Improving Adolescent Adherence to Hormonal Contraception

The University of Texas System (UT)

Status: Completed

Conditions: Contraception

Treatments: Behavioral: educational instruction in clinic; Behavioral: educational instruction and phone follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT00584038

R40MC06634

06-060

Details and patient eligibility

About

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.

Enrollment: 1,155 patients

Sex: Female

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

1,155 participants in 3 patient groups

1 Standard Care (SC)

No Intervention group

Description:

Participants receive usual contraceptive care administered by clinic provider.

2 Standard Care + Educational (SCE)

Other group

Description:

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

Treatment:

Behavioral: educational instruction in clinic

3 Standard Care + Educational + Phone Calls (SCEP)

Other group

Description:

Participants receive standard contraceptive care from clinic provider, followed by phone calls weekly until onset of menses and monthly thereafter for six consecutive months.

Treatment:

Behavioral: educational instruction and phone follow-up