Protecting Our Future: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Change in self-reported STI screening at 3-months and 6-months
研究概览
简要总结
The aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. The investigators will randomize 450 youth and young adults ages 14-26 to the self-care intervention or a control program. Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a) sexual risk and protective behaviors; and b) psychosocial assets and resources. The investigators hypothesize the self-care intervention will increase protective behaviors by: i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii) motivating protection of those assets and resources; and iii) encouraging good health practices and making responsible choices.
详细描述
The proposed study is a RCT to test the efficacy of a self-care intervention for sexual health promotion among youth and young adults in a participating Native American community. The goal of the intervention is to increase protective sexual health practices. The investigators will compare outcomes between two groups: the 1) experimental group and the 2) comparison group. Youth will be enrolled in the study and assessed at baseline, 3-months and 6-months post-intervention. Participants ages 14-26 will be enrolled through a non-probability sampling frame at: a) the local Indian Health Service (IHS) facility, including the Emergency Department waiting room; b) local schools; c) during health fairs and other community-based events; and d) other community gathering spots. Eligible individuals will be of Native American ethnicity, 14-26 years of age, and have primary residence and/or employment within the participating tribe's reservation. Research staff will screen potential participants for inclusion/exclusion criteria, explain study goals and procedures, and administer informed consent. After obtaining participant consent, participants will complete a baseline assessment and then be randomized to receive the self-care intervention or a control program. Follow-up assessments will be administered at 3-months and 6-months post-intervention for all study participants. Each assessment is expected to take 20-30 minutes to complete. The baseline assessment will take place at the location of recruitment and consent; follow-up assessments will take place at home or in a private location. All assessments will be self-administered on tablets using REDCap mobile technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native American ethnicity
- •Membership in the participating Native American community. (Study participation is open to all Native American individuals who live on the participating Tribe's Reservation, on/near the border, and/or are employed on the participating Tribe's Reservation).
- •Have had sex at least once in their lifetime (vaginal)
- •Participant must have their own cell phone and agree to receiving generic text messages and phone calls from study staff
- •All participants must sign informed consent
排除标准
- •Unwilling to be randomized
- •Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
结局指标
主要结局
Change in self-reported STI screening at 3-months and 6-months
时间窗: 3-months and 6-months
Difference in completion of self-administered screening kit for gonorrhea, chlamydia, and trichomonas between intervention and control groups at 3-months and 6-months. Participants report if they completed a self-administered test at each time point.
次要结局
- Multiple partners(3-months and 6-months)
- Current symptoms of STI(3-months and 6-months)
- Alcohol and drug use(3-months and 6-months)
- Concurrent partners(3-months and 6-months)
- Sex without condom(3-months and 6-months)
- Sex without birth control(3-months and 6-months)
- New partners(3-months and 6-months)
- Alcohol and drug use before sex(3-months and 6-months)