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

1 de julho de 2026 atualizado por: Michele Ybarra, Center for Innovative Public Health Research

#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.

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

467

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: #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.
Comparador Ativo: 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.
Comportamental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rate of Condom-Protected Sex
Prazo: Month 5 (program end), 3 months post-program end, 6 months post-program end
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
Prazo: Month 5 (program end), 3 months post-program end, 6 months post-program end
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
Prazo: Month 5 (program end), 3 months post-program end, 6 months post-program end
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
% of Participants who Report an Unintended Pregnancy
Prazo: Month 5 (program end), 3 months post-program end, 6 months post-program end
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).
Month 5 (program end), 3 months post-program end, 6 months post-program end
Rate of PrEP Use
Prazo: Month 5 (program end), 3 months post-program end, 6 months post-program end
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.
Month 5 (program end), 3 months post-program end, 6 months post-program end
Relative Magnitude of Sexual Health Behavioral Intentions
Prazo: Month 5 (program end), 3 months post-program end, 6 months post-program end
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.
Month 5 (program end), 3 months post-program end, 6 months post-program end

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Center for Innovative Public Health Research

Colaboradores

National Institute of Nursing Research (NINR)

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de junho de 2026

Conclusão Primária (Estimado)

30 de junho de 2027

Conclusão do estudo (Estimado)

30 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

26 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de julho de 2026

Primeira postagem (Real)

2 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R01NR020846 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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