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Recruiting NCT06586151

Testing a Gender-inclusive HIV Prevention Program

No phase Interventional HIV Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcendent Health, Text Messaging with Information.
Who it may be relevant to
Registry conditions: HIV Prevention. Basic parameters: 14 years — 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral 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.
  • 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).

Primary outcome measures

  • Number testing for HIV and/or sexual transmitted infections [Time frame: At any time after baseline through 8-months.]
Secondary outcome measures (1)
  • Number Taking PreExposure Prophylaxis (PrEP) for HIV [Time frame: At any time after baseline through 8-months.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • None beyond not meeting inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Center for Innovative Public Health Research — San Clemente

Identifiers

NCT: NCT06586151 · R01NR020309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