在坦桑尼亚达累斯萨拉姆完成一项采用HIV-1 DNA初免和HIV-1 MVA加强免疫的I/II期HIV疫苗试验的志愿者中，社会伤害经历及性行为变化情况。
Experiences of social harm and changes in sexual practices among volunteers who had completed a phase I/II HIV vaccine trial employing HIV-1 DNA priming and HIV-1 MVA boosting in Dar es Salaam, Tanzania.
作者信息
Tarimo Edith A M, Munseri Patricia, Aboud Said, Bakari Muhammad, Mhalu Fred, Sandstrom Eric
机构信息
Department of Nursing Management, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
出版信息
PLoS One. 2014 Mar 6;9(3):e90938. doi: 10.1371/journal.pone.0090938. eCollection 2014.
BACKGROUND
Volunteers in phase I/II HIV vaccine trials are assumed to be at low risk of acquiring HIV infection and are expected to have normal lives in the community. However, during participation in the trials, volunteers may encounter social harm and changes in their sexual behaviours. The current study aimed to study persistence of social harm and changes in sexual practices over time among phase I/II HIV vaccine immunogenicity (HIVIS03) trial volunteers in Dar es Salaam, Tanzania.
METHODS AND RESULTS
A descriptive prospective cohort study was conducted among 33 out of 60 volunteers of HIVIS03 trial in Dar es Salaam, Tanzania, who had received three HIV-1 DNA injections boosted with two HIV-1 MVA doses. A structured interview was administered to collect data. Analysis was carried out using SPSS and McNemars' chi-square (χ2) was used to test the association within-subjects. Participants reported experiencing negative comments from their colleagues about the trial; but such comments were less severe during the second follow up visits (χ2 = 8.72; P<0.001). Most of the comments were associated with discrimination (χ2 = 26.72; P<0.001), stigma (χ2 = 6.06; P<0.05), and mistrust towards the HIV vaccine trial (χ2 = 4.9; P<0.05). Having a regular sexual partner other than spouse or cohabitant declined over the two follow-up periods (χ2 = 4.45; P<0.05).
CONCLUSION
Participants in the phase I/II HIV vaccine trial were likely to face negative comments from relatives and colleagues after the end of the trial, but those comments decreased over time. In this study, the inherent sexual practice of having extra sexual partners other than spouse declined over time. Therefore, prolonged counselling and support appears important to minimize risky sexual behaviour among volunteers after participation in HIV Vaccine trials.
背景
在I/II期HIV疫苗试验中的志愿者被认为感染HIV的风险较低，并期望在社区中过正常生活。然而，在参与试验期间，志愿者可能会遭遇社会伤害以及性行为的改变。当前研究旨在探讨坦桑尼亚达累斯萨拉姆I/II期HIV疫苗免疫原性（HIVIS03）试验志愿者中社会伤害的持续性以及性行为随时间的变化。
方法与结果
在坦桑尼亚达累斯萨拉姆HIVIS03试验的60名志愿者中的33名中进行了一项描述性前瞻性队列研究，这些志愿者接受了三次HIV-1 DNA注射，并以两次HIV-1 MVA剂量进行加强。通过结构化访谈收集数据。使用SPSS进行分析，并使用McNemars卡方检验（χ²）来检验受试者内部的关联。参与者报告称同事对试验有负面评价；但在第二次随访时此类评价不那么严重（χ² = 8.72；P < 0.001）。大多数评价与歧视（χ² = 26.72；P < 0.001）、污名化（χ² = 6.06；P < 0.05）以及对HIV疫苗试验的不信任（χ² = 4.9；P < 0.05）有关。在两个随访期内，除配偶或同居者外有固定性伴侣的情况有所减少（χ² = 4.45；P < 0.05）。
结论
I/II期HIV疫苗试验的参与者在试验结束后可能会面临亲属和同事的负面评价，但这些评价会随着时间减少。在本研究中，除配偶外有额外性伴侣的固有性行为随时间减少。因此，延长咨询和支持对于减少志愿者参与HIV疫苗试验后危险的性行为似乎很重要。
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