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Evaluation of long-lasting insecticide-treated bed
nets and a point-of-use water filter to delay HIV-1
         disease progression in Kenya


                        Judd L Walson, MD, MPH
                           Assistant Professor
                     Departments of Global Health,
       Medicine (Infectious Disease), Pediatrics and Epidemiology
                         University of Washington
0.3 log10        0.5 log10
                                                            1.0 log10 increase
                            increase         increase
        Increase in
       likelihood of
       heterosexual       18-20% 26-40%                          100%
       transmission
        Increase in
           risk of
        progression       24-25%              44%                113%
        to AIDS or
           death




Intro Background Malaria Helminths Implications Conclusions
Effect of modest VL reduction	





                                                         Gupta et al. JID 2007; 195 (Feb 15).


Intro Background Malaria Helminths Implications Conclusions
Study Objectives

PRIMARY: To determine whether the provision of a long
lasting insecticide-treated bed net (LLIN) and a point-of-
care water filtration device to HIV-1 infected ART-naĂŻve
adults in Kenya delays HIV-1 disease progression, as
measured by time to CD4 count <350 cells/mm3 and/or
death.

SECONDARY: To determine the effect of LLIN and a
simple microbiological water purification system on the
incidence of malaria and reported diarrheal disease when
added to the standard regimen of TMP/SMX among
antiretroviral naĂŻve, HIV infected adults in Kenya.
Study Recruitment and Eligibility
           Recruitment
           Public health campaign in Western Kenya for VCT,
           which provided LLIN and water filter and HIV care
           and treatment clinics in Western Kenya (Kisii
           Provincial, Kisumu District Hospitals).
           Inclusion Criteria
           •  18 years of age or older
           •  Confirmed HIV-1 infection
           •  ART naïve
           •  CD4 count >350 within previous 3 months
           •  WHO clinical stage I or II
           Exclusion Criteria
           •  Pregnancy
           •  History of ART (self reported)
Participation
Use of Intervention
    Water purification methods and use of bed nets during study follow-up between cohorts

                                                 Intervention     Control
                                                    N= 361        N= 127*
                                                           1             1           1
                                                    Est. %        Est. %      p-value
     Water purification methods
        % who drink purified water:                  99¡5           76¡0      < 0¡001
        Purification system:2
           % who boil                                 9¡0           29¡9      < 0¡001
           % who use chlorine                         5¡7           45¡4      < 0¡001
          % who use filter                           93¡0            0¡4      < 0¡001
     Use of bed nets
        % who have a net:                            97¡7           83¡1      < 0¡001
        % who both have a net and sleep
        under it:                                    97¡3           82¡4      < 0¡001
!
Impact on Diarrhea/Malaria

•  The use of LLIN/Water Filter reduced self-reported diarrhea
                        (RR: 0¡65; 95% CI: 0¡45, 0¡93)


•  The use of LLIN/Water Filter reduced self-reported malaria
                        (RR: 0¡75; 95% CI: 0¡60, 0¡93)


•  The use of LLIN/Water Filter reduced clinically diagnosed malaria
                        (RR: 0¡66; 95% CI: 0¡49, 0¡88)
Impact on HIV-1 Disease
      Progression
        Kaplan-Meier plot of time to disease progression by cohort:
                              Time to CD4<350




                           1.00
                           0.75
             Probability
                           0.50
                           0.25




                                                                               Control
                                                                               Intervention
                           0.00




                                  0          .5           1           1.5            2
                                               Ti me From Enroll ment, Years
Number at risk (Ev ents)
         Control       228            (32)   195   (39)   150   (19)   107    (9)    52   (8)
         Interv ention 361            (28)   327   (60)   259   (34)   149   (13)    52   (0)
Impact on HIV-1 Disease
            Progression
Kaplan-Meier plot of time to disease progression by cohort: Time to CD4<350 or Death




                               1.00
                               0.75
                 Probability
                               0.50
                               0.25




                                                                                    Control
                                                                                    Intervention
                               0.00




                                      0          .5            1           1.5            2
                                                   T i me From Enroll ment, Years
  N um ber at ris k (Ev ent s)
             C ontrol        228          (32)   195   (40)   150   (21)   107    (9)     52   (8)
             I nt erv ention 361          (30)   327   (61)   259   (35)   149   (14)     52   (0)
Results


• The combined intervention resulted in a 27% risk reduction in
 HIV disease progression, as measured by CD4 count ≤350
 cells/mm3 (HR: 0¡73; 95% CI: 0¡57, 0¡95). This difference
 remained significant after adjusting for either toilet type or water
 source (HR 0¡75; 95% CI: 0¡58, 0¡97).
Acknowledgements	


n     All the study participants	

n     University of Washington/KEMRI - Ben Piper, Grace John-
      Stewart, Benson Singa, Paul Ndungu, Toney Odhiambo, King
      Holmes, Barbara Payne, Barbra Richardson, Margaret Barrett,
      Chris Kealy, Rekha Patel, Rowena de Saram, Laura Sangare, Krista
      Yuhas, Frankline Onchiri, Patricia Pavlinac, Barbra Richardson,
      Phelgona Otieno	

n     The fantastic study staff in Nairobi	

n     The staff of all of the study sites	

n     KEMRI CCR – Dr. Bukusi, Dr. Rashid, Dr. Mpoke	

n     CDC –Jonathan Mermin, Becky Bunnell, Clement Zeh	

n     Vestergaard-Frandsen – Navneet Garg, Alexandre Doyen

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Evaluation of Long-lasting Insectide-Treated Bed and Point-of-use Water Filter to Delay HIV-1 Disease Progression in Kenya

