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RecruitingNCT06230367SHAGUpdated Jul 9, 2026

Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys

An interventional study of Sexual health advocacy for guys and Healthy lifestyle control in HIV Infections, sponsored by Center for Innovative Public Health Research. Recruiting at 2 sites in United States. Open to male participants aged 13 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
13 Years to 22 Years
Sex
Male
01

Study 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.

Read the detailed description

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. Harnessing the power of technology, young people will be recruited online and largely enrolled digitally. The main outcome of interest is HIV incidence. The impact of the intervention on STI testing and pre-exposure prophylaxis (PrEP) will also be examined.

02

Conditions studied

  • HIV Infections

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03

Who can participate

Ages eligible
13 Years to 22 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Being HIV positive
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
5,000 participants (estimated)

Study 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.

    Behavioral: Sexual health advocacy for guys

  • 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.

    Behavioral: Healthy lifestyle control

Interventions

  • BehavioralSexual health advocacy for guys

    5 month HIV prevention program delivered via text messaging

  • BehavioralHealthy lifestyle control

    5 month control group program delivered via text messaging

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What researchers measure

Primary outcomes

  1. HIV Incidence

    HIV Incidence determined by home testing kit

    Time frame: 12-months post-intervention and immediately post-intervention

Secondary outcomes

  1. Self-reported HIV incidence

    Self-reported HIV Status

    Time frame: Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post

  2. Proportion of Participants Testing for an STI

    This outcome will be measured as a cumulative indicator of whether the individual has tested for an STI

    Time frame: 12-month post intervention and immediately post-intervention

  3. Proportion of Participants having used PrEP/PEP

    This outcome will be measured as a cumulative indicator of whether the individual has used pre-exposure or post-exposure prophylaxis for HIV

    Time frame: 12-month post-Intervention and immediately post-intervention

06

Study locations

2 of 2 sites recruiting
  • Center for Innovative Public Health Research
    San Clemente, California 92672-6745, United States
    Recruiting
  • Center for Innovative Public Health Research
    San Clemente, California 92672, United States
    Recruiting
07

References and documents

Publications

  • Ybarra ML, Feaster DJ, Garofalo R, Bull S. Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among a national sample of sexual minority cisgender adolescent and young adult men. Trials. 2025 Jan 6;26(1):9. doi: 10.1186/s13063-024-08540-9. PubMed 39762976 ↗

Individual participant data

Plan to share: Yes — Individual-level de-identified data will be made available through controlled access.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT06230367
Lead sponsor
Center for Innovative Public Health Research
Responsible party
Sponsor
First posted
Jan 30, 2024
Start date
Jan 15, 2024
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jul 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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