Improving Contraceptive Counseling in the United States

Treatment as Usual Clinical Trial

— ICC  

Official title:

Improving Contraceptive Counseling in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801266
• Other study ID #: FPRPA006057
• Secondary ID: 12-9103
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1418
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

• Not seeking contraception from clinic on day of recruitment

Related Conditions & MeSH terms

• New Behavioral Protocol
• Treatment as Usual

Intervention

Behavioral:
• Evidence informed birth control counseling
Counselors underwent training on the use of 10 best practices for contraceptive counseling.

Locations

Country	Name	City	State
United States	New York University, Silver School of Social Work	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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