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Using the Healthcare Visit to Improve Contraceptive Use
This study has been completed.
Sponsors and Collaborators: Centers for Disease Control and Prevention
University of North Carolina
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00140296
  Purpose

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.


Condition Intervention
Pregnancy
Chlamydia
Behavioral: Contraceptive counseling

MedlinePlus related topics: Chlamydia Infections
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Using the Healthcare Visit to Improve Contraceptive Use

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Contraceptive use
  • Chlamydia infection
  • Pregnancy

Estimated Enrollment: 747
Study Start Date: March 2003
Estimated Study Completion Date: September 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140296

Locations
United States, North Carolina
Center for Women's Health Research, Universoty of North Carolina
Chapel Hill, North Carolina, United States, 27599-7521
Sponsors and Collaborators
University of North Carolina
Investigators
Principal Investigator: Ruth Petersen, MD, MPH University of North Carolina
  More Information

Contraceptive training information used for this study  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: CDC-NCCDPHP-TS-0768
Study First Received: August 30, 2005
Last Updated: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140296  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Chlamydia Infections

ClinicalTrials.gov processed this record on January 13, 2009