Contraceptive Awareness and Reproductive Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 10
- 主要终点
- Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
研究概览
简要总结
The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.
详细描述
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 14-21;
- •Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months;
- •Willing to comply with protocol, follow-up assessments, and provide at least one locator; and
- •Fluent in English.
排除标准
- •Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling);
- •Girls who are not sexually active; or
- •Currently pregnant.
研究组 & 干预措施
Motivational Intervention
There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up.
干预措施: Motivational Intervention (Behavioral)
Didactic Educational Intervention
There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up.
干预措施: Didactic Educational Intervention (Behavioral)
结局指标
主要结局
Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.
时间窗: 9 month follow-up
Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective.
Number of Participants With a Positive STI Test After A Baseline Negative Test.
时间窗: 9 month follow-up
Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection.
Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.
时间窗: 9 month follow up
Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months.
次要结局
- Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex.(9 month follow-up)
- Number of Participants With a Positive Pregnancy Test After Baseline Assessment(9 month follow up)
- Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.(9 month follow up)
研究者
Lynda Stein, Ph.D.
Professor
University of Rhode Island