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

Friends Research Institute

Status: Completed

Conditions: HIV

Treatments: Behavioral: Information/No Step; Behavioral: WebApp (App+Step); Behavioral: Text Messaging (Text+Step)

Study type: Interventional

Funder types: Other

Identifiers

NCT04000724

ATN160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 254 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

254 participants in 3 patient groups

Text+Step

Experimental group

Description:

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.

Treatment:

Behavioral: Text Messaging (Text+Step)

WebApp+Step

Experimental group

Description:

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.

Treatment:

Behavioral: WebApp (App+Step)

Information

Experimental group

Description:

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.

Treatment:

Behavioral: Information/No Step