HIV PreventionNCT06586151
Testing a Gender-inclusive HIV Prevention Program
A study testing Transcendent Health and Text Messaging with Information in people with HIV Prevention, run by Center for Innovative Public Health Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Transcendent Health and Text Messaging with Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- None beyond not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Innovative Public Health Research
San Clemente, California, 92672-6745
Michele L Ybarra, MPH PhD, 877-302-6858 ext. 801, Michele@InnovativePublicHealth.org
Michele L Ybarra, MPH PhD
About this study
Official title: Harnessing the Power of Technology to Develop a Population-based HIV Prevention Program for Trans Girls
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.
- Conditions
- HIV Prevention
- Being tested
- Transcendent Health, Text Messaging with Information
- Keywords
- HIV, Adolescence, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendent HealthBehavioural
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 InformationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Information, Motivation and Skills arm | Experimental | 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. Receives: Behavioral: Transcendent Health |
| Information Only arm | Placebo comparator | 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). Receives: Behavioral: Text Messaging with Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number testing for HIV and/or sexual transmitted infections
Self report of having been tested for either HIV or a sexually transmitted infection
Measured: 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.
Measured: At any time after baseline through 8-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586151
- Sponsor's protocol ID
- R01NR020309
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing the Power of Technology to Develop a Population-based HIV Prevention Program for Trans Girls
- ClinicalTrials.gov ID
- NCT06586151
- Acronym / sponsor ID
- R01NR020309
- Conditions
- HIV Prevention
- Keywords
- HIV, Adolescence, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- University of Miami, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information, Motivation and Skills arm | Experimental | Behavioral: Transcendent HealthText 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. |
| Information Only arm | Placebo comparator | Behavioral: Text Messaging with InformationText messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (1 listed)
- None beyond not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcendent HealthGender-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. | Behavioural | Information, Motivation and Skills arm |
| Text Messaging with InformationText messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem). | Behavioural | Information Only arm |
Primary outcome
Number testing for HIV and/or sexual transmitted infections
Time frame: At any time after baseline through 8-months.
Self report of having been tested for either HIV or a sexually transmitted infection
1 secondary outcome
Number Taking PreExposure Prophylaxis (PrEP) for HIV
Time frame: At any time after baseline through 8-months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendent Health and Text Messaging with Information in people with HIV Prevention, run by Center for Innovative Public Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Ybarra, PhD (8773026858 ext. 801, michele@innovativepublichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number testing for HIV and/or sexual transmitted infections (time frame: At any time after baseline through 8-months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.