Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your message, and disseminate results

Key messages are short statements that explain your study or address an issue related to your research. They are the main points you want people to remember. Effective key messages do not contain technical details or focus on complexities. They provide straightforward, clearly worded information that seeks to engage people and gets them interested in your work.

A good key message is:

• Concise—it uses accessible language
• Simple to say aloud
• Focused on one idea
• Easy for people to understand and remember
• Persuasive
• Nonjudgmental
• Relevant to the intended audience

This chapter will help your research team create, refine, and use key messages. It will be useful to all members of the research team who have a part in this process: researchers and their assistants, community liaison officers, community advisory board members, administrative staff, and others.

Your key messages provide the groundwork for your communications activities and the materials you’ll use throughout your study. If you invest the time and effort to develop effective key messages that address the needs of your audience, you will have built a strong foundation for the rest of your communications work.

IWhy key messages are important

Key messages provide a strong foundation for your communications work. During the course of your trial, you will probably develop several sets of key messages: some to provide basic information about your study, some to respond to specific issues or questions that arise, and some to help communicate and contextualize your findings.

Well-developed key messages facilitate interactions with the media, the public, and with stakeholders by:

• Helping you stay organized when speaking with the media or with stakeholders
• Providing you with the information you need to maintain your composure and professionalism in stressful situations
• Ensuring consistency and continuity of information, especially for studies with multiple sites or partners
• Improving the public’s understanding of your trial

Key messages help the study team convey consistent, accurate information. For example, a principal investigator preparing to speak with the department of health, a research associate writing an editorial for the local newspaper, or a community liaison officer giving an interview about study results could all consult the trial’s key messages. Key messages can help ensure that the study team communicates reliable information, no matter what situation is presented.

Key messages also provide a “frame” to help the listener interpret the information. In other words, your key messages should provide some context for the information you convey. A frame is an emphasis, an angle, or a broader context that provides a more complete understanding of the issue. As the examples below show, it is often helpful to frame a study in terms of the ultimate benefits it could provide.

Our study is testing whether doctors in remote regions can safely use a simpler, less-expensive blood test to monitor the well-being of patients who are taking potent anti-HIV drugs. If so, we could ensure that more people have access to these life-saving drugs.

In our vaccine study, fewer children in the group that received the oral vaccine for rotavirus became infected, compared to children who received the ”dummy” vaccine that contained no active ingredient. This is good news, as it shows the vaccine is effective in preventing diarrhea and saving children’s lives.

Microbicide trials help to save women’s lives in two ways: by advancing the search for new HIV prevention tools and by bringing needed health services to trial communities. Our trial provided women and their partners with state-of-the-art prevention services, including HIV testing, access to male and female condoms, supportive counseling, and quarterly screening and treatment for any sexually transmitted infections.

Back to Top

IIHow to develop key messages and supporting messages

You should consider developing your key messages with a group of people. The following steps outline one possible approach to developing key messages and supporting messages for your study.

Step 1. Decide what you need to communicate.

• Begin with the basics: Why are you doing the study? What do you hope to learn? Who could possibly benefit?
• Determine defining characteristics: How is this study unique? How does this study advance the larger public health issues?
• Brainstorm a list of probable questions and concerns from each of your target audiences.
• Discuss the answers to these questions.
• Prioritize the most important things to say.

Remember, all of the questions and answers that you come up with can generally find a home in one of your communications documents—your Q&A document, your study’s backgrounder, or the materials you prepare for the community. But the task of developing key messages is to choose the three most important messages that you want to communicate to each audience. People generally absorb only three key points in any single exchange—your job is to decide what those points should be.

Step 2. Write down the three or four most important points you want to convey.

• Write short sentences that summarize your main points.
• Use simple, jargon-free language.
• Use active rather than passive voice.

For example, a trial that is evaluating the safety and effectiveness of the drug tenofovir in women for use as pre-exposure prophylaxis (PrEP) might consider the following key, or “top-line,” messages:

Key message 1: We are conducting a research study to see if taking a pill every day can safely protect women against HIV infection.

Key message 2: This study is committed to safeguarding the well-being of all study participants and will strengthen HIV prevention and care services in the community.

Key message 3: If the pill proves safe and effective, it could provide women and couples a new way to prevent HIV infection that does not interrupt intimacy.

