Improving Adolescent Adherence to Hormonal Contraception

May 23, 2013 updated by: The University of Texas Medical Branch, Galveston
The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1155

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

  • United States
    • Texas
      • Galveston, Texas, United States, 77555-0587
        • The University of Texas Medical Branch

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

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.

Exclusion criteria:

  • Women who are currently pregnant or breastfeeding.
  • Women who wish to become pregnant within the next 12 months.
  • Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
  • Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
  • Current and previous users of oral contraceptives.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1 Standard Care (SC)
Participants receive usual contraceptive care administered by clinic provider.
Other: 2 Standard Care + Educational (SCE)
Participants receive standard contraceptive care from clinic provider, followed by 45-minute educational intervention.
Behavioral: educational instruction in clinic
Educational instruction in clinic.
Other: 3 Standard Care + Educational + Phone Calls (SCEP)
Participants receive standard contraceptive care from clinic provider, followed by phone calls weekly until onset of menses and monthly thereafter for six consecutive months.
Behavioral: educational instruction and phone follow-up
Educational instruction and phone follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of contraceptive adherence
Time Frame: 12 months
12 months
Measurement of dual method use
Time Frame: 12 months
12 months
Measurement of pregnancy rates and sexually transmitted diseases (STDs)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of contraceptive side effects
Time Frame: 12 months
12 months
Measurement of satisfaction with method
Time Frame: 12 months
12 months
Measurement of sexual activity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Abbey B. Berenson, MD, The University of Texas Medical Branch, Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-060
  • R40MC06634

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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