Improving Adolescent Adherence to Hormonal Contraception

Study Overview
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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.

Official Title
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Improving Adolescent Adherence to Hormonal Contraception

Conditions
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Contraception

Intervention / Treatment
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* Behavioral: educational instruction and phone follow-up
* Behavioral: educational instruction in clinic


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1 Standard Care (SC)<br>Participants receive usual contraceptive care administered by clinic provider. | |
| Other: 2 Standard Care + Educational (SCE)<br>Participants receive standard contraceptive care from clinic provider, followed by 45-minute educational intervention. | Behavioral: educational instruction in clinic<br>* Educational instruction in clinic.<br>|
| Other: 3 Standard Care + Educational + Phone Calls (SCEP)<br>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<br>* Educational instruction and phone follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of contraceptive adherence |  | 12 months | 
| Measurement of dual method use |  | 12 months | 
| Measurement of pregnancy rates and sexually transmitted diseases (STDs) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of contraceptive side effects |  | 12 months | 
| Measurement of satisfaction with method |  | 12 months | 
| Measurement of sexual activity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraceptive compliance, educational intervention, oral contraception