Testing a Gender-inclusive HIV Prevention Program

Center for Innovative Public Health Research

Status: Enrolling

Conditions: HIV Prevention

Treatments: Behavioral: Transcendent Health; Behavioral: Text Messaging with Information

Study type: Interventional

Funder types: Other

Identifiers

NCT06586151

R01NR020309 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Information, Motivation and Skills arm

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendent Health

Information Only arm

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: Text Messaging with Information