{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,7]],"date-time":"2025-12-07T02:00:51Z","timestamp":1765072851428,"version":"3.46.0"},"reference-count":24,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2021,9,7]],"date-time":"2021-09-07T00:00:00Z","timestamp":1630972800000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000200","name":"US Agency for International Development","doi-asserted-by":"crossref","award":["7200AA18C00074"],"award-info":[{"award-number":["7200AA18C00074"]}],"id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,8,25]]},"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Dolutegravir-based antiretroviral therapy (ART) is increasingly being used as the preferred first-line regimen for the treatment of HIV in low-income and middle-income countries. The National Program for the Control of STI\/HIV\/AIDS in Mozambique has planned a phased introduction of the tenofovir\/lamivudine\/dolutegravir (TLD) regimen. In 2019, concerns about a potential safety signal identified with dolutegravir identified in the results of the Tsepamo study, conducted in Botswana, led the National Directorate of Pharmacy and the National Program for the Control of STI\/HIV\/AIDS to establish an active pharmacovigilance surveillance system among newly placed patients on a TLD regimen. This activity aims to establish an active pharmacovigilance system to monitor adverse events in patients on a TLD regimen to support the effectiveness of Mozambique\u2019s public health programmes in improving the process of care and treatment outcomes for people with HIV\/AIDS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a prospective, non-interventional, descriptive cohort study to monitor HIV patients managed with TLD at 10 sentinel health centres in Mozambique. The cohort consists of HIV-infected patients commencing treatment with TLD, either as treatment na\u00efve patients or switched from other ART regimens. Patients have monthly routine follow-up visits for the first 3\u2009months after starting HIV treatment with TLD, and subsequently every 3\u2009months for a total period of 1\u2009year. Patients are monitored to identify possible adverse events during the follow-up period. The intended size of the cohort is 3000 patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was obtained from the National Commission on Bioethics in Health in Mozambique. Written informed consent is obtained from each participant who agrees to participate to have their information collected, analysed and stored. Findings will be reported to the Ministry of Health and participating health centres to inform policy and practice as well as disseminated by peer-review publications.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-050671","type":"journal-article","created":{"date-parts":[[2021,9,7]],"date-time":"2021-09-07T11:57:34Z","timestamp":1631015854000},"page":"e050671","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Protocol for active safety monitoring of a cohort of patients using a dolutegravir-based antiretroviral regimen in Mozambique"],"prefix":"10.1136","volume":"11","author":[{"given":"Merana","family":"Muss\u00e1","sequence":"first","affiliation":[{"name":"Pharmacovigilance Unit, National Directorate of Pharmacy, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ir\u00e9nio","family":"Gaspar","sequence":"additional","affiliation":[{"name":"National HIV\/AIDS Division, MISAU, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luisa","family":"Namburete","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit, National Directorate of Pharmacy, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T\u00e2nia Vuyeya","family":"Sitoie","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit, National Directorate of Pharmacy, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aleny","family":"Couto","sequence":"additional","affiliation":[{"name":"National HIV\/AIDS Division, MISAU, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jamal Mario","family":"Paulino","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit, National Directorate of Pharmacy, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abrao","family":"Lemos","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit, National Directorate of Pharmacy, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefia","family":"Vilanculos","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit, National Directorate of Pharmacy, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0448-7111","authenticated-orcid":false,"given":"Comfort Kunak","family":"Ogar","sequence":"additional","affiliation":[{"name":"MTaPS, Management Sciences for Health, FCT, Nigeria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denylson","family":"Namburete","sequence":"additional","affiliation":[{"name":"Medicine, Technologies and Pharmaceutical Services (MTaPS), Management Sciences for Health, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eunice Dias","family":"Seni","sequence":"additional","affiliation":[{"name":"Medicine, Technologies and Pharmaceutical Services (MTaPS), Management Sciences for Health, Maputo, Mozambique"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamara","family":"Hafner","sequence":"additional","affiliation":[{"name":"Medicines, Technologies and Pharmaceutical Sciences (MTaPS), Management Sciences for Health Inc Arlington, Arlington, Virginia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andy","family":"Stergachis","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, University of Washington School of Public Health, Seattle, Washington, USA"},{"name":"School of Pharmacy, University of Washington Seattle Campus, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,9,7]]},"reference":[{"key":"2025120617574351000_11.9.e050671.1","unstructured":"WHO . Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach - Second edition. 2nd ed. Geneva: World Health Organization, 2018. http:\/\/www.who.int\/hiv\/pub\/arv\/arv-2016\/en\/"},{"key":"2025120617574351000_11.9.e050671.2","unstructured":"WHO . Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV: interim guidelines: supplement to the 2016 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. 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