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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230367
Acronym
SHAG
Enrollment
5000
Registered
2024-01-30
Start date
2024-01-15
Completion date
2027-12-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

BEHAVIORALSexual health advocacy for guys

5 month HIV prevention program delivered via text messaging

5 month control group program delivered via text messaging

Sponsors

Center for Innovative Public Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Control group content is written to affect an experience as if one were in the intervention group.

Intervention model description

Participants will be randomized to either the intervention or control group

Eligibility

Sex/Gender
MALE
Age
13 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HIV Incidence12-months post-intervention and immediately post-interventionHIV Incidence determined by home testing kit

Secondary

MeasureTime frameDescription
Self-reported HIV incidencePost-Intervention, 3-months post, 6-months post, 9-months post, 12-month postSelf-reported HIV Status
Proportion of Participants Testing for an STI12-month post intervention and immediately post-interventionThis outcome will be measured as a cumulative indicator of whether the individual has tested for an STI
Proportion of Participants having used PrEP/PEP12-month post-Intervention and immediately post-interventionThis outcome will be measured as a cumulative indicator of whether the individual has used pre-exposure or post-exposure prophylaxis for HIV

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026