Improving Contraceptive Counseling in the United States (ICC)

New York University (NYU)

Status: Completed

Conditions: New Behavioral Protocol; Treatment as Usual

Treatments: Behavioral: Evidence informed birth control counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02801266

FPRPA006057

12-9103 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,418 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be seeking contraception from clinic on day of recruitment

Exclusion criteria

• Not seeking contraception from clinic on day of recruitment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,418 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.

Treatment:

Behavioral: Evidence informed birth control counseling

No intervention

No Intervention group

Description:

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