Contraception Navigator Program

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691270
• Other study ID #: 1801682245
• Secondary ID: 5K23HD094853-04
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraceptive Usage
• Health Care Utilization

Intervention

Behavioral:
• IN-Control (Birth Control Navigator Program)
Pilot Study of IN-Control Program within the state of Indiana

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wilkinson TA, Hawryluk B, Moore C, Peipert JF, Carroll AE, Wiehe S, Fortenberry JD. A human-centered designed outreach strategy for a youth contraception navigator program. PEC Innov. 2022 Dec;1:100093. doi: 10.1016/j.pecinn.2022.100093. Epub 2022 Oct 18. — View Citation

Wilkinson TA, Hawryluk B, Moore C, Peipert JF, Carroll AE, Wiehe S, Fortenberry JD. Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach. J Adolesc Health. 2022 Aug;71(2):217-225. doi: 10.1016/j.jadohealth.2022.03.005. Epub 2022 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Navigator Inquiries	Number of unique individuals contacting navigator program	Duration of Pilot Study, 2 years
Secondary	Website Utilization	Number of unique website visits	Duration of Pilot Study, 2 years
Secondary	Birth Control Decision Aid	Completion Rate of My Birth Control Decision Aid	Duration of Pilot Study, 2 years
Secondary	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

External Links

•   Program Website