Improving Adolescent Adherence to Hormonal Contraception

NCT ID: NCT00584038

Last Updated: 2013-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1 Standard Care (SC)

Participants receive usual contraceptive care administered by clinic provider.

Group Type NO_INTERVENTION

No interventions assigned to this group

2 Standard Care + Educational (SCE)

Participants receive standard contraceptive care from clinic provider, followed by 45-minute educational intervention.

Group Type OTHER

educational instruction in clinic

Intervention Type BEHAVIORAL

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.

Group Type OTHER

educational instruction and phone follow-up

Intervention Type BEHAVIORAL

Educational instruction and phone follow-up.

Interventions

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educational instruction and phone follow-up

Educational instruction and phone follow-up.

Intervention Type BEHAVIORAL

educational instruction in clinic

Educational instruction in clinic.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbey B. Berenson, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston

Locations

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The University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

References

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Berenson AB, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception. 2012 Dec;86(6):716-24. doi: 10.1016/j.contraception.2012.06.007. Epub 2012 Jul 25.

Reference Type DERIVED
PMID: 22840278 (View on PubMed)

Other Identifiers

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R40MC06634

Identifier Type: -

Identifier Source: secondary_id

06-060

Identifier Type: -

Identifier Source: org_study_id

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