NCT02157285

Brief Summary

This is a prospective, randomized-controlled trial in which subjects will be randomized to receive either routine contraceptive counseling or peer mentoring plus routine contraceptive counseling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 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

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

March 19, 2013

Last Update Submit

June 5, 2014

Conditions

Keywords

Unintended pregnancy in adolescenceLARCcontraception

Outcome Measures

Primary Outcomes (1)

  • Number of study participants who chose long-acting reversible contraception (LARC) after all contraceptive counseling was done.

    This data was obtained by the number of participants who chose to have an IUD or Implant inserted after counseling at their clinic visit.

    at enrollment/baseline visit

Secondary Outcomes (2)

  • Number of participants who maintained LARC uptake

    4 months from enrollment/baseline visit

  • Number of participants who maintained a positive opinion of LARC method as their primary choice for birth control

    4 months after enrollment/baseline visit.

Study Arms (2)

Routine Counseling

NO INTERVENTION

Subjects randomized to receive routine counseling before selecting a method of contraception

Peer Mentor counseling

EXPERIMENTAL

Subjects randomized to receive peer counseling before selecting a method of contraception

Behavioral: Peer Mentor Counseling

Interventions

Peer mentoring will entail the peer mentor describing her positive experience with her LARC method. The participant will then have a chance to ask any experience related questions to the mentor. Any clinical inquiries or questions the mentor does not feel comfortable answering, she will defer to the contraceptive counselor/ physician who will be subsequently providing the routine counseling. The entire peer mentor encounter should not last more than 10 minutes.

Peer Mentor counseling

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Female
  • Age 13-21 years old at enrollment
  • Desiring contraception; either currently not taking any method of contraception, or not satisfied with current method, and not desiring pregnancy in the next 12 months
  • Willing and able to follow the study protocol

You may not qualify if:

  • Male gender
  • Younger than 13 years old, older than 21 years old
  • Pregnant or desiring pregnancy within the coming year
  • Issues or concerns in the judgement of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Courtney A Schreiber, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Fellowship in Family Planning

Study Record Dates

First Submitted

March 19, 2013

First Posted

June 5, 2014

Study Start

February 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations