Cervical DysplasiaNCT06086054
Effect of a Childcare Resource on Cervical Cancer Prevention
A study testing Navigation and EMR referral to childcare facility in people with Cervical Dysplasia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Aim 1: Determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia. 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
- Cervical Dysplasia
- What is being tested?
- Navigation and EMR referral to childcare facility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient
Who cannot join
- Pregnant women
- Patients <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum
Aim 1: Determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia.
Aim 2: Conduct a pilot pragmatic patient-randomized control trial (RCT) to evaluate the effectiveness of an intervention linking eligible patients to our childcare facility compared to standard of care on retention in care, defined as show-rate for the initial visit in the gynecology dysplasia clinic. The intervention will consist of 1) patient navigation to our childcare facility prior to the initial visit in the gynecology dysplasia clinic and 2) placement of an electronic medical record (EMR) referral to our childcare facility.
Read more
Hypothesis: The study team hypothesizes that women receiving the intervention will have increased retention in care compared to women randomized to standard of care among women with abnormal cervical cancer screening referred to gynecology for diagnostic work-up.
These two aims will demonstrate the significance of childcare as a social determinant of health in the cervical cancer screening and diagnostic continuum by assessing the burden of unmet childcare needs among women with cervical dysplasia and measuring the effect of health system-integrated childcare as an intervention for unmet childcare needs on retention in care and subsequent completion of diagnostic work-up among women with cervical dysplasia. This study will rigorously provide the first evidence illustrating the effect of health systems' investment in addressing unmet childcare needs on preventive care like cervical cancer screening. The findings of this proposed pilot study will be utilized to develop future large-scale studies with extramural funding, building a longitudinal program of research on addressing childcare as a social determinant of health in this and other similar clinical contexts (e.g., breast cancer screening and treatment).
- Conditions
- Cervical Dysplasia
- Being tested
- Navigation and EMR referral to childcare facility
- Keywords
- Childcare, Social determinant of health, Patient navigation
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation and EMR referral to childcare facilityBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | The intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials. Receives: Behavioral: Navigation and EMR referral to childcare facility |
| Standard Care | No intervention | Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show-rate for initial visit to gynecology dysplasia clinic
Show-rate assessed via EMR
Measured: Up to 2 years
Secondary outcomes (3)
Rate of completion of indicated diagnostic and therapeutic procedures
May include colposcopy, biopsies, and cervical excisional procedures, including hysterectomy, in the clinic and operating room (OR). Will vary based on clinical indication and assessment during initial appointment.
Measured: Up to 2 years
Show-rate for follow-up visits in gynecology
Show-rate assessed via EMR
Measured: Up to 2 years
Rate of utilization of childcare facility during scheduled gynecology visits
Rate of utilization assessed by health system's dashboard for childcare facility
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start31 Oct 2023
- Primary completion7 Jan 2025
- Study completion30 Jun 2025
Why it stopped: Our previous childcare vendor's contract ended in January of 2025 and was not renewed. As of June 2025, a new vendor was still not established, and the decision was made by the study team to discontinue enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Martin, University of Texas Southwestern Medical Center
- Investigators
- Anisha Ganguly, MD, MPH, Principal investigator, Parkland Health & Hospital System - - Dallas, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086054
- Sponsor's protocol ID
- STU-2021-0309
- Status last verified
- Jul 2025
- First submitted
- 14 Sep 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not permitted under our system's Office of Research Administration policies with regards to this type of collected patient data.
Publications
Alvarez KS, Bhavan K, Mathew S, Johnson C, McCarthy A, Garcia B, Callies M, Stovall K, Harms M, Kho KA. Addressing childcare as a barrier to healthcare access through community partnerships in a large public health system. BMJ Open Qual. 2022 Oct;11(4):e001964. doi: 10.1136/bmjoq-2022-001964.
PubMed 36261213
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum
- ClinicalTrials.gov ID
- NCT06086054
- Acronym / sponsor ID
- STU-2021-0309
- Conditions
- Cervical Dysplasia
- Keywords
- Childcare, Social determinant of health, Patient navigation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our previous childcare vendor's contract ended in January of 2025 and was not renewed. As of June 2025, a new vendor was still not established, and the decision was made by the study team to discontinue enrollment.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Oct 2023 (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.
Aim 1: Determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia.
Aim 2: Conduct a pilot pragmatic patient-randomized control trial (RCT) to evaluate the effectiveness of an intervention linking eligible patients to our childcare facility compared to standard of care on retention in care, defined as show-rate for the initial visit in the gynecology dysplasia clinic. The intervention will consist of 1) patient navigation to our childcare facility prior to the initial visit in the gynecology dysplasia clinic and 2) placement of an electronic medical record (EMR) referral to our childcare facility.
Hypothesis: The study team hypothesizes that women receiving the intervention will have increased retention in care compared to women randomized to standard of care among women with abnormal cervical cancer screening referred to gynecology for diagnostic work-up.
These two aims will demonstrate the significance of childcare as a social determinant of health in the cervical cancer screening and diagnostic continuum by assessing the burden of unmet childcare needs among women with cervical dysplasia and measuring the effect of health system-integrated childcare as an intervention for unmet childcare needs on retention in care and subsequent completion of diagnostic work-up among women with cervical dysplasia. This study will rigorously provide the first evidence illustrating the effect of health systems' investment in addressing unmet childcare needs on preventive care like cervical cancer screening. The findings of this proposed pilot study will be utilized to develop future large-scale studies with extramural funding, building a longitudinal program of research on addressing childcare as a social determinant of health in this and other similar clinical contexts (e.g., breast cancer screening and treatment).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Navigation and EMR referral to childcare facilityThe intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials. |
| Standard Care | No intervention | –Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient
Key exclusion criteria (2 listed)
- Pregnant women
- Patients <18 years of age
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 |
|---|---|---|
| Navigation and EMR referral to childcare facilitySee arm description | Behavioural | Intervention |
Primary outcome
Show-rate for initial visit to gynecology dysplasia clinic
Time frame: Up to 2 years
Show-rate assessed via EMR
3 secondary outcomes
Rate of completion of indicated diagnostic and therapeutic procedures
Time frame: Up to 2 years
Show-rate for follow-up visits in gynecology
Time frame: Up to 2 years
Rate of utilization of childcare facility during scheduled gynecology visits
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Our previous childcare vendor's contract ended in January of 2025 and was not renewed. As of June 2025, a new vendor was still not established, and the decision was made by the study team to discontinue enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 36261213Alvarez KS, Bhavan K, Mathew S, Johnson C, McCarthy A, Garcia B, Callies M, Stovall K, Harms M, Kho KA. Addressing childcare as a barrier to healthcare access through community partnerships in a large public health system. BMJ Open Qual. 2022 Oct;11(4):e001964. doi: 10.1136/bmjoq-2022-001964.
- Individual participant dataSharing planned: No. This is not permitted under our system's Office of Research Administration policies with regards to this type of collected patient data.
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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. This study is not recruiting at the moment.
Anisha Ganguly, MD, MPH principal investigator
Parkland Health & Hospital System - - Dallas, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation and EMR referral to childcare facility in people with Cervical Dysplasia, run by University of Texas Southwestern Medical Center 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 5 Aug 2025. 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. 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?
The study was stopped early (reason given: Our previous childcare vendor's contract ended in January of 2025 and was not renewed. As of June 2025, a new vendor was still not established, and the decision was made by the study team to discontinue enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Show-rate for initial visit to gynecology dysplasia clinic (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06086054, which also lists 1 linked publication.
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 5 Aug 2025.