ContraceptionMyPathNCT04584294
Patient-Centered Reproductive Decision Support Tool for Women Veterans
A study testing MyPath Web-Based Informational and Decision Support Tool in people with Contraception and Contraception Behavior, run by VA Office of Research and Development at 12 sites in United States.
Trial summary
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Contraception Behavior, Prepregnancy Health
- What is being tested?
- MyPath Web-Based Informational and Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Mar 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- Female sex identified in medical record
- 18 - 44 years old
- Has a scheduled VA medical appointment with an enrolled study provider
- Has at least one valid telephone number available in medical record
- Interested in receiving information or talking with their provider about pregnancy and/or birth control
Show all 10Show fewer
- Providers:
- Primary Care Provider (MD, Nurse Practitioner, Physician Assistant) at a study site
- Designated as a Women's Health Provider [defined in VA directive 1330.01 as primary care providers who have demonstrated proficiency (e.g. pelvic exams and pap smears) in women's health and who have at least 10% of their panel comprised of women]
- Completed appointments with at least 30 unique female patients ages 18-44 in the past year at a study site
Who cannot join
- Patients:
- Currently pregnant
- Medical record or self-reported history of hysterectomy, bilateral oophorectomy; or self-report of not having a uterus
- Unable to communicate in English
- Impaired decision-making
- Used the decision tool prior to study enrollment (e.g. during pilot testing of the tool)
Show all 10Show fewer
- Providers:
- Previous involvement as a provider in MyPath pilot work (identified by the PI)
- Medical trainee
- Self-report that they have plans to leave VA, go on extended leave, retire, stop primary care practice, or change VA site in the 18 months following their enrollment
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
El Paso VA Health Care System, El Paso, TX
El Paso, Texas, 79930-4211
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Orlando VA Medical Center, Orlando, FL
Orlando, Florida, 32803
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504-7451
About this study
Official title: MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.
Read the detailed description
Counseling and care that supports individuals' ability to achieve their reproductive goals is an essential component of primary care. National organizations, including the Centers for Disease Control and Prevention (CDC), recommend that clinicians routinely engage in patient-centered conversations about reproductive goals and offer care to help optimize health and well-being prior to desired pregnancies and to prevent unwanted pregnancy and births. This counseling is particularly critical for women Veterans, who face elevated risks of adverse pregnancy and birth outcomes due to a high prevalence of chronic medical and mental health conditions as well as psychosocial stressors including sexual trauma histories, intimate partner violence, and homelessness. Moreover, stark racial/ethnic disparities in pregnancy outcomes are well-documented, and nearly half of reproductive-aged women Veterans are minority race/ethnicity. Despite these national recommendations, however, conversations about reproductive needs are often absent in primary care both outside and within the VA, and the conversations that do happen frequently fail to incorporate women's values and preferences. Interventions are needed to improve both the frequency and quality of counseling about reproductive needs in primary care settings.
This study will investigate the effect of a novel, web-based, patient-facing decision support tool designed to be used prior to VA primary care visits to help women Veterans with reproductive capacity consider their reproductive goals; improve their knowledge about fertility, contraception, and prepregnancy health risks; align contraceptive decisions with their preferences and goals; and engage in shared decision making (SDM) with providers.
The investigators will conduct a multi-site randomized controlled trial (RCT) clustered at the provider level among VA primary care providers and their reproductive-aged women Veteran patients. Study outcomes will be assessed among participants shortly after their scheduled appointment and at 3- and 6-months follow up. The study will test the primary hypothesis that participants who receive the tool weblink prior to visits will be more likely to report patient-centered conversations about their reproductive needs at their visit. The investigators also hypothesize that intervention participants will report higher perceived self-efficacy in communicating with providers, reproductive health knowledge, contraception decision quality, and contraception utilization. Exploratory outcomes include behaviors to modify preconception health risks among participants considering pregnancy in the future and intervention effects by race/ethnicity. The study will also collect quantitative and qualitative data to assess the feasibility of implementing the tool more widely in VA primary care settings.
