ContraceptionPRISM-CSNCT06819787
Patient Experiences With Contraceptive Care Provided by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform
A study testing Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services in people with Contraception, run by OvaryIt, LLC at 5 sites in United States.
Trial summary
Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first… Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Jul 2025to 31 Jan 2026
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women presenting for hormonal contraceptives
Who cannot join
- Age less than 18 years
- Pregnancy
- Unable to become pregnant
- Not English speaking
- Suspected coercion
- Unable to consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Calabasas Pharmacy
Calabasas, California, 91302
Local Health Pharmacy
Chicago, Illinois, 60647
Desert Pharmacy
El Centro, California, 92243
Gaston Family Pharmacy
Gaston, South Carolina, 29053
Wolves Den Pharmacy
Stanford, Montana, 59479
About this study
Official title: Patient-Reported Outcomes of Contraceptive Services Rendered by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform: The PRISM-CS Study
Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first seeing another healthcare provider. The Pharmacist Resource to Implement Services as Modules (PRISM) is an Electronic Health Record platform designed to streamline workflows and provide clinical decision support, making it easier and safer to deliver clinical services in community pharmacies. This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community pharmacies across the United States over a 12-week period. The study will assess the quality of care, contraception continuation and failure rates, side effect rates, preventative healthcare utilization, and overall patient experience with pharmacy contraceptive services.
- Conditions
- Contraception
- Being tested
- Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services
- Keywords
- Contraception, Pregnancy Prevention, Digital Health, Pharmacist, Community Pharmacy Services, Patient-reported Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive ServicesOther
An electronic health record (EHR) platform specifically designed to support community pharmacists in delivering contraceptive services. The platform streamlines clinical workflows, provides clinical decision support, and promotes adherence to the US Medical Eligibility Criteria (USMEC) guidelines and state regulatory requirements.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-Rendered Contraceptive Services | Experimental | Participants in this single-arm study are women seeking contraceptive services to prevent pregnancy in a community pharmacy setting. Pharmacists will deliver these services using an Electronic Health Record system that assists in evaluating each patient's eligibility based on the US Medical Eligibility Criteria (USMEC) guidelines. Pharmacists will be instructed to provide patient-centered contraceptive care. They retain full discretion to decide whether to issue a prescription, and if so, to select the most appropriate FDA-approved contraceptive option based on their clinical judgment. Receives: Other: Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person-Centered Contraceptive Counseling (PCCC) Measure
The percentage of patients who report that the pharmacist provided overall patient-centered care, as defined by achieving the highest rating on all four items of the PCCC survey.
Measured: Within 7 days post-intervention
Secondary outcomes (1)
Three-month Contraceptive Continuation Rate
The percentage of patients who report continuous use of their selected contraceptive method three months after the pharmacist encounter. Continuous use is defined as using the method at the time of the survey with no gaps in use of one month or longer.
Measured: Within 97 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start12 Jul 2025
- Primary completion1 Nov 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- OvaryIt, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of Utah
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819787
- Sponsor's protocol ID
- 2R44HD110346-02A1
- Acronym
- PRISM-CS
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes of Contraceptive Services Rendered by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform: The PRISM-CS Study
- ClinicalTrials.gov ID
- NCT06819787
- Acronym / sponsor ID
- PRISM-CS / 2R44HD110346-02A1
- Conditions
- Contraception
- Keywords
- Contraception, Pregnancy Prevention, Digital Health, Pharmacist, Community Pharmacy Services, Patient-reported Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- OvaryIt, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of Utah
- Study start
- 12 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 11 Feb 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.
Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first seeing another healthcare provider. The Pharmacist Resource to Implement Services as Modules (PRISM) is an Electronic Health Record platform designed to streamline workflows and provide clinical decision support, making it easier and safer to deliver clinical services in community pharmacies. This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community pharmacies across the United States over a 12-week period. The study will assess the quality of care, contraception continuation and failure rates, side effect rates, preventative healthcare utilization, and overall patient experience with pharmacy contraceptive services.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-Rendered Contraceptive Services | Experimental | Other: Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive ServicesParticipants in this single-arm study are women seeking contraceptive services to prevent pregnancy in a community pharmacy setting. Pharmacists will deliver these services using an Electronic Health Record system that assists in evaluating each patient's eligibility based on the US Medical Eligibility Criteria (USMEC) guidelines. Pharmacists will be instructed to provide patient-centered contraceptive care. They retain full discretion to decide whether to issue a prescription, and if so, to select the most appropriate FDA-approved contraceptive option based on their clinical judgment. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women presenting for hormonal contraceptives
Key exclusion criteria (6 listed)
- Age less than 18 years
- Pregnancy
- Unable to become pregnant
- Not English speaking
- Suspected coercion
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 |
|---|---|---|
| Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive ServicesAn electronic health record (EHR) platform specifically designed to support community pharmacists in delivering contraceptive services. The platform streamlines clinical workflows, provides clinical decision support, and promotes adherence to the US Medical Eligibility Criteria (USMEC) guidelines and state regulatory requirements. | Other | Pharmacist-Rendered Contraceptive Services |
Primary outcome
Person-Centered Contraceptive Counseling (PCCC) Measure
Time frame: Within 7 days post-intervention
The percentage of patients who report that the pharmacist provided overall patient-centered care, as defined by achieving the highest rating on all four items of the PCCC survey.
1 secondary outcome
Three-month Contraceptive Continuation Rate
Time frame: Within 97 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services in people with Contraception, run by OvaryIt, LLC at 5 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 1 inclusion and 6 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Person-Centered Contraceptive Counseling (PCCC) Measure (time frame: Within 7 days post-intervention). 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 4 Feb 2026.