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Clinical Trials/NCT06230367
NCT06230367
Recruiting
Not Applicable

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

Center for Innovative Public Health Research1 site in 1 country5,000 target enrollmentJanuary 15, 2024
ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Center for Innovative Public Health Research
Enrollment
5000
Locations
1
Primary Endpoint
HIV Incidence
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
July 31, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Center for Innovative Public Health Research
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • have been assigned male sex at birth and currently have a cisgender identity;
  • be aged 13-22 years old;
  • have had anal sex in the past 12 months;
  • be English-speaking;
  • 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;
  • have Internet access to complete online surveys;
  • 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;
  • 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
  • not currently enrolled in another HIV prevention program; or
  • know anyone already enrolled in the RCT.

Exclusion Criteria

  • Being HIV positive

Outcomes

Primary Outcomes

HIV Incidence

Time Frame: 12-months post-intervention and immediately post-intervention

HIV Incidence determined by home testing kit

Secondary Outcomes

  • Proportion of Participants having used PrEP/PEP(12-month post-Intervention and immediately post-intervention)
  • Self-reported HIV incidence(Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post)
  • Proportion of Participants Testing for an STI(12-month post intervention and immediately post-intervention)

Study Sites (1)

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