Recruiting

Observational Study

Sponsor:

Center for Innovative Public Health Research

Code:

NCT06586151

Conditions

HIV Prevention

Eligibility Criteria

Sex: Male

Age: 14 - 18

Healthy Volunteers: Accepted

Interventions

Transcendent Health

Text Messaging with Information

Study Details

Brief summary:

If, over time, data suggest the intervention impacts HIV preventive behavior at the population level, it will be unique in that it can be quickly and cost effectively scaled up to impact thousands of trans girls and nonbinary youth assigned male at birth.

Conditions

HIV Prevention

Study ID

NCT06586151

Start date

Sep 1, 2024

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 14 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

1. assigned male sex at birth and currently have a non-cisgender identity (e.g., transgender girl, non-binary, gender fluid, unsure);
2. aged 14-18 years and have not yet graduated high school;
3. English-speaking;
4. the sole user of a cell phone with an unlimited text messaging plan;
5. have access to the Internet to complete online surveys;
6. intend to have the same cell number for the next 6 months;
7. provide informed assent;
8. not have taken part in a previous #TranscendentHealth study activity or know someone who is in the study to increase the diversity of input from transgirls, and
9. agree to enroll over the phone with study staff.

Exclusion Criteria:

  • None beyond not meeting inclusion criteria

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Information, Motivation and Skills arm

Text messaging-based program that lasts 5 months. Content includes information, motivation and behavioral skills about how to prevent HIV, as well as information about healthy and unhealthy romantic relationships, and navigating issues related to one's gender.

placebo comparator: Information Only arm

Text messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem).

Interventions

Transcendent Health

Gender-inclusive HIV prevention program: Text messaging-based program that lasts 5 months. Content includes information, motivation and behavioral skills about how to prevent HIV, as well as information about healthy and unhealthy romantic relationships, and navigating issues related to one\'s gender.

Text Messaging with Information

Text messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem).

Primary outcome measure

  • Number testing for HIV and/or sexual transmitted infections [ Time Frame: At any time after baseline through 8-months. ]

Central Contacts and Locations

Central contacts

Michele Ybarra, PhD

8773026858michele@innovativepublichealth.org

Locations

Center for Innovative Public Health Research

Recruiting

San Clemente, California, United States, 92672-6745

Contacts

Michele L Ybarra, MPH PhD

877-302-6858Michele@InnovativePublicHealth.org

Principal Investigator:

Michele L Ybarra, MPH PhD

More Information

Sponsor

Center for Innovative Public Health Research

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • HIV
  • Adolescence
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Innovative Public Health Research on 2025-12-08.