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

NCT02367807 | Completed

• 1 other identifier: IN-US-276-1295
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV

Keywords

HIV prevention; PrEP; young men who have sex with men; Truvada

Outcome Measures

Primary Outcomes (2)

• Evaluate program retention

  We will determine whether this community intervention can achieve 70% program retention at the end of 48 weeks, as defined by the proportion of patients initiating Truvada who pick up at least 50% of their medication through 48 weeks and who have a study visit in the 48-week window (subject may have this final study visit within an allowed window of 4 weeks before or after the 48-week visit in accordance with the FDA snapshot algorithm). Intermediate retention assessment will also be conducted at weeks 12, 24, and 36 by assessing the proportion of patients who have picked up at least 50% of their medication prior to those time points and who have a study visit at the end of those periods using +/- 4 week snapshot analysis.

  48 weeks

• Evaluate adherence to PrEP

  This will be assessed by the proportion of medication pick-up visits attended (a function of pharmacy refill data), and the proportion of study subjects with detectable urine drug concentrations over the 48 week study period. We will compare the estimates of adherence obtained with these measurements to two plasma tenofovir concentrations (collected at weeks 24 and 48) using the cutoff of 16 fmol/106 cells as the level associated with 90% adherence or greater.

  48 weeks

Secondary Outcomes (3)

• Assess behavioral change

  48 weeks

• Measure program acceptability and feasibility

  48 weeks

• Measure the success rate in linking to care participants who seroconvert to HIV positive status while receiving PrEP

  48 weeks

Interventions

Emtricitabine and tenofovir disoproxil fumarate DRUG

This study will enroll 50 subjects who are offered TDF/FTC for 48 weeks as part of a combined biomedical/behavioral intervention offered in a community-based setting serving high-risk youth in an urban setting.

Also known as: Truvada, TDF/FTC

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 biological males from urban Philadelphia who identify as men who have sex with men (MSM) ages 18-30 at risk of HIV acquisition

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philadelphia Fight: lead

Study Sites (1)

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and plasma samples for measurement of tenofovir concentration, blood samples for measurement of safety labs, and urine/plasma samples and rectal/pharyngeal swabs for sexually transmitted infection screening

MeSH Terms

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Helen C Koenig, MD, MPH

  Philadelphia Fight

  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 13, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

US (1)