Improving the HIV PrEP Cascade Using an Intervention for Healthcare Providers (PrEP-OI)

September 15, 2025 updated by: University of California, San Francisco
The PrEP Optimization Intervention (PrEP-OI) aims to educate healthcare providers on PrEP and assist providers in the appropriate targeting of patients at increased risk for HIV acquisition, initiating PrEP when appropriate, and providing guidance on the ongoing monitoring and adherence counseling of patients on PrEP. The intervention includes a web-based panel management tool (called PrEP-Rx) and PrEP coordination (by a PrEP Coordinator). The PrEP-OI study will take place among participating primary care and specialty clinics across the San Francisco Department of Public Health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite data indicating nearly 80,000 individuals starting HIV pre-exposure prophylaxis (PrEP) by the end of 2015, the Centers for Disease Control and Prevention (CDC) estimates that there are over 1.2 million adults with a substantial risk for HIV acquisition. Therefore, only 6% of these individuals are receiving PrEP. One of the barriers to PrEP implementation is lack of healthcare provider (HCP) knowledge and willingness to prescribe it. In a 2015 national survey, only 66% of primary care clinicians were aware of PrEP. However, once PrEP was defined, 91% indicated a willingness to prescribe it for high risk patients and expressed an interest in education about how to deliver PrEP. A descriptive report on the early experiences with PrEP uptake and delivery in San Francisco identified the following priority steps for HCPs to address PrEP delivery issues and to maximize PrEP's public health impact: (1) increase PrEP knowledge among HCPs and (2) expand PrEP access by training HCPs and developing tools to facilitate PrEP delivery in clinical settings. Additionally, based on the framework of the PrEP care continuum, interventions to enhance PrEP uptake include HCP education, tools to assess sexual risk, and systems to minimize HCP burden. Given these proposals and recommendations, innovative and effective approaches are needed to support and provide guidance to HCPs regardless of level of experience prescribing PrEP.

The investigators propose a PrEP optimization intervention targeted at HCPs to increase PrEP uptake and persistence among those at risk for HIV acquisition. This intervention includes: (1) an integrated web-based panel management tool called PrEP-Rx, which provides structured HIV risk assessment, automates reminders for laboratory testing and appointments, and reports patients' history of PrEP use; and (2) a centralized PrEP coordination overseen by a clinical support staff (referred to as the PrEP coordinator) who can identify individuals at high risk for HIV through direct patient contact or by reviewing registries for sexually transmitted infections (STIs) and who can support multiple HCPs. PrEP-Rx consists of three components: (a) Risk Assessment, (b) Provider Dashboard, and (c) Knowledge Base. The brief online behavioral Risk Assessment will be provided to patients to complete prior to their initial visits with HCPs. This assessment allows patients to respond to sensitive risk questions in private, removes the need for HCPs to ask detailed risk questions, provides a standardized and comprehensive view of patient's HIV risk, and decreases the time burden on HCPs. Based on responses to the Risk Assessment, a patient's risk is categorized (high, medium, or low) and results are presented to the HCP on a "Provider Dashboard" along with laboratory test results that are required prior to PrEP initiation, and the patient's history of PrEP use (if applicable). Based on these data, the HCP and patient can discuss the risks and benefits of PrEP initiation. If a PrEP prescription is given, PrEP-Rx will generate automated follow-up reminders which are sent to the PrEP Coordinator for scheduling office appointments or laboratory visits. The activities of PrEP-Rx and the role of the HCP are augmented and managed by the PrEP Coordinator, who has the ability to identify and contact patients who have tested positive for STIs, follow-up with patients to minimize loss-to-follow-up and improve adherence, and ensure timely laboratory monitoring. PrEP-Rx also contains a Knowledge Base for HCP education and ongoing training.

Therefore, the investigators propose the following aims:

Primary Aim: Evaluate the efficacy of the PrEP optimization intervention (PrEP Coordinator + PrEP-Rx) to increase PrEP prescriptions through a stepped-wedge design among 10 San Francisco primary care clinics. The investigators hypothesize that the mean number of prescriptions issued will be significantly higher when the clinics use the PrEP intervention versus when they do not.

Secondary Aims:

  1. Explore differences in PrEP initiation, duration of use, and reasons for discontinuation based on patient's age, race/ethnicity, and sex/gender, and by clinic and HCP characteristics among study clinics.
  2. Explore sustainability of the intervention during an eight-month follow-up after the Stepped-wedge Phase.
  3. Investigate facilitators and barriers of PrEP delivery and experiences with the proposed PrEP intervention through qualitative interviews with HCPs, PrEP Coordinators, and clinic directors of study clinics.

The combination of the PrEP Coordinator plus PrEP-Rx has the potential to improve all steps of the PrEP continuum and enhance overall care by identifying individuals at high risk of HIV acquisition, standardizing HIV risk assessment, helping in PrEP initiation, systematizing follow-up visits or laboratory assessments, and educating HCPs about emerging PrEP data. These goals can have a significant public health impact and be attained with minimal burden on existing clinic resources.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Center for AIDS Prevention Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • San Francisco Department of Public Health (DPH) clinics that have agreed to participate
  • HCPs and medical directors employed at the study clinics
  • Patients who are seen at these study clinics and are offered HIV PrEP during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrEP-OI Intervention
All clinics that have crossed over to initiate the intervention at this time. The order of crossover is determined at random.
Other: PrEP Optimization Intervention (PrEP-OI)
PrEP-Rx + PrEP Coordinator
No Intervention: Control until randomized for intervention
All clinics that have not yet initiated the intervention at this time (i.e., control clinics). A new clinic will cross over to receive the intervention each month, with the order of clinic crossover determined at random, until all clinics are receiving the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of PrEP-OI
Time Frame: 10 months
Mean number of PrEP prescriptions initiated
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP usage
Time Frame: 10 months
Explore differences in PrEP initiation, duration of use, and reasons for discontinuation
10 months
Sustainability during 12 month Follow-up Phase
Time Frame: 22 months
Explore sustainability of the intervention by determining if prescription numbers change in the Follow-up relative to the Stepped-wedge Phase
22 months
Facilitators and barriers of PrEP delivery
Time Frame: 22 months
Investigate facilitators and barriers of PrEP delivery and experiences with the proposed PrEP intervention through one-on-one qualitative interviews with HCPs and PrEP Coordinators
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Nursing Research (NINR)
San Francisco Department of Public Health

Investigators

  • Principal Investigator: Parya Saberi, PharmD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

April 29, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR017573 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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