Testing a Gender-inclusive HIV Prevention Program

Part of paid clinical trials in San Clemente, California.

Sponsor
Center for Innovative Public Health Research
Study ID
NCT06586151
Status
Recruiting
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Conditions

  • HIV Prevention

Eligibility Criteria

Sex
MALE
Age
14 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Transcendent Health — 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.
  • Text Messaging with Information — 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).

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.
  • 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).

Primary Outcome Measure

Number testing for HIV and/or sexual transmitted infections [ Time Frame: At any time after baseline through 8-months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Innovative Public Health ResearchSan ClementeCalifornia92672-6745
Michele L Ybarra, MPH PhD
[email protected]
877-302-6858
Michele L Ybarra, MPH PhD (PRINCIPAL_INVESTIGATOR)

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