HIV InfectionsPrEDICTNCT05245201
Clinical Decision Support for PrEP
A study testing Clinical decision support for PrEP in people with HIV Infections and Preexposure Prophylaxis (PrEP), run by Harvard Pilgrim Health Care at 3 sites in United States.
Trial summary
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Preexposure Prophylaxis (PrEP)
- What is being tested?
- Clinical decision support for PrEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2022to Aug 2027
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary care providers at participating clinics who are licensed to prescribe PrEP
Who cannot join
- N/A
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roanoke Chowan Community Health Center
Ahoskie, North Carolina, 27910
Kintegra Health
Gastonia, North Carolina, 28052
Saban Community Clinic
Los Angeles, California, 90038
About this study
Official title: Optimizing EHR-Based Prediction Models to Improve HIV Preexposure Prophylaxis Use in Community Health Centers
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.
- Conditions
- HIV Infections, Preexposure Prophylaxis (PrEP)
- Being tested
- Standard of care, Clinical decision support for PrEP
- Keywords
- HIV, preexposure prophylaxis (PrEP), risk prediction, clinical decision support, electronic health records
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Two control clinics will be selected based on a set of matching criteria, e.g., urbanity and the sex, race, and age distributions of the patient population. Control clinics will not participate in study activities.
Clinical decision support for PrEPOther
Healthcare providers at 2 intervention clinics (total of approximately 60 providers anticipated) will be prompted by an EHR-based tool to discuss PrEP with patients whose demographics and clinical history indicate increased predicted HIV risk. Providers will be offered clinical decision support tools to guide sexual health discussions and support PrEP prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard of care | Active comparator | Standard of care Receives: Other: Standard of care |
| Arm 2 - Clinical decision support for PrEP | Active comparator | EHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk Receives: Other: Clinical decision support for PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP prescriptions
Number of patients with increased predicted HIV risk who are prescribed PrEP
Measured: 9 months
Secondary outcomes (2)
Feasibility of clinical decision support system
Rates at which providers view alerts about patients with increased predicted HIV risk and rates at which providers access the EHR-based decision support tools using Epic date-time stamps
Measured: 6 months
Acceptability of clinical decision support system
One-on-one feedback interviews with clinic administrators and 3-5 providers at intervention clinics
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 posted17 Feb 2022
- Study start11 Jul 2022
- Primary completionSep 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be implemented in 2-3 clinics, with 2-3 control clinics receiving standard of care. Eligible community health centers will be those with at least 500 patients and a minimum of 10 HIV diagnoses. Clinics located in counties identified as HIV hotspots will be prioritized. Clinics specializing in HIV or sexual health care, where providers may have less need for PrEP decision support, will be excluded. Overall, 26 clinics are expected to meet these eligibility criteria, with a total of 831 incident HIV diagnoses in 2018. Of eligible clinics, 2-3 will be recruited to receive the intervention. Using a covariate-constrained matching procedure with EHR data on important covariates (e.g., urbanity and the sex, race, and age distributions of the patient population), 2-3matched control clinics will be selected.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., Oregon Health and Science University, National Institute of Mental Health (NIMH), Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Julia Marcus, PhD, Principal investigator, Harvard Pilgrim Health Care InstituteDouglas Krakower, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245201
- Sponsor's protocol ID
- PH000739A
- Other IDs
- R34MH122291
- Acronym
- PrEDICT
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing EHR-Based Prediction Models to Improve HIV Preexposure Prophylaxis Use in Community Health Centers
- ClinicalTrials.gov ID
- NCT05245201
- Acronym / sponsor ID
- PrEDICT / PH000739A
- Conditions
- HIV Infections, Preexposure Prophylaxis (PrEP)
- Keywords
- HIV, preexposure prophylaxis (PrEP), risk prediction, clinical decision support, electronic health records
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- OCHIN, Inc., Oregon Health and Science University, National Institute of Mental Health (NIMH), Beth Israel Deaconess Medical Center
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Feb 2022 (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.
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be implemented in 2-3 clinics, with 2-3 control clinics receiving standard of care. Eligible community health centers will be those with at least 500 patients and a minimum of 10 HIV diagnoses. Clinics located in counties identified as HIV hotspots will be prioritized. Clinics specializing in HIV or sexual health care, where providers may have less need for PrEP decision support, will be excluded. Overall, 26 clinics are expected to meet these eligibility criteria, with a total of 831 incident HIV diagnoses in 2018. Of eligible clinics, 2-3 will be recruited to receive the intervention. Using a covariate-constrained matching procedure with EHR data on important covariates (e.g., urbanity and the sex, race, and age distributions of the patient population), 2-3matched control clinics will be selected.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard of care | Active comparator | Other: Standard of careStandard of care |
| Arm 2 - Clinical decision support for PrEP | Active comparator | Other: Clinical decision support for PrEPEHR-based decision support tools to support PrEP discussions and prescribing for patients who have increased predicted HIV risk |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care providers at participating clinics who are licensed to prescribe PrEP
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Standard of careTwo control clinics will be selected based on a set of matching criteria, e.g., urbanity and the sex, race, and age distributions of the patient population. Control clinics will not participate in study activities. | Other | Arm 1 - Standard of care |
| Clinical decision support for PrEPHealthcare providers at 2 intervention clinics (total of approximately 60 providers anticipated) will be prompted by an EHR-based tool to discuss PrEP with patients whose demographics and clinical history indicate increased predicted HIV risk. Providers will be offered clinical decision support tools to guide sexual health discussions and support PrEP prescribing. | Other | Arm 2 - Clinical decision support for PrEP |
Primary outcome
PrEP prescriptions
Time frame: 9 months
Number of patients with increased predicted HIV risk who are prescribed PrEP
2 secondary outcomes
Feasibility of clinical decision support system
Time frame: 6 months
Acceptability of clinical decision support system
Time frame: 6 months
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 18 Sep 2026.
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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.
Julia Marcus, PhD principal investigator
Harvard Pilgrim Health Care Institute
Douglas Krakower, MD principal investigator
Beth Israel Deaconess Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support for PrEP in people with HIV Infections and Preexposure Prophylaxis (PrEP), run by Harvard Pilgrim Health Care at 3 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 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
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?
PrEP prescriptions (time frame: 9 months). 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 18 Sep 2026.