Improving Adolescent Adherence to Hormonal Contraception

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00584038
First received: December 20, 2007
Last updated: May 23, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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, Galveston:

Primary Outcome Measures:
  • Measurement of contraceptive adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measurement of dual method use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measurement of pregnancy rates and sexually transmitted diseases (STDs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of contraceptive side effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measurement of satisfaction with method [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measurement of sexual activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 24 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584038

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

No publications provided by The University of Texas, Galveston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00584038     History of Changes
Other Study ID Numbers: 06-060, R40MC06634
Study First Received: December 20, 2007
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014