Condition category
Infections and Infestations
Date applied
03/07/2009
Date assigned
19/08/2009
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.tropinst.med.uni-muenchen.de

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

Publication citations

Additional files

Editorial Notes