Contraception Navigator Program

• Sponsor: Indiana University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05691270
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception; Contraceptive Usage; Health Care Utilization	Behavioral: IN-Control (Birth Control Navigator Program)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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,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)
• Primary Purpose: Health Services Research
• Official Title: IN Control: Contraception Navigator Program for Adolescents and Young Adults in Indiana
• Anticipated Study Start Date: Jan 23, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Pilot Study Participants 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); Pilot Study of IN-Control Program within the state of Indiana

Outcome Measures

Primary Outcome Measures

1. 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

1. Navigator Inquiries [Duration of Pilot Study, 2 years]

   Number of unique individuals contacting navigator program

2. Website Utilization [Duration of Pilot Study, 2 years]

   Number of unique website visits

3. Birth Control Decision Aid [Duration of Pilot Study, 2 years]

   Completion Rate of My Birth Control Decision Aid

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 19 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adolescents between the ages of 15-19yrs

• English speaking

• Lives within central Indiana couties: Boone, Brown, Hamilton, Hancock, Hendricks, Johnson, Marion, Morgan, Putnam and Shelby (determined by zip code of primary -

Exclusion Criteria:

• Adolescents younger than 15 or older than 19yrs

• Non-English speaking

• Lives outside of central Indiana

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Dec 13, 2022

More Information

Additional Information:

• Program Website

Publications

• 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.
• 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.

• Responsible Party: Tracey Wilkinson, Assistant Professor of Pediatrics, Indiana University
• ClinicalTrials.gov Identifier: NCT05691270
• Other Study ID Numbers: 1801682245
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 20, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tracey Wilkinson, Assistant Professor of Pediatrics, Indiana University: Birth Control Access; Access; Navigator

Study Results

No Results Posted as of Jan 20, 2023