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      The Effects of Workplace-Based HIV Self-testing on Uptake of Testing and Linkage to HIV Care or Prevention by Men in Uganda (WISe-Men): Protocol for a Cluster Randomized Trial

      research-article
      , BSN, MSN, PhD 1 , , , BSN, MSN 1 , , MBChB, MPH, PhD 2 , , RN, PhD 3 , , MBChB, MPH 4 , , BSN, MA, MPH 1 , , BSN 5 , , MBChB, MMed, PhD 6 , , MBChB, MMed, MSc 6
      (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      Africa, workplace HIV testing, HIV self-testing, linkage to care, linkage to prevention

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          Abstract

          Background

          HIV testing uptake remains low among men in sub-Saharan Africa. HIV self-testing (HIVST) at the workplace is a novel approach to increase the availability of, and access to, testing among men. However, both access and linkage to posttest services remain a challenge.

          Objective

          The aim of this protocol is to describe a cluster randomized trial (CRT)—Workplace-Based HIV Self-testing Among Men (WISe-Men)—to evaluate the effect of HIVST in workplace settings on the uptake of HIV testing services (HTS) and linkage to treatment and prevention services among men employed in private security services in Uganda.

          Methods

          This is a two-arm CRT involving men employed in private security services in two Ugandan districts. The participants in the intervention clusters will undergo workplace-based HIVST using OraQuick test kits. Those in the control clusters will receive routine HTS at their work premises. In addition to HTS, participants in both the intervention and control arms will undergo other tests and assessments, which include blood pressure assessment, blood glucose and BMI measurement, and rapid diagnostic testing for syphilis. The primary outcome is the uptake of HIV testing. The secondary outcomes include HIV status reporting, linkage into HIV care and confirmatory testing following HIVST, initiation of antiretroviral therapy following a confirmatory HIV test, the uptake of voluntary medical male circumcision, consistent condom use, and the uptake of pre-exposure prophylaxis by the most at-risk populations.

          Results

          Participant enrollment commenced in February 2020, and the trial is still recruiting study participants. Follow-up for currently enrolled participants is ongoing. Data collection and analysis is expected to be completed in December 2021.

          Conclusions

          The WISe-Men trial will provide information regarding whether self-testing at worksites increases the uptake of HIV testing as well as the linkage to care and prevention services at male-dominated workplaces in Uganda. Additionally, the findings will help us propose strategies for improving men’s engagement in HTS and ways to improve linkage to further care following a reactive or nonreactive HIVST result.

          Trial Registration

          ClinicalTrials.gov NCT04164433; https://clinicaltrials.gov/ct2/show/NCT04164433

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/25099

          Related collections

          Most cited references43

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          Consort 2010 statement: extension to cluster randomised trials

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            Better reporting of harms in randomized trials: an extension of the CONSORT statement.

            In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.
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              Changing AIDS-risk behavior.

              This article contains a comprehensive, critical review of the acquired immunodeficiency syndrome (AIDS)-risk-reduction literature on interventions that have targeted risky sexual behavior and intravenous drug use practices. A conceptually based, highly generalizable model for promoting and evaluating AIDS-risk behavior change in any population of interest is then proposed. The model holds that AIDS-risk reduction is a function of people's information about AIDS transmission and prevention, their motivation to reduce AIDS risk, and their behavioral skills for performing the specific acts involved in risk reduction. Supportive tests of this model, using structural equation modeling techniques, are then reported for populations of university students and gay male affinity group members.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                November 2021
                1 November 2021
                : 10
                : 11
                : e25099
                Affiliations
                [1 ] School of Health Sciences College of Health Sciences Makerere University Kampala Uganda
                [2 ] School of Public Health College of Health Sciences Makerere University Kampala Uganda
                [3 ] Yale School of Nursing Yale University New Haven, CT United States
                [4 ] Infectious Diseases Institute College of Health Sciences Makerere University Kampala Uganda
                [5 ] Department of Infectious Diseases Research African Center for Health Equity Research and Innovation Kampala Uganda
                [6 ] School of Medicine College of Health Sciences Makerere University Kampala Uganda
                Author notes
                Corresponding Author: Patience A Muwanguzi pamuwanguzi@ 123456gmail.com
                Author information
                https://orcid.org/0000-0003-0403-9327
                https://orcid.org/0000-0002-8228-6270
                https://orcid.org/0000-0003-2471-9290
                https://orcid.org/0000-0002-2630-602X
                https://orcid.org/0000-0003-2923-6482
                https://orcid.org/0000-0003-2394-4445
                https://orcid.org/0000-0001-9952-7483
                https://orcid.org/0000-0002-0935-2112
                https://orcid.org/0000-0001-9362-053X
                Article
                v10i11e25099
                10.2196/25099
                8593794
                34723826
                bd2536e9-a468-4517-aa07-5aa024abd262
                ©Patience A Muwanguzi, Tom Denis Ngabirano, Noah Kiwanuka, LaRon E Nelson, Esther M Nasuuna, Charles Peter Osingada, Racheal Nabunya, Damalie Nakanjako, Nelson K Sewankambo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 01.11.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 17 October 2020
                : 18 November 2020
                : 11 December 2020
                : 30 December 2020
                Categories
                Protocol
                Protocol

                africa,workplace hiv testing,hiv self-testing,linkage to care,linkage to prevention

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