Status:
COMPLETED
HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
Lead Sponsor:
HIV Prevention Trials Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
MALE
18+ years
Brief Summary
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2015
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01808352
Start Date
August 15 2013
End Date
September 30 2015
Last Update
May 7 2025
Active Locations (3)
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1
UCLA Vine Street Clinic
Los Angeles, California, United States, 90095
2
George Washington University CRS
Washington D.C., District of Columbia, United States, 20007
3
UNC CRS
Chapel Hill, North Carolina, United States, 27514