NCT05691270

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

November 23, 2022

Results QC Date

January 26, 2026

Last Update Submit

February 26, 2026

Conditions

ContraceptionContraceptive UsageHealth Care Utilization

Keywords

Birth Control AccessAccessNavigator

Outcome Measures

Primary Outcomes (1)

  • Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied

    Survey of participants that interacted with navigator program (number 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

Study Arms (1)

Pilot Study Participants

OTHER

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)

Interventions

IN-Control (Birth Control Navigator Program)BEHAVIORAL

Pilot Study of IN-Control Program within the state of Indiana

Pilot Study Participants

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents between the ages of 15-19 yrs
  • English speaking
  • Lives in Indiana

You may not qualify if:

  • Adolescents younger than 15 or older than 19 yrs
  • Non-English speaking
  • Lives outside of Indiana

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • 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.

    PMID: 35562301BACKGROUND

  • 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.

    PMID: 36540664BACKGROUND

Related Links

MeSH Terms

Conditions

Contraception BehaviorPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorTreatment Adherence and ComplianceHealth Behavior

Results Point of Contact

Title
Tracey Wilkinson
Organization
Indiana University School of Medicine
tracwilk@iu.edu
3172780552

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

November 23, 2022

First Posted

January 20, 2023

Study Start

June 28, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

March 19, 2026

Results First Posted

March 19, 2026

Record last verified: 2026-02

Locations

US(1)