Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140296
Status:
COMPLETED
Last Update Posted:
2005-09-01
First Post:
2005-08-30
Brief Title:
Using the Healthcare Visit to Improve Contraceptive Use
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Using the Healthcare Visit to Improve Contraceptive Use
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 eg smoking and exercise Differences between the study arms at 12-months may illustrate the longer term influence of the intervention
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 eg 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 womens 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 eg smoking and exercise Differences between the study arms at 12-months may illustrate the longer term influence of the intervention
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 eg smoking and exercise Differences between the study arms at 12-months may illustrate the longer term influence of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None