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临床试验/NCT00140296
NCT00140296已完成不适用

Using the Healthcare Visit to Improve Contraceptive Use

Centers for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 747 人开始时间: 2003年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
747
试验地点
1
主要终点
Contraceptive use

研究概览

简要总结

Consistent and correct use of an effective contraceptive method is a primary determinant in preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately address women's contraceptive needs. We have developed a standardized behavioral-based contraceptive counseling model that can be used by providers and other clinic staff to address this limitation. The model, ESP, is an adaptation of motivational interviewing and involves: Exploring discrepancies between pregnancy intention and contraceptive use and between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce risk.

Study question: Does ESP counseling lead to an increase in consistency and effectiveness of contraceptive use among women at risk of unintended pregnancy?

Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in North Carolina. Intervention participants received individualized ESP counseling from a health educator to address barriers to effective and consistent contraceptive use. Risk reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were assessed at baseline and follow-up. "Highly effective" contraceptive use was defined as a combination of effectiveness and consistency. Women in the control arm received general preventive health counseling (e.g., smoking and exercise). Differences between the study arms at 12-months may illustrate the longer term influence of the intervention.

详细描述

Consistent and correct use of an effective contraceptive method is a primary determinant in preventing pregnancy. Unfortunately, only a minority of healthcare providers adequately address women's contraceptive needs. We have developed a standardized behavioral-based contraceptive counseling model that can be used by providers and other clinic staff to address this limitation. The model, ESP, is an adaptation of motivational interviewing and involves: Exploring discrepancies between pregnancy intention and contraceptive use and between risk of STDs and condom use; Sharing information; and Promoting behaviors to reduce risk.

Study question: Does ESP counseling lead to an increase in consistency and effectiveness of contraceptive use among women at risk of unintended pregnancy?

Methods: Randomized controlled trial of 747 women, ages 16-44, at self-identified risk of unintended pregnancy enrolled from March 2003 to September 2004 at healthcare settings in North Carolina. Intervention participants received individualized ESP counseling from a health educator to address barriers to effective and consistent contraceptive use. Risk reduction steps were negotiated. Pregnancy, Chlamydia infection and contraceptive use were assessed at baseline and follow-up. "Highly effective" contraceptive use was defined as a combination of effectiveness and consistency. Women in the control arm received general preventive health counseling (e.g., smoking and exercise). Differences between the study arms at 12-months may illustrate the longer term influence of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Educational Counseling Training
盲法
Single

入排标准

年龄范围
16 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women aged 16-44
  • •English-speaking
  • •Do not wish to be pregnant or unsure of pregnancy intention
  • •Have an appointment for non-acute care
  • •Currently using no method of contraception, inconsistent use of methods, pills, condoms, diaphragms, periodic abstinence, or methods associated with higher pregnancy rates
  • •Ability to read at least at 8th grade level
  • •Willing to participate in follow-up visits at 2, 8, and 12 months
  • •Able to be contacted by telephone

排除标准

  • •Women less than 16 or greater than 44 years
  • •Women who are sterilized, or whose partners are sterilized or who use the IUD for contraception
  • •Appointments for acute care
  • •Non-English speaking
  • •Inability to read at or above 8th grade level
  • •Pregnant at time of enrollment
  • •Lack of ability for telephone contact

结局指标

主要结局

Contraceptive use

Chlamydia infection

Pregnancy

次要结局

未报告次要终点

研究者

发起方
Centers for Disease Control and Prevention
申办方类型
Fed

研究点 (1)

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