Testing a Gender-inclusive HIV Prevention Program

NCT06586151 | Recruiting

• 1 other identifier: R01NR020309
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; Adolescence; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number Taking PreExposure Prophylaxis (PrEP) for HIV

  At any time after baseline through 8-months.

Study Arms (2)

Information, Motivation and Skills arm

EXPERIMENTAL

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

Information Only arm

PLACEBO COMPARATOR

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

Interventions

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.

Information, Motivation and Skills arm

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).

Information Only arm

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Transgender girls and non-binary youth; not exclusively cisgender identified
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Center for Innovative Public Health Research: lead
• University of Miami: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Center for Innovative Public Health Research

San Clemente, California, 92672-6745, United States

RECRUITING

Central Study Contacts

Michele Ybarra, PhD

CONTACT

8773026858; michele@innovativepublichealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants, but not researchers, will be blinded to study assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)