Pediatric Primary Care Connections for Birth Control

Overseen By Tania Caballero, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Bilateral tubal ligation

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how pediatricians can assist mothers with family planning during their child's first year by assessing birth control needs. The study introduces a new screening process in pediatric visits and measures its effectiveness in identifying and addressing these needs. It includes surveys, interviews, and feedback from both families and healthcare providers. This trial suits Spanish-speaking, foreign-born Latina mothers with a child who is a patient at Baltimore Medical Systems. As an unphased trial, it allows participants to contribute to important research that could enhance family planning support for mothers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on contraceptive needs and screening, so it's best to discuss your specific situation with the trial coordinators.

What prior data suggests that this screening process is safe for families?

Research has shown that the Conecta program, which assists Spanish speakers with contraceptive needs through screening and referrals, is safe and well-liked. Studies have found that similar tools used in doctor's offices are generally accepted by patients, suggesting that users of the Conecta tool will likely find it easy to use and beneficial.

Studies of this program have reported no negative effects. Since the study focuses on screening and referrals, not on medical treatments or drugs, it is expected to be well-tolerated. Overall, the safety record appears strong, with no known problems so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Conecta intervention because it offers a fresh approach to advancing reproductive health through pediatric care. Unlike traditional methods that may focus solely on adult women, Conecta integrates a contraceptive need screening and referral process into pediatric well visits, targeting mothers during an early and influential time in their child's development. Additionally, this intervention is designed specifically in Spanish, which may enhance accessibility and effectiveness for Spanish-speaking communities. By bundling this process with developmental screenings, Conecta aims to provide a more holistic and proactive approach to family planning and maternal health.

What evidence suggests that this trial's treatments could be effective for advancing reproductive health?

Research has shown that asking women about their birth control needs during regular doctor visits can aid in family planning. Studies have found that discussing reproductive goals during these visits might lead to increased birth control use among women. This approach provides women with the necessary information and support. In this trial, the Conecta program, one of the study arms, uses a Spanish-language questionnaire to identify and address birth control needs during children's doctor visits. This can help mothers make informed decisions about birth control while attending their child's appointment. ^{2 6 7 8 9}

Who Is on the Research Team?

Tania Caballero, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for mothers with children aged 12-15 months who visit pediatricians' offices. It aims to support family planning by screening for contraceptive needs during well child visits. Participants should be willing to have their contraceptive use experiences surveyed and follow a screening process over 12 months.

Inclusion Criteria

I am a foreign-born Latina, prefer to communicate in Spanish, over 22, and have a 12-month-old child who is a BMS patient.

Staff of the Baltimore Medical Systems (BMS) medical practice, which includes clinicians (i.e. M.D., D.O., N.P.), medical assistants, nurses, receptionists

Community health care providers including clinicians, case managers, social workers, and nurses

Exclusion Criteria

Individuals with bilateral tubal ligation (permanent contraception) at time of recruitment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Conecta intervention, including screening and referral process for contraceptive needs during pediatric well visits

12 months

Regular visits during well child check-ups

Follow-up

Participants are monitored for effectiveness of the intervention and feedback is collected from families and clinic staff

3 months

Focus groups and interviews

What Are the Treatments Tested in This Trial?

Interventions

• Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

Trial Overview The study tests a new approach in pediatric care where mothers are screened for birth control needs at their child's check-ups. The effectiveness of this screener in identifying unmet contraceptive needs and its usage will be evaluated through surveys, medical record tracking, interviews, and focus groups.

How Is the Trial Designed?

Group I: Contraceptive need screener 'Conecta' Experimental Treatment 2 Interventions

The Conecta intervention is a Spanish language contraceptive need screening and referral process that includes a screener and referral to social needs navigation bundled with developmental screener in 0-12 month old pediatric well visit for written completion by the mother of the patient

Group II: Historical control group Placebo Group 1 Intervention

One time survey of contraceptive use and need experience among mothers of 12-15 month olds. Recruitment will occur prior to intervention with a sample of individuals who will be comparable to those who will participate in intervention.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07064837

Study Details | NCT07064837 | Utilizing Pediatric Primary Care ... The purpose of this study is to understand in what ways the pediatrician's office can support women's family planning by screening for contraceptive needs ...

2. withpower.com withpower.com/trial/phase-contraceptive-use-9-2024-98407

Pediatric Primary Care Connections for Birth Control The purpose of this study is to understand in what ways the pediatrician's office can support women's family planning by screening for contraceptive needs ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5892170/

A systematic review of the effect of reproductive intention ... No recommendations exist for routine reproductive intention screening in primary care. The objective of this systematic review is to assess ...

4. sph.cuny.edu sph.cuny.edu/wp-content/uploads/2017/09/Burgess_SystReview_OKQ_FamPrac_2017.pdf

A systematic review of the effect of reproductive intention ... Chronological summary of studies assessing the effects of inclusion of reproductive intention screening in primary care setting on reproductive ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10012234/

Preconception, Interconception, and reproductive health ... Effectiveness of a pediatric primary care intervention to increase maternal folate use: results from a cluster randomized controlled trial. J Pediatr. 2018 ...

6. ctv.veeva.com ctv.veeva.com/study/utilizing-pediatric-primary-care-connections-to-advance-reproductive-health

Utilizing Pediatric Primary Care Connections to Advance ... The aims of this study are: Aim 1: To refine Conecta, a stakeholder-informed Spanish language contraceptive needs screening and care ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9805867/

Women's Perspectives on a Reproductive Health Services ... A systematic review of the effect of reproductive intention screening in primary care settings on reproductive health outcomes. Fam Pract ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/psrh.12261

Assessing perspectives on an intervention connecting ... This study demonstrates the acceptability of connecting adolescents in outpatient psychiatry care to contraceptive counseling.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1877575625000114

The importance of patient-centered contraceptive care People who perceived coercion in their contraceptive care reported higher levels of psychological distress and worse mental well-being.