The Share Health Study: Teens Social Connections and Health (Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,099
- 试验地点
- 2
- 主要终点
- Contraceptive use among secondary participants
研究概览
简要总结
The purpose of this study is to determine whether delivery of SpeakOut, a behavioral intervention to increase social communication about long-acting reversible contraceptive (LARC) methods among adolescents, is associated with increased contraceptive use among the social contacts of SpeakOut recipients.
The investigators will conduct a cluster randomized controlled trial of SpeakOut with adolescent LARC users and their female peers. Over three years, SpeakOut will be implemented in eight partner clinics. IUD and implant users aged 15 to 19 will be recruited online and invited to enroll in the evaluation study as "primary" participants and receive either SpeakOut or a control intervention about alcohol use called PartyWise. The social contacts of primary participants will be asked to enroll in the study as "secondary" participants. The study's primary outcome will be the proportion of sexually-active secondary participants who are using any contraceptive method at 9-month follow-up.
详细描述
Teen pregnancy results from under-use contraception by sexually active teens. Social networks are important influences on teen contraceptive knowledge and use. Encouraging social communication to increase knowledge and acceptability of LARC among female adolescents can increase use of contraception.
The Share Health Study is a cluster randomized control trial, randomized at the primary participant level. Primary participants will be randomized to receive either SpeakOut or a control intervention about alcohol use (PartyWise) immediately before intervention delivery. A cluster consists of primary participants and the secondary participants recruited to the study via a specialized snowball sampling procedure carried out with the assistance of the primary participant, described below.
Primary participant procedures
Adolescents ages 15-19 years old who are using an IUD or implant will be recruited through targeted social media advertisements.
After providing consent, each primary participant will complete a baseline survey collecting demographic information and asking about contraceptive knowledge, attitudes, use, and social communication as well as drug and alcohol behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary participants:
- •Age 15 to 19
- •Able to speak and read English or Spanish easily
- •Uses an IUD or implant for birth control
- •Is comfortable with close friend knowing that they use an IUD or implant
- •Can think of at least one friend or family member they would be comfortable asking to join a study about health topics like birth control and alcohol use
- •If minor, lives in state where they are able to consent for reproductive health services
- •Secondary participants:
- •15 to 20 years old
- •Able to speak and read English or Spanish easily
- •Was listed as a social contact by a primary participant at enrollment, and can name that primary participant at screening
- •If minor, lives in state where they are able to consent for reproductive health services.
排除标准
- •Primary participants:
- •Previous enrollment as a primary or secondary participant in the study
- •Pregnant at baseline
- •Secondary participants:
- •Pregnant at baseline
- •Previous enrollment as a primary secondary participant in the study*
结局指标
主要结局
Contraceptive use among secondary participants
时间窗: Up to 9 months
Proportion of secondary participants reporting use of any contraceptive method in follow-up surveys. Outcome is dichotomous (Yes, USING contraception/No, NOT using contraception) and based on responses to PI-authored Survey item 1: What birth control method (s) are you currently using to prevent pregnancy? (Check all that apply of the following 11 response options) "Yes, USING contraception" defined as those who check any of the following: 1. Pill (Birth control pill) 2. Patch (Birth control patch) 3. Ring ("Nuvaring") 4. Shot ("Depo") 5. Hormonal IUD (Mirena, Liletta, or Skyla) 6. Non-hormonal IUD (Paragard or "copper T") 7. Implant (Nexplanon or Implanon, rod under skin of arm) 8. Condoms "No, NOT using contraception" defined as those who do not check items 1-8 above, whether or not they check any of the following response options: 9. Withdrawal/pulling out 10. Other 11. I am not currently using a method to prevent pregnancy
次要结局
- IUD initiation (ie current IUD use among those not using an IUD at baseline) among secondary participants(Up to 9 months)
- Positive social communication about LARC method between primary and secondary participants(Up to 9 months)
- Initiation of contraceptive used by primary participant among secondary participants reporting sexual active(Up to 9 months)
- Positive attitudes towards cluster primary participant's LARC method among secondary participants(Up to 9 months)
- Knowledge of cluster primary participant's LARC use among secondary participants(Up to 9 months)
- Knowledge of LARC methods among secondary participants(Up to 9 months)
- Negative social communication about LARC method between primary and secondary participants(Up to 9 months)
- Diagnosis of sexually transmitted infection among secondary participants(Up to 9 months)
- Risk of unintended pregnancy (ie sex without contraception)(Up to 9 months)
- Alcohol use(Up to 9 months)
- Condom use at last sexual intercourse among sexually active secondary participants(Up to 9 months)
- Initiation of sexual activity among secondary participants(Up to 9 months)
- Initiation of social communication about LARC method among primary participants(Up to 9 months)
- IUD continuation among primary participants(Up to 9 months)
- Positive attitudes towards LARC method among primary participants(Up to 9 months)
- Pregnancy among primary participants(Up to 9 months)
- Knowledge of binge-drinking behaviors(Up to 9 months)
- Pregnancy among secondary participants(Up to 9 months)
- Implant continuation among primary participants(Up to 9 months)
- Knowledge of LARC method among primary participants(Up to 9 months)
- Acceptability of PartyWise [control intervention](Up to 9 months)
- Acceptability of SpeakOut(Up to 9 months)
- Implant initiation (among all secondary participants, those recently sexually active, and ever sexually active)(Up to 9 months)