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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