Step 3. Develop supporting messages for each key message. The next step is to develop a short list of supporting messages for each of your key messages.

Supporting messages provide the facts, examples, and simple explanations that reinforce your key messages. The supporting messages can also vary in detail and scientific sophistication, depending on the different audiences you wish to reach.

For the example described above, the supporting messages for a lay audience might read as follows:

Key message 1:

We are conducting a research study to see if taking a pill every day can safely protect women against HIV infection.

Supporting messages

• The pill, called oral tenofovir or TDF, is currently being used to treat people already infected with HIV.
• We know that the pill is safe to use and slows the progression of HIV in people already infected.
• We do not know if the pill can be taken regularly to help prevent HIV infection in people at high risk. This is why we are conducting this study.

Key message 2:

This study is committed to safeguarding the well-being of all study participants and will strengthen HIV prevention and care services in the community.

Supporting messages:

• The study has been reviewed and approved by our national ethics committee, regulatory bodies, and the Ministry of Health.
• An independent data and safety monitoring board (DSMB) will meet regularly to review the trial and monitor the well-being of participants.
• The study will provide all participants with high-quality health services, including HIV testing and risk-reduction counseling, family planning services, access to male and female condoms, and testing and treatment for sexually transmitted infections.
• Because of these services, women in the trial will likely have a reduced chance of becoming HIV positive compared with other women in the community. Despite access to counseling and free condoms, some women may not be able to negotiate condom use 100 percent of the time and will become infected during the trial. That is why it is so critical to continue research to find effective HIV prevention methods that women can use.
• We are working closely with the local antiretroviral (ARV) clinic to set up a referral system and help strengthen its services both for women in our trial and for the wider community.

Key message 3:

If the pill proves safe and effective, it could provide women and couples a new way to prevent HIV infection that does not interrupt intimacy.

Supporting messages:

• Although condom uptake has risen dramatically among casual sex partners, a majority of couples in long-term relationships report that condoms interfere with intimacy. A once-a-day pill would overcome this obstacle.
• Currently less than half of all couples in this community report having used a condom the last time they had sex, even though almost one in three people are infected with HIV. People need more options to help them avoid infection.

Tip

Informed consent materials reviewed by your institutional review board (IRB) may be good sources of well-developed, simple messages appropriate for other lay audiences, such as community leaders or local radio stations.

Step 4. Tailor your key messages and supporting messages to different groups of stakeholders. The best communicators adapt their style of communication, their language, and their supporting arguments for each target audience. When adapting your supporting messages for different audiences:

• Consider what information is potentially most useful or compelling to different groups. For example, emphasize the “big picture” when addressing lay audiences, and the implications for policy when addressing policymakers.
• Try to use locally relevant analogies (such as sports if you are talking with men’s groups or farming if you are in a rural community) to help explain your point. This can help people relate to your research by drawing on familiar experiences.
• Be sure to adapt your language and the level of detail provided to suit your audience’s needs.

For example, in the PrEP trial described above, you might choose to provide more technical detail in your supporting messages when communicating with a scientifically sophisticated audience.

A re-worked version for message 1 for a scientific audience might read:

Re-worked key message 1:

We are conducting a study to test the safety and effectiveness of oral tenofovir, taken once a day, to prevent HIV infection.

Re-worked supporting messages:

• The concept of using therapeutic agents as a prophylactic (known as pre-exposure prophylaxis, or PrEP) has proven effective with other infectious diseases such as malaria.
  • Several studies suggest that the use of antiretrovirals (ARVs) before exposure to HIV may prevent HIV infection.
  • A single dose of the ARV drug nevirapine—given to the mother during labor and given to her newborn after birth—cuts the HIV infection rate by 50 percent.
  • Giving tenofovir to a monkey just before and just after exposure to simian immune virus (SIV) can prevent an infection.
• Tenofovir’s excellent safety and resistance profile, along with convenient dosing, make it an ideal candidate for PrEP.

If you are talking to policymakers, you might emphasize a slightly different set of messages, focusing less on the potential benefits of tenofovir for individuals and more on its potential role and impact in a national HIV prevention program.

A re-worked version of key message 3 for a policy audience might read:

Re-worked key message 3:

If the pill proves safe and effective, it could provide a new way to prevent HIV infections and reduce the incidence of HIV.

