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Completed

NCT Number: NCT02801266

Improving Contraceptive Counseling in the United States

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University, Silver School of Social Work

New York, 10001, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be seeking contraception from clinic on day of recruitment

Exclusion criteria

  • Not seeking contraception from clinic on day of recruitment

Treatment and study plan

Evidence informed birth control counseling

Behavioral

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

Other names: Improving contraceptive counseling in the United States

Primary outcomes

  1. Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.

    Time frame: immediately after counseling session

  2. Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.

    Time frame: immediately after counseling session

  3. Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.

    Time frame: immediately after counseling session

  4. Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.

    Time frame: 6 months from initial clinic visit

  5. Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.

    Time frame: 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).

    Time frame: six months to one year from initial clinic visit

Other outcomes

  1. 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

    Time frame: six months to one year from initial clinic visit

  2. 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

    Time frame: six months to one year from initial clinic visit

  3. 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

    Time frame: six months to one year from initial clinic visit

  4. Pill users retrospective report of the number of missed pills using a questionnaire designed for this study

    Time frame: six months to one year from initial clinic visit

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • Planned Parenthood Federation of America

Registry information

Acronym: ICC

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 15, 2016
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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