Testing a Gender-inclusive HIV Prevention Program

Not Applicable

Recruiting

• Conditions: HIV Prevention
• Interventions: Behavioral: Transcendent Health; Behavioral: Text Messaging with Information

• Registration Number: NCT06586151
• Lead Sponsor: Center for Innovative Public Health Research

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-09-01
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• None beyond not meeting inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information, Motivation and Skills arm	Transcendent Health	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 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 Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Innovative Public Health Research; 🇺🇸 San Clemente, California, United States