What Happens in Vegas: PEP to PrEP Opportunities

What Happens in Vegas: Identifying Opportunities to Expand an HIV Prevention Network to Improve PEP and PrEP Delivery

Observational study looking at barriers to care for individuals seeking care, Post Exposure Prophylaxis (PEP) after an actual or perceived exposure to HIV. Following PEP treatment subjects will be asked about there intent to transition to Pre-Exposure Prophylaxis (PrEP) and surveyed about barriers to care or perceptions of care

Study Overview

• Status: Unknown
• Conditions: Exposure to Human Immunodeficiency Virus (Event)
• Intervention / Treatment: Drug: Currently approved medications

Detailed Description

The primary objective of this study is to assess the rate of engagement in a PEP to PrEP HIV provider network for those patients presenting following a non-occupational HIV exposure.

The development of a referral network and intensive clinical follow up of PEP patients will result in more patients appropriately initiating PEP, being referred to appropriate follow up, and post exposure transition and maintaining on PrEP (if indicated) at completion of the PEP medications.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Recruiting
      • Huntridge Family Clinic
      • Contact: John (Rob) Phoenix, APRN; Phone Number: 702-979-1111; Email: jphoenixaprn@gmail.com
      • Principal Investigator: John Phoenix, APRN
      • Principal Investigator: Christina Madison, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV negative Men, Women, Transgender Men, Transgender Women age who self identify as having had an actual or perceived non-occupational exposure to HIV

HIV negative Men, Women, Transgender Men, Transgender Women age who self identify at risk of acquisition of HIV after having had an actual or perceived non-occupational exposure to HIV

Description

Inclusion Criteria:

• Actual or perceived non-occupational exposure to HIV, by self report, within 72 hours of enrollment and referred for care
• able and willing to provide informed consent
• available for 12 months of post expoure follow-up Southern Nevada Ryan White defined service area

Exclusion Criteria:

• HIV+ at time of screeing via 4th genderation (Antibody/Antigen) testing
• Current PEP and/or PrEP product condrainidications as listed in the medication product insert.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of engagement	Assess the rate of engagement in a PEP to PrEP HIV prevention provider network for those patients presenting following a non-occupational HIV exposure	from enrollment to day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
characteristics	Describe the characteristics of patients successfully engaging in HIV prevention via a patient collected survey using a qualtric survey.	from enrollment through end of study for all participants
barriers	Identify and assess barriers to access to HIV prevention care including PEP in the period immediately following HIV exposure from a patient collected survey using a qualtric survey tool	from enrollment through end of study for all participants
Network characteristics	Analyze the network characteristics that faciliate engagement in HIV prevention services from a patient collected survey using a qualtric survey tool	from enrollment through end of study for all participants
transition barriers	Determine and assess to transitioning from PEP to PrEP from a patient collected survey using a qualtric survey tool	from enrollment through end of study for all participants
Retention	Compare and contrast the barriers to access and ongoing retention to PrEP from a patient collected survey using a qualtric survey tool.	from enrollment through end of study for all participants

Collaborators and Investigators

• Sponsor: Huntridge Family Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: PEP; Post Exposure Prophylaxis; nPEP; non occupational exposure to HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HFC018001

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