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

NCT07681908 | Not Yet Recruiting

• 1 other identifier: R01NR020846
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy (Unwanted); Sexually Transmitted Disease (STD); HIV Infection; Sexual Behavior

Keywords

transgender youth; Nonbinary youth; Assigned female at birth (AFAB); Pregnancy prevention; Text messaging; mHealth; Sexual health; Gender minority youth; HIV prevention; Contraception

Outcome Measures

Primary Outcomes (3)

• Rate of Condom-Protected Sex

  The number of sex acts in the past 90 days divided by the number of sex acts in which a condom was used, assessed separately for penile-vaginal sex, penile-anal sex, sex with a sex toy and vagina, and sex with a sex toy and anus.

  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

  The number of youth who report using any other type of birth control (i.e., oral contraceptive pill, injectable contraceptive (Depo-Provera), vaginal ring (NuvaRing), transdermal patch (Xulane), intrauterine device (IUD, e.g., Paragard), or subdermal implant (e.g., Implanon)) divided by the number of youth in the cohort.

  Month 5 (program end), 3 months post-program end, 6 months post-program end

• Rate of HIV and STI Testing

  The percent of participants who report being tested for HIV, and being tested for STIs other than HIV, since the last survey.

  Month 5 (program end), 3 months post-program end, 6 months post-program end

Secondary Outcomes (3)

• % of Participants who Report an Unintended Pregnancy

  Month 5 (program end), 3 months post-program end, 6 months post-program end

• Rate of PrEP Use

  Month 5 (program end), 3 months post-program end, 6 months post-program end

• Relative Magnitude of Sexual Health Behavioral Intentions

  Month 5 (program end), 3 months post-program end, 6 months post-program end

Study Arms (2)

#TranscendentHealth

EXPERIMENTAL

Participants receive a gender-tailored text messaging sexual health program over 5 months. Program content addresses condom use, birth control options, HIV/STI testing, PrEP, gender-affirming care, sexual relationships, gender dysphoria, and social stressors relevant to AFAB transgender youth. The program includes a Text Buddy feature for peer-to-peer support with a matched participant, and interactive achievement Badges.

Behavioral: #TranscendentHealth

Universal Sexual Health Program

ACTIVE COMPARATOR

Participants receive a universal (non-gender-tailored) sexual health text messaging program over the same 5-month period. The program delivers a comparable number of messages covering general adolescent sexual health education that is not tailored by gender identity. This arm does not include the Text Buddy peer-support feature.

Behavioral: Universal Sexual Health Program

Interventions

#TranscendentHealth BEHAVIORAL

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.

#TranscendentHealth

Universal Sexual Health Program BEHAVIORAL

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

Universal Sexual Health Program

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Eligibility requires a non-exclusively cisgender gender identity
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Innovative Public Health Research: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Center for Innovative Public Health Research (CiPHR)

San Clemente, California, 92672, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases; HIV Infections; Sexual Behavior

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Central Study Contacts

Michele Ybarra, PhD

CONTACT

877-302-6858; michele@innovativepublichealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both the control and intervention content are written to address issues of pregnancy prevention with the intention of blinding those who have been assigned to the control.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

US (1)