Sugarman Jeremy, Trumble Ilana, Hamilton Erica, Sarasvita Riza, Dumchev Kostyantyn, Viet Ha, Hoffman Irving, Miller William, Hanscom Brett
Harvey M. Meyerhoff professor of bioethics and medicine at the Berman Institute of Bioethics and the Department of Medicine at Johns Hopkins University.
Research assistant and PhD student in the Department of Biostatistics and Informatics at the Colorado School of Public Health.
Ethics Hum Res. 2019 Sep;41(5):28-34. doi: 10.1002/eahr.500030.
Given ethical concerns about research involving people who inject drugs and those affected by HIV, identifying potential participation benefits is important. We evaluated participant-reported benefits in a trial conducted in Indonesia, Ukraine, and Vietnam that assessed an intervention combining psychosocial counseling and referral for antiretroviral therapy and substance use treatment for HIV-infected people who use drugs. Reported benefits were aggregated into three groups: clinical (antiretroviral therapy, reduced cravings, reduced drug use, lab testing, medical referral, mental health, physical health), social (employment, financial, relationships, reduced stigma), and general (gained knowledge, life improvement). Overall, 438 index participants (90.5%) and 642 injection partners (83.1%) reported at least one benefit. Significantly more index participants who received the study intervention reported at least one benefit versus those who received the standard of care. Clinical trial participation can provide broad direct and indirect benefits for stigmatized populations, which has implications for assessing the ethical appropriateness of studies with such populations.
鉴于涉及注射吸毒者和受艾滋病毒影响者的研究存在伦理问题，确定潜在的参与益处很重要。我们在印度尼西亚、乌克兰和越南进行的一项试验中评估了参与者报告的益处，该试验评估了一种干预措施，即结合心理社会咨询以及为感染艾滋病毒的吸毒者提供抗逆转录病毒治疗和药物使用治疗的转介服务。报告的益处被归为三类：临床（抗逆转录病毒治疗、减少渴望、减少药物使用、实验室检测、医疗转介、心理健康、身体健康）、社会（就业、经济、人际关系、减少耻辱感）和一般（获得知识、生活改善）。总体而言，438名指标参与者（90.5%）和642名注射伙伴（83.1%）报告了至少一项益处。与接受标准治疗的参与者相比，接受研究干预的指标参与者报告至少一项益处的人数显著更多。参与临床试验可以为受污名化人群带来广泛的直接和间接益处，这对于评估针对此类人群的研究在伦理上的适当性具有重要意义。
