Improving Adolescent Adherence to Hormonal Contraception - Full Text View

Sponsored by:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00584038

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:	Prevention, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment, Efficacy Study
Official Title:	Improving Adolescent Adherence to Hormonal Contraception

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

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 ]

Estimated Enrollment:	1400
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Standard Care (SC): No Intervention 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 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

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

Responsible Party:	The University of Texas Medical Branch, Galveston TX ( Abbey B. Berenson, MD; Principal Investigator )
Study ID Numbers:	06-060, R40MC06634
Study First Received:	December 20, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00584038 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

contraceptive compliance
educational intervention
oral contraception

Study placed in the following topic categories:

Contraceptive Agents

ClinicalTrials.gov processed this record on September 10, 2009