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

Completed

Conditions studied: HIV

In brief

Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.

Key facts

Study ID

NCT01808352

Run by

HIV Prevention Trials Network

People needed

226

Starts

2013-08-15

Expected to finish

2015-09-30

Last updated by the study team

2025-05-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Vine Street Clinic — Los Angeles, California, United States
• George Washington University CRS — Washington D.C., District of Columbia, United States
• UNC CRS — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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