Evaluation of the Talking Matters Teen Pregnancy Prevention Program Through a Randomized Controlled Trial Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 2
- 主要终点
- Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up.
研究概览
简要总结
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely.
Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health.
The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.
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
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Identifies as Black or African American
- •14 to 19 years old at baseline
- •Lives in Philadelphia, PA
- •English-speaking
- •Able to or will be able to obtain access to the internet through a phone, tablet, or computer
排除标准
- •Does not identify as Black or African American
- •Less than 14 years old or 20 years or older at baseline
- •Does not live in Philadelphia, PA
- •Unable to speak or understand English
- •Unable to access internet through a phone, tablet, or computer
结局指标
主要结局
Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up.
时间窗: Baseline up to 6 months post-baseline
Maintained condom use at last vaginal sex (yes/no) from baseline to follow up.
时间窗: Baseline up to 6 months post-baseline
Change in the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
时间窗: Baseline up to 6 months post-baseline
Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up.
时间窗: Baseline up to 6 months post-baseline
Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used)
Change in the number of partners with whom participants had oral, vaginal, and/or anal sex without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up.
时间窗: Baseline up to 6 months post-baseline
Change in condom use at last vaginal sex (yes/no) from baseline to follow up.
时间窗: Baseline up to 6 months post-baseline
次要结局
- Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up.(Baseline up to 6 months post-baseline)
- Change in mental health literacy from baseline to follow up.(Baseline up to 6 months post-baseline)
- Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up(Baseline up to 6 months post-baseline)
- Change in intentions to use condoms from baseline to follow up.(Baseline up to 6 months post-baseline)
- Change in sexual and reproductive health knowledge from baseline to follow up.(Baseline up to 6 months post-baseline)
- Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up(Baseline up to 6 months post-baseline)
- Change in self-efficacy for using condoms from baseline to follow up.(Baseline up to 6 months post-baseline)
研究者
Archana LaPollo
Senior Project Director
Public Health Management Corporation