Condition category
Infections and Infestations
Date applied
28/09/2020
Date assigned
05/10/2020
Last edited
05/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Both HIV infection and schistosomiasis (infection with a parasitic flatworm caught by contact with fresh water) are major public health problems worldwide, with 1.8 million new HIV infections each year and up to 110 million untreated schistosomiasis (bilharzia) cases globally. The Rift Valley in Africa suffers a high rate of both HIV infection and schistosomiasis, but both are treatable if the infection is diagnosed. Lake fishermen are more at risk of HIV and schistosomiasis than the general population. Recent studies have suggested that female genital schistosomiasis increases the risk of HIV infection 3 to 4 times in women. The link between HIV and genital schistosomiasis is not yet established in men, but it is biologically plausible. There are local initiatives to control HIV in fishing communities, but these might not reach everyone and it is not known whether HIV and schistosomiasis can be tackled together effectively.
The aim of this trial is to identify the best methods of delivering integrated HIV and schistosomiasis services for fishermen, particularly investigating the effect of using social networks, HIV self-test kits and beach clinic services.

Who can participate?
Male adult (aged 18 years or older) fishermen resident in the Mangochi lake district of Malawi

What does the study involve?
Boat teams of fishermen will be randomly allocated to one of three arms. The first group will be given a leaflet explaining the importance of receiving treatment for schistosomiasis (a drug called praziquantel) and HIV services for fishermen. The second group will receive the leaflet and will have it explained to them by a fellow fisherman who has been trained as a peer educator. The third group will receive the leaflet and will have it explained to them by a fellow fisherman who has been trained as a peer educator and will also provide HIV self-test kits to the group.
A beach clinic will be set up as part of the trial. The clinic will provide HIV services including HIV testing and referral for treatment at the nearest HIV treatment clinic, and treatment for schistosomiasis without a diagnosis (presumptive treatment) for all trial arms. 9 months following delivery of the trial services, fishermen will provide a urine sample to assess the percentage of fishermen cured from genital schistosomiasis as well as answering questions on whether they started HIV treatment for those with a positive HIV test result.

What are the possible benefits and risks of participating?
Potential risks include discomfort with some questions on the questionnaire. Treatment for schistosomiasis may lead to headache, nausea, abdominal pain, dizziness, drowsiness, fatigue, weakness, joint/muscle pains, loss of appetite, vomiting, sweating, itching. These are usually mild and transient, lasting from 30 minutes to up to 4 hours. Serious side effects that are very rare include bloody diarrhoea, fever, irregular or slow heartbeat or seizures/convulsions.
There are no side effects to using oral HIV self-test kits. However, misunderstandings between the wider fishermen group and the peer educator may occur and could lead to physical violence or abuse.
There are no direct benefits for participating in the trial.

Where is the study run from?
Malawi Liverpool Wellcome Trust Clinical Research Programme (Malawi)

When is the study starting and how long is it expected to run for?
August 2019 to December 2022

Who is funding the study?
Wellcome Trust (UK) and the National Institute for Health Research (UK)

Who is the main contact?
Dr Augustine Choko, achoko@mlw.mw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Augustine Talumba Choko

ORCID ID

https://orcid.org/0000-0001-6095-9430

Contact details

Malawi Liverpool Wellcome Trust Clinical Research Programme
PO Box 30096
Chichiri
Blantyre
-
Malawi
+265 0999577452
achoko@mlw.mw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

WT 216458/Z/19/Z

Study information

Scientific title

Creating demand for fishermen’s schistosomiasis and HIV services (FISH): piloting and delivery of a 3-arm cluster randomized control trial (cRCT) in Malawi

Acronym

FISH

Study hypothesis

HIV self-testing (HIVST) promoted by peer educators (PE) or provided by peer-distributor-educators (PDE) will achieve higher coverage of health interventions (recent HIV testing, linkage to voluntary male medical circumcision [VMMC] and antiretroviral therapy [ART] as indicated, and praziquantel) than beach-side services alone, and will leave men with increased understanding of the benefits of early treatment and prevention for both diseases.

Ethics approval

1. Approved 16/09/2020, University of Malawi College of Medicine Research and Ethics Committee, (Mahatma Gandhi Road, Chimutu Building Room # 822, P/Bag 360 Chichiri, Blantyre 3, Malawi; +265 01 871 911/01 874 377; comrec@medcol.mw), ref: P.03/20/2975
2. Approved 14/04/2020, Liverpool School of Tropical Medicine Research Ethics Committee (Pembroke Place, Liverpool, L3 5QA, UK; +44 (0)151 705 3100; lstmrec@lstmed.ac.uk), ref: 20-027

Study design

3-arm open-label cluster randomized trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

See additional files

Condition

HIV infection and/or schistosomiasis (Schistosoma haematobium) infection

Intervention

'Boat teams' will be randomised 1:1:1 using computerized restricted randomization (geographical spread, cluster size, traditional authority, and HIV and schistosomiasis estimates) at a public randomisation ceremony.

Arms:
1. Standard of care (SOC) arm with leaflets available at the shore explaining the importance of receiving presumptive treatment for schistosomiasis (praziquantel) and HIV services for fishermen
2. SOC plus a peer (peer-educator [PE]) explaining the leaflet to his fellow fishermen in a boat team
3. Peer-distributor-educator (PDE) arm with HIV self-test kits delivered to the boat team fishermen by the PDE in addition to the PDE explaining the leaflet

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

All primary outcome measures will be assessed at 9 months of trial delivery
1. Number of boat-team fishermen who self-report starting ART
2. Number of boat-team fishermen who self-report undergoing VMMC
3. Number of boat-team fishermen who have at least one S. haematobium egg seen on light microscopy of the filtrate from 10 ml urine ('egg-positive').

Secondary outcome measures

All secondary outcome measures will be assessed at 9 months of trial delivery
1. Number of boat-team fishermen who self-report recent (last 9 months) HIV testing
2. HIV prevention knowledge score assessed using a questionnaire at endline (9 months after enrollment)
3. Schistosomiasis knowledge score assessed using a questionnaire at endline (9 months after enrollment)
4. Number of boat-team fishermen who self-report high-risk sex in the previous month
5. S. haematobium intensity assessed using urine sample at endline (9 months after enrollment)

Overall trial start date

15/08/2019

Overall trial end date

30/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Fisherman resident in a fishing community in Mangochi, Malawi
2. Aged 18 years or older

Participant type

Mixed

Age group

Adult

Gender

Male

Target number of participants

4,500

Participant exclusion criteria

1. Already on HIV treatment
2. Already taken praziquantel in the last 3 months

Recruitment start date

01/01/2021

Recruitment end date

30/10/2021

Locations

Countries of recruitment

Malawi

Trial participating centre

Mangochi District Health Office
Ministry of Health Mangochi District Hospital PO Box 42 Mangochi
Mangochi
265
Malawi

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3100
lstmrec@lstmed.ac.uk

Sponsor type

University/education

Website

http://www.lstmed.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Wellcome, The Wellcome Trust, WT

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results will be used to inform the Malawi Ministry of Health on HIV self-testing scale-up plans and integration of HIV and schistosomiasis services for fishermen, and will also be disseminated through the University of Malawi College of Medicine, and through conference presentations and publication in peer-reviewed journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository (https://datacompass.lshtm.ac.uk/)

Intention to publish date

01/01/2024

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

05/10/2020: The participant information sheets were uploaded as additional files. 29/09/2020: Trial’s existence confirmed by Liverpool School of Tropical Medicine