Testing a Gender-inclusive HIV Prevention Program

NCT ID: NCT06586151

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants, but not researchers, will be blinded to study assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Transcendent Health

Intervention Type 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 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).

Group Type PLACEBO_COMPARATOR

Text Messaging with Information

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

Ann and Robert H Lurie Childrens Hospital of Chicago

UNKNOWN

Sponsor Role collaborator

Center for Innovative Public Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center for Innovative Public Health Research

San Clemente, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michele Ybarra, PhD

Role: CONTACT

8773026858 ext. 801

Facility Contacts

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Michele L Ybarra, MPH PhD

Role: primary

877-302-6858 ext. 801

Other Identifiers

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R01NR020309

Identifier Type: NIH

Identifier Source: org_study_id

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