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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532191
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
San Francisco Department of Public Health
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
HIV/AIDS Other: PrEP Optimization Intervention (PrEP-OI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. Efficacy of PrEP-OI [ Time Frame: 10 months ]
    Mean number of PrEP prescriptions initiated


Secondary Outcome Measures :
  1. PrEP usage [ Time Frame: 10 months ]
    Explore differences in PrEP initiation, duration of use, and reasons for discontinuation

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
  • Patients who are seen at these study clinics and are offered HIV PrEP during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532191


Locations
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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
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Parya Saberi, PharmD, MAS University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03532191    
Other Study ID Numbers: R01NR017573 ( U.S. NIH Grant/Contract )
R01NR017573 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Quality Improvement
Healthcare Providers
Health Disparity
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases