Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial

PLOS ONE STUDY PROTOCOL Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 OPEN ACCESS Citation: Choko AT, Coates TJ, Mphande M, Balakasi K, Robson I, Phiri K, et al. (2023) Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial. PLoS ONE 18(2): e0281472. https:// doi.org/10.1371/journal.pone.0281472 Editor: Richard Ali, UNITED KINGDOM Received: December 15, 2022 Accepted: January 22, 2023 Augustine T. Choko1,2, Thomas J. Coates3, Misheck Mphande1, Kelvin Balakasi1, Isabella Robson1, Khumbo Phiri1, Sam Phiri ID1, Michal Kulich4, Michael Sweat5, Morna Cornell6, Risa M. Hoffman3, Kathryn Dovel ID1,3* 1 Partners in Hope, Lilongwe, Malawi, 2 College of Medicine, University of Malawi, Blantyre, Malawi, 3 David Geffen School of Medicine, Division of Infectious Diseases, Los Angeles, California, United States of America, 4 Department of Probability and Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic, 5 Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, United States of America, 6 Centre for Infectious Disease Epidemiology & Research, School of Public Health, University of Cape Town, Cape Town, South Africa * Abstract Background Men experience twice the mortality of women while on ART in sub-Saharan Africa (SSA) largely due to late HIV diagnosis and poor retention. Here we propose to conduct an individually randomized control trial (RCT) to investigate the impact of three-month home-based ART (hbART) on viral suppression among men who were not engaged in care. Published: February 24, 2023 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.0281472 Copyright: © 2023 Choko 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. Data Availability Statement: No datasets were generated or analysed during the current study. All Methods and design A programmatic, individually randomized non-blinded, non-inferiority-controlled trial design (ClinicalTrials.org NCT04858243). Through medical chart reviews we will identify “nonengaged” men living with HIV, �15years of age who are not currently engaged in ART care, including (1) men who have tested HIV-positive and have not initiated ART within 7 days; (2) men who have initiated ART but are at risk of immediate default; and (3) men who have defaulted from ART. With 1:1 computer block randomization to either hbART or facilitybased ART (fbART) arms, we will recruit men from 10–15 high-burden health facilities in central and southern Malawi. The hbART intervention will consist of 3 home-visits in a 3month period by a certified male study nurse ART provider. In the fbART arm, male participants will be offered counselling at male participant’s home, or a nearby location that is preferred by participants, followed with an escort to the local health facility and facility navigation. The primary outcome is the proportion of men who are virally suppressed at 6- PLOS ONE | https://doi.org/10.1371/journal.pone.0281472 February 24, 2023 1 / 13 PLOS ONE relevant data from this study will be made available upon study completion. Funding: This study was funded by the National Institute of Mental Health (RO1MH122308) and Fogarty International (K01-TW011484-01). KD was also supported by UCLA GSTTP. Competing interests: The authors declare that they have no competing interests. Engaging men with differentiated care to improve ART initiation and viral suppression (ENGAGE) months after ART initiation. Assuming primary outcome achievement of 24.0% and 33.6% in the two arms, 350 men per arm will provide 80% power to detect the stated difference. Discussion Identifying effective ART strategies that are convenient and accessible for men in SSA is a priority in the HIV world. Men may not (re-)engage in facility-based care due to a myriad of barriers. Two previous trials investigated the impact of hbART on viral suppression in the general population whereas this trial focuses on men. Additionally, this trial involves a longer duration of hbART i.e., three months compared to two weeks allowing men more time to overcome the initial psychological denial of taking ART. Introduction Men are a priority group for HIV services in sub-Saharan Africa (SSA) because of their low uptake of both testing and ART services. In SSA, compared with women, men living with HIV are disproportionately unaware of their HIV status and are not engaged in antiretroviral therapy (ART) programs [1, 2]. Once on ART, men have twice the mortality than women [3, 4], largely due to late diagnosis and poor retention in care [5–8]. Men also cycle through ART programs at a greater rate than women, with high rates of stopping and restarting HIV treatment and multiple extended periods outside HIV care throughout their lifetimes [9, 10]. Once engaged or re-engaged in care, the highest risk for default is within the six several months after (re)initiation [11]. This is a critical period for men to develop the internal motivation and external support needed to sustain ongoing engagement in care, and to learn problem-solving techniques to overcome the multiple barriers facing men. We need to engage more men to achieve the UNAIDS 95/95/95 targets: 95% of people living with HIV are diagnosed, 95% of those diagnosed are on treatment, and 95% of those on treatment are virally suppressed by 2030 [12]. However, there is limited literature on differentiated models of care (DMOC) to support men’s ART initiation (or re-initiation) and early retention in care, and whether such models work for men who have otherwise struggled to engage in care [13–15]. Two overarching barriers prevent HIV-positive men from accessing ART services. First, health facilities usually lack male-friendly services [16–18]. Male-friendly services are private and convenient (requiring minimal time), and offered by health workers who understand the unique needs of men [19–21]. In general, men have little exposure to the health system, which offers little to meet their needs [22, 23], and are unfamiliar with navigating preventative and chronic care services except for outpatient departments [24]. Without male-friendly services men m (...truncated)