Recruiting

HIV Prevention

Sponsor:

Center for Innovative Public Health Research

Code:

NCT06230367

Conditions

HIV Infections

Eligibility Criteria

Sex: Male

Age: 13 - 22

Healthy Volunteers: Accepted

Interventions

Sexual health advocacy for guys

Healthy lifestyle control

Study Details

Brief summary:

SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.

Conditions

HIV Infections

Study ID

NCT06230367

Start date

Jan 15, 2024

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 13 - 22

Healthy Volunteers: Accepted

Inclusion Criteria:

1. have been assigned male sex at birth and currently have a cisgender identity;
2. be aged 13-22 years old;
3. have had anal sex in the past 12 months;
4. be English-speaking;
5. exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;
6. have Internet access to complete online surveys;
7. provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;
8. Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and
9. not currently enrolled in another HIV prevention program; or
10. know anyone already enrolled in the RCT.

Exclusion Criteria:

  • Being HIV positive

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: SHAG (Sexual Health Advocacy for Guys)

Young people assigned to the intervention arm will receive \~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior.

placebo comparator: Attention-matched control

Young people assigned to the control arm will receive \~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages.

Interventions

Sexual health advocacy for guys

5 month HIV prevention program delivered via text messaging

Healthy lifestyle control

5 month control group program delivered via text messaging

Primary outcome measure

  • HIV Incidence [ Time Frame: 12-months post-intervention and immediately post-intervention ]

Central Contacts and Locations

Locations

Center for Innovative Public Health Research

Recruiting

San Clemente, California, United States, 92672-6745

Contacts

Michele L Ybarra, MPH PhD

877-302-6858Michele@InnovativePublicHealth.org

Principal Investigator:

Michele L Ybarra, MPH PhD

Center for Innovative Public Health Research

Recruiting

San Clemente, California, United States, 92672

Contacts

Michele Ybarra, MPH PhD

8773026858help@projectshag.com

More Information

Sponsor

Center for Innovative Public Health Research

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Innovative Public Health Research on 2026-07-09.