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
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Text Messaging (Text+Step) Behavioral: WebApp (App+Step) Behavioral: Information/No Step||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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.
- 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.
- 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.
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
|Contact: Keith J Horvath, PhDemail@example.com|
|Contact: Cathy J Reback, PhDfirstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Demetria Cain, PhD, MPH email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Mary E Paul, MD|
|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|