ClinicalTrials.gg
TerminatedNCT05691270Updated Mar 19, 2026Results posted

Contraception Navigator Program

An interventional study of IN-Control (Birth Control Navigator Program) in Contraception, Contraceptive Usage and Health Care Utilization, sponsored by Indiana University. Terminated at 1 site in United States. Open to female participants aged 15 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Indiana University · Not applicable, Interventional, and Health services research

Why this study was terminated
Target recruitment was not achieved prior to funding end.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
15 Years to 19 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Contraception
  • Contraceptive Usage
  • Health Care Utilization

Keywords

  • Birth Control Access
  • Access
  • Navigator
03

In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's enrollment of 18 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Adolescents younger than 15 or older than 19 yrs
  • Non-English speaking
  • Lives outside of Indiana
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralIN-Control (Birth Control Navigator Program)

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

06

What researchers measure

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)

    Time frame: Within 2-4weeks after contact with the IN-Control Program

07

Results

Posted Mar 19, 2026

Participant flow

During the project period, 136,069 total website visits occurred, and 101 users initiated the Decision Aid tool and 8 completed it. From those visits, 35 individuals requested navigator support, and program staff were able to successfully connect with 30 of them. All adolescents who engaged with the navigator program were asked if they would like to participate in the study after navigator assistance was completed. Eighteen (18) then agreed to participate in the pilot study.

Participant flow — Overall Study
MilestonePilot Study Participants
Started18
Completed18
Not completed0

Outcome measures

PrimaryNumber 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)

Time frame:
Within 2-4weeks after contact with the IN-Control Program
Reported as:
Count of participants · Participants
Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied
ParticipantsPilot Study Participants
Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied17

Adverse events

Collected over Adverse event data was collected through a participant's study completion, up to 1 year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pilot Study Participants0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pilot Study Participants
<=18 years13
Between 18 and 65 years5
>=65 years0
Age, Continuous
Age, Continuous(years)Pilot Study Participants
Mean17.3 (15 to 19)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Pilot Study Participants
Reported Gender — Non-Binary1
Reported Gender — Missing2
Reported Gender — Female15
Reported Gender — Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pilot Study Participants
Hispanic or Latino7
Not Hispanic or Latino10
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pilot Study Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American6
White5
More than one race3
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)Pilot Study Participants
United States18
08

Study locations

1 site
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
09

References and documents

Publications

  • 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. PubMed 35562301 ↗
  • 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. PubMed 36540664 ↗

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — There is no current plan to share the data with any other researchers.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jul 2024, 13 months.

Results were first posted in Mar 2026, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2022
First posted
Jan 20, 2023
StartActual
Jun 28, 2023
Primary completionActual
Jul 31, 2024
CompletionActual
Jul 31, 2024
Results first posted
Mar 19, 2026
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05691270
Lead sponsor
Indiana University
Responsible party
Tracey Wilkinson (Assistant Professor of Pediatrics, Indiana University) — Principal investigator
First posted
Jan 20, 2023
Start date
Jun 28, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Results posted
Mar 19, 2026
Last update
Mar 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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