{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T20:30:14Z","timestamp":1765830614609,"version":"3.48.0"},"reference-count":29,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000061","name":"Fogarty International Center at NIH","doi-asserted-by":"publisher","award":["R25TW010507"],"award-info":[{"award-number":["R25TW010507"]}],"id":[{"id":"10.13039\/100000061","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,13]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting and participants<\/jats:title>\n                    <jats:p>\n                      From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"22964075\">ISRCTN22964075<\/jats:ext-link>\n                      ) and ODYSSEY (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"91737921\">ISRCTN91737921<\/jats:ext-link>\n                      )] at the Joint Clinical Research Centre Mbarara, Uganda.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome measures<\/jats:title>\n                    <jats:p>The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants\u2019 lived experiences and were aimed at adding context.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents\u2019 trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents\u2019 consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-077546","type":"journal-article","created":{"date-parts":[[2024,3,2]],"date-time":"2024-03-02T00:00:11Z","timestamp":1709337611000},"page":"e077546","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"isrctn22964075","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn91737921","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn22964075","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn91737921","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-2284-9017","authenticated-orcid":false,"given":"Shafic","family":"Makumbi","sequence":"first","affiliation":[{"name":"Joint Clinical Research Centre, Mbarara, Uganda"},{"name":"Mbarara University of Science and Technology, Mbarara, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francis","family":"Bajunirwe","sequence":"additional","affiliation":[{"name":"Department of Community Health, Mbarara University of Science and Technology, Mbarara, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Ford","sequence":"additional","affiliation":[{"name":"Medical Research Council Clinical Trials Unit, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Turkova","sequence":"additional","affiliation":[{"name":"Medical Research Council Clinical Trials Unit, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8912-2001","authenticated-orcid":false,"given":"Annabelle","family":"South","sequence":"additional","affiliation":[{"name":"Medical Research Council Clinical Trials Unit, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abbas","family":"Lugemwa","sequence":"additional","affiliation":[{"name":"Joint Clinical Research Centre, Mbarara, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Victor","family":"Musiime","sequence":"additional","affiliation":[{"name":"Joint Clinical Research Centre, Mbarara, Uganda"},{"name":"Makerere University, Kampala, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana","family":"Gibb","sequence":"additional","affiliation":[{"name":"Medical Research Council Clinical Trials Unit, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imelda K","family":"Tamwesigire","sequence":"additional","affiliation":[{"name":"Department of Community Health, Mbarara University of Science and Technology, Mbarara, Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,3,1]]},"reference":[{"key":"2025121512242652000_14.3.e077546.1","unstructured":"Code N . 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