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

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 self-test 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 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.

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Voluntary Medical Male Circumcision: A Cross-Sectional Study Comparing Circumcision Self-Report and Physical Examination Findings in Lesotho

PLoS ONE ◽

10.1371/journal.pone.0027561 ◽

2011 ◽

Vol 6 (11) ◽

pp. e27561 ◽

Cited By ~ 25

Author(s):

Anne Goldzier Thomas ◽

Bonnie Robin Tran ◽

Marcus Cranston ◽

Malerato Cecilia Brown ◽

Rajiv Kumar ◽

...

Keyword(s):

Physical Examination ◽

Male Circumcision ◽

Cross Sectional Study ◽

Self Report ◽

Voluntary Medical Male Circumcision ◽

Sectional Study ◽

Cross Sectional ◽

Medical Male Circumcision

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The Risks and Benefits of Providing HIV Services during the COVID-19 Pandemic

10.1101/2021.03.01.21252663 ◽

2021 ◽

Author(s):

John Stover ◽

Sherrie L. Kelly ◽

Edinah Mudimu ◽

Dylan Green ◽

Tyler Smith ◽

...

Keyword(s):

Health Services ◽

Health Workers ◽

Diagnostic Testing ◽

Simulation Models ◽

Hiv Infections ◽

Early Response ◽

Voluntary Medical Male Circumcision ◽

Medical Male Circumcision ◽

Hiv Services ◽

Trade Offs

AbstractIntroductionThe COVID-19 pandemic has caused widespread disruptions including to health services. In the early response to the pandemic many countries restricted population movements and some health services were suspended or limited. In late 2020 and early 2021 some countries re-imposed restrictions. Health authorities need to balance the potential harms of additional SARS-CoV-2 transmission due to contacts associated with health services against the benefits of those services, including fewer new HIV infections and deaths. This paper examines these trade-offs for select HIV services.MethodsWe used four HIV simulation models (Goals, HIV Synthesis, Optima HIV and EMOD) to estimate the benefits of continuing HIV services in terms of fewer new HIV infections and deaths. We used three COVID-19 transmission models (Covasim, Cooper/Smith and a simple contact model) to estimate the additional deaths due to SARS-CoV-2 transmission among health workers and clients. We examined four HIV services: voluntary medical male circumcision, HIV diagnostic testing, viral load testing and programs to prevent mother-to-child transmission. We compared COVID-19 deaths in 2020 and 2021 with HIV deaths occurring now and over the next 50 years discounted to present value. The models were applied to countries with a range of HIV and COVID-19 epidemics.ResultsMaintaining these HIV services could lead to additional COVID-19 deaths of 0.002 to 0.15 per 10,000 clients. HIV-related deaths averted are estimated to be much larger, 19 - 146 discounted deaths per 10,000 clients.DiscussionWhile there is some additional short-term risk of SARS-CoV-2 transmission associated with providing HIV services, the risk of additional COVID-19 deaths is at least 100 times less than the HIV deaths averted by those services. Ministries of Health need to take into account many factors in deciding when and how to offer essential health services during the COVID-19 pandemic. This work shows that the benefits of continuing key HIV services are far larger than the risks of additional SARS-CoV-2 transmission.

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Voluntary Medical Male Circumcision: A Cross-Sectional Study Comparing Circumcision Self-Report and Physical Examination Findings in Lesotho

10.21236/ada562780 ◽

2011 ◽

Author(s):

Anne G. Thomas ◽

Bonnie R. Tran ◽

Marcus Cranston ◽

Malerato C. Brown ◽

Rajiv Kumar ◽

...

Keyword(s):

Physical Examination ◽

Male Circumcision ◽

Cross Sectional Study ◽

Self Report ◽

Voluntary Medical Male Circumcision ◽

Sectional Study ◽

Cross Sectional ◽

Medical Male Circumcision

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The risks and benefits of providing HIV services during the COVID-19 pandemic

PLoS ONE ◽

10.1371/journal.pone.0260820 ◽

2021 ◽

Vol 16 (12) ◽

pp. e0260820

Author(s):

John Stover ◽

Sherrie L. Kelly ◽

Edinah Mudimu ◽

Dylan Green ◽

Tyler Smith ◽

...

Keyword(s):

Health Services ◽

Health Workers ◽

Diagnostic Testing ◽

Simulation Models ◽

Hiv Infections ◽

Early Response ◽

Voluntary Medical Male Circumcision ◽

Medical Male Circumcision ◽

Hiv Services ◽

Trade Offs

Introduction The COVID-19 pandemic has caused widespread disruptions including to health services. In the early response to the pandemic many countries restricted population movements and some health services were suspended or limited. In late 2020 and early 2021 some countries re-imposed restrictions. Health authorities need to balance the potential harms of additional SARS-CoV-2 transmission due to contacts associated with health services against the benefits of those services, including fewer new HIV infections and deaths. This paper examines these trade-offs for select HIV services. Methods We used four HIV simulation models (Goals, HIV Synthesis, Optima HIV and EMOD) to estimate the benefits of continuing HIV services in terms of fewer new HIV infections and deaths. We used three COVID-19 transmission models (Covasim, Cooper/Smith and a simple contact model) to estimate the additional deaths due to SARS-CoV-2 transmission among health workers and clients. We examined four HIV services: voluntary medical male circumcision, HIV diagnostic testing, viral load testing and programs to prevent mother-to-child transmission. We compared COVID-19 deaths in 2020 and 2021 with HIV deaths occurring now and over the next 50 years discounted to present value. The models were applied to countries with a range of HIV and COVID-19 epidemics. Results Maintaining these HIV services could lead to additional COVID-19 deaths of 0.002 to 0.15 per 10,000 clients. HIV-related deaths averted are estimated to be much larger, 19–146 discounted deaths per 10,000 clients. Discussion While there is some additional short-term risk of SARS-CoV-2 transmission associated with providing HIV services, the risk of additional COVID-19 deaths is at least 100 times less than the HIV deaths averted by those services. Ministries of Health need to take into account many factors in deciding when and how to offer essential health services during the COVID-19 pandemic. This work shows that the benefits of continuing key HIV services are far larger than the risks of additional SARS-CoV-2 transmission.

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Voluntary Medical Male Circumcision to Prevent HIV in Tanah Papua, Indonesia: Field Trial to Assess Acceptability and Feasibility

Current HIV Research ◽

10.2174/1570162x15666171005170849 ◽

2017 ◽

Vol 15 (5) ◽

Author(s):

M. Ridwan Ansari ◽

Elan Lazuardi ◽

Frank Stephen Wignall ◽

Constant Karma ◽

Sylvanus A. Sumule ◽

...

Keyword(s):

Male Circumcision ◽

Field Trial ◽

Voluntary Medical Male Circumcision ◽

Medical Male Circumcision

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Voluntary Medical Male Circumcision among Rwanda Defense Force Members

Current HIV Research ◽

10.2174/1570162x15666170517095733 ◽

2017 ◽

Vol 15 (2) ◽

Author(s):

Michael P. Grillo ◽

Djeneba Audrey Djibo ◽

Caroline A. Macera ◽

Charles Murego ◽

Eugene Zimulinda ◽

...

Keyword(s):

Male Circumcision ◽

Voluntary Medical Male Circumcision ◽

Medical Male Circumcision

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Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽

10.1186/s12912-021-00616-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Olga L. Cortés ◽

Mauricio Herrera-Galindo ◽

Juan Carlos Villar ◽

Yudi A. Rojas ◽

María del Pilar Paipa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critical Care ◽

Pressure Ulcers ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Link Type ◽

Cluster Randomized ◽

The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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