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

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

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.

Study Overview

• Status: Completed
• Conditions: IV Drug Usage; Unsafe Sex

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • Phoenix Children's Hospital, Bill Holt Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Youth aged 13 through 24 in the Phoenix area who are high risk for HIV infections because of unsafe sex practices and or IV drug use and have been offered PrEP as part of their standard medical care.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Uptake	Uptake of PrEP offered to youth presenting for PrEP ages 13-24	3 years

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-196

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