Pregnancy Clinical Trial
Official title:
Using the Healthcare Visit to Improve Contraceptive Use
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training
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