NCT Number: NCT04000724
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.
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Notify Me15 year–24 year
All sexes
Interventional
Not applicable
Children's Hospital Los Angeles, Los Angeles, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Time frame: 9 Months
HIV tests will be collected at each time point. Incident infections will be recorded.
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.
Friends Research Institute, Inc.
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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