Investigating ways of encouraging fishermen in Malawi to access schistosomiasis and HIV testing and treatment

ISRCTN ISRCTN14354324
DOI https://doi.org/10.1186/ISRCTN14354324
Secondary identifying numbers WT 216458/Z/19/Z
Submission date
28/09/2020
Registration date
05/10/2020
Last edited
17/12/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 2024

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

Contact information

Dr Augustine Talumba Choko
Scientific

Malawi Liverpool Wellcome Trust Clinical Research Programme
PO Box 30096
Chichiri
Blantyre
-
Malawi

ORCiD logoORCID ID 0000-0001-6095-9430
Phone +265 0999577452
Email achoko@mlw.mw

Study information

Study design3-arm open-label cluster randomized trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typeTreatment
Participant information sheet ISRCTN14354324_PIS_baseline_v1.3_26Aug2020.pdf
Scientific titleCreating demand for fishermen’s schistosomiasis and HIV services (FISH): piloting and delivery of a 3-arm cluster randomized control trial (cRCT) in Malawi
Study acronymFISH
Study objectivesHIV 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(s)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
Health condition(s) or problem(s) studiedHIV 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 typeMixed
Primary outcome measureAll 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 measuresAll 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 study start date15/08/2019
Completion date30/12/2024

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants4,500
Key inclusion criteria1. Fisherman resident in a fishing community in Mangochi, Malawi
2. Aged 18 years or older
Key exclusion criteria1. Already on HIV treatment
2. Already taken praziquantel in the last 3 months
Date of first enrolment01/01/2021
Date of final enrolment30/10/2021

Locations

Countries of recruitment

  • Malawi

Study participating centre

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

Sponsor information

Liverpool School of Tropical Medicine
University/education

Pembroke Place
Liverpool
L3 5QA
England
United Kingdom

Phone +44 (0)151 705 3100
Email lstmrec@lstmed.ac.uk
Website http://www.lstmed.ac.uk/
ROR logo "ROR" https://ror.org/03svjbs84

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Wellcome, WT
Location
United Kingdom
National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/01/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planThe 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 planThe datasets generated during and/or analysed during the current study will be stored in a publically available repository (https://datacompass.lshtm.ac.uk/)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version v1.3 26/08/2020 05/10/2020 No Yes
Participant information sheet version v1.3 26/08/2020 05/10/2020 No Yes
Protocol article 07/01/2022 10/01/2022 Yes No
Protocol file version 1.4 11/01/2021 20/07/2022 No Yes
Statistical Analysis Plan version 0.1 20/07/2022 20/07/2022 No Yes
Results article Baseline survey findings 04/05/2023 09/05/2023 Yes No

Additional files

ISRCTN14354324_PIS_baseline_v1.3_26Aug2020.pdf
uploaded 05/10/2020
ISRCTN14354324_PIS_endline_v1.3_26Aug2020.pdf
uploaded 05/10/2020
ISRCTN14354324_ FISH_SAP_v0.1.pdf
ISRCTN14354324 FISH_protocol_v1.4_.pdf

Editorial Notes

17/12/2024: Publication reference added.
09/05/2023: Publication reference added.
20/07/2022: The statistical analysis plan and protocol were uploaded as additional files.
10/01/2022: Publication reference added.
04/10/2021: The overall trial end date has been changed from 30/12/2022 to 30/12/2024 and the plain English summary updated accordingly.
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