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Table 2 Schedule of safety and clinical assessments

From: M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

Assessment name Pre-SCR SCR BSL 8 w 12 w 3M 16 w 20 w 6M 9M 12M 15M 18M As clinically prescribed
Point-of-care HIV, HCV, and pregnancy rapid testing   X             X
Hepatitis A virus test, anti-HBs, anti-HBc   X             X
Pregnancy and birth control assessment   X X    X    X X X X X  
Medical and psychiatric history   X             
Physical exams and vital signs   X             X
HCV Ab, HCV RNA   X X    X    X X X X X X
Liver and kidney function   X X            X
HIV, syphilis, chlamydia, gonorrhea, and hepatitis B    X    X    X X X X X  
Concomitant medications    X    X    X X X X X  
Adverse events and serious adverse events    X    X    X X X X X  
Treatment               
Clinical management    X            X
Dried blood spot    X X X   X X X X X X X  
HCV treated participants               
HCV RNA 12w post-Tx initiation, 12w post-end of treatment
  1. SCR screening, BSL baseline, Tx treatment, w week, M month