Contact information
Type
Scientific
Primary contact
Dr Elmar Saathoff
ORCID ID
Contact details
Leopoldstr. 5
Munich
80802
Germany
+49 (0)89 2180 3830
elmarsaathoff@web.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DFG protocol No.: SA 1878/1-1
Study information
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
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
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
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human immunodeficiency virus-1 (HIV-1) infection/helminth infections
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/08/2009
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Participation in the EMINI cohort study. Participants of all age groups and both sexes will be included.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
18500
Participant exclusion criteria
The study will only include consenting members of households who participate in the EMINI study, no other exclusion criteria apply.
Recruitment start date
01/08/2009
Recruitment end date
31/07/2011
Locations
Countries of recruitment
Tanzania
Trial participating centre
Leopoldstr. 5
Munich
80802
Germany
Sponsor information
Organisation
Department for Infection and Tropical medicine (Abteilung fuer Infektions- und Tropenmedizin) (Germany)
Sponsor details
Abteilung fuer Infektions- und Tropenmedizin
Ludwig-Maximilans-University (LMU) Munich University Hospital
Leopoldstr. 5
Munich
80802
Germany
+49 (0)89 2180 3830
tropinst@lrz.uni-muenchen.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: SA 1878/1-1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Commission (Belgium) - DGVIII AIDCO (donor of EMINI) (ref: SANTE/2006/129-931)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary