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

Part of paid clinical trials in San Clemente, California.

Sponsor
Center for Innovative Public Health Research
Study ID
NCT07681908
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 18 Years
Healthy Volunteers
Accepted

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.
  • 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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
467 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: #TranscendentHealth
    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.
  • Active Comparator: Universal Sexual Health Program
    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.

Primary Outcome Measure

Rate of Condom-Protected Sex [ Time Frame: Month 5 (program end), 3 months post-program end, 6 months post-program end ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Innovative Public Health Research (CiPHR)San ClementeCalifornia92672
Michele Ybarra, PhD
[email protected]
877-302-6858

Find similar trials in San Clemente, CA

By condition
HIV
By specialty
Infectious disease
By research site
Center for Innovative Public Health Research (CiPHR)· San Clemente, CA

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