Patient and Public Involvement (PPI)
In line with the MRC CTU Patient and Public Involvement policy and the UNAIDS/AVAC Good Participatory Practice Guidelines, the PROUD pilot study team use a number of mechanisms to promote effective and appropriate engagement in the research project.
Participant Involvement (PI): Through the Participant Involvement mechanism, we will host meetings or discussion forums throughout the course of the study, actively involving participants in the research process. Participants are informed of meetings and discussion forums via the study team, advertisments in the clinics, or the website where participants complete study questionnaires. Participants are invited to join Participant Involvement meetings or on-line discussion forums at their discretion. In this way, we hope to encourage men to participate in discussions on topics that are of particularly interested to them. During the PROUD pilot study, we aim to involve participants in advising on the conduct of the pilot study but also on the design of the future clinical trial. The types of topics we envisage participants being involved with include:
- Assessing and improving study procedures, recruitment and retention strategies
- Assessing and improving public involvement and communication plans
- Development of plans for result dissemination and post-study access to study product
- Development of the trial protocol, including questionnaires, participant information sheets and consent forms
Below is a list of the participant involvement meetings held to date:
12th November 2013: ‘Future Options for PROUD’
19th March 2014: 'Future HIV prevention research priorities'
9th & 11th September 2014: ‘Study design and data collection tools for a larger PROUD trial’
16th and 18th February 2015: ‘PROUD Study Results’
18th & 25th June 2015: ‘World
Health Organisation PrEP Implementation Guidelines’
For more information about the Participant Involvement meetings please contact Mitzy Gafos at email@example.com.
Study participants can find out about upcoming Participant Involvement meetings by logging into their online diary homepage. Meeting dates will be listed below the links where you select your online diary and online questionnaire. Participants can suggest topics for discussion or register for meetings by emailing Mitzy Gafos at firstname.lastname@example.org.
Community Engagement Group (CEG): The CEG meet approximately twice per year. The group is chaired by a member of the Trial Management Group (Dr Alan McOwan) and includes independent members representing the UK’s leading HIV charities. The role of the CEG is to advise the trial team on community engagement activities, including recruitment materials, communication and media activities.
|Gus Cairns – NAM
||Alan McOwan - chair|
|Yusef Azad – National AIDS Trust (NAT)
|Rob Cookson – Lesbian and Gay Foundation (LGF)
|Tom Doyle – MESMAC
|Cary James – Terrence Higgins Trust (THT)
|Justin Harbottle - Terrence Higgins Trust (THT)
|Roger Pebody - NAM
|Matthew Hodson – GMFA
Marion Wadibia – NAZ
For more information about the CEG please contact the PROUD study team at email@example.com
Community Meetings: Through the CEG, we host additional community meetings to address specific questions as they arise. The meetings, discussion topics and outcomes are listed below:
In June 2013 we facilitated a meeting with representatives from the UK’s leading HIV charities, gay media and dating websites to discuss ways to improve public awareness of PrEP in the UK. This meeting resulted in the the UK’s leading HIV charities releasing a joint statement outlining their position on Pre-Exposure Prophylaxis (PrEP) – available at http://www.proud.mrc.ac.uk/news.aspx. It also resulted in a number of media articles about PrEP including an article entitled “PrEP: A new pill in the fight against HIV” in QX magazine, and an article entitled “PrEP Gets Real?” in Baseline, as well as a series of awareness messages by THT on GRINDR .
In September 2014 we co-hosted a public meeting with THT which was facilitated by Jim Picket from International Rectal Microbicide Advocates (IRMA) entitled ‘The bottom line on HIV prevention’ to discuss the role of rectal microbicides and oral PrEP in HIV prevention. The meeting slides and report are available here.
Trial Steering Committee (TSC): The TSC meet approximatley twice per year. In addition to members of the Trial Management Group, the TSC includes independent members, including the joint Chairs who represent community (Gus Cairns) and clinical (Prof Mike Adler) perspectives. Gilead Sciences have an observational role on the TSC. The role of the TSC is to provide overall supervision for the pilot and provide advice to the MRC CTU through the independent Chairs. The ultimate decision regarding the feasibility of the trial, lies with the TSC. Further details about the TSC are available in the PROUD study protocol available at: http://www.proud.mrc.ac.uk/study_protocol.aspx
|Mr Gus Cairns – co-chair
||Prof Sheena McCormack|
|Prof Mike Adler – co-chair
||Prof Brian Gazzard|
|Dr Dan Clutterbuck
||Prof Noel Gill|
|Mr Rob Cookson
||Prof Anne Johnson|
|Dr Claire Foreman
||Prof Andrew Phillips|
|Mr Stephen Nicholson
|Dr Tariq Sadiq
|Mr Matt Williams
For more information about the TSC please contact the PROUD study team at firstname.lastname@example.org.