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Pregnancy (Unwanted)THPPNCT07681908

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

A study testing #TranscendentHealth and Universal Sexual Health Program in people with Pregnancy (Unwanted) and Sexually Transmitted Disease (STD), run by Center for Innovative Public Health Research at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 years, women onlyHealthy volunteers can take part
What is being tested?
#TranscendentHealth and Universal Sexual Health Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
467 participants
Where
1 siteUnited States
Study dates
30 Jun 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Center for Innovative Public Health Research (CiPHR)

    San Clemente, California, 92672

    Michele Ybarra, PhD, 877-302-6858 ext. 801, michele@innovativepublichealth.org

Other trials in United States

About this study

Official title: #TranscendentHealth - Adapting an LGB+ Inclusive Teen Pregnancy Prevention Program for Transgender Boys

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.

Read more

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.

Read the 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.

Being tested
#TranscendentHealth, Universal Sexual Health Program
Keywords
transgender youth, Nonbinary youth, Assigned female at birth (AFAB), Pregnancy prevention, Text messaging, mHealth, Sexual health, Gender minority youth, HIV prevention, Contraception
Medical subject headings
Sexually Transmitted Diseases, HIV Infections, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • #TranscendentHealthBehavioural

    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 ProgramBehavioural

    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 groups in NCT07681908
Study groupRoleWhat they receive
#TranscendentHealthExperimentalParticipants 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.
Receives: Behavioral: #TranscendentHealth
Universal Sexual Health ProgramActive comparatorParticipants 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.
Receives: Behavioral: Universal Sexual Health Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. % 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.

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

  3. 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.

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

Secondary outcomes (3)
  1. % of Participants who Report an Unintended Pregnancy

    The number of youth who report an unintended pregnancy divided by the number of youth in the cohort. Assessed since the last survey (follow-up assessments) and ever (baseline).

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

  2. Rate of PrEP Use

    Among participants who meet clinical criteria indicating PrEP use (based on reported sexual behaviors), this will be the number of youth who report having used pre-exposure prophylaxis (PrEP) divided by the total number of youth who are eligible for PrEP.

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

  3. Relative Magnitude of Sexual Health Behavioral Intentions

    Using scales adapted for this intervention, continuous measures will be created by summing the responses to 5-point Likert scale items that reflect: Intentions to use condoms, initiate birth control, get tested for HIV/STIs, and discuss PrEP with a healthcare provider. Both sexually experienced and inexperienced participants will provide responses to these scales.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
467 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681908
Sponsor's protocol ID
R01NR020846
Other IDs
R01NR020846
Acronym
THPP
Status last verified
Jun 2026
First submitted
26 Jun 2026
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33568491

Questions about this trial

What is this clinical trial studying?

A study testing #TranscendentHealth and Universal Sexual Health Program in people with Pregnancy (Unwanted) and Sexually Transmitted Disease (STD), run by Center for Innovative Public Health Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michele Ybarra, PhD (877-302-6858 ext. 801, michele@innovativepublichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Condom-Protected Sex (time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07681908, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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