- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7521
- Center for Women's Health Research, Universoty of North Carolina
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Edukacyjne/Doradztwo/Szkolenia
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
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Ciąża
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Contraceptive use
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Chlamydia infection
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Ruth Petersen, MD, MPH, University of North Carolina
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Infekcje
- Choroby zakaźne
- Choroby przenoszone drogą płciową
- Zakażenia bakteriami Gram-ujemnymi
- Infekcje bakteryjne
- Infekcje bakteryjne i grzybice
- Zakażenia Chlamydiaceae
- Choroby przenoszone drogą płciową, bakteryjne
- Zakażenia Chlamydiami
- Fizjologiczne skutki leków
- Środki kontroli reprodukcji
- Środki antykoncepcyjne
Inne numery identyfikacyjne badania
- CDC-NCCDPHP-TS-0768
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