TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
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ClinicalTrials.gov Identifier: NCT04000724 |
Recruitment Status :
Completed
First Posted : June 27, 2019
Last Update Posted : June 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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HIV | Behavioral: Text Messaging (Text+Step) Behavioral: WebApp (App+Step) Behavioral: Information/No Step | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 254 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 |
Actual Primary Completion Date : | May 31, 2022 |
Actual Study Completion Date : | May 31, 2022 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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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.

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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 |
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.

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
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Massachusetts | |
The Fenway Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
PRIDE Health Research Consortium at Hunter CUNY | |
New York, New York, United States, 10018 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
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 |
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: | June 7, 2022 |
Last Verified: | June 2022 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Text Messaging mHealth HIV AIDS PrEP |