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Worms and human immunodeficiency virus (HIV) Interaction Study - Epidemiology component
ISRCTN ISRCTN63722214
DOI 10.1186/ISRCTN63722214
ClinicalTrials.gov identifier
EudraCT number
Public title Worms and human immunodeficiency virus (HIV) Interaction Study - Epidemiology component
Scientific title Intestinal helminth infections and schistosomiasis and their relation to human immunodeficiency virus-1 (HIV-1) incidence, disease progression and immunology in Mbeya Region, Tanzania - epidemiology component
Acronym WHIS_Epi
Serial number at source DFG protocol No.: SA 1878/1-1
Study hypothesis 1. The incidence of human immunodeficiency virus-1 (HIV-1) infection in initially HIV negative participants is reduced after targeted treatment of helminth infections (after diagnosis) when compared to initially HIV negative participants who have neither been examined nor treated for helminth infections
2. HIV disease progression and the onset of acquired immune deficiency syndrome (AIDS) in HIV-1 positive participants is delayed after targeted treatment of helminth infections (after diagnosis) when compared to HIV positive participants who have neither been examined nor treated for helminth infections
Lay summary
Ethics approval Local Institutional Review Board (IRB) in Munich (Ethikkommission der Medizinischen Fakultät der LMU Muenchen) approved on the 3rd April 2009.

Approval for collection of required data and to treat helminth infections:
1. National Institute of Medical Research (NIMR) Institutional Review Board (IRB), gained in 2005
2. Mbeya Medical Research and Ethics Committee, gained in 2006

Approval to use the obtained data for this study has been applied for with the two above local IRBs but is still pending.
Study design Observational longitudinal study
Countries of recruitment Tanzania
Disease/condition/study domain Human immunodeficiency virus-1 (HIV-1) infection/helminth infections
Participants - inclusion criteria Participation in the EMINI cohort study. Participants of all age groups and both sexes will be included.
Participants - exclusion criteria The study will only include consenting members of households who participate in the EMINI study, no other exclusion criteria apply.
Anticipated start date 01/08/2009
Anticipated end date 31/07/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 18500
Interventions This is an observational longitudinal study, implemented within the framework of a large, household based single-centre population-based cohort study (EMINI), which is conducted by the Mbeya Medical Research Programme in cooperation with Munich University.

EMINI cohort activities started in 2006 involving ~18500 participants of all ages and both sexes from 4283 households. Thus most potential WHIS_Epi participants have already been followed up since then (exception: new household members). Since the start of EMINI, participating households have been visited annually, in order to collect lab samples and interview data regarding HIV, malaria, tuberculosis (Tb) and other infectious diseases from all consenting household members.

In August 2008, examination for intestinal nematode infection and schistosomiasis (using Kato-Katz faecal thick smears and urine filtration) and standard helminth treatment was introduced in parts of the EMINI population. In accordance with national Tanzanian (TZ) guidelines treatment is 400 mg albendazole for participants older than 3 years and 200 mg albendazole for participants younger than 3 years from households where intestinal nematode infections were found, and 40 mg praziquantel per kg for individual treatment of diagnosed schistosomiasis infection. Due to logistic and financial constraints we were initially only able to offer these services to only half of the participating households.

However, during the next round of follow-up starting 1st August 2009, all study participants will receive diagnosis for helminth infection and treatment if needed. The WHIS-Epi study will link data of previous helminth infection and respective treatment with data on HIV incidence and disease progression in both parts of the EMINI cohort.

Joint/scientific contact details:
Dr Leonard Maboko
Managing Director of MMRP
Mbeya Medical Research Programme
Mbeya
Tanzania
Primary outcome measure(s) 1. Hypothesis 1: Seroconversion to HIV since last study visit; applied tests:
1.1. Initial HIV screening with SD Bioline HIV1/2
1.2. Positive results retested with Enzygnost HIV1/2 Plus
1.3. Discordant results confirmed by Western Blot
2. Hypothesis 2:
2.1. Change in Karnofsky score
2.2. HIV staging
2.3. Presence/absence of opportunistic infections (all determined by medical examination)
2.4. Changes in viral load

Assessed one and two years after deworming.
Secondary outcome measure(s) 1. Prevalence of intestinal nematode infections and schistosomiasis in the study population, measured before worm treatment
2. Effect of albendazole and praziquantel treatment on helminth infection, measured one and two years after deworming
3. Helminth reinfection after deworming, measured one and two years after deworming

Intestinal nematode and S. mansoni infection for all above outcomes will be diagnosed by Kato-Katz microscopy, S. haematobium infection by urine filtration and microscopy.
Sources of funding 1. German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: SA 1878/1-1)
2. European Commission (Belgium) - DGVIII AIDCO (donor of EMINI) (ref: SANTE/2006/129-931)
Trial website
Publications
Contact name Dr  Elmar  Saathoff
  Address Leopoldstr. 5
  City/town Munich
  Zip/Postcode 80802
  Country Germany
  Tel +49 (0)89 2180 3830
  Fax +49 (0)89 336038
  Email elmarsaathoff@web.de
Sponsor Department for Infection and Tropical medicine (Abteilung fuer Infektions- und Tropenmedizin) (Germany)
  Address Abteilung fuer Infektions- und Tropenmedizin
Ludwig-Maximilans-University (LMU) Munich University Hospital
Leopoldstr. 5
  City/town Munich
  Zip/Postcode 80802
  Country Germany
  Tel +49 (0)89 2180 3830
  Fax +49 (0)89 3360 38
  Email tropinst@lrz.uni-muenchen.de
  Sponsor website: http://www.tropinst.med.uni-muenchen.de
Date applied 03/07/2009
Last edited 19/08/2009
Date ISRCTN assigned 19/08/2009
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