Testing a Gender-inclusive HIV Prevention Program

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Transcendent Health; Behavioral: Text Messaging with Information

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Ybarra, PhD; Phone Number: 801 8773026858; Email: michele@innovativepublichealth.org

Study Locations

• United States
  • California
    • San Clemente, California, United States, 92672-6745
      • Recruiting
      • Center for Innovative Public Health Research
      • Contact: Michele L Ybarra, MPH PhD; Phone Number: 801 877-302-6858; Email: Michele@InnovativePublicHealth.org
      • Principal Investigator: Michele L Ybarra, MPH PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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).	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number testing for HIV and/or sexual transmitted infections	Self report of having been tested for either HIV or a sexually transmitted infection	At any time after baseline through 8-months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Taking PreExposure Prophylaxis (PrEP) for HIV	Self-report of taking PrEP at any time since the prior assessment.	At any time after baseline through 8-months.

Collaborators and Investigators

• Sponsor: Center for Innovative Public Health Research
• Collaborators: University of Miami; Ann and Robert H Lurie Childrens Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HIV; mHealth; Adolescence
• Other Study ID Numbers: R01NR020309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No