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NCT Number: NCT06230367

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

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.

Recruiting

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Key information

Age range

13 year–22 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovative Public Health Research, San Clemente, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sexual health advocacy for guys

Behavioral

5 month HIV prevention program delivered via text messaging

Healthy lifestyle control

Behavioral

5 month control group program delivered via text messaging

Primary outcomes

  1. HIV Incidence

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

    HIV Incidence determined by home testing kit

Secondary outcomes

  1. Self-reported HIV incidence

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

    Self-reported HIV Status

  2. Proportion of Participants Testing for an STI

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

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

  3. Proportion of Participants having used PrEP/PEP

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

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

Sponsors and collaborators

Lead sponsor

Center for Innovative Public Health Research

Other

Registry information

Official study title

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

Acronym: SHAG

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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