- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00140296
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7521
- Center for Women's Health Research, Universoty of North Carolina
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Uddannelse/Rådgivning/Træning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Graviditet
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Contraceptive use
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Chlamydia infection
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ruth Petersen, MD, MPH, University of North Carolina
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme
- Gram-negative bakterielle infektioner
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Chlamydiaceae infektioner
- Seksuelt overførte sygdomme, bakteriel
- Klamydia infektioner
- Lægemidlers fysiologiske virkninger
- Reproduktive kontrolmidler
- Præventionsmidler
Andre undersøgelses-id-numre
- CDC-NCCDPHP-TS-0768
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