Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training

Not Applicable

Completed

• Conditions: Contraception Behavior
• Interventions: Behavioral: LARC education and training

• Registration Number: NCT01360216
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LARC education and training	LARC education and training	Clinicians and contraceptive educators practicing in clinics assigned to this arm receive a special half-day Continuing Medical Education (CME/CEU) accredited LARC education and training session.

Primary Outcome Measures

Name	Time	Method
Proportion of contraceptive patients choosing a LARC method	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Unintended pregnancy	12 months	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.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States