NCT02093884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

March 19, 2014

Last Update Submit

January 18, 2017

Conditions

Pregnancy

Keywords

PregnancyPregnancy, unplannedReproductive behaviorPregnancy in AdolescenceText messaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient visits to Family Planning Clinic

    3 months after initial enrollment

  • Follow up for contraceptive counseling to a doctor or nurse

    3 months after initial enrollment

  • Change in pregnancy intentions

    3 months after initial enrollment

Other Outcomes (1)

  • Text messaging intervention safety

    3 months after initial enrollment

Study Arms (2)

Text Messaging Intervention

EXPERIMENTAL

Patients in the text messaging group will receive educational and motivational text messages.

Other: Text Messaging Intervention

Standard Referral

ACTIVE COMPARATOR

Patients in the standard referral arm will receive paper based information about the Family Planning Clinic.

Other: Standard Referral

Interventions

Text Messaging InterventionOTHER
Text Messaging Intervention
Standard ReferralOTHER
Standard Referral

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 14-19 years
  • Sexually active with males in the past three months
  • Presenting to the ED for a reproductive health complaint.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morgan Stanley Children's Hospital Emergency Department

Manhattan, New York, 10032, United States

Location

Related Publications (1)

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PMID: 32779730DERIVED

MeSH Terms

Conditions

Reproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lauren Chernick, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 21, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)