HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP) (NCT01808352) | Clinical Trial Compass
CompletedNot Applicable
HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
United States226 participantsStarted 2013-08-15
Plain-language summary
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial 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 UL…