Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial.

Autor:	Dovel K; Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA kdovel@mednet.ucla.edu.; Department of Implementation Science, Partners in Hope, Lilongwe, Malawi., Balakasi K; Department of Implementation Science, Partners in Hope, Lilongwe, Malawi., Hubbard J; Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA., Phiri K; Department of Implementation Science, Partners in Hope, Lilongwe, Malawi., Nichols BE; Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.; Department of Medical Microbiology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, Netherlands.; Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland., Coates TJ; Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.; Global Health Institute, University of California, San Francisco, California, USA., Kulich M; Department of Probability and Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czechia., Chikuse E; Department of Implementation Science, Partners in Hope, Lilongwe, Malawi., Phiri S; Department of Implementation Science, Partners in Hope, Lilongwe, Malawi., Long LC; Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.; Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Hoffman RM; Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA., Choko AT; Clinical Research Programme, Malawi Liverpool Wellcome Programme, Blantyre, Malawi.; Liverpool School of Tropical Medicine, Liverpool, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Jul 12; Vol. 13 (7), pp. e070896. Date of Electronic Publication: 2023 Jul 12.
DOI:	10.1136/bmjopen-2022-070896
Abstrakt:	Introduction: Men in sub-Saharan Africa are less likely than women to initiate antiretroviral therapy (ART) and more likely to have longer cycles of disengagement from ART programmes. Treatment interventions that meet the unique needs of men are needed, but they must be scalable. We will test the impact of various interventions on 6-month retention in ART programmes among men living with HIV who are not currently engaged in care (never initiated ART and ART clients with treatment interruption). Methods and Analysis: We will conduct a programmatic, individually randomised, non-blinded, controlled trial. 'Non-engaged' men will be randomised 1:1:1 to either a low-intensity, high-intensity or stepped arm. The low-intensity intervention includes one-time male-specific counseling+facility navigation only. The high-intensity intervention offers immediate outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. In the stepped arm, intervention activities build in intensity over time for those who do not re-engage in care with the following steps: (1) one-time male-specific counselling+facility navigation→(2) ongoing male mentorship+facility navigation→(3) outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. Our primary outcome is 6-month retention in care. Secondary outcomes include cost-effectiveness and rates of adverse events. The primary analysis will be intention to treat with all eligible men in the denominator and all men retained in care at 6 months in the numerator. The proportions achieving the primary outcome will be compared with a risk ratio, corresponding 95% CI and p value computed using binomial regression accounting for clustering at facility level. Ethics and Dissemination: The Institutional Review Board of the University of California, Los Angeles and the National Health Sciences Research Council in Malawi have approved the trial protocol. Findings will be disseminated rapidly in national and international forums and in peer-reviewed journals and are expected to provide urgently needed information to other countries and donors. Trial Registration Number: NCT05137210. Date and Version: 5 May 2023; version 3. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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