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Improving Contraceptive Counseling in the United States

NCT02801266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1418

Last updated 2022-11-02

No results posted yet for this study

Summary

This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.

Conditions

  • New Behavioral Protocol
  • Treatment as Usual

Interventions

BEHAVIORAL

Evidence informed birth control counseling

Counselors underwent training on the use of 10 best practices for contraceptive counseling.

Sponsors & Collaborators

  • Planned Parenthood Federation of America

    collaborator OTHER

  • New York University

    lead OTHER

Principal Investigators

  • James J Jaccard, PhD · New York University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801266 on ClinicalTrials.gov