both at baseline and at 3-month follow-up. The value of interest is the difference between these two values.
  • Change in Condomless Intercourse Events during Sex Work [ Time Frame: 3 Months ]
    Participants will report the number of condomless sexual intercourse events they have engaged in during sex work for the past 30 days both at baseline and at 3-month follow-up. The value of interest is the difference between these two values.
  • PrEP Adherence [ Time Frame: 9 Months ]
    Mitra blood microsamples (10-30 µL) will be collected at each time point to verify PrEP uptake and adherence.
  • HIV Seroconversion [ Time Frame: 9 Months ]
    Initial and confirmatory HIV tests (OraQuick, SURE CHECK, or INSTI) 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.
  • Incident Syphilis [ Time Frame: 9 Months ]
    Participants will be tested for syphilis via a blood draw by a trained phlebotomist at each time point. Incident syphilis cases will be recorded.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
Transgender Syndemic Health Index [ Time Frame: 9 Months ]
Participants will endorse items on a pre-populated list of structural-level (e.g., transphobia, housing insecurity, educational attainment, access to healthcare) and individual-level (e.g., identity formation, gender transition, gender expression, stigma, discrimination) factors known to be detrimental to transgender health. Endorsements will be factor analyzed at each time point to construct an index representing the syndemic burden on each participant.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Official Title  ICMJE TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Text Messaging (Text+Step)
  • 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.
    Intervention: Behavioral: WebApp (App+Step)
  • 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.
    Intervention: Behavioral: Information/No Step
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 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
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Keith J Horvath, PhD 619-594-7113 khorvath@sdsu.edu
Contact: Cathy J Reback, PhD 323-463-1601 reback@friendsresearch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000724
Other Study ID Numbers  ICMJE ATN160
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party Friends Research Institute, Inc.
Study Sponsor  ICMJE Friends Research Institute, Inc.
Collaborators  ICMJE
  • San Diego State University
  • University of North Carolina
  • Emory University
  • Baylor College of Medicine
  • Children's Hospital of Philadelphia
  • The Fenway Institute
  • Hunter College of City University of New York
  • Children's Hospital Los Angeles
Investigators  ICMJE
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
PRS Account Friends Research Institute, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP