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Recruiting NCT06230367

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

No phase Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sexual health advocacy for guys, Healthy lifestyle control.
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: 13 years — 22 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States

Overview

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.

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.

Interventions

  • Behavioral Sexual health advocacy for guys
    5 month HIV prevention program delivered via text messaging
  • Behavioral Healthy lifestyle control
    5 month control group program delivered via text messaging

Primary outcome measures

  • HIV Incidence [Time frame: 12-months post-intervention and immediately post-intervention]
Secondary outcome measures (3)
  • Self-reported HIV incidence [Time frame: Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post]
  • Proportion of Participants Testing for an STI [Time frame: 12-month post intervention and immediately post-intervention]
  • Proportion of Participants having used PrEP/PEP [Time frame: 12-month post-Intervention and immediately post-intervention]

Eligibility criteria

Inclusion criteria

  • have been assigned male sex at birth and currently have a cisgender identity;
  • be aged 13-22 years old;
  • have had anal sex in the past 12 months;
  • be English-speaking;
  • 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;
  • have Internet access to complete online surveys;
  • 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;
  • 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
  • not currently enrolled in another HIV prevention program; or
  • know anyone already enrolled in the RCT.

Exclusion criteria

  • Being HIV positive

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Center for Innovative Public Health Research — San Clemente
  • Center for Innovative Public Health Research — San Clemente

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. PMID 39762976

Identifiers

NCT: NCT06230367 · U01HD108738

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