Using the Healthcare Visit to Improve Contraceptive Use

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00140296
• Collaborator: University of North Carolina (Other)
• Enrollment: 747
• Location: 1
• Duration (Months): 30.1
• Patients Per Site Per Month: 24.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pregnancy; Chlamydia	Behavioral: Contraceptive counseling	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Educational/Counseling/Training
• Official Title: Using the Healthcare Visit to Improve Contraceptive Use
• Study Start Date: Mar 1, 2003
• Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. Contraceptive use []

2. Chlamydia infection []

3. Pregnancy []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Center for Women's Health Research, Universoty of North Carolina	Chapel Hill	North Carolina	United States	27599-7521

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• University of North Carolina

Investigators

• Principal Investigator: Ruth Petersen, MD, MPH, University of North Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

• Petersen R, Payne P, Albright J, Holland H, Cabral R, Curtis KM. Applying motivational interviewing to contraceptive counseling: ESP for clinicians. Contraception. 2004 Mar;69(3):213-7.

• ClinicalTrials.gov Identifier: NCT00140296
• Other Study ID Numbers: CDC-NCCDPHP-TS-0768
• First Posted: Sep 1, 2005
• Last Update Posted: Sep 1, 2005
• Last Verified: Aug 1, 2005

• Additional relevant MeSH terms: Chlamydia Infections; Contraceptive Agents

Study Results

No Results Posted as of Sep 1, 2005