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

• Register: ISRCTN
• Last refreshed on: 9 November 2020
• Main ID: ISRCTN14354324
• Date of registration: 05/10/2020
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Investigating ways of encouraging fishermen in Malawi to access schistosomiasis and HIV testing and treatment
• 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
• Date of first enrolment: 01/01/2021
• Target sample size: 4500
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN14354324
• Study type: Interventional
• Study design: 3-arm open-label cluster randomized trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Malawi

Contacts

• Name: Augustine Talumba Choko

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

HIV infection and/or schistosomiasis (Schistosoma haematobium) infection
Infections and Infestations

Intervention(s)

'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

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

Nil known

WT 216458/Z/19/Z

Source(s) of Monetary Support

Wellcome Trust, National Institute for Health Research

Results

• Date Completed: 30/12/2022