Exposure to Human Immunodeficiency Virus (Event)NCT03775083
What Happens in Vegas: PEP to PrEP Opportunities
An observational study of Exposure to Human Immunodeficiency Virus (Event), run by Huntridge Family Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exposure to Human Immunodeficiency Virus (Event)
- What is being tested?
- Currently approved medications
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Huntridge Family Clinic
Las Vegas, Nevada, 89104
John (Rob) Phoenix, APRN, 702-979-1111, jphoenixaprn@gmail.com
John Phoenix, APRN
About this study
Official title: 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
Read the 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.
- Being tested
- Currently approved medications
- Keywords
- PEP, nPEP, Post Exposure Prophylaxis, non occupational exposure to HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Currently approved medicationsDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to day 90
Secondary outcomes (5)
characteristics
Describe the characteristics of patients successfully engaging in HIV prevention via a patient collected survey using a qualtric survey.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: from enrollment through end of study for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Sep 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Human Immunodeficiency Virus (Event)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huntridge Family Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Phoenix, Huntridge Family Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775083
- Sponsor's protocol ID
- HFC018001
- Status last verified
- Dec 2018
- First submitted
- 6 Sep 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Happens in Vegas: Identifying Opportunities to Expand an HIV Prevention Network to Improve PEP and PrEP Delivery
- ClinicalTrials.gov ID
- NCT03775083
- Acronym / sponsor ID
- HFC018001
- Keywords
- PEP, nPEP, Post Exposure Prophylaxis, non occupational exposure to HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Huntridge Family ClinicUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Currently approved medicationssubjects 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 | Drug | – |
Primary outcome
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
5 secondary outcomes
characteristics
Time frame: from enrollment through end of study for all participants
barriers
Time frame: from enrollment through end of study for all participants
Network characteristics
Time frame: from enrollment through end of study for all participants
transition barriers
Time frame: from enrollment through end of study for all participants
Retention
Time frame: from enrollment through end of study for all participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Exposure to Human Immunodeficiency Virus (Event)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure to Human Immunodeficiency Virus (Event), run by Huntridge Family Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John (Rob) Phoenix, MSN, APRN (702-979-1111, jphoenixaprn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of engagement (time frame: from enrollment to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.