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
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
Additional files
- ISRCTN14354324_PIS_baseline_v1.3_26Aug2020.pdf uploaded 05/10/2020
- ISRCTN14354324_PIS_endline_v1.3_26Aug2020.pdf uploaded 05/10/2020