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Completed

NCT Number: NCT03637322

Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) 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.

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Key information

Conditions

Unsafe Sex Behavior IV Drug Usage Sexual Behavior

Age range

13 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix Children's Hospital, Bill Holt Clinic

Phoenix, Arizona, 85044, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PrEP Uptake

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2018
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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