aWomen's Global Health Imperative, RTI International, San Francisco, California, USA bInternational Partnership for Microbicides (IPM), Paarl, South Africa cFHI 360, Durham, North Carolina, USA dUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA eUniversity of Washington, Seattle, Washington, USA fUniversity of Alabama, Birmingham, Alabama, USA gUniversity of Zimbabwe, Harare, Zimbabwe hMakerere University, Kampala, Uganda iSouth African Medical Research Council HIV Prevention Research Unit, Durban, South Africa jWits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa kCentre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
AIDS. 2019 Nov 15;33(14):2237-2244. doi: 10.1097/QAD.0000000000002346.
Assessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.
Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.
Social harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.
Measurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (<4% per 100 person-years), and the majority have been partner-related events. However, any incidence of social harm within the context of HIV prevention is important to capture and understand for the safety of individuals, and for the successful impact of prevention methods in a real-world context.
安全性评估是临床试验实时监测的一个组成部分。在艾滋病毒预防研究中，已将研究产品和试验参与的安全性扩展到包括监测“社会危害”，一般定义为试验参与可能以社会、心理或身体方式表现出的负面后果。需要进一步研究艾滋病毒预防研究中的社会危害，以了解女性面临的潜在安全风险，并推进在现实环境中实施预防方法。
对撒哈拉以南非洲地区三项候选杀微生物剂随机、双盲、安慰剂对照试验的定量数据进行二次分析。此外，我们评估了两项前瞻性队列研究的数据，这些研究包括在母试验期间感染艾滋病毒或怀孕的参与者。
在最大和最新的杀微生物剂研究中，社会危害报告率较低。阶段性试验中每 100 人年的社会危害发生率从 1.10（95%CI 0.78-1.52）到 3.25（95%CI 2.83-3.74）不等。报告因剂量机制（例如阴道凝胶、口服片剂、环）和研究而异，这很可能是由于测量差异所致。社会危害最常与男性伴侣有关，而不是与社区中的耻辱感等有关。
测量和筛查社会危害是进行新型艾滋病毒预防方法伦理研究的重要组成部分。迄今为止，杀微生物剂试验报告的社会危害发生率相对较低（每 100 人年不到 4%），且大多数与伴侣相关的事件。然而，在艾滋病毒预防背景下，任何社会危害的发生都需要加以捕捉和理解，这对于个人的安全以及预防方法在现实环境中的成功影响都很重要。
