HIV Infections Clinical Trial
— SHAGOfficial title:
Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States
Verified date | January 2024 |
Source | Center for Innovative Public Health Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Center for Innovative Public Health Research |
United States,
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 |
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