Development of an intervention for improved management of self-reported abnormal vaginal discharge by women in rural north India.

背景：我们建议进行一项早期研究，以开发一种干预措施，以解决自我报告的“异常阴道分泌物”(AVD)的公共卫生问题，这是一种在世界范围内特别是在南亚高度流行的综合征。AVD是一个公共卫生问题，因为它可能预示着淋病、衣原体或滴虫病等性传播感染，或细菌性阴道病或念珠菌等内源性生殖道感染。世界卫生组织倡导对AVD使用症状管理指南(在症状指南中称为阴道排泄综合征)，该指南遵循循序渐进的方法，在实验室设施不可用的低资源环境中检测和管理感染。然而，现在公认的是，综合症方法不能很好地预测感染，特别是性传播的感染，而且流程图导致大量过度使用抗生素。此外，在南亚，与AVD的投诉有关的文化和心理社会因素错综复杂。这可能与阿育吠陀关于体液重要性的传统信仰有关。AVD指的是由于各种生理和心理原因造成的重要体液损失，如虚弱、担忧、“骨头融化”和“性乱”，印度、孟加拉国和斯里兰卡的女性在不同的研究中表达了这一观点。印度和巴基斯坦的研究发现，AVD与精神健康问题(大多是轻微和中度的)之间存在很强的关联，这可能与女性经历的压力、社会冲突、性别劣势、贫困和婚姻不和有关。事实上，有人认为AVD是南亚女性痛苦的文化习语，在那里寻求心理健康护理是一种耻辱。AVD是印度、孟加拉国、尼泊尔和斯里兰卡妇女常见的生殖疾病，据报道，印度总人口中高达30%的妇女和孟加拉国近50%的孕妇报告了AVD。随着(A)细菌性阴道病、念珠菌和滴虫病的快速诊断或护理点检测的出现，(B)初级保健环境中经过验证的精神健康筛查工具，以及(C)精神健康分级护理模式被证明是成功的(在这种模式下，训练有素的非专业卫生工作者为患有轻度精神健康问题的患者提供基本水平的心理社会咨询，医生和专家管理严重病例)，南亚AVD的管理需要变革。我们在这项研究中的目的是开发一种干预措施，将这三个要素(连同被评估为有性风险的人的衣原体和淋病的分子检测)整合到一种新的风险评估工具或方案中，并在未来的试验中将这一修订后的工具与综合征处理进行比较。方法：采用定性研究的方法，探讨社区妇女和卫生工作者对AVD的认知和目前的做法。将与卫生系统中的其他利益攸关方进行面谈，包括医务人员、妇女健康专家、精神健康专家和实验室工作人员，以了解卫生系统在实施实验室和病人管理程序方面的需求。我们将与一小群选定的当地专家和卫生部门工作人员密切合作，制定修订后的评估工具，并与20名卫生工作者(通过与妇女和卫生部门工作人员协商确定)和40名患有AVD的妇女实施这一工具，这些妇女将在3个月和6个月时接受跟踪。将对他们的结果(自我报告的AVD、感染和精神健康)进行分析，并使用利益相关者访谈进行最终过程评估，从而形成试点干预计划的大纲。

Background: We propose an early phase study to develop an intervention to address the public health issue of self-reported 'abnormal vaginal discharge'(AVD), a highly prevalent syndrome worldwide and in South Asia in particular. AVD is a public health concern as it may signal a sexually transmitted infection like gonorrhoea, chlamydia or trichomoniasis, or an endogenous reproductive tract infection like bacterial vaginosis or candida. The World Health organization has advocated use of syndromic management guidelines for AVD (referred to as vaginal discharge syndrome in the syndromic guidelines) which follows a stepwise approach to detect and manage infections in low resource settings where laboratory facilities are unavailable. However it is now accepted that the syndromic approach is a poor predictor of infections, especially the sexually transmitted ones and the flowcharts lead to considerable over treatment with antibiotics. Moreover in South Asia, there are complex cultural and psychosocial factors associated with the complaint of an AVD. It may be linked with traditional Ayurvedic beliefs about the importance of bodily fluids. AVD signifies the loss of vital bodily fluids resulting from various physical and psychosocial causes like weakness, worry, 'melting of bones' and 'sexual promiscuity', as expressed by women in different studies in India, Bangladesh and Sri Lanka. Studies in India and Pakistan have found strong associations between AVD and mental health problems (mostly mild and moderate ones) that could be linked with stress, social conflicts, gender disadvantage, poverty and marital discord that women experience. In fact it has been suggested that AVD is a cultural idiom of distress among women in S.Asia where seeking care for mental health is stigmatised. AVD is a common reproductive complaint of women in India, Bangladesh, Nepal and Sri Lanka, reported by up to 30% women in the general population in India and nearly 50% of pregnant women in Bangladesh. So its management should be a healthcare priority in these settings.With the availability of (a) Rapid Diagnostics or Point of Care tests for bacterial vaginosis, candida and trichomoniasis, (b) validated tools for mental health screening in primary care setting and (c) proven success of a stepped care model of mental healthcare (in which trained lay health workers provide a basic level of psychosocial counselling to patients with mild mental health problems and doctors and specialists manage the severe cases), the management of AVD in S. Asia calls for a transformation. Our aim in this study is to develop an intervention that integrates these three elements (together with molecular testing for chlamydia and gonorrhoea for those assessed to be at sexual risk) in a novel risk assessment tool or protocol and compare this revised tool with syndromic management in a future trial. Methods: Using qualitative research methods we will explore AVD perceptions and current practices amongst women in the community and health workers who are most sought by them for AVD. Interviews with other stakeholders in the health system including medical officers, women's health specialists, mental health experts and laboratory staff will be conducted to understand health system needs with respect to operationalising the laboratory and patient management procedures. Working closely with a small group of selected local experts and health department staff, we will develop the revised assessment tool and implement this with 20 health workers (identified through consultations with women and health department staff) and 40 women presenting with an AVD, who will be followed up at 3 and 6 months. Their outcomes (self-reported AVD, infections and mental health) will be analysed and a final process evaluation using stakeholder interviews will lead to an outline of a plan for piloting the intervention.