- Being tested
- MyPath Web-Based Informational and Decision Support Tool
- Keywords
- Shared decision making, Primary care, Patient decision support, Patient-centered outcomes research, Reproductive autonomy, Patient-Centered Care, Provider-Patient Communication
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPath Web-Based Informational and Decision Support ToolBehavioural
The MyPath Decision Support Tool includes the following sections and features:
- Questions to capture reproductive goals and orientations towards a potential pregnancy
- Education modules about the menstrual cycle, fertility, and prepregnancy health with the opportunity to flag topics that are relevant and of interest to the patient
- A contraceptive decision module that provides education, elicits patient preferences about different aspects of contraception, and suggests methods most appropriate based on the patient's preferences
- A feature for adding free-text questions that patients may have for their provider
- An email with a summary page that the patient can bring to a visit to guide discussions with primary care providers about reproductive needs
| Study group | Role | What they receive |
|---|---|---|
| Intervention (MyPath) | Experimental | Patients scheduled to see providers randomized to this arm will receive a weblink to the decision tool via text message after study enrollment and prior to their scheduled visit. Receives: Behavioral: MyPath Web-Based Informational and Decision Support Tool |
| Usual Care | No intervention | Patients scheduled to see providers randomized to the usual care arm will receive no intervention and will receive usual primary care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
Self-report of whether a discussion occurred during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making (SDM). SDM is measured by participant self-report with the CollaboRATE scale, which uses three 5-point Likert scale questions to assess SDM (score 0-12, with higher scores indicating more shared decision making; SDM defined using a top box score).
Measured: Within one month post-visit
Secondary outcomes (15)
Occurrence of Reproductive Needs Discussion
Self-report of whether a discussion of pregnancy goals, prepregnancy health, or contraception occurred during the scheduled primary care visit, regardless of occurrence of SDM.
Measured: Within one month post-visit
Perceived Self-efficacy in Communicating With Providers
Assessed with a modified version of the validated 5-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale, which uses five Likert scale questions ranging from 1 to 5 (score 5-25, with higher scores indicating higher levels of perceived efficacy).
Measured: Within one month post-visit
Reproductive Health Knowledge
Participant responses to 14 items assessing knowledge of fertility, prepregnancy health, and contraception. The measure is self-developed and derived from previously published assessments of fertility and contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don't know" coded as incorrect (score 0-14, with higher scores indicating more accurate knowledge).
Measured: Within one month post-visit
Contraceptive Decision Conflict
Assessed with the Decision Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16-items with 5-point Likert scale response options ranging from 0-4. Scores are converted to range from 0 (no decisional conflict) to 100 (highest decisional conflict). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: Within one month post-visit
Confidence That Contraceptive Method is "Right for me."
Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: Within one month post-visit
Choice of Prescription or Procedural Contraceptive Method
Self-report of continuing or changing to a prescription or procedural method after their visit. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: Within one month post-visit
Choice of Procedural Contraceptive Method
Self-report of continuing or changing to a procedural method after their visit. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: Within one month post-visit
Use of Prescription or Procedural Contraceptive Method
Self-reported use of a prescription or procedural method at follow-up. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: 6 months
Use of Procedural Contraceptive Method
Self-reported use of a procedural method at follow-up. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: 6 months
Continuous Use of Any Contraception
Self-reported use of a contraceptive method over the past 6 months without a gap of greater than 4 weeks. This combines self-reported use at 3 months and 6 months. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For participants lost to follow-up at the 6 month timepoint, their 6-month values will be singly imputed, carrying forward 3-month continuous use reports when those data are available.
Measured: 6 months
Continuous Use of Prescription or Procedural Contraception
Self-reported use of a prescription or procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: 6 months
Continuous Use of Procedural Contraception
Self-reported use of a procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: 6 months
Contraceptive Method Satisfaction
Assessed using a single question ("How satisfied are you with your current birth control method") with Likert response options from 1 (very dissatisfied) to 5 (very satisfied). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. While this outcome was measured at 6 months, for participants lost to follow-up at 6 months, we singly imputed these data by pulling forward their 3-month satisfaction, when available.
Measured: 6 months
Incidence of Unplanned Pregnancy
Proportion of participants who self-report an unplanned pregnancy, as determined by responses to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items measuring attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of <10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: 6 months
Confidence That Current Contraceptive Method is "Right for me."
Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Mar 2021
- Primary completion30 Aug 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- Provider participants are randomized to one of two groups - usual care or intervention group - at the start of the study, prior to any Veteran enrollment. Subsequently, Veterans scheduled to see these providers will be enrolled as patient participants and automatically allocated to the study group of their scheduled provider.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Kaiser Permanente, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Lisa S Callegari, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584294
- Sponsor's protocol ID
- IIR 19-387
- Acronym
- MyPath
- Status last verified
- Oct 2025
- First submitted
- 5 Oct 2020
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Veteran participant data will be deposited into the "Reproductive, Sexual, and Socio-Behavioral Health Data Repository and Registry" VA data repository and registry housed and managed at the VA Puget Sound Health Care System. The data will be stored indefinitely in accordance with VHA regulations under VA IRB and R\&D Committee oversight. Procedures are as follows.
Publications
Callegari LS, Benson SK, Mahorter SS, Nelson KM, Arterburn DE, Hamilton AB, Taylor L, Hunter-Merrill R, Gawron LM, Dehlendorf C, Borrero S. Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2022 Nov;122:106940. doi: 10.1016/j.cct.2022.106940. Epub 2022 Sep 28.
PubMed 36179982Callegari LS, Benson SK, Nelson KM, Arterburn DE, Hamilton AB, Taylor L, Mahorter SS, Hunter-Merrill R, Pleasure ZH, Yogendran A, Merkel CG, Mog AC, Dehlendorf C, Borrero S. Text Message Delivery of a Digital Tool for Reproductive Health Discussions in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2635075. doi: 10.1001/jamanetworkopen.2026.35075.
PubMed 42776530
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans
- ClinicalTrials.gov ID
- NCT04584294
- Acronym / sponsor ID
- MyPath / IIR 19-387
- Keywords
- Shared decision making, Primary care, Patient decision support, Patient-centered outcomes research, Reproductive autonomy, Patient-Centered Care, Provider-Patient Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Kaiser Permanente, University of California, San Francisco
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.
Detailed description
Counseling and care that supports individuals' ability to achieve their reproductive goals is an essential component of primary care. National organizations, including the Centers for Disease Control and Prevention (CDC), recommend that clinicians routinely engage in patient-centered conversations about reproductive goals and offer care to help optimize health and well-being prior to desired pregnancies and to prevent unwanted pregnancy and births. This counseling is particularly critical for women Veterans, who face elevated risks of adverse pregnancy and birth outcomes due to a high prevalence of chronic medical and mental health conditions as well as psychosocial stressors including sexual trauma histories, intimate partner violence, and homelessness. Moreover, stark racial/ethnic disparities in pregnancy outcomes are well-documented, and nearly half of reproductive-aged women Veterans are minority race/ethnicity. Despite these national recommendations, however, conversations about reproductive needs are often absent in primary care both outside and within the VA, and the conversations that do happen frequently fail to incorporate women's values and preferences. Interventions are needed to improve both the frequency and quality of counseling about reproductive needs in primary care settings.
This study will investigate the effect of a novel, web-based, patient-facing decision support tool designed to be used prior to VA primary care visits to help women Veterans with reproductive capacity consider their reproductive goals; improve their knowledge about fertility, contraception, and prepregnancy health risks; align contraceptive decisions with their preferences and goals; and engage in shared decision making (SDM) with providers.
The investigators will conduct a multi-site randomized controlled trial (RCT) clustered at the provider level among VA primary care providers and their reproductive-aged women Veteran patients. Study outcomes will be assessed among participants shortly after their scheduled appointment and at 3- and 6-months follow up. The study will test the primary hypothesis that participants who receive the tool weblink prior to visits will be more likely to report patient-centered conversations about their reproductive needs at their visit. The investigators also hypothesize that intervention participants will report higher perceived self-efficacy in communicating with providers, reproductive health knowledge, contraception decision quality, and contraception utilization. Exploratory outcomes include behaviors to modify preconception health risks among participants considering pregnancy in the future and intervention effects by race/ethnicity. The study will also collect quantitative and qualitative data to assess the feasibility of implementing the tool more widely in VA primary care settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Provider participants are randomized to one of two groups - usual care or intervention group - at the start of the study, prior to any Veteran enrollment. Subsequently, Veterans scheduled to see these providers will be enrolled as patient participants and automatically allocated to the study group of their scheduled provider.
