Improving Contraceptive Counseling in the United States

NCT02801266 | Completed

• 2 other identifiers: FPRPA00605712-9103
• Study Type: interventional
• Target: 1,418
• Locations: 1 country
• Sites: 1

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.

Conditions

New Behavioral Protocol; Treatment as Usual

Keywords

Contraception; Reproductive and Sexual Health; Counseling; Contraceptive Counseling

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

No intervention

NO INTERVENTION

The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive.

Interventions

Evidence informed birth control counseling BEHAVIORAL

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

Also known as: Improving contraceptive counseling in the United States

Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be seeking contraception from clinic on day of recruitment

You may not qualify if:

• Not seeking contraception from clinic on day of recruitment

Sponsors & Collaborators

• New York University: lead
• Planned Parenthood Federation of America: collaborator

Study Sites (1)

New York University, Silver School of Social Work

New York, New York, 10001, United States

Location

Study Officials

• James J Jaccard, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 15, 2016
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: November 2, 2022

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)