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TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission

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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.

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Text Messaging (Text+Step) Behavioral: WebApp (App+Step) Behavioral: Information/No Step Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. HIV Seroconversion [ Time Frame: 9 Months ]
    HIV tests will be collected at each time point. Incident infections will be recorded.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
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
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000724


Contacts
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Contact: Keith J Horvath, PhD 619-594-7113 khorvath@sdsu.edu
Contact: Cathy J Reback, PhD 323-463-1601 reback@friendsresearch.org

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Julie McAvoy-Banerjea, MPH, CCRP       JMcAvoy@chla.usc.edu   
Principal Investigator: Marvin Belzer, MD         
United States, Massachusetts
The Fenway Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Julian Dormitzer, RN    617-927-6400    jdormitzer@fenwayhealth.org   
Principal Investigator: Kenneth Mayer, MD         
United States, New York
PRIDE Health Research Consortium at Hunter CUNY Recruiting
New York, New York, United States, 10018
Contact: Simone Skeen       sskeen@prideresearch.org   
Contact: Demetria Cain, PhD, MPH       dcain@prideresearch.org   
Principal Investigator: Demetria Cain, PhD, MPH         
United States, Pennsylvania
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Dalisa Santiago    832-822-1038    dxsantia@texaschildrens.org   
Principal Investigator: Mary E Paul, MD         
Sponsors and Collaborators
Friends Research Institute, Inc.
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
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04000724    
Other Study ID Numbers: ATN160
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Friends Research Institute, Inc.:
Text Messaging
mHealth
HIV
AIDS
PrEP