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What Happens in Vegas: PEP to PrEP Opportunities

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775083
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
John Phoenix, Huntridge Family Clinic

Brief Summary:
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

Condition or disease Intervention/treatment
Exposure to Human Immunodeficiency Virus (Event) 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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: What Happens in Vegas: Identifying Opportunities to Expand an HIV Prevention Network to Improve PEP and PrEP Delivery
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Drug: Currently approved medications
    subjects will be treated according to current Department of Health and Human Services (DHHS) Center for Disease control and prevention (CDC), Society for Healthcare Epidemiology of American (SHEA guidelines for nPEP


Primary Outcome Measures :
  1. rate of engagement [ Time Frame: from enrollment to day 90 ]
    Assess the rate of engagement in a PEP to PrEP HIV prevention provider network for those patients presenting following a non-occupational HIV exposure


Secondary Outcome Measures :
  1. characteristics [ Time Frame: from enrollment through end of study for all participants ]
    Describe the characteristics of patients successfully engaging in HIV prevention via a patient collected survey using a qualtric survey.

  2. barriers [ Time Frame: from enrollment through end of study for all participants ]
    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

  3. Network characteristics [ Time Frame: from enrollment through end of study for all participants ]
    Analyze the network characteristics that faciliate engagement in HIV prevention services from a patient collected survey using a qualtric survey tool

  4. transition barriers [ Time Frame: from enrollment through end of study for all participants ]
    Determine and assess to transitioning from PEP to PrEP from a patient collected survey using a qualtric survey tool

  5. Retention [ Time Frame: from enrollment through end of study for all participants ]
    Compare and contrast the barriers to access and ongoing retention to PrEP from a patient collected survey using a qualtric survey tool.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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.

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): NCT03775083


Contacts
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Contact: John (Rob) Phoenix, MSN, APRN 702-979-1111 jphoenixaprn@gmail.com
Contact: Christina Madison, PharmD 702-968-2044 cmadison@roseman.edu

Locations
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United States, Nevada
Huntridge Family Clinic Recruiting
Las Vegas, Nevada, United States, 89104
Contact: John (Rob) Phoenix, APRN    702-979-1111    jphoenixaprn@gmail.com   
Principal Investigator: John Phoenix, APRN         
Principal Investigator: Christina Madison, PharmD         
Sponsors and Collaborators
Huntridge Family Clinic
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Responsible Party: John Phoenix, Clinical Director, Huntridge Family Clinic
ClinicalTrials.gov Identifier: NCT03775083    
Other Study ID Numbers: HFC018001
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
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 John Phoenix, Huntridge Family Clinic:
PEP
nPEP
Post Exposure Prophylaxis
non occupational exposure to HIV
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases