Clinical trial NCT06230367: Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys
Official title: Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 5000
Sex: MALE
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the intervention or control group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV Incidence
timeFrame: 12-months post-intervention and immediately post-intervention
Secondary outcomes:
measure: Self-reported HIV incidence
timeFrame: Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post
measure: Proportion of Participants Testing for an STI
timeFrame: 12-month post intervention and immediately post-intervention
measure: Proportion of Participants having used PrEP/PEP
timeFrame: 12-month post-Intervention and immediately post-intervention
Other outcomes:
Locations:
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
Study officials:
References: