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

PrEP for HIV prevention with once daily Truvada has been shown to be extremely safe and
efficacious in multiple populations when taken consistently. Young men who have sex with men
of color (yMSMc) comprise the group at the highest risk of new HIV infections and the only
group whose HIV infection rates continue to increase. New data suggest interrupting
transmission among MSM can reduce HIV acquisition among other risk groups as well. However,
accessing, linking, and retaining yMSMc in a PrEP program is both critical to successful HIV
prevention and historically difficult to achieve. Philadelphia FIGHT initiated a PrEP
program at the youth site, Youth Health Empowerment Project (Y-HEP), for yMSMc approximately
1.5 years ago that also gives all participants access to general primary care. Y-HEP
utilizes a unique biomedical/biobehavioral approach to enhance adherence and retention of
yMSMc receiving PrEP.

The purpose of this protocol is to increase access to safe and effective PrEP to yMSMc in
order to reduce incident HIV infections and health disparities in HIV incidence and
prevalence through the use of a combined biomedical/behavioral intervention in a
community-based setting servicing high-risk youth in Philadelphia. It is hypothesized this
unique, combined biomedical/behavioral HIV prevention strategy will lead to high recruitment
and retention rates in this community setting. All subjects will be offered primary care
services as well as a package of HIV risk reduction interventions including once daily PrEP
with tenofovir and emtricitabine (TDF/FTC), condoms, risk reduction counseling, HIV testing,
and sexually transmitted infection (STI) screening and treatment. A weekly support group
will aim to maximize medication adherence and retention by engaging subjects in prevention,
risk-reduction and behavioral counseling, education about HIV, leadership training, and
social networking.

Subjects will consist of 50 HIV-negative biological males between the ages of 18 and 30 who
meet eligibility criteria as defined below.

All subjects will receive Truvada as PrEP on Monday evenings on an either weekly, biweekly,
or monthly basis depending on an initial assessment of their need for adherence support,
with provisions to obtain medication the following day(s) at Y-HEP if they are unable to
attend the Monday night session. Study subjects will be considered to have picked up their
medications if they come any time during the week designated as a medication pick-up week.
In addition, all subjects will receive standard HIV prevention services including condom
provision, risk reduction counseling, HIV testing, STI screening and treatment, as well as
basic medical care and linkage to HIV care in the event of PrEP failure. Subjects will
receive a behavioral intervention consisting of youth-focused men's wellness services
centered around education about HIV, adherence counseling and knowledge of PrEP efficacy on
risk behavior, general health services such as smoking cessation support and nutritional
counseling, job and leadership training, and sexual health and well-being promotion.

Subjects will be screened for HIV, STIs, and renal function at baseline and every three
months, and will also have a rapid test for HIV on a monthly basis (Table 1). Treatment will
be provided for all STIs diagnosed during this study, and non-immune subjects will be
offered vaccines against hepatitis A and B. Adherence will be assessed by the percentage of
medication pick-up visits attended as well as urine tenofovir levels every 2-4 weeks and
plasma tenofovir levels at weeks 24 and 48. Risk behaviors will be assessed by STI rates and
the adapted Risk Assessment Battery at baseline, and weeks 24 and 48. A qualitative
interview will be conducted at the end of the study to assess program acceptability.

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