Contraception Behavior Clinical Trial
— LARCOfficial title:
Cluster, Randomized Trial on Provider LARC Education and Training
NCT number | NCT01360216 |
Other study ID # | 2010-5442 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | August 2013 |
Verified date | July 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to measure whether an education and training intervention for clinicians and contraceptive counselors on long-acting reversible contraception (LARC) will result in greater use of the methods among contraceptive patients.
Status | Completed |
Enrollment | 1500 |
Est. completion date | August 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 25 Years |
Eligibility |
Inclusion Criteria: This study involves two groups of human subjects: patients and staff at participating Planned Parenthood (PP) clinics in the United States. Patient participants are young women receiving contraceptive counseling at Planned Parenthood clinics and staff participants are the clinicians and health educators serving these women. Patients must be: Female; - Age 18-25; - Fluent in English or Spanish; - Not wanting to become pregnant in the next 12 months; - Sexually active in past 3 months; - At risk of pregnancy; - Received contraceptive counseling; - Not pregnant; - Willing to be contacted by telephone over the next 12 months. Clinic staff must be: - Employed by a participating PP clinic; and - Offer clinical care, counseling or education for abortion or contraception at the clinic. (This may include physicians, advance practice clinicians, nurses, social workers and health educators.) For clinics to be eligible to be study sites, they must: - Not share staff - Have no active LARC interventions ongoing - Have >400 clients/year |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Planned Parenthood Federation of America |
United States,
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Kavanaugh ML, Jones RK, Finer LB. Perceived and insurance-related barriers to the provision of contraceptive services in U.S. abortion care settings. Womens Health Issues. 2011 May-Jun;21(3 Suppl):S26-31. doi: 10.1016/j.whi.2011.01.009. — View Citation
Kittur ND, Secura GM, Peipert JF, Madden T, Finer LB, Allsworth JE. Comparison of contraceptive use between the Contraceptive CHOICE Project and state and national data. Contraception. 2011 May;83(5):479-85. doi: 10.1016/j.contraception.2010.10.001. Epub 2010 Nov 23. — View Citation
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Shelton JD. Risk of clinical pelvic inflammatory disease attributable to an intrauterine device. Lancet. 2001 Feb 10;357(9254):443. — View Citation
Speidel JJ, Harper CC, Shields WC. The potential of long-acting reversible contraception to decrease unintended pregnancy. Contraception. 2008 Sep;78(3):197-200. doi: 10.1016/j.contraception.2008.06.001. Epub 2008 Jul 9. — View Citation
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Stanwood NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002 Feb;99(2):275-80. — View Citation
Thompson KM, Speidel JJ, Saporta V, Waxman NJ, Harper CC. Contraceptive policies affect post-abortion provision of long-acting reversible contraception. Contraception. 2011 Jan;83(1):41-7. doi: 10.1016/j.contraception.2010.06.008. Epub 2010 Sep 20. — View Citation
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sub-analysis for primary outcome, decision to use LARC method | We will assess the outcome decision to use LARC, by important factors affecting contraceptive methods, including policy variables for contraceptive coverage (Medicaid expansion waiver states, mandates for contraceptive coverage for private insurance), clinic visit type (post-abortion or family planning), pregnancy intentions, mental health and domestic violence, male partner, provider-patient interaction, sociodemographic factors (age, race/ethnicity, education). | Baseline | |
Other | Sub-analyses for pregnancy during 12-month study | We will assess the secondary outcome, pregnancy during 12-month study, by important pregnancy risk variables, including clinic visit type (post-abortion or family planning), pregnancy intentions, mental health and domestic violence, provider-patient interaction, male partner, sociodemographic (age, race/ethnicity, education) and policy variables (Medicaid expansion waiver states, mandates for contraceptive coverage for private insurance). | 12 months (Baseline to 12-month Follow-up) | |
Other | Provider LARC knowledge and practices | We will measure providers' LARC knowledge and practices (discuss LARC methods with contraceptive clients) at baseline and 12-month follow-up, using provider survey data) to assess whether they integrate LARC into standard clinic practice in the intervention arm. | Baseline and 12-month Follow-up | |
Other | LARC use over time | We will measure patient use of LARC methods with patient data (n=1500) over the course of the study, and assess factors associated with continued use over time, including sociodemographic, reproductive, mental health, and contraceptive policy factors. | 12 months (baseline to 12 month follow-up) | |
Primary | Proportion of contraceptive patients choosing a LARC method | We are measuring the proportion of patients deciding to use a LARC method at intervention and control clinics in a patient cohort aged 18-25 years (n=1500). We are also measuring with clinic service statistics the proportion of contraceptive patients selecting LARC v. non-LARC methods during the 12 month-period before the intervention and the 12-month period after the intervention, to supplement the analysis with individual patient data. | Baseline | |
Secondary | Unintended pregnancy | We are measuring unintended pregnancy among contraceptive patients receiving contraceptive counseling at intervention and control clinics (total number 1,500) during a 12 month period. | 12 months |
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