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

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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.