Improving Contraceptive Counseling in the United States (ICC)

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.

Study Overview

• Status: Completed
• Conditions: Treatment as Usual; New Behavioral Protocol
• Intervention / Treatment: Behavioral: Evidence informed birth control counseling

• Study Type: Interventional
• Enrollment (Actual): 1418
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • New York University, Silver School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

• Not seeking contraception from clinic on day of recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.	Behavioral: Evidence informed birth control counseling; Counselors underwent training on the use of 10 best practices for contraceptive counseling.; Other Names: Improving contraceptive counseling in the United States
No Intervention: No intervention; The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.	immediately after counseling session
Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.	immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.	immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.	6 months from initial clinic visit
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.	one year from initial clinic visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Type of contraceptive method currently using (including none and dual use) as assessed by a questionnaire designed for this study (e.g., what method of birth control are you currently using).	six months to one year from initial clinic visit

Other Outcome Measures

Outcome Measure	Time Frame
Method switching for pill users as assessed by a questionnaire designed for this study asking current method used at posttest to determine if it is no longer the pill using questions designed for this study	six months to one year from initial clinic visit
Gaps in pregnancy protection (number of weeks not using any birth control during contraceptive method switches as assessed by a questionnaire designed for this study using retrospective recall	six months to one year from initial clinic visit
Counselor behavior (topics covered during counseling) as assessed by a questionnaire designed for this study asking if counselor did or did not address key topics about method use	six months to one year from initial clinic visit
Pill users retrospective report of the number of missed pills using a questionnaire designed for this study	six months to one year from initial clinic visit

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: Planned Parenthood Federation of America
• Investigators: Principal Investigator: James J Jaccard, PhD, New York University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 11, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Counseling; Contraception; Reproductive and Sexual Health; Contraceptive Counseling
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: FPRPA006057; 12-9103 (Other Identifier: NYU Committee on Activities Involving Human Subjects)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO