Using the Healthcare Visit to Improve Contraceptive Use

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00140296
First received: August 30, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Using the Healthcare Visit to Improve Contraceptive Use

Resource links provided by NLM:


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

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

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014