NCT03532191

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 29, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

April 29, 2018

Last Update Submit

September 15, 2025

Conditions

Keywords

Quality ImprovementHealthcare ProvidersHealth Disparity

Outcome Measures

Primary Outcomes (1)

  • Efficacy of PrEP-OI

    Mean number of PrEP prescriptions initiated

    10 months

Secondary Outcomes (3)

  • PrEP usage

    10 months

  • Sustainability during 12 month Follow-up Phase

    22 months

  • Facilitators and barriers of PrEP delivery

    22 months

Study Arms (2)

PrEP-OI Intervention

EXPERIMENTAL

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)

Control until randomized for intervention

NO 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.

Interventions

PrEP-Rx + PrEP Coordinator

PrEP-OI Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Center for AIDS Prevention Studies

San Francisco, California, 94158, United States

Location

Related Publications (7)

  • Saberi P, Stoner MCD, Ming K, Lisha NE, Hojilla JC, Scott HM, Liu AY, Steward WT, Johnson MO, Neilands TB. The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions. AIDS. 2022 Nov 1;36(13):1783-1789. doi: 10.1097/QAD.0000000000003283. Epub 2022 Jun 22.

  • Shrestha I, Ming K, Jimenez V, Wendelborn J, Vazquez A, Steward W, Scott H, Saberi P. Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. AIDS Res Hum Retroviruses. 2022 Aug;38(8):611-614. doi: 10.1089/AID.2022.0013. Epub 2022 Jun 16.

  • Saberi P, Ming K, Shrestha I, Scott H, Thorson B, Liu A. Feasibility and Acceptability of Home-Collected Samples for Human Immunodeficiency Virus Preexposure Prophylaxis and Severe Acute Respiratory Syndrome Coronavirus 2 Laboratory Tests in San Francisco Primary Care Clinics. Open Forum Infect Dis. 2022 Jan 21;9(2):ofab657. doi: 10.1093/ofid/ofab657. eCollection 2022 Feb.

  • Chan CT, Ming K, Camp C, Saberi P. Sexual Behaviors, Substance Use, and Quality of Life Among Individuals Using PrEP in San Francisco During the COVID-19 Pandemic Shelter-In-Place Orders: A Cross-Sectional Survey. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):e39-e42. doi: 10.1097/QAI.0000000000002900. No abstract available.

  • Saberi P, Ming K, Scott H, Liu A, Steward W. "You can't have a PrEP program without a PrEP Coordinator": Implementation of a PrEP panel management intervention. PLoS One. 2020 Oct 16;15(10):e0240745. doi: 10.1371/journal.pone.0240745. eCollection 2020.

  • Ming K, Shrestha I, Vazquez A, Wendelborn J, Jimenez V, Lisha N, Neilands TB, Scott H, Liu A, Steward W, Johnson MO, Saberi P. Improving the HIV PrEP continuum of care using an intervention for healthcare providers: a stepped-wedge study protocol. BMJ Open. 2020 Jul 14;10(7):e040734. doi: 10.1136/bmjopen-2020-040734.

  • Saberi P, Ming K, Hojilla JC, Scott HM, Neilands TB. HIV Preexposure Prophylaxis in the Time of COVID-19: How a Robust and Responsive HIV Preexposure Prophylaxis Intervention Can Avert Loss of HIV Prevention Coverage During a Global Pandemic. J Acquir Immune Defic Syndr. 2021 May 1;87(1):e173-e176. doi: 10.1097/QAI.0000000000002652. No abstract available.

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Parya Saberi, PharmD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2018

First Posted

May 22, 2018

Study Start

November 1, 2018

Primary Completion

September 30, 2020

Study Completion

January 31, 2021

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations