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临床试验/NCT00230880
NCT00230880已完成不适用

Randomized Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and STIs Among Adolescent Females Receiving Family Planning Clinic Services

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
800
试验地点
2
主要终点
Contraceptive use at time of last sexual intercourse

研究概览

简要总结

The New Generation Health Center/University of California, San Francisco (UCSF) will implement an intervention to impact contraceptive behavior and reduce unintended pregnancy and sexually transmitted infections (STIs) among adolescent females who receive services at the New Generation Health Center (NGHC)/UCSF in San Francisco. Study subjects will be randomized into either standard reproductive health services or standard services plus follow-up motivational counseling telephone calls. Outcomes will be evaluated by ETR (Education, Training, Research)Associates, who will conduct follow-up surveys with all study participants at baseline, 6 months, 12 months and 18 months.

详细描述

The United States has one of the highest teen pregnancy rates of any western industrialized nation. In 1999, the last year for which state pregnancy data are available, California had the seventh highest pregnancy rate in the country. Within San Francisco, the Mission and Bayview Hunters Point districts have rates that are almost three times and two times higher than the state average respectively. In addition to high rates of unintended pregnancy, residents in the Bayview Hunters Point district experience STI transmission rate much higher than that of other neighborhoods.

Currently there is very little research on the impact of different types of reproductive health clinic protocols on adolescent contraceptive use. Different outcomes have been found in the few studies that do exist on this topic. Hercog-Baron found that follow-up phone calls did not affect contraceptive use; however, explained that most youth stopped using contraception after the first three months of supply had run out and no calls were made beyond that time-frame. Authors suggested that the intervention may be more effective with a longer duration of follow-up. Alternatively, another study reported that their program substantially reduced teen pregnancy rates over time. Although the intervention had many components, the authors reported that the staff credited the positive relationships they created between the health educator and each student, and the frequent reminders contributed to the reduction in sexual risk-taking and pregnancy.

A review by Miller and Sanchez concluded that the following seven elements of brief interventions induced positive change in a variety of health areas:

  1. feedback and counseling on personal risk,
  2. emphasis on personal responsibility for change,
  3. clear message about behavior change,
  4. a menu of behavior change options,
  5. therapist/counselor empathy,
  6. facilitation of client self-efficacy and
  7. use of a "motivational interviewing style".

To the extent feasible, these elements will be incorporated into the Project REACH phone calls. Although there is very little data available in this area, the studies summarized above suggest that multiple contacts over time, even though brief, can have an impact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Attending a family planning clinic visit
  • At risk for unintended pregnancy (using no contraceptive method, using condoms for contraception, or not using a hormonal contraceptive method continuously for the last 3 months)

排除标准

  • Using a hormonal contraceptive method continuously for the last 3 months
  • Not willing to be contacted by phone for the intervention.

结局指标

主要结局

Contraceptive use at time of last sexual intercourse

时间窗: 18 months

次要结局

  • Unintended pregnancy(18 months)
  • Sexually transmitted infections(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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