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Contraception Navigator Program

NCT ID: NCT05691270

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2025-11-01

Brief Summary

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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

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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.

Conditions

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Contraception Contraceptive Usage Health Care Utilization

Keywords

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Birth Control Access Access Navigator

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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,
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

IN-Control (Birth Control Navigator Program)

Intervention Type BEHAVIORAL

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

Interventions

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IN-Control (Birth Control Navigator Program)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Tracey Wilkinson

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35562301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36540664 (View on PubMed)

Related Links

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http://www.in-control.me

Program Website

Other Identifiers

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5K23HD094853-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1801682245

Identifier Type: -

Identifier Source: org_study_id