Contraceptive UseNCT07064837
Utilizing Pediatric Primary Care Connections to Advance Reproductive Health
A study testing Conecta Familia and Contraceptive need survey in people with Contraceptive Use, run by Johns Hopkins University at 1 site in United States.
Trial summary
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 at each well child visit over the first 12 months of the child's life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Use
- What is being tested?
- Conecta Familia and Contraceptive need survey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals with bilateral tubal ligation (permanent contraception) at time of recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore Medical Systems Yard 56
Baltimore, Maryland, 21224
About this study
Official title: Conecta: A Stakeholder-informed Implementation Intervention for Contraceptive Screening, Referral, and Care Coordination.
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 at each well child visit over the first 12 months of the child's life. Part one of the study will be working with families and clinic-based social needs navigators around where and how the screening process will be integrated into an existing pediatric workflow. Part two of the study will include (a) surveying mothers of 12-15 month olds about contraceptive use experience to get a baseline followed by (b) implementing the screening process into pediatrics and measuring how well the screener is able to identify unmet contraceptive needs and how people are or are not using the screening process. This will occur over approximately 12 months. Part (b) includes enrolling families who have a contraceptive need case and following the case in the child's medical record. At the end of the 12 month intervention the investigators will (c) invite some families to participant in an interview about the experience with the contraceptive need screener. Part three will be focus group feedback from clinicians and staff about the contraceptive need screening process. Part four will be key informant interviews with community stakeholders on the expansion of this screener.
Read the detailed description
The investigators propose to design and test a Spanish-language maternal contraceptive needs screening and care coordination intervention within primary care pediatrics called Conecta. The investigator's goal is to determine if this intervention can reduce unmet contraceptive need among Latina immigrant mothers. The aims of this study are:
Aim 1: To refine Conecta, a stakeholder-informed Spanish language contraceptive needs screening and care coordination intervention for implementation with existing pediatric social needs navigation, Hopkins Community Connection (HCC). The investigators will translate workflow observations into process maps and present and discuss the process maps with stakeholders who will visually assess the stakeholder's role and interaction in the workflow. Stakeholders will focus feedback on specific, practical ways that contraceptive needs screening and care coordination support would be valuable. This feedback will help the investigators build Conecta from the existing scaffolding of the HCC structure.
Aim 2: To conduct a Hybrid Type 1 implementation-effectiveness pilot of Conecta and evaluate 1) Conecta's effectiveness in reducing unmet contraceptive need, and 2) Conecta's
- Conditions
- Contraceptive Use
- Being tested
- Conecta Familia, Contraceptive need survey
- Keywords
- contraceptive need mothers, contraceptive need Latinas, pediatric clinic, screening, contraceptive choice, contraceptive need
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conecta FamiliaOther
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
Contraceptive need surveyOther
brief survey describing demographic information and contraceptive need, use, and experience
| Study group | Role | What they receive |
|---|---|---|
| Contraceptive need screener 'Conecta' | Experimental | 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 Receives: Other: Conecta Familia; Other: Contraceptive need survey |
| Historical control group | Placebo comparator | 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. Receives: Other: Contraceptive need survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of unmet maternal contraceptive need
Unmet need will be defined using a combination of widely used family planning and contraceptive use questions in a single survey. The same survey items will be administered to historical control group and then the cohort. There are three questions measuring contraceptive satisfaction, confidence in current contraceptive method use, and switching likelihood. These are 5 scaled answer options ranging from "very satisfied/confident to very dissatisfied/not confident at all" There are 2 possible definitions of unmet contraceptive need: 1) "Are you or your spouse or partner doing anything now to keep from getting pregnant?". 'No' and "Would you like to be using birth control right now to keep from getting pregnant? " 'Yes" and/or; 2) Low satisfaction and low confidence scores supports high likelihood of method switching and unmet need. Investigators will compare number of participants who meet unmet contraceptive need definition in cohort to number in historical control group.
Measured: At child's 12th month of life
Secondary outcomes (4)
Feasibility of Intervention Measure (FIM) score
The survey will include 4-item measures of feasibility. Score range is 4-20, higher scores indicate greater feasibility.
Measured: Baseline and 12 months of implementation
Acceptability of Intervention Measure (AIM)
The survey will include 4-item measures of acceptability; total mean scores range from 1 - 5, higher scores indicate greater acceptability,
Measured: Baseline and at 12 months of implementation
Intervention Appropriateness Measure (IAM)
The survey will include 4-item measures of appropriateness. Total mean scores 1-5, higher score indicates greater appropriateness,
Measured: Baseline and at 12 months of implementation
Number of clinic staff engaged with the intervention
As part of implementation evaluation investigators will conduct a focus group using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Measured: Up to 15 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Oct 2024
- Primary completionApr 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One arm will be exposed to the intervention (contraceptive need screener). Other individuals will be participating in other aspects of the study (interviews, focus groups, one time survey) to help contextualize the intervention but will not receive an actual intervention.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Tania Caballero, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064837
- Sponsor's protocol ID
- IRB00389763
- Other IDs
- 1K23HD110615-01A1
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conecta: A Stakeholder-informed Implementation Intervention for Contraceptive Screening, Referral, and Care Coordination.
- ClinicalTrials.gov ID
- NCT07064837
- Acronym / sponsor ID
- IRB00389763
- Conditions
- Contraceptive Use
- Keywords
- contraceptive need mothers, contraceptive need Latinas, pediatric clinic, screening, contraceptive choice, contraceptive need
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 at each well child visit over the first 12 months of the child's life. Part one of the study will be working with families and clinic-based social needs navigators around where and how the screening process will be integrated into an existing pediatric workflow. Part two of the study will include (a) surveying mothers of 12-15 month olds about contraceptive use experience to get a baseline followed by (b) implementing the screening process into pediatrics and measuring how well the screener is able to identify unmet contraceptive needs and how people are or are not using the screening process. This will occur over approximately 12 months. Part (b) includes enrolling families who have a contraceptive need case and following the case in the child's medical record. At the end of the 12 month intervention the investigators will (c) invite some families to participant in an interview about the experience with the contraceptive need screener. Part three will be focus group feedback from clinicians and staff about the contraceptive need screening process. Part four will be key informant interviews with community stakeholders on the expansion of this screener.
Detailed description
The investigators propose to design and test a Spanish-language maternal contraceptive needs screening and care coordination intervention within primary care pediatrics called Conecta. The investigator's goal is to determine if this intervention can reduce unmet contraceptive need among Latina immigrant mothers. The aims of this study are:
Aim 1: To refine Conecta, a stakeholder-informed Spanish language contraceptive needs screening and care coordination intervention for implementation with existing pediatric social needs navigation, Hopkins Community Connection (HCC). The investigators will translate workflow observations into process maps and present and discuss the process maps with stakeholders who will visually assess the stakeholder's role and interaction in the workflow. Stakeholders will focus feedback on specific, practical ways that contraceptive needs screening and care coordination support would be valuable. This feedback will help the investigators build Conecta from the existing scaffolding of the HCC structure.
Aim 2: To conduct a Hybrid Type 1 implementation-effectiveness pilot of Conecta and evaluate 1) Conecta's effectiveness in reducing unmet contraceptive need, and 2) Conecta's
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One arm will be exposed to the intervention (contraceptive need screener). Other individuals will be participating in other aspects of the study (interviews, focus groups, one time survey) to help contextualize the intervention but will not receive an actual intervention.
| Arm | Type | Receives |
|---|---|---|
| Contraceptive need screener 'Conecta' | Experimental | Other: Conecta Familia, Other: Contraceptive need surveyThe 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 |
| Historical control group | Placebo comparator | Other: Contraceptive need surveyOne 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Individuals with bilateral tubal ligation (permanent contraception) at time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conecta FamiliaThe 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 | Other | Contraceptive need screener 'Conecta' |
| Contraceptive need surveybrief survey describing demographic information and contraceptive need, use, and experience | Other | Contraceptive need screener 'Conecta', Historical control group |
Primary outcome
Proportion of unmet maternal contraceptive need
Time frame: At child's 12th month of life
Unmet need will be defined using a combination of widely used family planning and contraceptive use questions in a single survey. The same survey items will be administered to historical control group and then the cohort. There are three questions measuring contraceptive satisfaction, confidence in current contraceptive method use, and switching likelihood. These are 5 scaled answer options ranging from "very satisfied/confident to very dissatisfied/not confident at all" There are 2 possible definitions of unmet contraceptive need: 1) "Are you or your spouse or partner doing anything now to keep from getting pregnant?". 'No' and "Would you like to be using birth control right now to keep from getting pregnant? " 'Yes" and/or; 2) Low satisfaction and low confidence scores supports high likelihood of method switching and unmet need. Investigators will compare number of participants who meet unmet contraceptive need definition in cohort to number in historical control group.
4 secondary outcomes
Feasibility of Intervention Measure (FIM) score
Time frame: Baseline and 12 months of implementation
Acceptability of Intervention Measure (AIM)
Time frame: Baseline and at 12 months of implementation
Intervention Appropriateness Measure (IAM)
Time frame: Baseline and at 12 months of implementation
Number of clinic staff engaged with the intervention
Time frame: Up to 15 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tania Caballero, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conecta Familia and Contraceptive need survey in people with Contraceptive Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tania Caballero, MD (443-831-6561', tcaball1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of unmet maternal contraceptive need (time frame: At child's 12th month of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.