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Not Yet Recruiting NCT07681908

#TranscendentHealth: A Text Messaging Pregnancy Prevention Program for Transgender Boys

Conditions: Pregnancy (Unwanted), Sexually Transmitted Disease (STD), HIV Infection, Sexual Behavior

Sex: Female
Ages: 14 Years – 18 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 467
Sponsor: Center for Innovative Public Health Research

Location: Center for Innovative Public Health Research (CiPHR) San Clemente California

Summary

Transgender and gender-diverse young people who were assigned female at birth (AFAB), including transgender boys, nonbinary youth, and others, face real sexual health disparities. Existing pregnancy and HIV prevention programs are designed for cisgender girls and do not meet the needs of AFAB trans youth, leaving this group without programs that speak to their lives. #TranscendentHealth is a text messaging sexual health program developed specifically for AFAB transgender and gender-diverse youth ages 14 to 18. It builds on Girl2Girl, a program shown to improve sexual health behaviors in LGB+ cisgender girls, and updates the content to reflect the identities, relationships, and health needs of AFAB trans youth. The study has two parts. In the first part, AFAB trans youth help shape the program through focus groups, Content Advisory Teams (youth review panels that give feedback on program messages), and a small pilot test. In the second part, a national randomized controlled trial enrolls 467 AFAB transgender youth ages 14 to 18 across the United States. Participants are randomly assigned to receive either #TranscendentHealth or a general sexual health text messaging program. Both programs are delivered entirely by text message over 5 months, with no in-person visits required. Youth complete short online surveys at the start of the program, at program end (5 months), and at 3 and 6 months after the program ends. The study's main goals are to determine whether #TranscendentHealth improves rates of condom-protected sex, use of other birth control methods (such as the pill, shot, or IUD), and HIV/STI testing. Secondary goals include reducing unintended pregnancy, increasing PrEP uptake among eligible participants, and improving intentions to use sexual health services.

Eligibility Criteria

Inclusion Criteria: * Assigned female sex at birth * Does not have an exclusively cisgender gender identity (e.g., identifies as transgender boy, nonbinary, gender fluid, or unsure of gender identity) * Age 14 to 18 years and has not yet graduated from high school * Exclusive owner of a cell phone with an unlimited text messaging plan * Has access to the Internet to complete online surveys * Plans to keep the same cell phone number for at least the next 6 months * Able to provide informed assent (ages 14-17) or consent (age 18), including the capacity to do so * Has not participated in a prior #TranscendentHealth study activity and does not know anyone currently enrolled in the study Exclusion Criteria: * Has graduated from high school * Has participated in a prior #TranscendentHealth study activity (focus groups, Content Advisory Teams, or beta test) * Knows another person currently enrolled in the study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07681908). StuddyBuddy aggregates publicly available trial information.