Title: Menopause in women living with HIV in the UK: the Menopoz Study
Funder: Department of Health and Social Care

Abstract: We propose the first large-scale study in the UK on HIV and the menopause. We aim to explore the impact of the menopause on HIV-positive women's wellbeing and engagement with HIV care. The primary objectives are to: (1) estimate the prevalence of menopause (stratified by age) and menopausal symptoms in HIV-positive women, (2) explore the association between menopausal status and symptoms, and: mental health, sexual functioning, quality of life, antiretroviral adherence, attendance for HIV care, and condom use, and (3) explore the mechanisms by which the menopause may impact upon engagement with HIV care and wellbeing in women living with HIV. This mixed-methods observational study, combining quantitative and qualitative approaches, will recruit 1500 HIV-positive women aged 40-56 years of age from 8 NHS clinics in England. We aim to recruit 500 HIV-positive premenopausal women (Group 1) and 1000 menopausal women (Group 2, comprising both peri and postmenopausal women).We will administer questionnaires to all participants and obtain consent to extract data from clinical databases. Where possible, standardised and validated questions will be used. Information will be collected on demographics, socio-economic status, menstrual history, quality of life, sexual functioning, mental health, antiretroviral adherence, attendance for HIV care, use of condoms and current and historical laboratory markers. The questionnaire development will be informed by focus group discussions with women living with HIV and interviews with key stakeholders.A subgroup study will be undertaken of the women in the premenopausal group (Group 1). Consent will be sought from these women to obtain data through questionnaires, including information on menopausal status and symptoms, at 18 months. Approximately 20-30 semi-structured interviews, depending on data saturation, will be conducted with peri- and post-menopausal women living with HIV who participated in the baseline questionnaire study. Areas of interest that emerge from preliminary analysis of the quantitative data will be explored in detail through qualitative interviews. Other key themes will include sources of support, and the interpretation and management of menopausal symptoms. Consent at baseline will be sought from all participants to prospectively collect clinical data and to contact for further interviews should this be required.The design and interpretation of the Menopoz questionnaire study will be informed by preliminary analyses of data collected for the POPPY study. This prospective, observational study, sponsored by Imperial College London, seeks to examine the effects of ageing on clinical outcomes of people living with HIV in England and Ireland. I will conduct an analysis of data on approximately 250 HIV-positive women and 100 HIV-negative women, all aged 50 and over. The objectives will be to explore the association between HIV-seropositivity (i) menopausal status, and (ii) age at menopause. The association between menopausal status and: (i) quality of life, and (ii) antiretroviral adherence, will also be examined in the HIV-positive group.The Menopoz study will quantify, for the first time in the UK, the prevalence of menopause (by age) and menopausal symptoms in HIV-positive women living in the UK. Furthermore, it will enable us to explore the association between menopausal status and symptoms, and engagement with HIV care and wellbeing in this group. It will allow us to identify unmet clinical need amongst this growing population of women and will inform the development of national guidelines for the care of HIV-positive women transitioning through menopause, an area that has been overlooked in current national standards for the care of people living with HIV. We hope that this study will inform the provision of appropriate services to this population in terms of symptom management and support in maintaining health-sustaining behaviours.

Lay abstract: We aim to explore the impact of the menopause on HIV-positive women's wellbeing (e.g. sexual functioning and quality of life) and engagement with HIV care (e.g. use of HIV medication and HIV clinic attendance) in the UK. This study of 1500 HIV-positive women recruited from NHS clinics will combine quantitative and qualitative methods. We will administer questionnaires to participants, collect data from clinic databases, and conduct in-depth interviews with a proportion of participants. We will seek permission to follow-up participants. This work will identify unmet clinical need and address important public health questions, informing the care of this growing population.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: INFECTION