NCT01641380

Brief Summary

While there have been major declines in teenage pregnancy around the country, Baltimore, Maryland has continued to experience increases over the last several years. Access and adherence to contraception has been found to be a major contributor to declines in teen pregnancy worldwide. The aim of this proof of concept pilot project is to determine preliminary efficacy of the DepoText Intervention. We will randomize urban adolescent girls who have elected Depo-Provera for ongoing contraception to receive either standard counseling and clinic appointment reminders or a text messaging (DepoTEXT) follow-up intervention. Participants in the DepoTEXT intervention will receive reminders for clinic visits and encouraging messages each month for STI prevention. The primary outcome is the preliminary efficacy for improving appointment adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 20, 2018

Completed
Last Updated

March 2, 2021

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

July 10, 2012

Results QC Date

January 1, 2016

Last Update Submit

February 8, 2021

Conditions

Contraceptive Behavior

Keywords

DepoproveraContraceptionAppointment adherence/attendancePregnancy Prevention

Outcome Measures

Primary Outcomes (2)

  • Appointment Adherence (Efficacy)

    Participants who returned on-time for appointments

    9 months

  • Responsiveness to Appointment Messages

    Overall responsiveness to delivery confirmation requests with A) Appointment messages and B) Informational Messages

    9 months

Secondary Outcomes (1)

  • Proportion of Patients Satisfied With Messaging Service

    9 months

Other Outcomes (1)

  • Acceptability

    Baseline Recruitment

Study Arms (2)

Control

NO INTERVENTION

Adolescents in the Control Arm received standard of care. They continue to receive the DepoProvera injections through scheduled appointment, but would not receive a call from the nurse case manager regarding DepoProvera appointments until they have missed their scheduled DepoProvera appointment.

Text Messaging Intervention

EXPERIMENTAL

Adolescents in the intervention arm receive text message reminders for appointments and positive sexual health messages regarding use of DepoProvera in between scheduled appointments. They are encouraged to seek care for assistance with obtaining condoms and/or if they are having problems with the medication.

Behavioral: Text Messaging Intervention

Interventions

Text Messaging InterventionBEHAVIORAL

1. Online enrollment in the Compliance for Life® (CFL) system through iReminder) 2. Welcome Message 24 hrs after enrollment 3. Appointment Reminder prior to 3 month injection cycles 4. Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder 6.Call for missed appointment or no reply to appointment reminder (or other text message)

Also known as: Compliance for Life®
Text Messaging Intervention

Eligibility Criteria

Age13 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Selected Depo-Provera for ongoing contraception
  • Have a cell phone with text messaging capacity for personal use, and
  • Agree to be randomized

You may not qualify if:

  • Adolescent girls using other forms of contraception
  • Adolescents who do not have a cell phone w/ text messaging capability for personal use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

Related Links

MeSH Terms

Conditions

Contraception Behavior

Interventions

Compliance

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

ElasticityMechanical PhenomenaPhysical Phenomena

Limitations and Caveats

1\) Limited generalizability 2) Pilot study not powered to measure longitudinal efficacy; however, the preliminary data support expansion. 3) Data on duration of Depo- Provera use were not captured in enrollment data.

Results Point of Contact

Title
Maria Trent, MD, MPH, Principal Investigator
Organization
Johns Hopkins University School of Medicine
mtrent2@jhmi.edu
443-287-8945

Study Officials

  • Maria Trent, MD, MPH

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 16, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

September 1, 2017

Last Updated

March 2, 2021

Results First Posted

December 20, 2018

Record last verified: 2019-01

Locations

US(1)