Improving Adolescent Adherence to Hormonal Contraception

The University of Texas Medical Branch, Galveston1,155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,155

Conditions

Contraception

Interventions

educational instruction and phone follow-upBEHAVIORAL

Educational instruction and phone follow-up.

educational instruction in clinicBEHAVIORAL

Educational instruction in clinic.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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