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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000724
• Other study ID #: ATN160
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2024
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Fenway Institute	Boston	Massachusetts
United States	Baylor College of Medicine	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	PRIDE Health Research Consortium at Hunter CUNY	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (9)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	Baylor College of Medicine, Children's Hospital Los Angeles, Children's Hospital of Philadelphia, Emory University, Hunter College of City University of New York, San Diego State University, The Fenway Institute, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condomless Intercourse Events	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.	9 Months
Primary	Condomless Intercourse Events While High on Drugs/Alcohol	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.	9 Months
Primary	Condomless Intercourse Events During Sex Work	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.	9 Months
Primary	HIV Seroconversion	HIV tests will be collected at each time point. Incident infections will be recorded.	9 Months
Primary	Incident STIs	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.	9 Months