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Contraception Navigator Program

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05691270
Enrollment
18
Registered
2023-01-20
Start date
2023-06-28
Completion date
2024-07-31
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Contraceptive Usage, Health Care Utilization

Keywords

Birth Control Access, Access, Navigator

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.

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.

Interventions

BEHAVIORALIN-Control (Birth Control Navigator Program)

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

Sponsors

Indiana University
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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,

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling SatisfiedWithin 2-4weeks after contact with the IN-Control ProgramSurvey 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)

Countries

United States

Participant flow

Recruitment details

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.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
13 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
Age, Continuous17.3 years
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
6 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
18 participants
Sex/Gender, Customized
Reported Gender
Female
15 Participants
Sex/Gender, Customized
Reported Gender
Male
0 Participants
Sex/Gender, Customized
Reported Gender
Missing
2 Participants
Sex/Gender, Customized
Reported Gender
Non-Binary
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 18
other
Total, other adverse events
0 / 18
serious
Total, serious adverse events
0 / 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026