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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the IN-Control Birth Control Navigator Program treatment?

The research suggests that programs involving personalized contraceptive counseling and decision aids can improve knowledge and confidence in contraceptive use, leading to better family planning outcomes and potentially fewer unintended pregnancies. This indicates that the IN-Control Birth Control Navigator Program, which likely includes similar elements, could be effective in improving access to and use of birth control. ^{1 2 3 4 5}

What makes the IN-Control Birth Control Navigator Program unique compared to other birth control treatments?

The IN-Control Birth Control Navigator Program is unique because it provides personalized support to help individuals overcome specific barriers to accessing birth control, using a trained navigator to guide them through the process, which is different from traditional methods that focus solely on the medical aspects of contraception. ^{1 4 6 7 8}

Eligibility Criteria

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

English speaking

Lives in Indiana

I am between 15 and 19 years old.

Exclusion Criteria

Lives outside of Indiana

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

I do not speak English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a computerized contraceptive decision aid for adolescent patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Pathways to reproductive autonomy: Using path analysis to predict family planning outcomes in the United States. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of contraceptive counseling on Texans who can and cannot receive no-cost post-abortion contraception. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A human-centered designed outreach strategy for a youth contraception navigator program. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Contraceptive Technology: Present and Future. [2021]