Contraceptive Awareness and Reproductive Education

Study Overview
=================
Brief Summary
-----------------
The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.

Detailed Description
-----------------
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 325 at risk youth from Juvenile Justice programs, alternative schools, group homes, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.

Official Title
-----------------
Contraceptive Awareness and Reproductive Education

Conditions
-----------------
Pregnancy, Sexually Transmitted Infections

Intervention / Treatment
-----------------
* Behavioral: Motivational Intervention
* Behavioral: Didactic Educational Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Age 14-21; 2) Currently sexually active with males defined as having had coital sex and intending to have coital sex within the next 6 months; 3) Willing to comply with protocol, follow-up assessments, and provide at least one locator; and 4) Fluent in English. Exclusion Criteria: 1) Inability to give informed consent secondary to organic brain dysfunction, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that preclude participation in assessment or counseling); 2) Girls who are not sexually active; or 3) Currently pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Intervention<br>There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. | Behavioral: Motivational Intervention<br>* There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.<br>* Other names: Motivational Interviewing (MI);|
| Active Comparator: Didactic Educational Intervention<br>There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. | Behavioral: Didactic Educational Intervention<br>* There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.<br>* Other names: Awareness of Sexual Health (ASH);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. | Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective. | 9 month follow-up | 
| Number of Participants With a Positive STI Test After A Baseline Negative Test. | Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection. | 9 month follow-up | 
| Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. | Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months. | 9 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Positive Pregnancy Test After Baseline Assessment | The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks. | 9 month follow up | 
| Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs. | Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported. | 9 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, STI prevention, adolescents, probation