An interventional study of #TranscendentHealth and Universal Sexual Health Program in Pregnancy (Unwanted), Sexually Transmitted Disease (STD) and HIV Infection, sponsored by Center for Innovative Public Health Research. Not yet recruiting at 1 site in United States. Open to female participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end
% 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).
Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end
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.
Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end
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.
Time frame: Month 5 (program end), 3 months post-program end, 6 months post-program end
Plan to share: Undecided
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Sexually Transmitted Diseases→
Center for Innovative Public Health Research