Assessing the efficacy of an integrated intervention to create demand for fishermen’s schistosomiasis and HIV services (FISH) in Mangochi, Malawi: Study protocol for a cluster randomized control trial

PLOS ONE STUDY PROTOCOL Assessing the efficacy of an integrated intervention to create demand for fishermen’s schistosomiasis and HIV services (FISH) in Mangochi, Malawi: Study protocol for a cluster randomized control trial a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 Donaldson F. Conserve1, Sekeleghe Kayuni2, Moses K. Kumwenda3, Kathryn L. Dovel4, Augustine Talumba Choko ID3* 1 Department of Prevention and Community Health, Milken Institute of Public Health, George Washington University, Washington, District of Columbia, United States of America, 2 Medical Aid Society of Malawi (MASM), Blantyre, Malawi, 3 Malawi Liverpool Wellcome Trust Clinical Research Programme (MLW), Blantyre, Malawi, 4 David Geffen School of Medicine, The University of California, Los Angeles, California, United States of America * OPEN ACCESS Citation: Conserve DF, Kayuni S, Kumwenda MK, Dovel KL, Choko AT (2022) Assessing the efficacy of an integrated intervention to create demand for fishermen’s schistosomiasis and HIV services (FISH) in Mangochi, Malawi: Study protocol for a cluster randomized control trial. PLoS ONE 17(1): e0262237. https://doi.org/10.1371/journal. pone.0262237 Editor: Jamie Royle, UNITED KINGDOM Received: November 28, 2021 Accepted: December 6, 2021 Published: January 7, 2022 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal.pone.0262237 Copyright: © 2022 Conserve et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: ATC was funded by Wellcome Trust & National Institute for Health Research, UK (grant number: 216458_Z_19_Z). The sponsor and Abstract Background Both HIV and schistosomiasis are major public health problems worldwide with 1.8 million new HIV infections, and up to 110 million untreated schistosomiasis cases globally. Although a causal link has not been established, there are strong suggestions that having schistosomiasis increases onward transmission of HIV from co-infected men to women. With both HIV and schistosomiasis treatment readily available in Malawi, there is a need to investigate the feasibility, acceptability and health impacts of joint management of these two hazards, with special focus on health education and demand-creation for fishermen. The aim of this project is to identify optimal models 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 in Mangochi, Malawi. Methods We have mapped 45 boat teams or landing sites for a 3-arm cluster randomized trial using “boat team” as the unit of randomization. The three arms are: 1) Standard of care (SOC) with leaflets explaining the importance of receiving presumptive treatment for schistosomiasis (praziquantel) and HIV services for fishermen, and two intervention arms of 2) SOC + a peer explaining the leaflet to his fellow fishermen in a boat team; and 3) arm 2 with HIV selftest kits delivered to the boat team fishermen by the peer. The primary outcomes measured at 9 months of trial delivery will compare differences between arms in the proportions of boat-team fishermen: 1) who self-report starting antiretroviral therapy or undergoing PLOS ONE | https://doi.org/10.1371/journal.pone.0262237 January 7, 2022 1 / 13 PLOS ONE funders had no role in study design, writing of the report; and the decision to submit the report for publication. DFC was supported by a training grant from the National Institute of Health (R00MH110343: PI, DFC) and the HIV Dissemination Science Training Program for Underrepresented Investigators grant (R25MH080665). The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the funder. Competing interests: The authors have declared that no competing interests exist Abbreviations: SOC, standard of care; HIVST, HIV self-testing; MDA, mass drug administration; ART, antiretroviral therapy; CRT, cluster randomized trial (CRT); PE, peer educator; PDE, peer-distributoreducators; VMMC, voluntary male medical circumcision; CI, confidence interval. Demand creation for fishermen’s schistosomiasis and HIV services voluntary medical male circumcision; and 2) who have �1 S. haematobium egg seen on light microscopy of the filtrate from 10mls urine (“egg-positive”). Discussion This is the first evaluation of an integrated HIV and schistosomiasis services intervention for fishermen, particularly investigating the effect of using social networks, HIVST kits and beach clinic services. The findings will support future efforts to integrate HIVST with other health services for fishermen in similar settings if found to be efficacious. Trial registration This trial is registered in the ISRCTN registry: ISRCTN14354324; date of registration: 05 October 2020. https://www.isrctn.com/ISRCTN14354324?q=ISRCTN14354324&filters= &sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search. Linked to protocol version number 1.4 of 11 January 2021. Background Both HIV and schistosomiasis are major public health problems worldwide with 1.8 million new HIV infections, and up to 110 million untreated schistosomiasis cases globally [1]. HIV prevalence in Malawi is among the highest globally, with 9.6% of the adult population living with HIV, and 39,000 new infections and 17,000 deaths from HIV in 2017 [2]. Fishing communities throughout Africa have much higher HIV prevalence than national averages with, for instance, complex ‘fish-for-sex’ trading networks described in Malawi [3]. In addition, in freshwaters, including Lake Malawi, urinary schistosomiasis (Schistosoma haematobium) is a further occupational hazard and, among other pathologies, commonly causes male and female genital lesions resulting in subfertility, haemospermia, genital and pelvic pain [4,5]. Although a causal link has not been established, there are strong suggestions that having schistosomiasis increases onward transmission of HIV from co-infected men to women, and also that schistosomiasis increases susceptibility to HIV in HIV-negative women [4,5]. Most recently, stored serum showed 59% baseline schistosome-antibody positivity in a large Zambian cohort of HIV discordant couples (i.e. only one partner HIV-positive at baseline) that documented 335 HIV seroconversion events during follow-up [5]. Baseline HIV-positive schistosome-positive partners were more likely to transmit HIV to their HIV-negative partner (adjusted hazard ratios 1.8 for men and 1.4 for women), with HIV-nega (...truncated)