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Pregnancy RelatedNCT06636110

Piloting JUN_Pregnancy Mobile Medical App

A study testing Jun mHealth app in people with Pregnancy Related and Pregnancy, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Pregnancy
What is being tested?
Jun mHealth app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
3 Mar 2025to 31 Dec 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 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant female 18-50 years
  • Within first 6 months of pregnancy
  • Either on community supervision or without criminal system involvement
  • Located in Texas, Minnesota or Oregon

Who cannot join

  • Individuals who do not identify as women
  • Later pregnancy, beyond the first 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Piloting of JUN to Enhance Self-Efficacy Pregnant Women

This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women.

JUN is an intervention being developed to provide education and assist with decision making during pregnancy.

The researchers hope to learn differences in how effectively the participant use of the app is amongst women with and without criminal justice oversight such as adult probation or parole.

Read the detailed description

In this proposed pilot study, the investigators will use mixed methods to examine differences across three months among pregnant women. Sampling will be within three ethnically and geographically diverse sites, Texas, Oregon, and Minnesota to determine if there are differences in self-efficacy amongst pregnant women on Community Service (CS) compared to pregnant women without criminal justice oversight.

Being tested
Jun mHealth app
Keywords
Community Supervision, Criminal Justice Oversight, Jun App

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jun mHealth appDevice

    Also called Mobile Medical Health App

    The intervention will be a mHealth app, JUN, across 3 months during pregnancy.

Study groups in NCT06636110
Study groupRoleWhat they receive
Pregnant without Criminal Justice OversightExperimentalPregnant women who are without criminal justice oversight
Receives: Device: Jun mHealth app
Pregnant with Criminal Justice OversightExperimentalPregnant women who are under Community Supervision (CS), on probation or parole with criminal justice oversight
Receives: Device: Jun mHealth app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self Rated Abilities for Health Practice (SRAHP)

    The Self Rated Abilities for Health Practices Scale (SRAHP) is a 28-item, 5-point scale to measure self-perceived ability to implement health-promoting behaviors. SRAHP contains four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being. Each subscale has seven items. Respondents are asked to rate the extent to which they are able to perform health practices related to these four domains. An example of an item from the Health Practices subscale is "I am able to get help from others when I need it." Items are rated from 0 (not at all) to 4 (completely). Ratings for each subscale are summed to yield subscale scores. Subscale scores are summed to obtain a total score. Total scores range from 0-112. Higher scores indicate greater self-efficacy for health practices.

    Measured: Baseline to Post-Intervention survey (approximately 3 months)

  2. JUN mHealth app Timing

    Timing of use of JUN app.

    Measured: Month 1 to Month 3

  3. JUN mHealth app Frequency

    Frequency of use of the JUN app

    Measured: Month 1 to Month 3

Secondary outcomes (5)

  1. Accountable Health Communities Health-Related Social Needs Screening (AHC HRSN)

    There are five core domains of the AHC HRSN Screening Tool: (1) living situation, (2) food, (3) transportation, (4) utilities, and (5) safety. For each domain, if the participant answers yes to one of the items, it is a positive screen. There is not a total score for this measure. Rather, it assesses what participants have and do not have.

    Measured: Baseline to Post-Intervention survey (approximately 3 months)

  2. Sigma-Related Rejection Scale

    A 9 item scale which uses multiple answer formats. The Stigma-Related Rejection Scale (SRS) (or its variations, like the Substance Abuse version) is a survey measuring interpersonal stigma and rejection experiences, with higher scores indicating greater perceived stigma and rejection.

    The SRS assesses the ongoing experiences of personal rejection related to enacted stigma, focusing on how individuals with mental health conditions or substance abuse problems perceive and experience stigma in their daily lives. Items are typically scored on a scale of 1 to 7, with higher scores indicating greater agreement with the statement and thus, higher levels of perceived rejection.

