#TranscendentHealth: A Text Messaging Pregnancy Prevention Program for Transgender Boys
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: #TranscendentHealth, Universal Sexual Health Program.
- Who it may be relevant to
- Registry conditions: Pregnancy (Unwanted), Sexually Transmitted Disease (STD), HIV Infection, Sexual Behavior. Basic parameters: 14 years — 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
#TranscendentHealth - Adapting an LGB+ Inclusive Teen Pregnancy Prevention Program for Transgender Boys
Overview
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.
Detailed description
Background
AFAB transgender and gender-diverse youth experience substantial sexual health disparities yet are largely absent from evidence-based prevention programs. Pilot data from an earlier cohort recruited by Dr. Ybarra show that, compared with cisgender girls, AFAB trans youth are less likely to use barrier protection at last sex (p \< 0.5) and at least as likely to experience adolescent pregnancy. Programs designed for cisgender girls do not address the social stressors these youth face (including discrimination, gender dysphoria, and rejection) and do not affirm their gender identities. As a result, these programs have limited uptake and effectiveness in this population.
Intervention
#TranscendentHealth adapted Girl2Girl, an evidence-based text messaging sexual health program, for AFAB trans youth. The resulting program addresses condom use, birth control options, HIV/STI testing, PrEP, gender-affirming care, dysphoria, and relationships as experienced by AFAB trans youth. The control arm delivers a universal (not gender-tailored) sexual health text messaging program with a comparable number of messages.
Study Design
National RCT (Aim 2):
A total of 467 AFAB trans youth ages 14-18 are recruited nationally through social media (Instagram and Facebook) and randomized 1:1 to intervention or control, stratified by gender (transgender boy vs. nonbinary) and sexual experience at baseline. A permuted block randomization procedure is used. All study procedures are conducted remotely: online screener, telephone enrollment, text messaging program, and online surveys. No in-person contact is required.
Participants complete assessments at baseline, program end (month 5), 3 months after program end, and 6 months after program end. Participants receive graduated incentives.
Recruitment targets are set to ensure diversity: at least 25% Hispanic, 28% multiracial, 15% Black/African American, 30% from low-income households, and approximately equal representation across urban, suburban, and rural settings. Approximately 40% of the RCT sample will be sexually inexperienced at baseline.
Interventions
- Behavioral #TranscendentHealth
A 5-month text messaging sexual health program for AFAB transgender and gender-diverse youth ages 14-18, adapted from the Girl2Girl program. Content is gender-inclusive and addresses sexual health protective behaviors, gender-affirming care, relationships, and social stressors specific to AFAB trans youth. Delivered entirely via text message; no in-person contact is required. - Behavioral Universal Sexual Health Program
5-month general (non-gender-tailored) text messaging sexual health program covering contraception, STI testing, and healthy relationships - same duration and message volume as Arm 1, no Text Buddy feature
Primary outcome measures
- Rate of Condom-Protected Sex [Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end]
- % of Participants who Report Use of Birth Control Other Than Condoms [Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end]
- Rate of HIV and STI Testing [Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end]
Secondary outcome measures (3)
- % of Participants who Report an Unintended Pregnancy [Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end]
- Rate of PrEP Use [Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end]
- Relative Magnitude of Sexual Health Behavioral Intentions [Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Center for Innovative Public Health Research (CiPHR) — San Clemente
Publications
- Wang-Schweig M, Kviz FJ, Altfeld SJ, Miller AM, Miller BA. Building a conceptual framework to culturally adapt health promotion and prevention programs at the deep structural level. Health Promot Pract. 2014 Jul;15(4):575-84. doi: 10.1177/1524839913518176. Epub 2014 Jan 6. PMID 24396122
- Ybarra ML, DuBois LZ, Saewyc E. Sexual Health of US Transgender Boys, Nonbinary Youth, and Cisgender Girls. JAMA Pediatr. 2025 May 12;179(7):773-80. doi: 10.1001/jamapediatrics.2025.0676. Online ahead of print. PMID 40354068
- Ybarra ML, Liu W, Prescott TL, Phillips G 2nd, Mustanski B. The Effect of a Text Messaging Based HIV Prevention Program on Sexual Minority Male Youths: A National Evaluation of Information, Motivation and Behavioral Skills in a Randomized Controlled Trial of Guy2Guy. AIDS Behav. 2018 Oct;22(10):3335-3344. doi: 10.1007/s10461-018-2118-1. PMID 29696403
- Ybarra M, Rosario M, Saewyc E, Goodenow C, Dunsiger S. One-Year Follow-up After a Pregnancy Prevention Intervention for LGB+ Teens: An RCT. Pediatrics. 2023 Apr 1;151(4):e2022059172. doi: 10.1542/peds.2022-059172. PMID 36924134
- Ybarra M, Goodenow C, Rosario M, Saewyc E, Prescott T. An mHealth Intervention for Pregnancy Prevention for LGB Teens: An RCT. Pediatrics. 2021 Mar;147(3):e2020013607. doi: 10.1542/peds.2020-013607. Epub 2021 Feb 10. PMID 33568491
Identifiers
NCT: NCT07681908 · R01NR020846 · R01NR020846