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NCT03637322 Clinical Trial

Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) Access Project for Youth Aged 13-24

Unsafe Sex Clinical Trial

Official title:
Evaluation of Implementation of the Phoenix PrEP Access Project for Youth Aged 13-24

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03637322
Other study ID # 17-196
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2022

Study information
Verified date March 2023
Source Phoenix Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and continue taking PrEP will be examined.

Description:

This observational study will describe the barriers encountered and the benefits found as youth engage in a PrEP program, the Phoenix PrEP Access Project and as they participate in PrEP provided through standard medical care. This study does not investigate the safety, efficacy or other medical benefits of PrEP, but looks at the issues surrounding youth who are trying to access PrEP.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 13 Years to 24 Years
Eligibility Inclusion Criteria - sexually active youth aged 13 through 24, - at risk for contracting HIV, - Negative for HIV as indicated by Negative Elisa and Western Blot (WB) or Negative 4th Generation test, - weight greater than 35kg, - offered PrEP to reduce the risk of contracting HIV. Exclusion Criteria - Unknown or Positive HIV status, - Renal Impairment as indicated by elevated BUN or Creatinine, abnormal urinalysis, - Active infection with Hepatitis B Virus, - Taking other medications containing Emtricitabine, Tenofovir or tenofovir alafenamide(TAF) such as Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, and Viread taking drugs containing lamivudine, - taking Hepsera, - clinical symptoms consistent with acute viral infection within the past month.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Phoenix Children's Hospital, Bill Holt Clinic Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PrEP Uptake Uptake of PrEP offered to youth presenting for PrEP ages 13-24 3 years
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