Clinical trial NCT01881321: Use of Motivational Interviewing to Increase Contraception Use Among Young Women
Official title: Use of Motivational Interviewing to Increase Contraception Use Among Young Women: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unplanned Pregnancy
Keywords: Contraception
Counseling
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study design: This is a 2-phase study. During the first phase, the investigators developed a contraceptive counseling intervention based on the principles of Motivational Interviewing, trained counselors, and conducted a small pilot study to develop skills and refine the intervention.

The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes between:

Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the principles of motivational interviewing, vs.

Group 2 - Women receiving usual clinic care.

Population: Women, aged 15-29 years, presenting to the University of Chicago family planning clinic for termination of an unintended pregnancy.

Hypothesis: A larger proportion of women who are randomized to receive the MI counseling intervention will be using very effective contraception 3 months after the intervention.


Eligibility criteria: Inclusion Criteria:

1. Aged 15-29 years
2. Presenting for elective termination of an unintended pregnancy
3. Has not had contraceptive counseling from the team.
4. Willing and able to understand and comply with study protocol
5. Willing and able to sign an informed consent in English

Exclusion Criteria:

1. Current pregnancy intended
2. Current pregnancy desired
3. Reason for pregnancy termination not elective (e.g. fetal anomalies, pregnancy resulted from rape or incest)
4. Plans pregnancy within 6 months
5. Has been administered any sedatives or cervical ripening agents
6. For minors, must not be a ward of the state.

Primary outcomes:
measure: Use of very effective contraception
timeFrame: up to 3 months after termination of pregnancy appointment
Secondary outcomes:
measure: Correct, consistent use of contraceptive method
timeFrame: up to 3 months
measure: Use of any contraceptive method
timeFrame: up to 3 months
measure: Contraceptive method satisfaction
timeFrame: up to 3 months
measure: Intention to continue current method
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Amy Whitaker, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown BP, Chor J, Hebert LE, Webb ME, Whitaker AK. Shared negative experiences of long-acting reversible contraception and their influence on contraceptive decision-making: a multi-methods study. Contraception. 2019 Apr;99(4):228-232. doi: 10.1016/j.contraception.2019.01.002. Epub 2019 Jan 24.
citation: Whitaker AK, Quinn MT, Munroe E, Martins SL, Mistretta SQ, Gilliam ML. A motivational interviewing-based counseling intervention to increase postabortion uptake of contraception: A pilot randomized controlled trial. Patient Educ Couns. 2016 Oct;99(10):1663-9. doi: 10.1016/j.pec.2016.05.011. Epub 2016 May 9.