HIVPrEDICTNCT06805877
Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing
A study testing Predictive Analytics and Clinical Decision Support in people with HIV, run by Harvard Pilgrim Health Care at 16 sites in United States.
Trial summary
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the U.S. initiative to end the HIV epidemic, but healthcare providers lack tools to support PrEP discussions and prescribing for patients likely to benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Predictive Analytics and Clinical Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 16 sitesUnited States
- Study dates
- 21 Apr 2025to Jul 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Delivery site saw at least 500 distinct patients in 2024 during in-person or telehealth visits
- Delivery site had at least 10 new HIV diagnoses or positive HIV screening tests in 2023
- Delivery site provides primary care other than pediatrics, and the primary care department(s) were active on OCHIN Epic as of 1/1/2023
Who cannot join
- Delivery site specializing in HIV or STI care
- Correctional facilities
- Mobile sites
- School-based health center sites
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Mercy Care Decatur Street
Atlanta, Georgia, 30312
Southwest Community Health Center 968 Fairfield Avenue
Bridgeport, Connecticut, 06605
Neighborhood Family Practice Ridge Community Health Center
Cleveland, Ohio, 44102
Bay Area Community Health Liberty Clinic
Fremont, California, 94538
Bee Busy Wellness Center Bray Oaks
Houston, Texas, 77031
Lynn Community Health Center 269 Union
Lynn, Massachusetts, 01901
Mattapan Community Health Center Blue Hill
Mattapan, Massachusetts, 02126
Lifelong East Oakland Health Center
Oakland, California, 94605
TrueCare Oceanside Family Medicine
Oceanside, California, 92054
Variety Care Sequoyah
Oklahoma City, Oklahoma, 73112
Signature Health Painesville
Painesville, Ohio, 44077
DAP Legacy
Palm Springs, California, 92262
Prism Belmont
Portland, Oregon, 97214
One Community Health Midtown Campus
Sacramento, California, 95811
Seattle Roots Community Health Carolyn Downs Community Clinic
Seattle, Washington, 98122
Siouxland Community Health Center Sioux City
Sioux City, Iowa, 51105
About this study
Official title: Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing in Community Health Centers
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the U.S. initiative to end the HIV epidemic, but healthcare providers lack tools to support PrEP discussions and prescribing for patients likely to benefit. This research will evaluate whether integrating automated tools into electronic health records to help providers efficiently and equitably identify potential candidates for PrEP, discuss PrEP, and prescribe PrEP can improve PrEP initiation and persistence in safety-net community health centers. It will achieve this by conducting a stepped-wedge trial of a decision support tool with an embedded HIV prediction model to identify patients likely to benefit from PrEP. The intervention will be delivered to healthcare providers in 16 community health centers within the national OCHIN network.
- Conditions
- HIV
- Being tested
- Predictive Analytics and Clinical Decision Support
- Keywords
- HIV, PrEP, pre-exposure prophylaxis, prevention, prediction model, clinical decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive Analytics and Clinical Decision SupportOther
The intervention will include automated EHR notifications to clinicians at 16 OCHIN community health centers about patients who are likely to benefit from PrEP. These patients will be identified by an HIV prediction model that was developed and validated during the pilot phase of this study using historical OCHIN EHR data. For patients above a preselected threshold of predicted HIV risk, clinicians will be notified at the point of care that the patient may benefit from PrEP and will be provided with EHR-based tools to support discussions and prescribing. The intervention will also include coaching on PrEP and the decision support tool, as well as project team support during the trial period.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Data will be extracted from EHRs of control clinics as a comparison, and those clinics will not actively participate in study activities |
| Predictive analytics and clinical decision support | Active comparator | Providers in enrolled intervention clinics will receive point-of-care notifications via the EHR-embedded decision support tool about patients who are at increased predicted HIV risk and therefore likely to benefit from PrEP Receives: Other: Predictive Analytics and Clinical Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initation
Proportion of patients above the prediction model risk threshold without a recently active PrEP prescription (within the prior 6 months) or prior HIV diagnosis who are prescribed PrEP during the study period.
Measured: 30 months
Secondary outcomes (1)
PrEP persistence
Proportion of patients prescribed PrEP who persist on PrEP for 6 and 12 months, as measured by prescription refills ordered.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start21 Apr 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), OCHIN, Inc., Oregon Health and Science University
- Responsible party
- Principal investigator, Julia Marcus, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805877
- Sponsor's protocol ID
- PH001008
- Other IDs
- R01MH133515
- Acronym
- PrEDICT
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Analytics and Clinical Decision Support to Improve PrEP Prescribing in Community Health Centers
- ClinicalTrials.gov ID
- NCT06805877
- Acronym / sponsor ID
- PrEDICT / PH001008
- Conditions
- HIV
- Keywords
- HIV, PrEP, pre-exposure prophylaxis, prevention, prediction model, clinical decision support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), OCHIN, Inc., Oregon Health and Science University
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 3 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.
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the U.S. initiative to end the HIV epidemic, but healthcare providers lack tools to support PrEP discussions and prescribing for patients likely to benefit. This research will evaluate whether integrating automated tools into electronic health records to help providers efficiently and equitably identify potential candidates for PrEP, discuss PrEP, and prescribe PrEP can improve PrEP initiation and persistence in safety-net community health centers. It will achieve this by conducting a stepped-wedge trial of a decision support tool with an embedded HIV prediction model to identify patients likely to benefit from PrEP. The intervention will be delivered to healthcare providers in 16 community health centers within the national OCHIN network.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Data will be extracted from EHRs of control clinics as a comparison, and those clinics will not actively participate in study activities |
| Predictive analytics and clinical decision support | Active comparator | Other: Predictive Analytics and Clinical Decision SupportProviders in enrolled intervention clinics will receive point-of-care notifications via the EHR-embedded decision support tool about patients who are at increased predicted HIV risk and therefore likely to benefit from PrEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Delivery site saw at least 500 distinct patients in 2024 during in-person or telehealth visits
- Delivery site had at least 10 new HIV diagnoses or positive HIV screening tests in 2023
- Delivery site provides primary care other than pediatrics, and the primary care department(s) were active on OCHIN Epic as of 1/1/2023
Key exclusion criteria (4 listed)
- Delivery site specializing in HIV or STI care
- Correctional facilities
- Mobile sites
- School-based health center sites
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 |
|---|---|---|
| Predictive Analytics and Clinical Decision SupportThe intervention will include automated EHR notifications to clinicians at 16 OCHIN community health centers about patients who are likely to benefit from PrEP. These patients will be identified by an HIV prediction model that was developed and validated during the pilot phase of this study using historical OCHIN EHR data. For patients above a preselected threshold of predicted HIV risk, clinicians will be notified at the point of care that the patient may benefit from PrEP and will be provided with EHR-based tools to support discussions and prescribing. The intervention will also include coaching on PrEP and the decision support tool, as well as project team support during the trial period. | Other | Predictive analytics and clinical decision support |
Primary outcome
PrEP initation
Time frame: 30 months
Proportion of patients above the prediction model risk threshold without a recently active PrEP prescription (within the prior 6 months) or prior HIV diagnosis who are prescribed PrEP during the study period.
1 secondary outcome
PrEP persistence
Time frame: 30 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 25 Sep 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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predictive Analytics and Clinical Decision Support in people with HIV, run by Harvard Pilgrim Health Care at 16 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 3 inclusion and 4 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 25 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 16 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 initation (time frame: 30 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 25 Sep 2026.