Odero Isdora, Ondeng'e Ken, Mudhune Victor, Okola Phoebe, Oruko Jecinter, Otieno George, Akelo Victor, Gust Deborah A
1 HIV Research Branch, Kenya Medical Research Institute, Kisumu, Kenya.
2 Division of Nutrition, Physical Activity and Obesity, U.S. Centers for Disease Control and Prevention, Atlanta, GA, United States.
Int J STD AIDS. 2019 Jan;30(1):12-19. doi: 10.1177/0956462418791946. Epub 2018 Aug 29.
We conducted an exploratory analysis of former HIV Prevention Trials Network 052 (HPTN 052) clinical trial participants in 2016 to assess their (1) satisfaction with the HPTN 052 clinical trial care and treatment, and reasons for joining the trial; and (2) perspectives about the post-trial transition to public HIV care centers. Quantitative data showed that, of the 70 survey participants, 94.3% (n = 66) reported being very satisfied with the care and treatment they received while participating in the clinical trial and 51.4% (n = 36) reported they joined the study because they would receive information to improve their own or their partner's health. Qualitative data (five in-depth interviews and two focus group discussions) analysis revealed the following themes: transition experiences; perceived superior clinical trial care; study benefits not offered at public HIV care centers; and the public HIV care centers' indifference to the uninfected partner. For some HPTN 052 participants, transition to HIV care clinics was disappointing. Clinical trial investigators and local Institutional Review Boards should consider the need for safeguards and oversight of post-trial health care for trial participants after the trial ends, especially in resource-constrained settings, to avoid negative health outcomes.
2016年，我们对 former HIV Prevention Trials Network 052（HPTN 052）临床试验参与者进行了一项探索性分析，以评估他们：（1）对HPTN 052临床试验护理和治疗的满意度以及参与试验的原因；（2）对试验后转至公共艾滋病毒护理中心的看法。定量数据显示，在70名调查参与者中，94.3%（n = 66）报告对参与临床试验期间所接受的护理和治疗非常满意，51.4%（n = 36）报告他们参与该研究是因为他们将获得有助于改善自身或其伴侣健康的信息。定性数据（五次深入访谈和两次焦点小组讨论）分析揭示了以下主题：过渡经历；感知到的卓越临床试验护理；公共艾滋病毒护理中心未提供的研究益处；以及公共艾滋病毒护理中心对未感染伴侣的冷漠。对于一些HPTN 052参与者来说，转至艾滋病毒护理诊所令人失望。临床试验研究者和当地机构审查委员会应考虑在试验结束后对试验参与者的试验后医疗保健进行保障和监督的必要性，尤其是在资源有限的环境中，以避免不良健康后果。
