Clinical trial NCT02801266: Improving Contraceptive Counseling in the United States
Official title: Improving Contraceptive Counseling in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: New Behavioral Protocol
Treatment as Usual
Keywords: Contraception
Reproductive and Sexual Health
Counseling
Contraceptive Counseling
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2016-06-15
Enrollment: 1418
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

* Not seeking contraception from clinic on day of recruitment

Primary outcomes:
measure: Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.
timeFrame: immediately after counseling session
measure: Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
timeFrame: immediately after counseling session
measure: Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
timeFrame: immediately after counseling session
measure: Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.
timeFrame: 6 months from initial clinic visit
measure: Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.
timeFrame: one year from initial clinic visit
Secondary outcomes:
measure: 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).
timeFrame: six months to one year from initial clinic visit
Other outcomes:
measure: 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
timeFrame: six months to one year from initial clinic visit
measure: 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
timeFrame: six months to one year from initial clinic visit
measure: 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
timeFrame: six months to one year from initial clinic visit
measure: Pill users retrospective report of the number of missed pills using a questionnaire designed for this study
timeFrame: six months to one year from initial clinic visit
Locations:
city: New York
country: United States
facility: New York University, Silver School of Social Work
state: New York
Study officials:
affiliation: New York University
name: James J Jaccard, PhD
role: PRINCIPAL_INVESTIGATOR
References: