Risk factors for genital inflammation among women at high risk of HIV in Uganda: a mixed-method, longitudinal analysis

在全球范围内，艾滋病毒/艾滋病仍然是一个巨大的问题，有3700万人感染了艾滋病毒/艾滋病。其中三分之二生活在撒哈拉以南非洲，那里的妇女和女孩比男子和男孩更容易受到感染。最近的研究表明，在生殖道（阴道和子宫颈）有炎症的妇女比没有炎症的妇女更容易感染艾滋病毒。然而，我们还不明白为什么有些女性有这种炎症，而有些女性没有。到目前为止，艾滋病毒的研究主要集中在生殖道生理学和免疫学上，但最近的研究表明，遭受暴力或大量饮酒可能会增加生殖器炎症。这项研究将把这些领域的研究结合起来。它会问：生殖器炎症的生理原因是什么？哪些行为会让我们处于危险之中？为了回答这些问题，我们将对艾滋病毒感染高风险的乌干达妇女进行一项研究，这些妇女已经参加了一项名为“妇女健康项目”（GHWP）的长期队列研究。这些妇女中约有一半在过去六个月内遭受过身体或性暴力，约有一半是酗酒者，约有45%是艾滋病毒携带者。这个研究项目将持续三年。我们将从2018年10月开始招募首批750名未感染艾滋病毒的妇女，她们来到诊所并同意参加这项研究。女性在参加研究时（基线）将完成一项行为生物学调查，并在6-12个月后的随访中再次进行调查。我们将要求其中25名女性参加两次定性访谈，分别在接近基线和6-12个月后进行。全球健康计划目前要求队列中的妇女每次访问诊所时填写一份问卷，内容包括她们的年龄、收入、居住地、性行为、近期饮酒和吸毒情况以及激素避孕的使用情况。在我们的研究中，我们会问一些额外的问题：他们是否经历过身体暴力、性暴力或情感暴力？施暴者是谁？他们是否有精神疾病的症状（如抑郁、焦虑或创伤后应激障碍）？他们想自杀吗？她们的阴道清洗和清洁方法是什么？研究小组将提供专门的咨询服务，并在每次面谈时提供转介服务。在每次就诊时，我们已经为有症状的妇女提供快速艾滋病毒检测和其他感染检测。此外，在两次研究访问中，我们将要求妇女提供一管血液（用于检测HSV-2、梅毒和血液中的炎症）、一份尿液样本（用于检测血吸虫病感染）和4份生殖器拭子（用于检测淋病、衣原体、阴道毛滴虫和细菌性阴道炎）。我们还会要求女性戴上月经杯（类似于隔膜）两分钟，收集生殖器液体，我们将用它来检测生殖器炎症。当我们收集了所有的数据后，我们将使用统计分析来回答以下问题：1。哪些行为和生物学因素会引起生殖器炎症？它们是如何引起的？2. 女性生殖器炎症是保持稳定还是随时间变化？在这个群体中，女性遭受暴力的情况是怎样的？他们经历过什么样的暴力，发生频率有多高，施暴者是谁？4. 有多少女性患有精神疾病？5. 有多少女性患有生殖器炎症？我们将利用研究结果设计干预措施，以满足妇女的多种需求。这些措施可包括临床（如消炎药）、行为（如预防酒精）和赋权（如预防暴力）等内容，以补充现有的艾滋病毒服务。

Globally, HIV/AIDS remains a huge problem, with 37 million people living with HIV/AIDS. Two-thirds of these live in sub-Saharan Africa, where women and girls are more likely to be infected than men and boys. Recent research shows that a woman who has inflammation in her reproductive tract (vagina and cervix) is more likely to acquire HIV infection than a woman without inflammation. However, we do not yet understand the reasons why some women have this inflammation, while others do not. So far, HIV research has focused on reproductive tract physiology and immunology, but recent studies suggest that experiencing violence or heavy alcohol use may increase genital inflammation. This study will bring together these fields of research. It will ask: What are the physical causes of genital inflammation? And which behaviours put us at risk? To answer these questions, we will conduct a study with Ugandan women at high risk of HIV infection who are already enrolled in a long-term cohort study called The Good Health for Women Project (GHWP). Approximately half of these women will have experienced physical or sexual violence in the previous six months, approximately half are problem drinkers, and approximately 45% are living with HIV. The research project will run for three years. We will enrol the first 750 HIV uninfected women who attend the clinic from October 2018 and who consent to participate in the study. Women will complete a behavioural-biological survey when they enrol in the study (baseline), and again at a follow-up visit, 6-12 months later. We will ask 25 of these women to also participate in two qualitative interviews, conducted close to baseline and 6-12 months later. The GHWP currently asks women in the cohort to complete a questionnaire each time they visit the clinic, about their age, income, where they live, sexual behaviour, recent alcohol and drug use, and hormonal contraception use. For our study, we will ask additional questions: Have they have ever experienced physical, sexual or emotional violence and who the perpetrator was? Do they have symptoms of a mental health illness (such as depression, anxiety or PTSD)? Are they feeling suicidal? What are their vaginal washing and cleaning practices? The research team will provide a dedicated counselling service and will offer referrals to the service at each interview. At each clinic visit, we already offer rapid HIV testing and testing for other infections for women who have symptoms. In addition, at the two study visits we will ask women to provide a tube of blood (to test for HSV-2, syphilis, and inflammation in the blood), a urine sample (to test for schistosomiasis infection) and 4 genital swabs (to test for gonorrhoea, chlamydia, trichomonas vaginalis and bacterial vaginalis). We will also ask women to wear a menstrual cup (like a diaphragm) for two minutes to collect genital fluid, which we will use to test for genital inflammation. When we have collected all the data, we will use statistical analyses to answer the following questions: 1. Which behavioural and biological factors cause genital inflammation and how do they cause it? 2. Does genital inflammation remain stable in women or does it change over time?3. What does the violence landscape look like for women in this population? What kind of violence do they experience, how frequently and who are the perpetrators? 4. How many women have a mental health illness? 5. How many women have genital inflammation?We will use the findings to design interventions to address women's multiple needs. These might include clinical (e.g. anti-inflammatories), behavioural (e.g. alcohol prevention) and empowerment (e.g. violence prevention) components, to complement existing HIV services.