- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157285
Influence of Peer Mentoring on Adolescent Contraceptive Decision Making (ImPACCT)
June 5, 2014 updated by: Courtney Schreiber, University of Pennsylvania
The Influence of Peer Mentoring on Contraceptive Decision Making Among Adolescents
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Unintended adolescent pregnancy continues to be a significant public health problem in the United States.
While the use of highly effective forms of birth control, such as the long-acting, reversible contraceptives (LARC) have been found to be more effective in decreasing pregnancy rates than non-LARC methods of birth control, knowledge and use of LARC has been shown to be low in this vulnerable population.
We are interested in better understanding the influence peers may have on contraceptive decision making among adolescents.
The purpose of this study is to evaluate the impact of a peer mentoring intervention on adolescent contraceptive decision making, specifically with regard to increasing long-acting, reversible contraceptive uptake.
The main study intervention will consist of randomization to usual contraceptive counseling versus peer-mentoring plus usual contraceptive counseling.
Pre- and post-intervention questionnaires will be used to better understand peer influence on contraceptive decision making, and to assess the peer mentor-teen intervention interaction.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine Counseling
Subjects randomized to receive routine counseling before selecting a method of contraception
|
|
|
Experimental: Peer Mentor counseling
Subjects randomized to receive peer counseling before selecting a method of contraception
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of study participants who chose long-acting reversible contraception (LARC) after all contraceptive counseling was done.
Time Frame: at enrollment/baseline visit
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who maintained LARC uptake
Time Frame: 4 months from enrollment/baseline visit
|
This data is being obtained through a brief follow-up questionnaire conducted over the phone.
|
4 months from enrollment/baseline visit
|
|
Number of participants who maintained a positive opinion of LARC method as their primary choice for birth control
Time Frame: 4 months after enrollment/baseline visit.
|
This data is being obtained through a brief follow-up questionnaire conducted over the phone.
|
4 months after enrollment/baseline visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Courtney A Schreiber, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
March 19, 2013
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Estimate)
June 6, 2014
Last Update Submitted That Met QC Criteria
June 5, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 816769
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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