Contraception Navigator Program

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to pilot test the IN-Control Birth Control Navigator Program in Central Indiana for use by adolescents who would like to access birth control. The investigators hypothesize that facilitating access to contraception through our intervention will ultimately result in increased feelings of autonomy around these decisions and use of hormonal contraception.

Detailed Description
-----------------
The IN-Control Birth Control Navigator Program will provide personalized attention to adolescents and young adults and will be able to address self-efficacy skills, and abilities through personal interactions with navigator staff and use of targeted services. Importantly, the navigator can assist participants in overcoming specific environmental barriers (transportation, cost, clinical access) and personal barriers (knowledge and confidentiality concerns) before, during and after the clinical encounter.

Official Title
-----------------
IN Control: Contraception Navigator Program for Adolescents and Young Adults in Indiana

Conditions
-----------------
Contraception, Contraceptive Usage, Health Care Utilization

Intervention / Treatment
-----------------
* Behavioral: IN-Control (Birth Control Navigator Program)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents between the ages of 15-19 yrs English speaking Lives in Indiana Exclusion Criteria: Adolescents younger than 15 or older than 19 yrs Non-English speaking Lives outside of Indiana

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: All adolescents who engage with the IN-Control program will be asked if they would like to formally enroll as a study participant after interaction with the navigator; however, enrollment is not required to utilize the services of the navigator,
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pilot Study Participants<br>All adolescents who engage with the IN-Control Program will be asked if they would like to formally enroll as a study participant after interaction with the navigator. However, enrollment is not required to receive support from the navigator. | Behavioral: IN-Control (Birth Control Navigator Program)<br>* Pilot Study of IN-Control Program within the state of Indiana<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with IN Control Program (feeling comfortable, listened to, helpful, easy to contact) | Survey of participants that interacted with navigator program (percentage of participants reporting that the navigator program was easy to contact, made them feel comfortable, listened to and helpful) | Within 2-4weeks after contact with the IN-Control Program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigator Inquiries | Number of unique individuals contacting navigator program | Duration of Pilot Study, 2 years | 
| Website Utilization | Number of unique website visits | Duration of Pilot Study, 2 years | 
| Birth Control Decision Aid | Completion Rate of My Birth Control Decision Aid | Duration of Pilot Study, 2 years | 
| Contact Success Rate | number of individuals endorsing wanting additional help from navigator staff compared to the number of individuals successfully contacted by navigator staff | Duration of Pilot Study, 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Birth Control Access, Access, Navigator