Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03775083
Other study ID # HFC018001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date August 31, 2019

Study information

Verified date December 2018
Source Huntridge Family Clinic
Contact John (Rob) Phoenix, MSN, APRN
Phone 702-979-1111
Email jphoenixaprn@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 perceptions of care


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Huntridge Family Clinic Las Vegas Nevada

Sponsors (1)

Lead Sponsor Collaborator
Huntridge Family Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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