Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial

Detalhes bibliográficos
Autor(a) principal: Gross, Robert
Data de Publicação: 2019
Outros Autores: Ritz, Justin, Hughes, Michael D., Salata, Robert, Mugyenyi, Peter, Hogg, Evelyn, Wieclaw, Linda, Godfrey, Catherine, Wallis, Carole L., Mellors, John W., Mudhune, Victor O., Badal-Faesen, Sharlaa, Grinsztejn, Beatriz, Collier, Ann C.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/35629
Resumo: 2020-09-17
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spelling Gross, RobertRitz, JustinHughes, Michael D.Salata, RobertMugyenyi, PeterHogg, EvelynWieclaw, LindaGodfrey, CatherineWallis, Carole L.Mellors, John W.Mudhune, Victor O.Badal-Faesen, SharlaaGrinsztejn, BeatrizCollier, Ann C.2019-09-17T13:05:41Z2019-09-17T13:05:41Z2019GROSS, Robert et al. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digital Health, v. 1, p. 26-34, 2019.2589-7500https://www.arca.fiocruz.br/handle/icict/3562910.1016/S2589-7500(19)30006-8engElsevierTwo-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article2020-09-17University of Pennsylvania. Perelman School of Medicine. Department of Medicine (Infectious Diseases) and Department of Epidemiology, Biostatistics and Informatics. Philadelphia, PA, USA.Harvard TH Chan School of Public Health. Boston, MA, USA.Harvard TH Chan School of Public Health. Boston, MA, USA.Case Western Reserve University. Cleveland, OH, USA.Joint Clinical Research Centre. Kampala, Uganda.Social and Scientific Systems. Silver Spring, MD, USA.Frontier Science and Technology Research Foundation. Amherst, NY, USA.National Institute of Allergy and Infectious Diseases. Bethesda, MD, USALancet Laboratories, and Bio Analytical Research Corporation South Africa. Johannesburg, South Africa.University of Pittsburgh. Department of Medicine. Pittsburgh, PA, USA.Kenya Medical Research Institute. Department of Medicine. Kisumu, Kenya.University of Witwatersrand. Department of Internal Medicine. Clinical HIV Research Unit. Johannesburg, South Africa.Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Rio de Janeiro, RJ, Brasil.University of Washington. Seattle, WA, USA.Background: Antiretroviral therapy (ART) non-adherence causes HIV treatment failure. Past behaviour might predict future behaviour; failing second-line ART could indicate ongoing risk for subsequent non-adherence. We aimed to find out whether a two-way mobile phone-based communication intervention would increase HIV treatment success by improving medication adherence. Methods: We did a multinational, randomised controlled trial of patients at 17 sites in nine lower-income and middleincome countries in Africa, Asia, and the Americas. Patients aged 18 years and older, with HIV infection, and on second-line protease-inhibitor-based antiretroviral regimens, were randomly assigned (1:1) to either two-way mobile phone intervention plus standard of care (MPI+SOC) adherence support or standard-of-care alone (SOC). Our study was nested within a strategy study of ART after second-line ART failure (the main study, A5288). The main study had four cohorts, which were assigned regimens according to ART history and real-time genotype. Randomisation was stratified by the main study cohort with dynamic institutional balancing. Only the clinical management committee was masked, not the participants or site personnel. Text messages were sent over 48 weeks starting once a day and tapering down to once per week; participants were to respond once to each message if taking ART without issues. Repeated non-response to three messages over a 2-week period for the first 8 weeks, and then two messages over a 2-week period for the remainder of the study, triggered problem-solving counselling by staff. For this study, the primary endpoint was plasma HIV-1 RNA 200 copies per mL or less at 48 weeks and the secondary endpoint was virological failure (two consecutive HIV-1 RNA ≥1000 copies per mL) at 24 or more weeks. Prespecified intention-totreat analyses were adjusted for cohort. Follow-up continued until the last participant had reached 48 weeks, with a median follow-up time of 72 weeks. The trial is registered with ClinicalTrials.gov, number NCT01641367. Findings: Enrolment began on Feb 22, 2013, and ended on Dec 21, 2015, with the last participant completing follow-up on Feb 13, 2017. Of 545 participants in the main study, 521 (96%) were enrolled and randomly assigned to MPI+SOC (n=257) or SOC alone (n=264). 