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OpenTrials
Completed

NCT Number: NCT00140296

Using the Healthcare Visit to Improve Contraceptive Use

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.

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Key information

Age range

16 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Women's Health Research, Universoty of North Carolina

Chapel Hill, North Carolina, 27599-7521, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Contraceptive counseling

Behavioral

Primary outcomes

  1. Contraceptive use

  2. Chlamydia infection

  3. Pregnancy

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • University of North Carolina

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Sep 1, 2005
Registry last updated
Sep 1, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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