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Contraception BehaviorLARCNCT01360216

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

A study testing LARC education and training in people with Contraception Behavior, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Contraception Behavior
What is being tested?
LARC education and training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteUnited States
Study dates
May 2011to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
Show all 19Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Francisco

    San Francisco, California, 94118

Other trials in United States

About this study

Official title: Cluster, Randomized Trial on Provider LARC Education and Training

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.

Read the 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.

Being tested
LARC education and training
Keywords
Long-acting reversible contraception, Intrauterine contraception, Intrauterine devices, Single-rod implant, Hormonal contraception
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LARC education and trainingBehavioural

    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.

Study groups in NCT01360216
Study groupRoleWhat they receive
LARC education and trainingExperimentalClinicians 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.
Receives: Behavioral: LARC education and training
Standard practice- controlNo interventionClinicians and contraceptive educators practicing in clinics assigned to this arm do not receive special LARC training and education session. Standard practice will be followed at clinics assigned to the control arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

Secondary outcomes (1)

  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360216
Sponsor's protocol ID
2010-5442
Acronym
LARC
Status last verified
Jul 2020
First submitted
20 May 2011
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21134502

  • Harper CC, Blum M, de Bocanegra HT, Darney PD, Speidel JJ, Policar M, Drey EA. Challenges in translating evidence to practice: the provision of intrauterine contraception. Obstet Gynecol. 2008 Jun;111(6):1359-69. doi: 10.1097/AOG.0b013e318173fd83.

    PubMed 18515520

  • 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. No abstract available.

    PubMed 18692608

  • Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception. 2008 Aug;78(2):143-8. doi: 10.1016/j.contraception.2008.03.003. Epub 2008 May 14.

    PubMed 18672116

  • Goodman S, Hendlish SK, Benedict C, Reeves MF, Pera-Floyd M, Foster-Rosales A. Increasing intrauterine contraception use by reducing barriers to post-abortal and interval insertion. Contraception. 2008 Aug;78(2):136-42. doi: 10.1016/j.contraception.2008.03.008. Epub 2008 Jun 18.

    PubMed 18672115

  • Kavanaugh ML, Jones RK, Finer LB. How commonly do US abortion clinics offer contraceptive services? Contraception. 2010 Oct;82(4):331-6. doi: 10.1016/j.contraception.2010.04.010. Epub 2010 May 21.

    PubMed 20851226

  • 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.

    PubMed 21530835

  • Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.

    PubMed 17138775

  • Hladky KJ, Allsworth JE, Madden T, Secura GM, Peipert JF. Women's knowledge about intrauterine contraception. Obstet Gynecol. 2011 Jan;117(1):48-54. doi: 10.1097/AOG.0b013e318202b4c9.

    PubMed 21173643

  • Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

    PubMed 20541171

  • Madden T, Allsworth JE, Hladky KJ, Secura GM, Peipert JF. Intrauterine contraception in Saint Louis: a survey of obstetrician and gynecologists' knowledge and attitudes. Contraception. 2010 Feb;81(2):112-6. doi: 10.1016/j.contraception.2009.08.002. Epub 2009 Sep 16.

    PubMed 20103447

  • 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.

    PubMed 21477693

  • Fleming KL, Sokoloff A, Raine TR. Attitudes and beliefs about the intrauterine device among teenagers and young women. Contraception. 2010 Aug;82(2):178-82. doi: 10.1016/j.contraception.2010.02.020. Epub 2010 Apr 13.

    PubMed 20654760

  • Darney P, Patel A, Rosen K, Shapiro LS, Kaunitz AM. Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials. Fertil Steril. 2009 May;91(5):1646-53. doi: 10.1016/j.fertnstert.2008.02.140. Epub 2008 Apr 18.

    PubMed 18423453

  • Raine TR, Foster-Rosales A, Upadhyay UD, Boyer CB, Brown BA, Sokoloff A, Harper CC. One-year contraceptive continuation and pregnancy in adolescent girls and women initiating hormonal contraceptives. Obstet Gynecol. 2011 Feb;117(2 Pt 1):363-371. doi: 10.1097/AOG.0b013e31820563d3.

    PubMed 21252751

Questions about this trial

What is this clinical trial studying?

A study testing LARC education and training in people with Contraception Behavior, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of contraceptive patients choosing a LARC method (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360216, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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