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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Sexual health advocacy for guys
  5 month HIV prevention program delivered via text messaging
• Поведенческое Healthy lifestyle control
  5 month control group program delivered via text messaging

Первичные конечные точки

• HIV Incidence [Срок оценки: 12-months post-intervention and immediately post-intervention]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Being HIV positive

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Center for Innovative Public Health Research — San Clemente
• Center for Innovative Public Health Research — San Clemente

Публикации

• Ybarra ML, Feaster DJ, Garofalo R, Bull S. Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among a national sample of sexual minority cisgender adolescent and young adult men. Trials. 2025 Jan 6;26(1):9. doi: 10.1186/s13063-024-08540-9. PMID 39762976

Идентификаторы

NCT: NCT06230367 · U01HD108738

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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