Engaging communities with clinical trials in Malawi.

Community Meetings.

Community meetings are publicly held forums, allowing anyone who is a member of a local group or a resident to participate. Before conducting community meetings, one must seek gatekeepers’ consent from community leaders such as chiefs, relevant village committees, or religious leaders to discuss the trial. This is an opportunity to seek approval to conduct the meeting, enquire about context appropriate approaches to reach a wider audience, followed by discussions of convenient date, time, and venue about the intended meeting.

At Malawi Liverpool Wellcome Research Programme (MLW) we conduct community meetings prior to any community-based study to ensure that communities make informed decisions. In one randomized control trial aimed to understand how Pneumococcus is transmitted across individuals within households, we conducted community meetings in a rural setting to inform the community about the study, have two-way dialogue between the research team and community, discuss their concerns and solicit feedback. A mobile public address system was used a day before to mobilize the community members to attend the meeting. In addition, a women’s group named “mother care group” helped in spreading awareness about the meeting. During the meeting, music, traditional dances and drama were used to share information about medical research in general and the trial objectives. Community members were given the opportunity to ask questions and seek clarity about the trial. This promoted transparency, cleared misconceptions of research and ensured that majority of residents are well informed about the trial prior to recruitment and informed consenting process.

Radio.

Radio broadcasts provide real-time and up-to date information to the public. Radio has the ability to reach across borders and is a valuable source of information where reliable news is scarce and literacy levels are low. It provides an outlet for regular community messaging and activities such as local sports, community events, special events, local business advertising, health issues etc.

In research, radio is a potent tool for raising community understanding of the trial in addition to other methodologies. As one way of increasing access to information regarding clinical research and health related issues in the country, Malawi Liverpool Wellcome Research Programme (MLW) introduced a radio program titled Umoyo Nkukambirana which is broadcasted live on Times radio, MBC, and three community radio stations. Umoyo Nkukambirana is an interactive radio program between researchers, clinicians and the public. It tackles several issues ranging from upcoming or ongoing research projects, clears misconceptions about clinical trials, ethical issues and general health issues. One of the studies that was featured on this program involved Controlled Human Infection Model (CHIM) which involves introducing a pathogen to healthy volunteers to study the disease process and immune responses. CHIM study experts were featured in the program where they shared how they developed a pneumococcal CHIM to study the pneumococcus bacterium and how the study is being conducted. Listeners were able to call in live, ask questions about the trial and get their responses.

In addition, MLW recruited and trained nine Umoyo N’kukambirana Radio Listening Clubs in drama messaging. The training exercise aimed at upscaling the capacity of the radio listening clubs in drama scripting and performance, especially on issues of health and research. The radio listening clubs are involved in content creation for part of the program, including the development of radio plays in addition to giving feedback about each programme. The involvement of the listening clubs enhances community participation in co-creating key messages broadcasted within the program.

Consultative meeting pre-trial.

A consultative meeting is a meeting where relevant stakeholders gather to discuss their views of upcoming research, identify any ethical or practical concerns and ensure that these are addressed before study implementation.

In research, consultative meetings can be held with different stakeholder groups, especially from areas where a particular trial will take place. These can include chiefs, health care workers, village committee members, religious leaders, youth leaders, marginalized groups and people with lived experiences. These meetings are used to discuss the trial before it is actually implemented and community feedback is supposed to inform the research design and delivery. Consultative meetings can also be used to discuss trial information materials and informed consent forms to ensure that they are relevant to the context and understood by the target audience.

At MLW, we used consultative meetings in a phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Before the trial began, a consultative meeting was conducted with urban and rural community members. Key stakeholders drawn from diverse community groups including: Community leaders (Village chiefs/block leaders), religious leaders, community health workers, youths/adolescents, parents (fathers & mothers), carers for patients attended the participatory workshops.

A presentation of the trial including: objectives, methodology, sample size, target audience, locations, duration, risks and benefits was made. After the presentation, participants were divided into 4 smaller groups to present their views about the research. They were also asked to present a summary of the project’s description in their own words, list all the ethical and practical concerns and questions that they may have on the project.