N/A
N=254
TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
HIV
Bottom Line
View on ClinicalTrials.gov: NCT04000724 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Condomless Intercourse Events — 3.14; 3.17; 3.68 Expected events — p=0.141
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Text Messaging (Text+Step) (Behavioral); WebApp (App+Step) (Behavioral); Information/No Step (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Friends Research Institute, Inc.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Condomless Intercourse Events |
3.14; 3.17; 3.68 | 0.141 |
| PRIMARY Condomless Intercourse Events While High on Drugs/Alcohol |
1.04; 0.79; 1.02 | .127 |
| PRIMARY Condomless Intercourse Events During Sex Work |
0; 0.03; 0 | — |
| PRIMARY HIV Seroconversion |
0; 0; 0 | — |
| PRIMARY Incident STIs |
0.06; 0.02; 0.04 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04000724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.