ContraceptionNCT05691270
Contraception Navigator Program
A study of Contraception and Contraceptive Usage, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 19 years, women only
- Conditions the study is for
- Contraception, Contraceptive Usage, Health Care Utilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents between the ages of 15-19 yrs
- English speaking
- Lives in Indiana
Who cannot join
- Adolescents younger than 15 or older than 19 yrs
- Non-English speaking
- Lives outside of Indiana
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: 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.
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.
- Conditions
- Contraception, Contraceptive Usage, Health Care Utilization
- Being tested
- IN-Control (Birth Control Navigator Program)
- Keywords
- Birth Control Access, Access, Navigator
- Medical subject headings
- Contraception Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-Control (Birth Control Navigator Program)Behavioural
Pilot Study of IN-Control Program within the state of Indiana
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: IN-Control (Birth Control Navigator Program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 2-4weeks after contact with the IN-Control Program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start28 Jun 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Target recruitment was not achieved prior to funding end.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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,
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tracey Wilkinson, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691270
- Sponsor's protocol ID
- 1801682245
- Other IDs
- 5K23HD094853-04
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2022
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no current plan to share the data with any other researchers.
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 35562301Wilkinson 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN Control: Contraception Navigator Program for Adolescents and Young Adults in Indiana
- ClinicalTrials.gov ID
- NCT05691270
- Acronym / sponsor ID
- 1801682245
- Conditions
- Contraception, Contraceptive Usage, Health Care Utilization
- Keywords
- Birth Control Access, Access, Navigator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target recruitment was not achieved prior to funding end.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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,
| Arm | Type | Receives |
|---|---|---|
| Pilot Study Participants | Other | Behavioral: IN-Control (Birth Control Navigator Program)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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents between the ages of 15-19 yrs
- English speaking
- Lives in Indiana
Key exclusion criteria (3 listed)
- Adolescents younger than 15 or older than 19 yrs
- Non-English speaking
- Lives outside of Indiana
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN-Control (Birth Control Navigator Program)Pilot Study of IN-Control Program within the state of Indiana | Behavioural | Pilot Study Participants |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35562301Wilkinson 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.
- Background: PubMed 36540664Wilkinson 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.
- Program WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. There is no current plan to share the data with any other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Contraception and Contraceptive Usage, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.