search
Back to results

Using the Healthcare Visit to Improve Contraceptive Use

Primary Purpose

Pregnancy, Chlamydia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contraceptive counseling
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Pregnancy

Eligibility Criteria

16 Years - 44 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Contraceptive use
Chlamydia infection
Pregnancy

Secondary Outcome Measures

Full Information

First Posted
August 30, 2005
Last Updated
August 30, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT00140296
Brief Title
Using the Healthcare Visit to Improve Contraceptive Use
Official Title
Using the Healthcare Visit to Improve Contraceptive Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of North Carolina

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Chlamydia

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
747 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Contraceptive counseling
Primary Outcome Measure Information:
Title
Contraceptive use
Title
Chlamydia infection
Title
Pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Petersen, MD, MPH
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Women's Health Research, Universoty of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7521
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14969669
Citation
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.
Results Reference
background

Learn more about this trial

Using the Healthcare Visit to Improve Contraceptive Use

We'll reach out to this number within 24 hrs