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

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Public Health and Policy

Abstract

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.

Technical Summary

This project will identify the behavioural and biological risk factors for genital inflammation by conducting a longitudinal, mixed-method study with women at high risk of HIV infection, bringing together the violence/mental health and molecular biology/immunology fields of research. Genital inflammation is causally associated with HIV acquisition but the cause of genital inflammation is often unclear; behavioural risk factors have not been investigated. There are physiological and immunological reasons to suggest that violence experience and heavy alcohol use could increase HIV acquisition risk by increasing genital inflammation, potentially through a mental health pathway, but there have been no epidemiological studies to investigate this. We need to know (i) what the behavioural and biological risk factors for genital inflammation are and the pathways between these risk factors; (ii) if genital inflammation changes over time, according to exposure to and treatment of these risk factors; and (iii) the prevalence, severity and frequency of women's experience of violence, mental health morbidity and genital inflammation. This proposal will bring together different fields of analysis to answer these research questions. The proposed project will conduct a longitudinal, mixed-method study with 750 women at high risk of HIV infection in Kamapala, Uganda and examine all known and potential risk factors for genital inflammation, as well as potential confounders. Longitudinal qualitative research conducted with 25 women at two time-points, will be used to inform the conceptual pathway and the epidemiological analyses. The study findings will be used to design interventions to address women's multiple needs. This may include, for example, targeted clinical (e.g. anti-inflammatories; HIV Pre-exposure Prophylaxis (PreP)), behavioural (e.g. alcohol prevention) and empowerment (e.g. violence prevention) components, to complement existing HIV services.

Planned Impact

This project will:
1. identify the behavioural and biological risk factors for genital inflammation among a population at high risk of HIV infection;
2. establish the prevalence, severity and frequency of violence exposure, mental health morbidity and genital inflammation in this cohort;
3. explore women's perceptions and experiences of violence and mental health morbidity and how these inter-relate with alcohol and substance use and sexual risk behaviours;
4. examine the epidemiology of genital inflammation over time.

Women and girls in SSA. The population most likely to benefit from our research are women and girls at high risk of violence and HIV infection in the GHWP cohort and elsewhere in SSA and other LMIC. This will be the first study to have examined violence prevalence, severity and frequency, mental health morbidity and genital inflammation in this cohort. Research which understands the overall violence landscape that women might be encountering and how this relates to mental health and HIV risk can contribute to advocacy and the development of prevention packages and technologies which help protect women from these multiple harms. The study findings will used to inform the design of interventions to address women's multiple needs. This may include, for example, targeted clinical (e.g. anti-inflammatory, PreP), behavioural (e.g. alcohol prevention) and empowerment (e.g. violence prevention) components, to complement existing HIV services. Understanding if behavioural factors (such as violence and alcohol use) increase HIV risk by increasing genital inflammation is important for women and girls at high risk of violence and HIV elsewhere in SSA and other LMIC.

Clinical and programme staff. The findings from this study will also be useful for clinical staff working in violence, mental health and sexual health settings to understand how these factors inter-relate to increase risk of HIV infection. This could help them identify those most in need of violence, alcohol and mental health referral services and HIV prevention technologies such as HIV Pre-Exposure Prophylaxis.

HIV prevention programmers. Understanding the epidemiology of HIV transmission is crucial for designing effective programmes. If women who are at risk of violence or problem drinking are at increased risk of genital inflammation and therefore HIV infection, this research will provide evidence for the importance of addressing violence and alcohol use, and treating mental health morbidity in settings where this is not standard, such as sex worker communities in many LMIC. As HIV prevention technologies become increasingly available in the form of pre- and post-exposure prophylaxis, this research could also help identify women who would especially benefit from these drugs.
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Biotechnologists. Findings from this study will inform researchers from the HIV prevention fields to aid in the development of new technologies to prevent genital inflammation and HIV transmission, suitable for women experiencing ongoing domestic or workplace violence, problem drinking and associated mental health morbidity. This could include for example easily administered, discreet HIV prophylaxis or drugs to reduce genital inflammation.

Policy makers. Understanding the epidemiology of HIV transmission is crucial for designing effective policies. Findings will be of use to policy makers working in the violence prevention, mental health and HIV fields. These fields are often covered under different departments. Understanding how they are inter-related can help policy makers fund prevention programmes, using money from multiple sectors. For example, violence, mental health and HIV span 5 of the 17 sustainable development goals (health, women, inequality, habitation, and institutions).

Publications

10 25 50
 
Title Maisha Fiti short film 
Description As part of the MRC Festival of Medical Research, we made a short 9 minute film with female sex workers in Nairobi. This was screened as part of the MRC MRC Festival of Medical Research in Nairobi and in London in June 2019 to stakeholders, academics and policy makers. The film was uploaded onto youtube and the link made public. The film was screened at the Global Health Film Festival in London in December 2019 to the general public and to academics, policy makers and community members at the University of Nairobi HIV/STI International Conference in Nairobi in January 2020. It has also been shown to post-graduate students at the London School of Hygiene and Tropical Medicine as part of lectures on violence, HIV and sex work. At each film showing the film has sparked a lot of interest and debate around violence and sex work, including from a human rights perspective. The film has been submitted to the World Health Organisation short film festival and to the International AIDS conference and we are waiting to hear outcomes. 
Type Of Art Film/Video/Animation 
Year Produced 2019 
Impact Raised awareness of violence as a common and human rights issue for sex workers, and sparked debate amongst academics, policymakers, students and the general public. Currently being used to fundraise for programmatic funds with potential donors in Canada. Provided a voice for the two sex workers featured in the film, and experience in presenting at an international conference in Nairobi. 
URL https://www.youtube.com/watch?v=KtSvK_4QIlk
 
Description Conducting research on violence and mental health: Lessons learned from the Maisha Fiti study
Geographic Reach Africa 
Policy Influence Type Influenced training of practitioners or researchers
Impact Conducting violence and mental health research with marginilised populations such as sex workers requires careful thought to help ensure that participation causes no harm to either participants or the research team. The Maisha Fiti study team comprises clinicians, a psychologist, research assistants and community members (sex workers), none of who had worked on violence or mental health research. We developed training and study procedures to protect and support study participants and researchers .These included re-configuring the study clinic to be a welcoming and nurturing space for study participants and weekly de-brief meetings for study staff to help protect from trauma transference and study burnout. These practices were novel for the study team, and will likely be taken forward into future studies.
 
Description Kenya National AIDS & STI Control Programme - mental health interventions for key populations
Geographic Reach Africa 
Policy Influence Type Gave evidence to a government review
Impact Following the meeting with NASCOP in April 2019 and advocating for mental health interventions for key populations in Kenya, NASCOP developed the first mental health guidelines for key populations in Kenya.
 
Description Impact of violence, alcohol / substance use, and mental health impact on antiretroviral (ARV) uptake and adherence, emergence of ARV drug resistance, and HIV disease progression among female sex workers in Nairobi, Kenya
Amount £125,000 (GBP)
Organisation The Commonwealth Fund 
Sector Charity/Non Profit
Country United States
Start 10/2020 
End 09/2023
 
Description Maisha Fiti Short Film - MRC Festival of Medical Research
Amount £12,540 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 03/2019 
End 09/2019
 
Description Maisha Fiti Team, Kenya 
Organisation Partners for Health and Development in Africa
Country Kenya 
Sector Charity/Non Profit 
PI Contribution Expertise in conducting research on mental health, including alcohol and substance use and in violence research, as well as in working with vulnerable populations. Expertise in study design and quantitative and qualitative survey tools and data collection. Training of staff, including study team staff training and capacity building of early career researchers. Development of data analysis plans, data analysis, and drafting of academic manuscripts. Public engagement expertise including common branding for presentations, research brief development, creation of a short film with sex workers in Nairobi.
Collaborator Contribution Intellectual input and experience on sex work in this context; training of staff including study team training on violence against women; expertise on conducting research with vulnerable populations; data management and storage; laboratory expertise for conducting biological tests for STIs and schistosomiasis. Stakeholder engagement with end-users and with policy makers at the technical support unit, Ministry of Health.
Impact This collaboration is multi-disciplinary and involves immunology, quantitative epidemiology and social science. Maisha Fiti research brief Engagement with policy makers and drafting of a new mental health policy for key populations in Kenya Presentation of preliminary study findings at the University of Nairobi International HIV/STI conference in January 2019 and in January 2020 Short film for MRC Festival of Science (2019) New grant development on mental health interventions for female sex workers
Start Year 2018
 
