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

Cluster, Randomized Trial on Provider LARC Education and Training

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01360216
Acronym
LARC
Enrollment
1500
Registered
2011-05-25
Start date
2011-05-31
Completion date
2013-08-31
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Behavior

Keywords

Long-acting reversible contraception, Intrauterine contraception, Intrauterine devices, Single-rod implant, Hormonal contraception

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.

Interventions

BEHAVIORALLARC education and training

A CME/CEU accredited Grand Rounds education and training session will be given to clinicians and contraceptive educators practicing in clinics assigned to the intervention arm. Clinicians will have hands-on training as well. The half-day session emphasizes evidence-based contraceptive counseling and provision.

Sponsors

Planned Parenthood Federation of America
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of contraceptive patients choosing a LARC methodBaselineWe 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

MeasureTime frameDescription
Unintended pregnancy12 monthsWe are measuring unintended pregnancy among contraceptive patients receiving contraceptive counseling at intervention and control clinics (total number 1,500) during a 12 month period.

Other

MeasureTime frameDescription
Sub-analysis for primary outcome, decision to use LARC methodBaselineWe 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).
Sub-analyses for pregnancy during 12-month study12 months (Baseline to 12-month Follow-up)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).
Provider LARC knowledge and practicesBaseline and 12-month Follow-upWe 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.
LARC use over time12 months (baseline to 12 month follow-up)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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026