Clinical trial NCT05691270: Contraception Navigator Program
Official title: IN Control: Contraception Navigator Program for Adolescents and Young Adults in Indiana
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Contraceptive Usage
Health Care Utilization
Keywords: Birth Control Access
Access
Navigator
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-01-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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,
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction with IN Control Program (feeling comfortable, listened to, helpful, easy to contact)
timeFrame: Within 2-4weeks after contact with the IN-Control Program
Secondary outcomes:
measure: Navigator Inquiries
timeFrame: Duration of Pilot Study, 2 years
measure: Website Utilization
timeFrame: Duration of Pilot Study, 2 years
measure: Birth Control Decision Aid
timeFrame: Duration of Pilot Study, 2 years
measure: Contact Success Rate
timeFrame: Duration of Pilot Study, 2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References:
citation: 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.
citation: 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.