Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 3
- 主要终点
- HIV Incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Control group content is written to affect an experience as if one were in the intervention group.
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Being HIV positive
研究组 & 干预措施
SHAG (Sexual Health Advocacy for Guys)
Young people assigned to the intervention arm will receive ~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior.
干预措施: Sexual health advocacy for guys (Behavioral)
Attention-matched control
Young people assigned to the control arm will receive ~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages.
干预措施: Healthy lifestyle control (Behavioral)
结局指标
主要结局
HIV Incidence
时间窗: 12-months post-intervention and immediately post-intervention
HIV Incidence determined by home testing kit
次要结局
- 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)