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

Not Applicable

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT06230367
• Lead Sponsor: Center for Innovative Public Health Research

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.

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study Start: 2024-01-15
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 5000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV Incidence	12-months post-intervention and immediately post-intervention	HIV Incidence determined by home testing kit

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants having used PrEP/PEP	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
Self-reported HIV incidence	Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post	Self-reported HIV Status
Proportion of Participants Testing for an STI	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

Trial Locations

Locations (1)

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