Birth Control Navigation Program for Birth Control Access

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Age, Language, Location

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program to help teens in Central Indiana access birth control more easily. The aim is to determine if a dedicated person, called a navigator, can simplify the process for teens to obtain and use birth control, while also enhancing their sense of control over these choices. English-speaking teens aged 15 to 19 living in Indiana who seek better access to birth control may find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for improving teen access to birth control.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the IN-Control Birth Control Navigator Program is safe for adolescents?

Research shows that the IN-Control Birth Control Navigator Program is a new method developed with input from teenagers, ensuring it addresses their needs. This program does not involve taking medicine or undergoing medical procedures. Instead, it assists young people in obtaining birth control and making informed decisions about it.

As a support program rather than a medical treatment, it has no reports of physical side effects. Participants in similar programs have found them helpful for understanding their options without health risks. Therefore, the usual safety concerns of drug trials, such as side effects, do not apply here. The program focuses on providing information and support, which is generally safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IN-Control program because it offers a fresh approach to improving birth control access for adolescents. Unlike traditional methods that might focus solely on providing contraceptives, IN-Control emphasizes a personalized navigation system that guides young individuals through their birth control options with tailored support. This unique feature aims to empower adolescents by helping them make informed decisions, potentially increasing the effectiveness and satisfaction of their birth control choice. By addressing the personal and logistical barriers to accessing contraception, the IN-Control program stands out as a promising method to enhance reproductive health for young people.

What evidence suggests that the IN-Control Birth Control Navigator Program is effective for improving birth control access?

Research has shown that the IN-Control Birth Control Navigator Program improves teens' access to birth control through personalized support. This trial will evaluate the program's effectiveness in assisting adolescents. Studies indicate that the program helps young people overcome challenges in obtaining birth control. By working with trained guides, participants feel more in control and confident about their birth control choices. Early results suggest that this approach leads to better use of hormonal birth control among teens. The program was designed with input from young people to better meet their needs. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking teenagers aged 15-19 who live in specific counties of Central Indiana. It's designed to help them access birth control and increase their autonomy in making related decisions. Teens not within this age range, non-English speakers, or those living outside the specified Indiana counties cannot participate.

Inclusion Criteria

I am between 15 and 19 years old.

English speaking

Lives in Indiana

Exclusion Criteria

I am either younger than 15 or older than 19 years old.

Lives outside of Indiana

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the IN-Control Birth Control Navigator Program to receive personalized attention and support in accessing contraception.

2 years

Follow-up

Participants are monitored for satisfaction and effectiveness of the IN-Control Program, including feelings of autonomy and use of hormonal contraception.

2-4 weeks after contact

What Are the Treatments Tested in This Trial?

Interventions

• IN-Control

Trial Overview The IN-Control Birth Control Navigator Program is being tested to see if it helps adolescents feel more in control of their contraception choices and increases the use of hormonal birth control by providing easier access.

How Is the Trial Designed?

Group I: Pilot Study Participants Experimental Treatment 1 Intervention

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 is already approved in United States for the following indications:

Approved in United States as IN-Control Birth Control Navigator Program for:

• Access to contraception for adolescents

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A contraception navigator program designed for adolescents in central Indiana emphasizes the importance of building trust and addressing patient-specific barriers to contraception access, as identified through co-design sessions with 35 adolescents and 11 community stakeholders.

Key elements of the program include providing various communication methods and support for understanding contraceptive side effects, which are crucial for making the process of obtaining contraception less intimidating for young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach. Wilkinson, TA., Hawryluk, B., Moore, C., et al.[2023]

A study involving 949 young women at family planning clinics in Chicago and Madison showed that a computer-based contraceptive decision aid was well-accepted and improved knowledge and confidence regarding oral contraceptive efficacy.

Patients in Madison who used the decision aid had better long-term knowledge about oral contraceptives and a trend towards fewer pregnancies, while those in Chicago were more likely to adopt oral contraceptives after expressing their intention to do so.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a computerized contraceptive decision aid for adolescent patients. Chewning, B., Mosena, P., Wilson, D., et al.[2019]

The use of the 'My Birth Control' decision support tool in contraceptive counseling led to more patient-centered discussions, with providers focusing on multiple methods of interest rather than just directing patients to one option.

Patients reported gaining knowledge from the tool, indicating its effectiveness in enhancing understanding and engagement during counseling sessions, without requiring extensive training for providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. Holt, K., Kimport, K., Kuppermann, M., et al.[2020]

A study of 1,036 US women of reproductive age found that factors like contraceptive knowledge, insurance coverage, and engagement with healthcare providers significantly influence access to preferred contraceptive methods.