| Arm | Type | Receives |
|---|---|---|
| Intervention (MyPath) | Experimental | Behavioral: MyPath Web-Based Informational and Decision Support ToolPatients scheduled to see providers randomized to this arm will receive a weblink to the decision tool via text message after study enrollment and prior to their scheduled visit. |
| Usual Care | No intervention | –Patients scheduled to see providers randomized to the usual care arm will receive no intervention and will receive usual primary care. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female sex identified in medical record
- 18 - 44 years old
- Has a scheduled VA medical appointment with an enrolled study provider
- Has at least one valid telephone number available in medical record
- Interested in receiving information or talking with their provider about pregnancy and/or birth control
Key exclusion criteria (10 listed)
- Currently pregnant
- Medical record or self-reported history of hysterectomy, bilateral oophorectomy; or self-report of not having a uterus
- Unable to communicate in English
- Impaired decision-making
- Used the decision tool prior to study enrollment (e.g. during pilot testing of the tool)
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 |
|---|---|---|
| MyPath Web-Based Informational and Decision Support ToolThe MyPath Decision Support Tool includes the following sections and features: * Questions to capture reproductive goals and orientations towards a potential pregnancy * Education modules about the menstrual cycle, fertility, and prepregnancy health with the opportunity to flag topics that are relevant and of interest to the patient * A contraceptive decision module that provides education, elicits patient preferences about different aspects of contraception, and suggests methods most appropriate based on the patient's preferences * A feature for adding free-text questions that patients may have for their provider * An email with a summary page that the patient can bring to a visit to guide discussions with primary care providers about reproductive needs | Behavioural | Intervention (MyPath) |
Primary outcome
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)
Time frame: Within one month post-visit
Self-report of whether a discussion occurred during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making (SDM). SDM is measured by participant self-report with the CollaboRATE scale, which uses three 5-point Likert scale questions to assess SDM (score 0-12, with higher scores indicating more shared decision making; SDM defined using a top box score).
15 secondary outcomes
Occurrence of Reproductive Needs Discussion
Time frame: Within one month post-visit
Perceived Self-efficacy in Communicating With Providers
Time frame: Within one month post-visit
Reproductive Health Knowledge
Time frame: Within one month post-visit
Contraceptive Decision Conflict
Time frame: Within one month post-visit
Confidence That Contraceptive Method is "Right for me."
Time frame: Within one month post-visit
Choice of Prescription or Procedural Contraceptive Method
Time frame: Within one month post-visit
Choice of Procedural Contraceptive Method
Time frame: Within one month post-visit
Use of Prescription or Procedural Contraceptive Method
Time frame: 6 months
Use of Procedural Contraceptive Method
Time frame: 6 months
Continuous Use of Any Contraception
Time frame: 6 months
Continuous Use of Prescription or Procedural Contraception
Time frame: 6 months
Continuous Use of Procedural Contraception
Time frame: 6 months
Contraceptive Method Satisfaction
Time frame: 6 months
Incidence of Unplanned Pregnancy
Time frame: 6 months
Confidence That Current Contraceptive Method is "Right for me."
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36179982Callegari LS, Benson SK, Mahorter SS, Nelson KM, Arterburn DE, Hamilton AB, Taylor L, Hunter-Merrill R, Gawron LM, Dehlendorf C, Borrero S. Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2022 Nov;122:106940. doi: 10.1016/j.cct.2022.106940. Epub 2022 Sep 28.
- Derived from this study: PubMed 42776530Callegari LS, Benson SK, Nelson KM, Arterburn DE, Hamilton AB, Taylor L, Mahorter SS, Hunter-Merrill R, Pleasure ZH, Yogendran A, Merkel CG, Mog AC, Dehlendorf C, Borrero S. Text Message Delivery of a Digital Tool for Reproductive Health Discussions in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2635075. doi: 10.1001/jamanetworkopen.2026.35075.
- Individual participant dataSharing planned: Yes. Veteran participant data will be deposited into the "Reproductive, Sexual, and Socio-Behavioral Health Data Repository and Registry" VA data repository and registry housed and managed at the VA Puget Sound Health Care System. The data will be stored indefinitely in accordance with VHA regulations under VA IRB and R\&D Committee oversight. Procedures are as follows.
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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.
Lisa S Callegari, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPath Web-Based Informational and Decision Support Tool in people with Contraception and Contraception Behavior, run by VA Office of Research and Development at 12 sites 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 10 inclusion and 10 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 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM) (time frame: Within one month post-visit). 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 NCT04584294, which also lists 2 linked publications.
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 6 Nov 2025.