Improving Adolescent Adherence to Hormonal Contraception
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|ClinicalTrials.gov Identifier: NCT00584038|
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Behavioral: educational instruction and phone follow-up Behavioral: educational instruction in clinic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1155 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Adolescent Adherence to Hormonal Contraception|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||March 2012|
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.
- 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 ]
- 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 ]
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
|United States, Texas|
|The University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0587|
|Principal Investigator:||Abbey B. Berenson, MD||The University of Texas Medical Branch, Galveston|