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Table 3 Schedule of study procedures and 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

3M

6M

9M

12M

15M

18M

Verbal consent and pre-screening questionnaire

X

        

Screening informed consent form

 

X

       

Locator form

 

X

X

X

X

X

X

X

X

Medical release authorization forms

 

X

       

Injection drug use and eligibility questionnaire

 

X

       

HIV and HCV testing history and readiness, knowledge

 

X

       

Demographic questionnaire, health literacy

 

X

       

Trial informed consent form

  

X

      

Full sociodemographic survey

  

X

X

X

X

X

X

X

Substance use profile

  

X

X

X

X

X

X

X

Alcohol use, drug use

  

X

 

X

 

X

 

X

Injection profile, needle access, sharing needles and works

  

X

X

X

X

X

X

X

Overdose history survey

  

X

 

X

 

X

 

X

Attitudes towards HIV, attitudes towards HCV

  

X

      

Experience of illness scale

  

X

X

X

    

Medical mistrust

  

X

      

History of abuse and interpersonal violence

  

X

 

X

 

X

 

X

Social support and conflictual social interaction

  

X

      

Brief Pain Inventory

  

X

X

X

X

X

X

X

Brief Symptom Inventory

  

X

X

X

X

X

X

X

Household Food Survey

  

X

X

X

X

X

X

X

EuroQol-5D-5L

  

X

      

Crime and legal activities

  

X

X

X

X

X

X

X

Non medical and other services

  

X

X

X

X

X

X

X

Access to care

  

X

 

X

 

X

 

X

Sexual behavior

  

X

X

X

X

X

X

X

Condom use

  

X

 

X

 

X

 

X

Communicating w/ physician about PrEP/HCV Tx self-efficacy

  

X

X

X

    

Relationship with physician

  

X

X

X

    

PrEP adherence HCV-PA1 and 2

   

X

X

X

X

X

X

Adherence counseling/patient navigation satisfaction survey

EOI

  1. SCR screening, BSL baseline, EOI end of intervention, M month