52% of patients were men and the median HIV-1 RNA 4·4 log10 copies per mL (IQR 3·5 to 5·2). At week 48, HIV-1 RNA 200 copies per mL or less was reached in 169 (66%) of 257 patients in the MPI+SOC group and 164 (62%) of 264 patients in the SOC group (estimated difference 3·6% [95% CI −4·6% to 11·9%]; p=0·39). The adjusted odds ratio comparing MPI+SOC and SOC was 1·23 (0·82 to 1·84; p=0·32). Virological failure occurred in 66 (26%) patients in the MPI+SOC group and 89 (34%) patients in the SOC group during the median 72 weeks follow-up (adjusted p=0·027). Observed difference in virological failure favoured MPI+SOC in all cohorts. 23 (4%) participants died, 11 (4%) in the MPI+SOC group and 12 (5%) in the SOC group (p=0·89), with none of the deaths ascribed to ART, the MPI, or study procedures. Interpretation: Two-way MPI did not significantly improve week 48 suppression, but it did modestly affect virological failure. People failing second-line ART might not achieve benefits from phone-based triggers or enhanced adherence support (or both). More effective strategies are needed.Antiretroviral therapyHIV treatmentRandomised controlled trialMobile phone interventioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83104https://www.arca.fiocruz.br/bitstream/icict/35629/1/license.txt79178e5f2a0eb066867a274556814938MD51ORIGINALve_Gross_Robert_etal_INI_2019.pdfve_Gross_Robert_etal_INI_2019.pdfapplication/pdf833551https://www.arca.fiocruz.br/bitstream/icict/35629/2/ve_Gross_Robert_etal_INI_2019.pdff5d51d27d126f210dcc4b8cf6bc2ef3dMD52TEXTve_Gross_Robert_etal_INI_2019.pdf.txtve_Gross_Robert_etal_INI_2019.pdf.txtExtracted texttext/plain49384https://www.arca.fiocruz.br/bitstream/icict/35629/3/ve_Gross_Robert_etal_INI_2019.pdf.txt159489cf87cfdc0eb531e9919d37a7b5MD53icict/356292021-03-24 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dc.title.pt_BR.fl_str_mv Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
title Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
spellingShingle Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
Gross, Robert
Antiretroviral therapy
HIV treatment
Randomised controlled trial
Mobile phone intervention
title_short Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
title_full Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
title_fullStr Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
title_full_unstemmed Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
title_sort Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial
author Gross, Robert
author_facet Gross, Robert
Ritz, Justin
Hughes, Michael D.
Salata, Robert
Mugyenyi, Peter
Hogg, Evelyn
Wieclaw, Linda
Godfrey, Catherine
Wallis, Carole L.
Mellors, John W.
Mudhune, Victor O.
Badal-Faesen, Sharlaa
Grinsztejn, Beatriz
Collier, Ann C.
author_role author
author2 Ritz, Justin
Hughes, Michael D.
Salata, Robert
Mugyenyi, Peter
Hogg, Evelyn
Wieclaw, Linda
Godfrey, Catherine
Wallis, Carole L.
Mellors, John W.
Mudhune, Victor O.
Badal-Faesen, Sharlaa
Grinsztejn, Beatriz
Collier, Ann C.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Gross, Robert
Ritz, Justin
Hughes, Michael D.
Salata, Robert
Mugyenyi, Peter
Hogg, Evelyn
Wieclaw, Linda
Godfrey, Catherine
Wallis, Carole L.
Mellors, John W.
Mudhune, Victor O.
Badal-Faesen, Sharlaa
Grinsztejn, Beatriz
Collier, Ann C.
dc.subject.en.pt_BR.fl_str_mv Antiretroviral therapy
HIV treatment
Randomised controlled trial
Mobile phone intervention
topic Antiretroviral therapy
HIV treatment
Randomised controlled trial
Mobile phone intervention
description 2020-09-17
publishDate 2019
dc.date.accessioned.fl_str_mv 2019-09-17T13:05:41Z
dc.date.available.fl_str_mv 2019-09-17T13:05:41Z
dc.date.issued.fl_str_mv 2019
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv GROSS, Robert et al. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digital Health, v. 1, p. 26-34, 2019.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/35629
dc.identifier.issn.pt_BR.fl_str_mv 2589-7500
dc.identifier.doi.none.fl_str_mv 10.1016/S2589-7500(19)30006-8
identifier_str_mv GROSS, Robert et al. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digital Health, v. 1, p. 26-34, 2019.
2589-7500
10.1016/S2589-7500(19)30006-8
url https://www.arca.fiocruz.br/handle/icict/35629
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/35629/1/license.txt
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