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

NCT03637322 | Completed

• 1 other identifier: 17-196
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unsafe Sex; IV Drug Usage

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake

  Uptake of PrEP offered to youth presenting for PrEP ages 13-24

  3 years

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Phoenix Children's Hospital, Bill Holt Clinic

Phoenix, Arizona, 85044, United States

Location

MeSH Terms

Conditions

Unsafe Sex

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Janice Piatt, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: August 20, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)