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RecruitingNCT06586151Updated Dec 8, 2025

Testing a Gender-inclusive HIV Prevention Program

An interventional study of Transcendent Health and Text Messaging with Information in HIV Prevention, sponsored by Center for Innovative Public Health Research. Recruiting at 1 site in United States. Open to male participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • HIV Prevention

Keywords

  • HIV
  • Adolescence
  • mHealth
03

In context

Lead sponsor

Center for Innovative Public Health Research is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None beyond not meeting inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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

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).

06

What researchers measure

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

    Time frame: At any time after baseline through 8-months.

Secondary outcomes

  1. Number Taking PreExposure Prophylaxis (PrEP) for HIV

    Self-report of taking PrEP at any time since the prior assessment.

    Time frame: At any time after baseline through 8-months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Jun 2026, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2024
First posted
Sep 19, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jun 30, 2026
Last update
Dec 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586151
Lead sponsor
Center for Innovative Public Health Research
Collaborators
University of Miami, Ann & Robert H Lurie Children's Hospital of Chicago
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 1, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

Michele Ybarra, PhD
Contact
michele@innovativepublichealth.org
8773026858 ext. 801

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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