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Recruiting

NCT Number: NCT06586151

Testing a Gender-inclusive HIV Prevention Program

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.

Recruiting

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Key information

Conditions

HIV Prevention

Age range

14 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovative Public Health Research

San Clemente, California, 92672-6745, United States

Location status: Recruiting

Location contact

Michele L Ybarra, MPH PhD

CONTACT

[email protected]

877-302-6858 ext. 801

Michele L Ybarra, MPH PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • assigned male sex at birth and currently have a non-cisgender identity (e.g., transgender girl, non-binary, gender fluid, unsure);
  • aged 14-18 years and have not yet graduated high school;
  • English-speaking;
  • the sole user of a cell phone with an unlimited text messaging plan;
  • have access to the Internet to complete online surveys;
  • intend to have the same cell number for the next 6 months;
  • provide informed assent;
  • 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
  • agree to enroll over the phone with study staff.

Exclusion criteria

  • None beyond not meeting inclusion criteria

Treatment and study plan

Transcendent Health

Behavioral

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

Behavioral

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 outcomes

  1. Number testing for HIV and/or sexual transmitted infections

    Time frame: At any time after baseline through 8-months.

    Self report of having been tested for either HIV or a sexually transmitted infection

Secondary outcomes

  1. Number Taking PreExposure Prophylaxis (PrEP) for HIV

    Time frame: At any time after baseline through 8-months.

    Self-report of taking PrEP at any time since the prior assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Ybarra, PhD

CONTACT

[email protected]

8773026858 ext. 801

Sponsors and collaborators

Lead sponsor

Center for Innovative Public Health Research

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • University of Miami

Registry information

Official study title

Harnessing the Power of Technology to Develop a Population-based HIV Prevention Program for Trans Girls

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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