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

Phoenix Children's Hospital

Status: Completed

Conditions: IV Drug Usage; Unsafe Sex

Study type: Observational

Funder types: Other

Identifiers

NCT03637322

17-196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 13 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.