Using the Healthcare Visit to Improve Contraceptive Use

NCT ID: NCT00140296

Last Updated: 2005-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 747 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2005-09-30

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.

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.

Conditions

Pregnancy; Chlamydia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: SINGLE

Interventions

Contraceptive counseling

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Ruth Petersen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

References

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. doi: 10.1016/j.contraception.2003.10.007.

Reference Type: BACKGROUND

PMID: 14969669 (View on PubMed)

Other Identifiers

CDC-NCCDPHP-TS-0768

Identifier Type: -

Identifier Source: org_study_id