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Improving Contraceptive Counseling in the United States (ICC)

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ClinicalTrials.gov Identifier: NCT02801266
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
James Jaccard, 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.

Condition or disease Intervention/treatment Phase
New Behavioral Protocol Treatment as Usual Behavioral: Evidence informed birth control counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Improving Contraceptive Counseling in the United States
Study Start Date : October 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

  • Not seeking contraception from clinic on day of recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801266


Locations
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United States, New York
New York University, Silver School of Social Work
New York, New York, United States, 10001
Sponsors and Collaborators
New York University
Planned Parenthood Federation of America
Investigators
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Principal Investigator: James J Jaccard, PhD New York University
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Responsible Party: James Jaccard, Professor and Associate Dean for Research, New York University
ClinicalTrials.gov Identifier: NCT02801266    
Other Study ID Numbers: FPRPA006057
12-9103 ( Other Identifier: NYU Committee on Activities Involving Human Subjects )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James Jaccard, New York University:
Contraception
Reproductive and Sexual Health
Counseling
Contraceptive Counseling
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs