#TranscendentHealth for Unplanned Pregnancy

(THPP Trial)

MY
Overseen ByMichele Ybarra, PhD
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: Center for Innovative Public Health Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for transgender and gender-diverse youth ages 14 to 18 who were assigned female at birth, including trans boys and nonbinary teens. Participants must live in the U.S., be sexually active or considering sexual activity, and want information on pregnancy and HIV prevention.

Inclusion Criteria

I am able to understand and agree to participate in this study.
Exclusive owner of a cell phone with an unlimited text messaging plan
Has access to the Internet to complete online surveys
See 5 more

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

What Are the Treatments Tested in This Trial?

Interventions

  • #TranscendentHealth
  • Universal Sexual Health Program

Trial Overview

The study compares two text message-based sexual health programs over five months: #TranscendentHealth (tailored for AFAB trans youth) versus a general sexual health program. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: #TranscendentHealthExperimental Treatment1 Intervention
Group II: Universal Sexual Health ProgramActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Center for Innovative Public Health Research

Lead Sponsor

Trials
11
Recruited
8,100+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+