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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Text Messaging (Text+Step)
* Behavioral: WebApp (App+Step)
* Behavioral: Information/No Step


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text+Step<br>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)<br>* 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.<br>|
| Experimental: WebApp+Step<br>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)<br>* 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.<br>|
| Experimental: Information<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| PrEP Adherence | Mitra blood microsamples (10-30 µL) or dried blood spots will be collected at each time point to verify PrEP uptake and adherence. | 9 Months | 
| HIV Seroconversion | HIV tests will be collected at each time point. Incident infections will be recorded. | 9 Months | 
| 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 | 
| Incident Syphilis | 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. | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transgender Syndemic Health Index | 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. | 9 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Text Messaging, mHealth, HIV, AIDS, PrEP