Improving Contraceptive Counseling in the United States

Study Overview
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Brief Summary
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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.

Official Title
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Improving Contraceptive Counseling in the United States

Conditions
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New Behavioral Protocol, Treatment as Usual

Intervention / Treatment
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* Behavioral: Evidence informed birth control counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be seeking contraception from clinic on day of recruitment Exclusion Criteria: Not seeking contraception from clinic on day of recruitment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Counselors underwent training on the use of 10 best practices for contraceptive counseling.<br>* Other names: Improving contraceptive counseling in the United States;|
| No Intervention: No intervention<br>The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Reproductive and Sexual Health, Counseling, Contraceptive Counseling