NCT06805877

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable hiv

Timeline
50mo left

Started Apr 2025

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Apr 2025Jul 2030

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

4.2 years

First QC Date

January 28, 2025

Last Update Submit

April 23, 2025

Conditions

Keywords

HIVPrEPpre-exposure prophylaxispreventionprediction modelclinical decision support

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 months

Secondary Outcomes (1)

  • PrEP persistence

    30 months

Study Arms (2)

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

Other: Predictive Analytics and Clinical Decision Support

Interventions

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.

Predictive analytics and clinical decision support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Delivery site specializing in HIV or STI care
  • Correctional facilities
  • Mobile sites
  • School-based health center sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Bay Area Community Health Liberty Clinic

Fremont, California, 94538, United States

Location

Lifelong East Oakland Health Center

Oakland, California, 94605, United States

Location

TrueCare Oceanside Family Medicine

Oceanside, California, 92054, United States

Location

DAP Legacy

Palm Springs, California, 92262, United States

Location

One Community Health Midtown Campus

Sacramento, California, 95811, United States

Location

Southwest Community Health Center 968 Fairfield Avenue

Bridgeport, Connecticut, 06605, United States

Location

Mercy Care Decatur Street

Atlanta, Georgia, 30312, United States

Location

Siouxland Community Health Center Sioux City

Sioux City, Iowa, 51105, United States

Location

Lynn Community Health Center 269 Union

Lynn, Massachusetts, 01901, United States

Location

Mattapan Community Health Center Blue Hill

Mattapan, Massachusetts, 02126, United States

Location

Neighborhood Family Practice Ridge Community Health Center

Cleveland, Ohio, 44102, United States

Location

Signature Health Painesville

Painesville, Ohio, 44077, United States

Location

Variety Care Sequoyah

Oklahoma City, Oklahoma, 73112, United States

Location

Prism Belmont

Portland, Oregon, 97214, United States

Location

Bee Busy Wellness Center Bray Oaks

Houston, Texas, 77031, United States

Location

Seattle Roots Community Health Carolyn Downs Community Clinic

Seattle, Washington, 98122, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

April 21, 2025

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations