Clinical trial NCT01360216: Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training
Official title: Cluster, Randomized Trial on Provider LARC Education and Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Keywords: Long-acting reversible contraception
Intrauterine contraception
Intrauterine devices
Single-rod implant
Hormonal contraception
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2011-05-25
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Unintended pregnancy is extremely high in the United States among young women, and use of contraceptives with top-tier effectiveness, intrauterine contraception and implants, is low. Contraceptive providers in the US have low knowledge of current scientific evidence on LARC methods, and do not routinely include these methods in counseling patients at highest risk of unintended pregnancy. This intervention provides evidence-based education and hands-on training to clinicians and contraceptive educators in Planned Parenthood affiliated Title X clinics throughout the US on LARC methods.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of contraceptive patients choosing a LARC method
timeFrame: Baseline
Secondary outcomes:
measure: Unintended pregnancy
timeFrame: 12 months
Other outcomes:
measure: Sub-analysis for primary outcome, decision to use LARC method
timeFrame: Baseline
measure: Sub-analyses for pregnancy during 12-month study
timeFrame: 12 months (Baseline to 12-month Follow-up)
measure: Provider LARC knowledge and practices
timeFrame: Baseline and 12-month Follow-up
measure: LARC use over time
timeFrame: 12 months (baseline to 12 month follow-up)
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California San Francisco School of Medicine
name: Cynthia C Harper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California San Francisco School of Medicine
name: J. Joseph Speidel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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