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Table 1 Follow-up calendar for HIV-infected participants eligible for ART

From: Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial

 

D0/D15

M0

M1

M2

M3

M4

M5

M6

M7

M8

M9

M10

M11

M12

M13

M14

M15

M16

M17

M18

M19

M20

M21

M22

M23

M24

Consent

X

                         

Medical history

X

                         

Nurse

Physical examination

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Weight, height

X

   

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

WHO clinical staging

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Morbidity/hospitalisation

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

TB/STI screening if appropriate

X

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

CD4 point of care

X

      

X

     

X

     

X

     

X

ART initation

 

X

     

X

     

X

     

X

     

X

Adherence monitoring

  

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Laboratory

HIV VL

X

   

X

  

X

     

X

     

X

     

X

Genotyping

As clinically indicated, in case of confirmed virological failure

CD4 counts

X

      

X

     

X

     

X

     

X

Haematology

X

      

X

     

X

     

X

     

X

Biochemistry

X

   

X

  

X

     

X

     

X

     

X

HBsAg

X

                         

Beta hCG

X

   

X

  

X

     

X

     

X

     

X

Urinalysis

X

   

X

  

X

     

X

     

X

     

X

Plasma storage (−80°C)

X

   

X

  

X

     

X

     

X

     

X

Blood volume (mL)

                          

Questionnaires

History of HIV infection

 

X

                        

ART perception

 

X

                        

ART knowledge

 

X

     

X

     

X

     

X

     

X

Disclosure and couple

    

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

Social and community support

 

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

Stigma and discrimination

 

X

     

X

     

X

     

X

     

X

Self-reported adherence

    

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

Health expenditure

 

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

Economic situation

 

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

Sexual behaviour

 

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

  

X

Quality of life

       

X

     

X

     

X

     

X

Satisfaction with care

       

X

     

X

     

X

     

X

  1. ANRS 12249 TasP trial, WHO World Health Organisation, TB Tuberculosis, STI Sexually transmitted infections, ART Anti-retroviral treatment, VL Viral load, HBsAg Hepatitis B surface antigen, Beta hCG Beta human chorionic gonadotrophin.
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Trials

ISSN: 1745-6215