PRIME (Positive Transitions Through the Menopause) Study: a protocol for a mixed-methods study investigating the impact of the menopause on the health and well-being of women living with HIV in England.

Introduction: Advances in antiretroviral therapy have transformed HIV into a long-term condition with near-normal life expectancy for those in whom viral replication is well controlled on treatment. This means that age-related events, including menopause, is of increasing importance in the care of people living with HIV. The PRIME (Positive Transitions Through the Menopause) Study aims to explore the impact of the menopause on the health and well-being of women living with HIV (WLHIV).
Methods and Analysis: The PRIME Study is a multicentre, mixed-methods observational study deploying a multiphase sequential design with explanatory and exploratory phases. Phase 1 comprised three focus group discussions with WLHIV. In phase 2 we aimed to administer questionnaires comprising detailed assessment of menopausal status and symptoms to 1500 WLHIV aged 45-60 attending HIV clinics in England. Phase 3 comprised semistructured interviews with a subsample of phase 2 participants. Ongoing quantitative follow-up of 100 participants is planned between October 2018 and September 2019. Qualitative and quantitative data will be kept analytically distinct and analysed using appropriate methods. We will integrate quantitative and qualitative findings using coding matrices.
Ethics and Dissemination: The PRIME Study has ethical approval from the South East Coast-Surrey Research Ethics Committee on behalf of all National Health Service (NHS) sites, and approval from University College London Research Ethics Committee for qualitative work conducted in non-NHS sites. In conjunction with the study Expert Advisory Group (which includes WLHIV), we have drafted a dissemination strategy that takes into account a wide range of stakeholders, including patients, policy makers and healthcare providers. This includes at least five empirical research papers to be submitted to peer-reviewed journals, as well as an accessible report aimed primarily at a non-technical audience (published in May 2018 and launched at a live-streamed event). Both quantitative and qualitative data are held by the PRIME Study team and are available by request.
Competing Interests: Competing interests: ST has previously received a travel bursary funded by Janssen-Cilag through the British HIV Association, and speaker honoraria and funding for preparation of educational materials from Gilead Sciences. ST, FMB and CS are members of the steering group of SWIFT, a networking group for people involved in research in HIV and women, funded by Bristol-Myers Squibb. CS has received funding for membership in Data Safety and Monitoring Boards, Advisory Boards, speaker panels and for preparation of educational materials from Gilead Sciences, ViiV Healthcare and Janssen-Cilag. FMB has received consultancy fees and conference support from Gilead Sciences.
(© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)