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

HIV Infections Clinical Trial

— SHAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230367
• Other study ID #: U01HD108738
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: January 2024
• Source: Center for Innovative Public Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 20 Years

Eligibility

Inclusion Criteria:

1. have been assigned male sex at birth and currently have a cisgender identity;

2. be aged 13-20 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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	Center for Innovative Public Health Research	San Clemente	California
United States	Center for Innovative Public Health Research	San Clemente	California

Sponsors (1)

Lead Sponsor	Collaborator
Center for Innovative Public Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Incidence	HIV Incidence determined by home testing kit	12-months post-intervention and immediately post-intervention
Secondary	Self-reported HIV incidence	Self-reported HIV Status	Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post
Secondary	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	12-month post intervention and immediately post-intervention
Secondary	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	12-month post-Intervention and immediately post-intervention