    Measured: Baseline to Post-Intervention survey (approximately 3 months)

  3. Abuse Assessment Screening tool (AAS)

    This five-item tool detects abuse perpetrated against childbearing women with a sensitivity of 93%-94% and specificity of 55%-99% related to the question specific to abuse during pregnancy (e.g., "Since you were pregnant, have you been slapped, kicked, or otherwise physically hurt by someone," Within the past year, has anyone forced you to have sexual activities?"). Evidence: Women with SUD often live in potentially abusive or violent environments, which can negatively affect their perinatal health and may lead to a return to using illicit substances. Items 1 and 5 are answered yes/no; if items 2, 3, or 4 are answered yes, participant is asked to indicate category of abuser (Circle all that apply: husband, ex-husband, boyfriend, stranger, other, multiple); for items 2 and 3, participants are asked to mark the area of injury on a body map.

    For each violence incident, items are scored based on severity of (1-6)ǂ Cutoff for IPV: Affirmative response to ≥1 item(s)

    Measured: Baseline to Post-Intervention survey (approximately 3 months)

  4. Patient Health Questionnaire (PHQ)

    Patient Health Questionnaire (PHQ2) measures the frequency and severity of depressed mood, anhedonia, and anxiety in the past weeks (e.g., "Over the last two weeks, how often have you been bothered by the following problems…feeling down, depressed, or hopeless?"). Responses are summed across items to yield a total score (e.g., cut-off scores >3 are considered elevated). PHQ-2 has 2 questions scored on a scale of 0-3 with a total score of 0-6. A score of 3 or higher indicates a need for further evaluation.

    Measured: Baseline to Post-Intervention survey (approximately 3 months)

  5. Generalized Anxiety Disorder (GAD2)

    Patient Generalized Anxiety Disorder Survey (GAD2) measures the frequency and severity of depressed mood, anhedonia, and anxiety in the past weeks (e.g., "Over the last two weeks, how often have you been bothered by the following problems…feeling down, depressed, or hopeless?"). Responses are summed across items to yield a total score (e.g., cut-off scores >3 are considered elevated).

    GAD-2 has 2 questions scored on a scale of 0-3 with a total score of 0-6. A score of 3 or higher needs further diagnostic evaluation

    Measured: Baseline to Post-Intervention survey (approximately 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start3 Mar 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
1:1 selection of pregnant women with and without criminal justice oversight. There will be further random selection of a sub-sample (n=20) (n=10 with and n=10 without criminal justice oversight to interview using Health Belief Model (HBM)
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636110
Sponsor's protocol ID
STUDY00000755
Status last verified
Jan 2026
First submitted
8 Oct 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: No personally identifying data is anticipated to be recorded from human subjects, neither through survey responses or other interactions. The PI, Co-PIs, researchers, and staff plan to make all data generated from this IIMS proposal freely available to the research community after publication. Through the freedom of information act, the data in the publications and the raw data documents will be made available upon written request to the laboratory. Should intellectual property be generated which requires a patent, we will ensure that the technology (materials and data) remains widely available to research community in accordance with the NIH Principles and Guidelines referenced above.

Publications

  • Ihle AD, Wicks B, Metsis V, Starfall A, Clapham F, Gorbachev A, Shanley S, Strauser C, McGrath JM. Training an AI Chatbot to Manage Health in Underserved Populations: Methodological Approach. JMIR AI. 2026 Apr 1;5:e84145. doi: 10.2196/84145.

    PubMed 41921209

Questions about this trial

What is this clinical trial studying?

A study testing Jun mHealth app in people with Pregnancy Related and Pregnancy, run by The University of Texas Health Science Center at San Antonio 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 4 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: finished, as of the sponsor's last update on 27 Jan 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Self Rated Abilities for Health Practice (SRAHP) (time frame: Baseline to Post-Intervention survey (approximately 3 months)). The study lists 3 primary outcomes in all. 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 NCT06636110, 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 27 Jan 2026.

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