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

Center for Innovative Public Health Research

Status: Enrolling

Conditions: HIV Infections

Treatments: Behavioral: Healthy lifestyle control; Behavioral: Sexual health advocacy for guys

Study type: Interventional

Funder types: Other

Identifiers

NCT06230367

U01HD108738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: Male

Ages: 13 to 20 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,000 participants in 2 patient groups, including a placebo group

SHAG (Sexual Health Advocacy for Guys)

Experimental group

Description:

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.

Treatment:

Behavioral: Sexual health advocacy for guys

Attention-matched control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Healthy lifestyle control