ClinicalTrials.gg
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

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
13 Years to 22 Years
Sex
Male
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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.

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Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Center for Innovative Public Health Research is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 positive
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

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

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Study locations

2 of 2 sites recruiting
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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, Statistical analysis plan, Informed consent form

Time frame: Data will be available starting 12 months after the grant ends.

Access criteria: Data access requires sponsorship by an Institution on behalf of the prospective recipient. Requester must provide documentation of local IRB approval Requester agrees to make results of studies using the data available to the larger scientific community Requester must provide a letter of collaboration with the primary study investigator Use of the data is limited to not-for-profit organizations Use of the data is limited to health purposes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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No contact was published for this record. The registry link below has the sponsor’s details.

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