- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7521
- Center for Women's Health Research, Universoty of North Carolina
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Educatief/Counseling/Training
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Zwangerschap
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Contraceptive use
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Chlamydia infection
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ruth Petersen, MD, MPH, University of North Carolina
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen
- Gram-negatieve bacteriële infecties
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Chlamydiaceae-infecties
- Seksueel overdraagbare aandoeningen, bacterieel
- Chlamydia-infecties
- Fysiologische effecten van medicijnen
- Reproductieve controlemiddelen
- Anticonceptiemiddelen
Andere studie-ID-nummers
- CDC-NCCDPHP-TS-0768
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