Improving Contraceptive Counseling in the United States

Not Applicable

Completed

• Conditions: Treatment as Usual; New Behavioral Protocol
• Interventions: Behavioral: Evidence informed birth control counseling

• Registration Number: NCT02801266
• Lead Sponsor: New York University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-10
• Study Completion: 2015-10
• Status Verified: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-11
• Study First Posted: 2016-06-15
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1418

Inclusion Criteria

• Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria

• Not seeking contraception from clinic on day of recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Evidence informed birth control counseling	The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University, Silver School of Social Work; 🇺🇸 New York, New York, United States