Access to preferred contraceptive methods was linked to the use of more effective contraception and a reduced likelihood of unintended pregnancies, highlighting the importance of improving access to contraception for better family planning outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to reproductive autonomy: Using path analysis to predict family planning outcomes in the United States. Swan, LET., McDonald, SE., Price, SK.[2023]

Among 428 abortion patients, 68% expressed a desire for contraceptive counseling, which led to a change in contraceptive preference for 34% of participants, particularly benefiting low-income eligible individuals who were able to access more effective methods.

High-quality contraceptive counseling significantly improved 1-year contraceptive continuation rates for low-income eligible participants, but this benefit was not observed for those ineligible for no-cost methods, highlighting the importance of access to affordable contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of contraceptive counseling on Texans who can and cannot receive no-cost post-abortion contraception. Goyal, V., Madison, AM., Powers, DA., et al.[2022]

The outreach strategy for the youth contraception navigator program, named 'IN Control', was developed using a human-centered design approach, engaging adolescents aged 15-17 to ensure the messages resonate with their needs and experiences.

Key elements of the strategy include normalizing conversations about birth control, acknowledging access challenges, and using diverse imagery to build trust, which are crucial for effectively reaching and influencing young people's behavior regarding contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human-centered designed outreach strategy for a youth contraception navigator program. Wilkinson, TA., Hawryluk, B., Moore, C., et al.[2022]

New contraceptive options, such as a vaginal ring, transdermal patch, progestin-only pill, and spermicide, are being introduced to provide more choices for individuals capable of becoming pregnant.

Future contraceptive technologies are expected to be highly effective, user-friendly, cost-efficient, and well-tolerated, emphasizing the importance of patient choice and reproductive autonomy during counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive Technology: Present and Future. Gilbert, AL., Hoffman, BL.[2021]

The My Birth Control decision support tool did not significantly improve contraceptive continuation rates after 7 months, with continuation rates of 56.6% for the intervention group and 59.6% for the control group.

However, the tool enhanced the quality of the contraceptive counseling experience, leading to higher scores in interpersonal quality, informed decision-making, and contraceptive knowledge among users compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Dehlendorf, C., Fitzpatrick, J., Fox, E., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05691270?term=contraceptive%20OR%20birth%20control%20AND%20NICHD&viewType=Table&rank=9

NCT05691270 | Contraception Navigator Program 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329236/

Developing a Youth Contraception Navigator Program A contraception navigator program that provides a personalized approach to overcoming patient-specific barriers by a trained navigator in central Indiana.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772628222000784

A human-centered designed outreach strategy for a youth ... Our study involved adolescents as key stakeholders and HCD techniques in co-design of messages for a contraception navigator program named “In Control.” The ...

4. nbcnews.com nbcnews.com/health/womens-health/birth-control-access-report-family-planning-policies-us-rcna218744

Birth control access: Scorecard evaluates family planning ... A new report finds that only a third of states protect access to affordable contraception through their policies, such as Medicaid expansion.

5. researchgate.net researchgate.net/publication/364462281_A_human-centered_designed_outreach_strategy_for_a_youth_contraception_navigator_program

A human-centered designed outreach strategy for a youth ... PDF | Objective To identify key elements of an outreach strategy for a youth contraception navigator program designed to help young people ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9762731/

A human-centered designed outreach strategy for a youth ... Our study involved adolescents as key stakeholders and HCD techniques in co-design of messages for a contraception navigator program named “In Control.” The ...

7. apha.org apha.org/policy-and-advocacy/public-health-policy-briefs/policy-database/2022/01/07/contraceptive-access

Contraceptive Access Access to the full range of contraceptive methods and related services is an essential component of reproductive health equity and well-being.

8. researchgate.net researchgate.net/publication/394078231_Piloting_a_Birth_Control_Navigator_Program_for_Adolescents_and_Young_Adults_in_Indiana

Piloting a Birth Control Navigator Program for Adolescents ... Title X clinics play a key role in access to effective contraception across the US safety net. Strengthening the Title X program should ...

9. ajpmonline.org ajpmonline.org/article/S0749-3797(24)00310-6/fulltext

Providing Quality Family Planning Services in the United ... Providing quality family planning services in the United States: Recommendations of the US Office of Population Affairs (Revised 2024)