HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)

An open label demonstration study with PrEP and Client Centered Care Coordination (C4) to
assess the initiation, acceptability, safety, and feasibility of PrEP for Black MSM (BMSM)
in three US Cities. A subset of participants will also be recruited to participate in
qualitative interviews about facilitators and barriers regarding PrEP. The study will
recruit HIV-uninfected BMSM at risk for HIV infection in three US Cities. Enrollment will
include those aged 18 and over with an effort to recruit an equal number of BMSM under age
25 and over age 25 with a total of 225 participants (75 per site).

Inclusion Criteria:

BMSM who meet all of the following criteria are eligible for inclusion in this study:

- 18 years of age or older

- No prior HIV diagnosis (self-report)

- Male at birth

- High risk for acquiring HIV infection including any one of the following in the
previous 6 months:

- Unprotected sex during receptive or insertive anal intercourse with a male
partner

- Any protected or unprotected:

i. Receptive or insertive anal intercourse with more than three male sex
partners ii. Exchange of money, gifts, shelter or drugs for receptive or
insertive anal sex with a male partner iii. Receptive or insertive anal sex
while under the influence of drugs or alcohol (i.e., high or drunk within two
hours of the sex act) according to self-report"

- STI diagnosis (i.e., syphilis, gonorrhea and chlamydia) by self-report

- Willing to provide locator information in accordance with the Study Specific
Procedures (SSP) Manual

- Urine dipstick negative or trace for protein and glucose

- Hemoglobin > 11 g/dL, absolute neutrophil count > 750 cells/mm3, and platelet count ≥
100,000/mm3

- Serum creatinine < upper limit of normal (ULN) and calculated creatinine clearance of
at least 60 mL/min by the Cockcroft-Gault formula where:

o eCcr in mL/min = [(140 - age in years) x (actual body weight in kg)] / (72 x serum
creatinine in mg/dL) Alanine aminotransferase (AST) and aspartate aminotransferase
(ALT) < 3 times the upper limit of normal (ULN)

- Total bilirubin < 2.5 ULN

- Hepatitis B surface antigen (HBsAg) negative

Exclusion Criteria:

BMSM who meet any of the following criteria will be excluded from this study:

- Any reactive or positive HIV test at Screening, even if subsequent testing indicates
that the person is HIV-uninfected

- Transgender

- Active or chronic hepatitis B infection (as evidenced by HBsAg, HbsAb, and HbcAb
testing)

- Planning to move out of the area or to travel for more than 3 months during the study
follow-up period

- Unwilling to adhere to study procedures

- Current participation in any research study via self-report (however, strictly
non-HIV centered observational studies are not exclusionary)

- Previous participation in an HIV vaccine study is exclusionary unless documented
evidence of enrollment into a placebo arm

- Use of ARV drugs (PrEP or PEP) in the last 60 days

- Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering
the gastrointestinal tract or drug absorption (provided by self-report, or obtained
from medical history or records)

- Receipt of prohibited medications: interleukin therapy, medications with significant
nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides,
cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or
compete for elimination via active renal tubular secretion (including but not limited
to probenecid) - (provided by self-report, or obtained from medical history or
medical records)

- Any condition, that in the opinion of study staff, would make participation in the
study unsafe, or interfere with achieving the study objective