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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HD094853-04 | U.S. NIH Grant/Contract | View source |
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Target recruitment was not achieved prior to funding end.
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-Control (Birth Control Navigator Program) | Behavioral | Pilot Study of IN-Control Program within the state of Indiana |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Within 2-4weeks after contact with the IN-Control Program |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35562301 | Background | 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. | |
| 36540664 | Background | 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. |
| Label | URL |
|---|---|
| Program Website | View source |
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There is no current plan to share the data with any other researchers.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. IN-Control (Birth Control Navigator Program): Pilot Study of IN-Control Program within the state of Indiana |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Participants that consented to research cohort. | Posted | Count of Participants | Participants | Within 2-4weeks after contact with the IN-Control Program |
|
Adverse event data was collected through a participant's study completion, up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. IN-Control (Birth Control Navigator Program): Pilot Study of IN-Control Program within the state of Indiana |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracey Wilkinson | Indiana University School of Medicine | 3172780552 | tracwilk@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2018 | Feb 17, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2022 | Jan 14, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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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,
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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