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Improving Adolescent Adherence to Hormonal Contraception

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584038
First Posted: January 2, 2008
Last Update Posted: May 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose
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.

Condition Intervention
Contraception Behavioral: educational instruction and phone follow-up Behavioral: educational instruction in clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Adolescent Adherence to Hormonal Contraception

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Measurement of contraceptive adherence [ Time Frame: 12 months ]
  • Measurement of dual method use [ Time Frame: 12 months ]
  • Measurement of pregnancy rates and sexually transmitted diseases (STDs) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Measurement of contraceptive side effects [ Time Frame: 12 months ]
  • Measurement of satisfaction with method [ Time Frame: 12 months ]
  • Measurement of sexual activity [ Time Frame: 12 months ]

Enrollment: 1155
Study Start Date: January 2006
Study Completion Date: March 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 Standard Care (SC)
Participants receive usual contraceptive care administered by clinic provider.
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584038


Locations
United States, Texas
The University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Abbey B. Berenson, MD The University of Texas Medical Branch, Galveston
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00584038     History of Changes
Other Study ID Numbers: 06-060
R40MC06634
First Submitted: December 20, 2007
First Posted: January 2, 2008
Last Update Posted: May 24, 2013
Last Verified: May 2013

Keywords provided by The University of Texas Medical Branch, Galveston:
contraceptive compliance
educational intervention
oral contraception

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs