Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
University of California, San Francisco

Collaborator
San Francisco Department of Public Health

Information provided by (Responsible Party)
Parya Saberi, PharmD, MAS, University of California, San Francisco

ClinicalTrials.gov Identifier
NCT03532191

First received: April 29, 2018
Last updated: December 3, 2018
Last Verified: December 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS

Other : PrEP Optimization Intervention (PrEP-OI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The proposed intervention study will be implemented using a stepped-wedge design, which is a type of one-way crossover design in which all clinics will begin the study without the PrEP-OI intervention. Each clinic will cross over to receive the intervention one-by-one every month, with the order of clinic crossover determined at random to maximize internal validity.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving the HIV PrEP Cascade Using an Intervention for Healthcare Providers

Further study details as provided by Parya Saberi, PharmD, MAS, University of California, San Francisco:

Primary Outcome Measures

  • Efficacy of PrEP-OI [ Time Frame: 20 months ]
    Mean number of PrEP prescriptions initiated
Secondary Outcome Measures:
  • PrEP usage [ Time Frame: 20 months ]
    Explore differences in PrEP initiation, duration of use, and reasons for discontinuation
  • Sustainability during 8 month Follow-up Phase [ Time Frame: 28 months ]
    Explore sustainability of the intervention by determining if prescription numbers change in the Follow-up relative to the Stepped-wedge Phase
  • Facilitators and barriers of PrEP delivery [ Time Frame: 33 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

Enrollment: 11
Study Start Date: November 1, 2018
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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 11 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.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03532191

Locations

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

Sponsors and Collaborators

University of California, San Francisco
San Francisco Department of Public Health
More Information

More Information


Responsible Party: Parya Saberi, PharmD, MAS, Assistant Professor, University of California, San Francisco  
ClinicalTrials.gov Identifier: NCT03532191   History of Changes  
Other Study ID Numbers: R01NR017573  
Study First Received: April 29, 2018  
Last Updated: December 3, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Parya Saberi, PharmD, MAS, University of California, San Francisco:

Quality Improvement
Healthcare Providers
Health Disparity

ClinicalTrials.gov processed this data on August 19, 2019
This information is provided by ClinicalTrials.gov.