Re-worked supporting messages:

• One in every three adults in our country is infected with HIV.
• Despite national prevention programs, thousands of people is infected with HIV in our country every year.
• New HIV prevention approaches that can be used and controlled by women (and also used by men) are urgently needed.
• Use of tenofovir could provide an important new prevention strategy for our national HIV prevention program.

One excellent resource for evidence-based health information tailored for different audiences is http://www.cdc.gov/DiseasesConditions/, the U.S. Centers for Disease Control and Prevention (CDC) Web site. The site provides information in a question and answer format for a variety of users: health professionals, researchers, parents, travelers, and others. The CDC Web site is a good place to glean information for supporting messages and to see how information can be adapted for different groups. The British Medical Journal (BMJ) also publishes excellent key messages alongside clinical papers, helping journal readers absorb what is new and what is
important about study results. Box 7.1 provides examples of messages and supporting information that have been adapted for different audiences.

Box 7.1

Sample messages adapted for patients and providers

Step 5. Consider organizing your messages graphically. It can be useful to organize your messages graphically in a table or a message grid (a matrix-like arrangement of messages on a page). Graphic treatments can guide the user through the logic of the messages and provide a one-page, easy reference that he or she can review before talking to a stakeholder or the media. The grids themselves are not shared with people outside of the trial.

One way to organize your messages is to present them hierarchically as in the message grid below (see Figure 7.1). In this example—developed to explain the results of an HIV vaccine trial in Thailand—the overall topic of the message grid is described in the first box and the two key messages are summarized directly below it. There are two supporting messages for each key message.

Figure 7.1 Sample grid of key messages

A similar way to summarize your messages is to use a table with an introductory top-line message with four key messages underneath, as shown in Figure 7.2. (See Appendix 7.3 for a completed copy of this type of message grid or download the template.) An alternative type of grid—organized with sections for connecting with your audience, overcoming barriers, encouraging your audience to take action, and demonstrating the benefit of taking action—is presented in Appendix 7.4.

Figure 7.2. Sample grid to outline introductory and key messages

Back to Top

IIICreating tailored messages for any situation

In addition to the regular key messages, you may need to develop other messages to address situations that arise during the course of your study. Perhaps your research institution has a new organizational mission that you want to publicize, or you wish to respond to a new discovery that is related to your study.

For example, when microbicide researchers at the Microbicide Trials Network (MTN) and CAPRISA discovered that some participants were enrolling in two different microbicide studies at their sites in Durban, South Africa, at the same time, the researchers needed messages to address concerns about how such co-enrollment (which was a protocol violation) might affect the two trials.

The steps below follow this example to explain how to create key messages in response to a problematic situation.

Step 1. Identify the situation. It is important to know exactly why you want to communicate. Is there a crisis that you want to address? A rumor you want to quell? Misinformation you need to correct? New details or changes you seek to make public? Clearly stating the situation will be one of your key messages.

“The MTN leadership became aware of a serious situation concerning the co-enrollment of approximately 96 HPTN 035 participants into the CAPRISA 004 study.”

Step 2. State clearly how you are addressing the situation. Demonstrate your concern.

“We are working diligently to better understand exactly how this occurred, and we are actively considering measures to prevent future co-enrollment of participants in HIV prevention trials.”

Step 3. Provide information for the future.

“The impact of these co-enrollments on the scientific integrity of HPTN 035 is likely to be minimal.”

When you put all the steps together, you have developed a set of messages that form the foundation for your communications, in this case a letter from MTN, the HPTN 035 sponsor, to their stakeholders. (The CAPRISA 004 leadership also released its own statement to stakeholders to address the situation.)

You must be an active listener to develop a well-tailored message. Paying attention to conversations that are relevant to your research will help you develop messages that are relevant to the needs and concerns of your audiences.

For example, in one microbicide study, community liaison officers reported that some people in the community believed that the study was intentionally infecting people with HIV. The team took these rumors seriously and developed key messages to dispel this belief.

In another instance, religious leaders voiced concerns that a trial studying a vaccine to prevent a sexually transmitted infection might encourage young girls to be promiscuous. The study team developed messages about these concerns and hosted a tea hour to discuss the study with members of three local congregations.

Being an active listener helps you pick up on potential cues around you. Ask yourself:

• Do local staff members voice any concerns about trial procedures?
• What questions are raised in community meetings?
• What words do people use to describe relevant concepts?
• What questions or arguments have the media posed about the trial?

Back to Top

IVRefining and testing your messages

Refining and testing your messages is an important step in making sure they are effective.

To refine your messages:

• Read the message out loud. Does it sound conversational? If not, edit until it does.
• Simplify the language. Try to reduce complex technical language. Remember that key messages are broad statements; they do not include many details.
• Check the length. Keep it short.
• Make sure your key messages frame the issue.

Test your messages with representatives of your intended audience.

If possible, test your key messages with the following people:

Internal staff. Share the messages with staff members—especially those who work closely with your intended audiences. For example, if the messages are targeting donors, have the person who liaises with your funders look at the messages. If the messages are for local leaders, make sure the community liaison officer provides input.

Technical experts and researchers. Your colleagues will have a wide range of perspectives—they can comment on accuracy, candor, and transparency.

Intended audiences. To see if your messages are clear and easy to understand, try them with people who fit the profile of your intended audience. Choose independent outsiders who are not familiar with the topic—someone from another department in your institution, a family member, or even a teenager.

Members of your community advisory board, and local and global advocates. CAB members, advocates, and civil society representatives are often well informed. They can help you ensure that your messages are responsive to the questions and concerns of their respective communities.

Back to Top

VDelivering key messages

The following guidelines can help you with the delivery of your messages. Some general tips are also summarized in Box 7.2.

Guideline 1. Your key messages should form the foundation of your communications strategy. Use your message grid when developing materials to ensure that you are focused and succinct. You can incorporate key messages into a range of communications products including:

• Q&A fact sheets
• Text for your Web page or newsletter
• Media materials (see Chapter 9)
• Correspondence
• PowerPoint presentations

Whether you are writing an article for a local newspaper or an e-mail inviting community advocates to attend a social gathering, remember to use your key messages. Even stakeholders who are well acquainted with your study should be reminded why the study is important and why they should continue to stay engaged and support the research.

Guideline 2. Take every opportunity to reinforce key messages with the study’s staff. Share your key messages with the entire study team, including the administrative staff and others who are not directly involved in the research. Encourage everyone to learn and to use the key messages.

• Review key messages at staff meetings.
• Provide regular in-house trainings.
• Engage staff members in role-play activities.
• Write the messages on a small laminated card or brochure that staff members can refer to if needed.

Guideline 3. Update your messages as needed. At some point you will need to update your key messages. For example, if your messages say that your study is the only large-scale trial testing a certain product, and then a year later another large-scale study testing the same product is launched, you should revise and update the messages in all of your materials. Remember to share updated versions whenever you revise them.

Box 7.2

Five things to remember when delivering key messages

Guideline 4. Share your messages with others. Share your messages with other sites, with the trial network, and with colleagues who are conducting similar studies. Your colleagues may want to adapt your messages for their own studies. Welcome such requests: consistent messages across a scientific field can help manage expectations and promote accurate media coverage.

Figure 7.3 illustrates how the Microbicide Trials Network (MTN) incorporated messages into a variety of their communications materials that they developed on possible drug resistance associated with using ARVs to prevent HIV. They had three main messages on resistance: One explained how and why drug resistance develops; a second described how the study plans to limit the chance that a participant will develop resistance; and a third explained how drug resistance can be managed if it does develop. They included these messages in study-related fact sheets, adapted them with simple graphics for PowerPoint presentations, and reinforced them in materials available on the MTN Web site.

Based on these messages, the Global Campaign for Microbicides (GCM)—an international civil society advocacy organization—used this information to develop even simpler messages to describe drug resistance. They used the simplified information in their public trainings on ARV-based prevention strategies (see Figure 7.4).

Figure 7.3. VOICE study: explaining drug resistance

Figure 7.4. GCM training slide on drug resistance

Such key messages provide a foundation for communications activities and materials throughout a study.

“Preparation is everything in communication,” says FHI President for Research, Dr. Ward Cates. “Know your audience. Decide what you want to say and what you want to ask before you begin communicating at any level—on a conference call, at the podium, or in media interviews. Simpler is better.”

Back to Top

Back to Top