Trial Outcomes & Findings for Contraception Navigator Program (NCT NCT05691270)

NCT ID: NCT05691270

Last Updated: 2026-03-19

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

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

Results posted on

2026-03-19

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 milestones

Participant milestones
Measure
Pilot Study Participants
All adolescents who engaged with the Youth Contraception Navigator (YCN) program will be asked if they would like to formally enroll as a study participant after completion of the My Birth Control decision aid. Interested adolescents will be screened for eligibility online and then contacted to provide verbal assent for participation. Adolescents who do not wish to formally enroll as a study participant will still be able to utilize the services of the YCN, however, no additional data will be collected.
Overall Study
STARTED
18
Overall Study
COMPLETED
18
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contraception Navigator Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pilot Study Participants
n=18 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. IN-Control (Birth Control Navigator Program): Pilot Study of IN-Control Program within the state of Indiana
Age, Categorical
<=18 years
13 Participants
n=110 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=110 Participants
Age, Categorical
>=65 years
0 Participants
n=110 Participants
Age, Continuous
17.3 years
n=110 Participants
Sex/Gender, Customized
Reported Gender · Non-Binary
1 Participants
n=110 Participants
Sex/Gender, Customized
Reported Gender · Missing
2 Participants
n=110 Participants
Sex/Gender, Customized
Reported Gender · Female
15 Participants
n=110 Participants
Sex/Gender, Customized
Reported Gender · Male
0 Participants
n=110 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=110 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=110 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=110 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=110 Participants
Race (NIH/OMB)
Asian
0 Participants
n=110 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=110 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=110 Participants
Race (NIH/OMB)
White
5 Participants
n=110 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=110 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=110 Participants
Region of Enrollment
United States
18 participants
n=110 Participants

PRIMARY outcome

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

Population: Participants that consented to research cohort.

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)

Outcome measures

Outcome measures
Measure
Pilot Study Participants
n=18 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. IN-Control (Birth Control Navigator Program): Pilot Study of IN-Control Program within the state of Indiana
Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied
17 Participants

Adverse Events

Pilot Study Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracey Wilkinson

Indiana University School of Medicine

Phone: 3172780552

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place