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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02093884
Other study ID # AAAM3457
Secondary ID
Status Completed
Phase N/A
First received March 19, 2014
Last updated January 18, 2017
Start date January 2014
Est. completion date March 2015

Study information

Verified date January 2017
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.


Description:

Our hypothesis is that adolescent females at high pregnancy risk who receive text message reminders and motivational messages that promote contraception and referral to the Family Planning Clinic are more likely to start effective contraception than those who receive standard paper-based referral to the Family Planning Clinic alone.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria:

- Aged 14-19 years

- Sexually active with males in the past three months

- Presenting to the ED for a reproductive health complaint.

Exclusion Criteria:

- Presently pregnant

- Too ill for participation per the attending physician

- Cognitively impaired

- In foster care or a ward of the state

- Does not speak English or Spanish

- Does not own a cellular or mobile phone with text messaging capabilities

- Used contraception at last intercourse and/or is currently using any "highly effective" or "effective" form of contraception (as defined by the World Health Organization)

- Does not live in Manhattan or the Bronx

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Text Messaging Intervention

Standard Referral


Locations

Country Name City State
United States Morgan Stanley Children's Hospital Emergency Department Manhattan New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Text messaging intervention safety Safety will be assessed during the telephone follow up. 3 months after initial enrollment
Primary Initiation of highly effective contraception, as defined by the World Health Organization. We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up. 3 months after initial enrollment
Secondary Patient visits to Family Planning Clinic We assess Family Planning Clinic visits using our electronic medical records. 3 months after initial enrollment
Secondary Follow up for contraceptive counseling to a doctor or nurse We will be asking patients during our phone call follow if they have had contraceptive counseling with any healthcare professional. We will also be looking through electronic medical records for documentation of contraceptive counseling such as by ICD-9 coding or a physician's/nurse's note. 3 months after initial enrollment
Secondary Change in pregnancy intentions We will compare pregnancy intentions elicited from the answers provided in the baseline questionnaire to those reported on the telephone follow up for both study arms. 3 months after initial enrollment
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