Contraception Navigator Program

February 26, 2026 updated by: Tracey Wilkinson, Indiana University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied
Time Frame: Within 2-4weeks after contact with the IN-Control Program
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Navigator Inquiries
Time Frame: Duration of Pilot Study, 2 years
Number of unique individuals contacting navigator program
Duration of Pilot Study, 2 years
Website Utilization
Time Frame: Duration of Pilot Study, 2 years
Number of unique website visits
Duration of Pilot Study, 2 years
Birth Control Decision Aid
Time Frame: Duration of Pilot Study, 2 years
Completion Rate of My Birth Control Decision Aid
Duration of Pilot Study, 2 years
Contact Success Rate
Time Frame: 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
Duration of Pilot Study, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1801682245
  • 5K23HD094853-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is no current plan to share the data with any other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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