Contraception Navigator Program

Not Applicable

Recruiting

• Conditions: Contraceptive Usage; Health Care Utilization; Contraception
• Interventions: Behavioral: IN-Control (Birth Control Navigator Program)

• Registration Number: NCT05691270
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-20
• Study Start: 2023-06-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot Study Participants	IN-Control (Birth Control Navigator Program)	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.

Primary Outcome Measures

Name	Time	Method
Satisfaction with IN Control Program (feeling comfortable, listened to, helpful, easy to contact)	Within 2-4weeks after contact with the IN-Control Program	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States