PrEP With TDF/FTC to Prevent HIV-1 Acquisition in Young MSM and Transgender Women of Color

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a 48-week prospective observational study that will allow testing of the hypothesis that a program in which pre-exposure prophylaxis (PrEP) is administered to young men of color who have sex with men (yMSMc) in a community youth drop-in center in conjunction with a multifaceted behavioral intervention as well as standard HIV prevention interventions can achieve at least 70% retention, as well as a medication adherence rate significantly better than that previously reported in the literature. The proposed program evaluation can provide critical information for the enhancement and scale-up of successful PrEP programs at FIGHT and elsewhere in an effort to make PrEP available to a growing number of persons at risk of acquiring human immunodeficiency virus (HIV).

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Philadelphia Fight
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Age 18 to 30 years at the time of signed informed consent

• Willing and able to independently provide written informed consent

• Biological male at birth

• Tests HIV negative at time of screening using rapid HIV antibody test (HIV viral load testing is also conducted immediately prior to initiation of PrEP, but is not an inclusion criteria as screening labs may be collected weeks prior to medication initiation and we would like to confirm a negative viral load as close to medication initiation as possible for subject's safety)

• Willing to provide locator information to study staff for a 48-week period

• Current participant in I Am Men's Health PrEP program or willing to become a participant

Exclusion Criteria:

• Evidence of acute or chronic hepatitis B infection at the time of screening

• Other clinically significant acute or chronic medical condition, including severe infections requiring treatment such as tuberculosis, as determined by the study investigator

• Evidence of renal dysfunction (Creatinine Clearance < 50 ml/min) at the time of screening; Use Cockcroft-Gault equation: GFR = (140-Age in years) x (Weight in kg) / (72 x serum creatinine)

• History of bone fractures not explained by trauma

• Grade 3 laboratory abnormality on screening tests/assessments as defined by the DAIDS grading system

• Concurrent participation in an HIV vaccine study

• Known allergy/sensitivity to the study drug or its components

• Current use of any antiretroviral agent other than Truvada for any reason

• Experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)

• Any other clinical condition or prior therapy that, in the opinion of the Principal Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements