Using the Healthcare Visit to Improve Contraceptive Use

Pregnancy Clinical Trial

Official title:

Using the Healthcare Visit to Improve Contraceptive Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140296
• Other study ID #: CDC-NCCDPHP-TS-0768
• Status: Completed
• Phase: N/A
• First received: August 30, 2005
• Last updated: August 30, 2005
• Start date: March 2003
• Est. completion date: September 2005

Study information

• Verified date: August 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Chlamydia
• Pregnancy

Intervention

Behavioral:
• Contraceptive counseling

Locations

Country	Name	City	State
United States	Center for Women's Health Research, Universoty of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive use
Primary	Chlamydia infection
Primary	Pregnancy