Makumbi Shafic, Bajunirwe Francis, Ford Deborah, Turkova Anna, South Annabelle, Lugemwa Abbas, Musiime Victor, Gibb Diana, Tamwesigire Imelda K
Joint Clinical Research Centre, Mbarara, Uganda
Mbarara University of Science and Technology, Mbarara, Uganda.
BMJ Open. 2024 Mar 1;14(3):e077546. doi: 10.1136/bmjopen-2023-077546.
OBJECTIVES: To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors. DESIGN: Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews. SETTING AND PARTICIPANTS: 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 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda. OUTCOME MEASURES: 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' lived experiences and were aimed at adding context. RESULTS: 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. CONCLUSIONS: This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents' 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' consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.
目的：探讨儿科HIV临床试验中同意的自愿性及其相关因素。 设计：混合方法横断面研究，将定量调查与深入访谈同时进行。 设置与参与者：2021年1月至2021年4月，我们在乌干达姆巴拉拉联合临床研究中心对两项正在进行的儿科HIV临床试验[CHAPAS-4（ISRCTN22964075）和ODYSSEY（ISRCTN91737921）]中接受一线或二线抗逆转录病毒治疗（ART）的儿童的父母进行了访谈。 结局指标：结局指标为自愿同意的父母比例、影响自愿性的因素以及外部影响的来源。父母在自愿性阶梯上对其同意的自愿性进行评分。深入访谈描述了参与者的生活经历，旨在补充背景信息。 结果：所有151名随机抽取参与调查的父母均参与（84%为女性，中位年龄40岁）。大多数（67%）做出了完全自愿的决定，在自愿性阶梯上得分为10，而8%得分为9，9%得分为8，6%得分为7，8%得分为6，2.7%得分为4。对医学研究人员的信任（调整后的OR为9.90，95%CI为1.01至97.20，p=0.049）和父母为男性（调整后的OR为3.66，95%CI为1.00至13.38，p=0.05）与同意的自愿性呈正相关。既往研究经历（调整后的OR为0.31，95%CI为0.12至0.78，p=0.014）和咨询（调整后的OR为0.25，95%CI为0.10至0.60，p=0.002）与自愿性呈负相关。咨询和建议来自转诊的医护人员（36%）、配偶（29%）、其他家庭成员（27%）、朋友（15%）和研究人员（7%）。深入访谈（n=14）确定了儿童的健康状况、转诊医护人员的建议以及获得更好护理的机会是影响同意自愿性的因素。 结论：本研究表明同意的自愿性较高，男性父母以及父母对医学研究人员的信任会增强这种自愿性。儿童的既往研究经历以及医护人员和配偶的建议与父母同意的自愿性呈负相关。女性父母以及有既往研究经历的儿童的父母可能会从支持自愿参与的额外干预措施中受益。
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