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Testing a Gender-inclusive HIV Prevention Program

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06586151
Enrollment
200
Registered
2024-09-19
Start date
2024-09-01
Completion date
2026-06-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Keywords

HIV, Adolescence, mHealth

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.

Interventions

BEHAVIORALTranscendent 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.

BEHAVIORALText 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).

Sponsors

University of Miami
CollaboratorOTHER
Ann and Robert H Lurie Childrens Hospital of Chicago
CollaboratorUNKNOWN
Center for Innovative Public Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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

Eligibility

Sex/Gender
MALE
Age
14 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number testing for HIV and/or sexual transmitted infectionsAt any time after baseline through 8-months.Self report of having been tested for either HIV or a sexually transmitted infection

Secondary

MeasureTime frameDescription
Number Taking PreExposure Prophylaxis (PrEP) for HIVAt any time after baseline through 8-months.Self-report of taking PrEP at any time since the prior assessment.

Countries

United States

Contacts

Primary ContactMichele Ybarra, PhD
michele@innovativepublichealth.org8773026858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026