  • 1. Evaluation of long-lasting insecticide-treated bed nets and a point-of-use water filter to delay HIV-1 disease progression in Kenya Judd L Walson, MD, MPH Assistant Professor Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology University of Washington
  • 2. 0.3 log10 0.5 log10 1.0 log10 increase increase increase Increase in likelihood of heterosexual 18-20% 26-40% 100% transmission Increase in risk of progression 24-25% 44% 113% to AIDS or death Intro Background Malaria Helminths Implications Conclusions
  • 3. Effect of modest VL reduction Gupta et al. JID 2007; 195 (Feb 15). Intro Background Malaria Helminths Implications Conclusions
  • 4. Study Objectives PRIMARY: To determine whether the provision of a long lasting insecticide-treated bed net (LLIN) and a point-of- care water filtration device to HIV-1 infected ART-naĂŻve adults in Kenya delays HIV-1 disease progression, as measured by time to CD4 count <350 cells/mm3 and/or death. SECONDARY: To determine the effect of LLIN and a simple microbiological water purification system on the incidence of malaria and reported diarrheal disease when added to the standard regimen of TMP/SMX among antiretroviral naĂŻve, HIV infected adults in Kenya.
  • 5. Study Recruitment and Eligibility Recruitment Public health campaign in Western Kenya for VCT, which provided LLIN and water filter and HIV care and treatment clinics in Western Kenya (Kisii Provincial, Kisumu District Hospitals). Inclusion Criteria •  18 years of age or older •  Confirmed HIV-1 infection •  ART naĂŻve •  CD4 count >350 within previous 3 months •  WHO clinical stage I or II Exclusion Criteria •  Pregnancy •  History of ART (self reported)
  • 7. Use of Intervention Water purification methods and use of bed nets during study follow-up between cohorts Intervention Control N= 361 N= 127* 1 1 1 Est. % Est. % p-value Water purification methods % who drink purified water: 99¡5 76¡0 < 0¡001 Purification system:2 % who boil 9¡0 29¡9 < 0¡001 % who use chlorine 5¡7 45¡4 < 0¡001 % who use filter 93¡0 0¡4 < 0¡001 Use of bed nets % who have a net: 97¡7 83¡1 < 0¡001 % who both have a net and sleep under it: 97¡3 82¡4 < 0¡001 !
  • 8. Impact on Diarrhea/Malaria •  The use of LLIN/Water Filter reduced self-reported diarrhea (RR: 0¡65; 95% CI: 0¡45, 0¡93) •  The use of LLIN/Water Filter reduced self-reported malaria (RR: 0¡75; 95% CI: 0¡60, 0¡93) •  The use of LLIN/Water Filter reduced clinically diagnosed malaria (RR: 0¡66; 95% CI: 0¡49, 0¡88)
  • 9. Impact on HIV-1 Disease Progression Kaplan-Meier plot of time to disease progression by cohort: Time to CD4<350 1.00 0.75 Probability 0.50 0.25 Control Intervention 0.00 0 .5 1 1.5 2 Ti me From Enroll ment, Years Number at risk (Ev ents) Control 228 (32) 195 (39) 150 (19) 107 (9) 52 (8) Interv ention 361 (28) 327 (60) 259 (34) 149 (13) 52 (0)
  • 10. Impact on HIV-1 Disease Progression Kaplan-Meier plot of time to disease progression by cohort: Time to CD4<350 or Death 1.00 0.75 Probability 0.50 0.25 Control Intervention 0.00 0 .5 1 1.5 2 T i me From Enroll ment, Years N um ber at ris k (Ev ent s) C ontrol 228 (32) 195 (40) 150 (21) 107 (9) 52 (8) I nt erv ention 361 (30) 327 (61) 259 (35) 149 (14) 52 (0)
  • 11. Results • The combined intervention resulted in a 27% risk reduction in HIV disease progression, as measured by CD4 count ≤350 cells/mm3 (HR: 0¡73; 95% CI: 0¡57, 0¡95). This difference remained significant after adjusting for either toilet type or water source (HR 0¡75; 95% CI: 0¡58, 0¡97).
  • 12. Acknowledgements n  All the study participants n  University of Washington/KEMRI - Ben Piper, Grace John- Stewart, Benson Singa, Paul Ndungu, Toney Odhiambo, King Holmes, Barbara Payne, Barbra Richardson, Margaret Barrett, Chris Kealy, Rekha Patel, Rowena de Saram, Laura Sangare, Krista Yuhas, Frankline Onchiri, Patricia Pavlinac, Barbra Richardson, Phelgona Otieno n  The fantastic study staff in Nairobi n  The staff of all of the study sites n  KEMRI CCR – Dr. Bukusi, Dr. Rashid, Dr. Mpoke n  CDC –Jonathan Mermin, Becky Bunnell, Clement Zeh n  Vestergaard-Frandsen – Navneet Garg, Alexandre Doyen