Description Maisha Fiti Team, Toronto 
Organisation University of Toronto
Country Canada 
Sector Academic/University 
PI Contribution Expertise in conducting research on mental health, including alcohol and substance use and in violence research, as well as in working with vulnerable populations. Expertise in study design and quantitative and qualitative survey tools and data collection. Development of data analysis plans, data analysis, and drafting of academic manuscripts. Public engagement expertise including common branding for presentations, research brief development, creation of a short film with sex workers in Nairobi. Intellectual contribution to new PhD student based at University of Toronto.
Collaborator Contribution Expertise in working with vulnerable populations, including clinical and laboratory expertise in collecting and processing biological samples.
Impact This collaboration is multi-disciplinary and involves immunology, quantitative epidemiology and social science. Maisha Fiti research brief Presentation of preliminary study findings at the University of Nairobi International HIV/STI conference in January 2019 and in January 2020 Short film for MRC Festival of Science (2019)
Start Year 2018
 
Title Pilot intervention for sex workers with depression or alcohol use disorders 
Description We have piloted a low cost lay-counsellor delivered brief psychological intervention for sex workers in Nairobi with depression or alcohol use disorders. The pilot found the intervention to be feasible and acceptable to counsellors and clients. We are seeking funding to scale this up and evaluate this intervention in Nairobi. The interventions have been found to be effective through randomised control trials in India but haven't been used before in an African context or with sex workers. 
Type Therapeutic Intervention - Psychological/Behavioural
Current Stage Of Development Initial development
Year Development Stage Completed 2019
Development Status Actively seeking support
Impact The Kenyan Ministry of Health are interested in taking this intervention to scale with key populations across Kenya if the intervention is found to be feasible, acceptable and effective with sex workers in Nairobi. 
 
Description Community Engagement with Female Sex Workers in Nairobi 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Quarterly meeting with ~30 female sex workers to discuss the Maisha Fiti study, it's proposed design and implementation, and preliminary findings as they occur.
Year(s) Of Engagement Activity 2018,2019,2020
 
Description Maisha Fiti Research Brief 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact At the start of the study, we created a 4-page colourful research brief in lay-friendly language. The brief explained the scientific rationale behind the Maisha Fiti study and the key questions the study hopes to answer. This was distributed to community members, policy makers, and academics to support the information given in presentations.
Year(s) Of Engagement Activity 2019
 
Description Maisha Fiti Short Film 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact As part of the MRC Festival of Medical Research, we made a short 9 minute film with female sex workers in Nairobi. This was screened as part of the MRC MRC
Festival of Medical Research in Nairobi and in London in June 2019 to stakeholders, academics and policy makers. The film was uploaded onto youtube and the link made public. The film was screened at the Global Health Film Festival in London in December 2019 to the general public and to academics, policy makers and community members at the University of Nairobi HIV/STI International Conference in Nairobi in January 2020. It has also been shown to post-graduate students at the London School of Hygiene and Tropical Medicine as part of lectures on violence, HIV and sex work. At each film showing the film has sparked a lot of interest and debate around violence and sex work, including from a human rights perspective. The film has been submitted to the World Health Organisation short film festival and to the International AIDS conference and we are waiting to hear outcomes.
Year(s) Of Engagement Activity 2019,2020
URL https://www.youtube.com/watch?v=KtSvK_4QIlk
 
Description NASCOP - meeting with Kenya Ministry of Health on mental health interventions for key populations 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact In April 2019, the Maisha Fiti team presented to NASCOP (National AIDS & STI Control Programme) on the global evidence on the mental health of female sex workers in low and middle income countries and low-cost evidence based interventions. Following on from this meeting, NASCOP developed the first national guidelines for Kenya on mental health for key populations, which we commented on. They have since updated these guidelines to incorporate mental health prevalence estimates for Nairobi, generated as part of the Maisha Fiti study. We will present to them again in the future, when we have additional findings of interest.
Year(s) Of Engagement Activity 2019
 
Description University of Nairobi HIV/AIDS Collaborative Group Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact The University of Nairobi HIV/AIDS Collaborative Group Meeting is an annual conference in Nairobi, Kenya which attracts researchers from across Kenya as well as international academics from Europe, USA and Canada, who are working in Kenya. In January 2019, we presented the Maisha Fiti study. In January 2020, the Maisha Fiti team gave 6 presentations on violence and mental health preliminary quantitative and qualitative research findings, as well as the short film.
Year(s) Of Engagement Activity 2019,2020
URL https://www.stihivresearch-kenya.org/