Introducing New Study Concepts: A Community Engagement Perspective

 

When a new study concept is introduced, a critical component of the process is engaging study communities. Helping community members understand the benefits and risks of study participation allows them to make decisions about how they want to support or contribute to a study’s development. Whether a new drug, treatment method or technology, the messaging process is critical, and consultation at the protocol development stage is essential. The community engagement team at the KEMRI Centre for Global Health, aka Kisumu Clinical Research Site (CRS), in Kisumu, Kenya, regularly engage community stakeholders, including women, youth, female sex workers, and men who have sex with men.

Introducing New Study Concepts: A Community Engagement Perspective
Community Advisory Board members at Kisumu CRS offices

For the past six years, Arthur Ogendo has been the community liaison lead for the Kisumu CRS. He previously served as study coordinator for 11 years. Ogendo has implemented both programmatic and research-related community activities. Over his 22-year career, he has enjoyed working with communities, ensuring they get involved and contribute to the success of studies or projects. “In research, I feel fulfilled whenever we can reach our recruitment and retention targets, and whenever we get study participant feedback on their challenges and successes,” Ogendo said.

For HPTN 084, a Phase III study examining the safety and efficacy of long-acting injectable cabotegravir for pre-exposure prophylaxis, Ogendo and his community education colleagues facilitated the community engagement process, incorporating experiences from past studies. Some communication considerations included 1) the appropriateness of the terminologies, 2) clarity of the scientific principles, 3) knowledge base for the targeted audience, 4) study details with a focus on the objectives and recruitment criteria, and 5) cultural biases and taboos.

Before implementing a study, a community entry plan must be developed and include strategies for introducing community research concepts. For HPTN 084, Ogendo used a top-down approach where the Kisumu CRS involved community leaders and stakeholders before approaching community members, then finally reaching out to potential study participants. According to Ogendo, this helped obtain permission from authorities to operate within their localities and enabled community acceptance of new studies such as HPTN 084.

“Since the introduction of this approach, we have experienced better partnership and more participation by the community within our catchment area,” Ogendo said. “We are more accepted and believe many community members are more knowledgeable about the research concept.”

Securing trust from community partners matters a lot to the Kisumu CRS as they are likely to recruit repeatedly from the same community over a long time; therefore, good long-term relations are critical.

Introducing New Study Concepts: A Community Engagement Perspective
Community sensitization activity at a local school venue

For all its successes, the Kisumu CRS has had its fair share of challenges as well. For example, explaining the HPTN 084 study concept to a community of people from diverse backgrounds and beliefs required the use of analogies, demonstrations using skits and kits, use of simple terminologies based on their local perceptions and daily experiences as well as storylines related to their localities. Another problem was managing expectations. Some study participants came seeking jobs, school fees for their children, and donations.  The study staff had to explain the difference between research and charity programs and KEMRI’s mandate regarding community-based research.

“Looking back 18 years ago to when we started HIV research community engagement, a lot has changed, starting with the development of Community Advisory Boards (CAB) at the institutional level to key stakeholders advising the study decision-making process,” Ogendo said. “This means that in the future, community entry may be less taxing for researchers as there will be more informed community-based institutions and individuals taking care of community interests, especially study volunteers.”

Despite any favorable short-term outcomes, community education is an ongoing process that may last long after a study ends. Kisumu CRS HPTN 084 community educator Tereza Omoro said the greatest surprise for her was finding out that despite the significant amount of information regarding HIV throughout the Kisumu community, some people are still unaware of what HIV is and how to prevent it. Therefore, constant engagement and education, as well as maintaining good relationships with the community, are essential.

“The relationships that mattered most were the community gatekeepers [community leaders],” Omoro said. “They paved the way and made it less bumpy for us.”

As for lessons learned, Omoro said, “Communities are dynamic; you go with the intent of talking about HIV research, but they want to hear about cancer first, then HIV. Therefore, your scope of knowledge is broad.”

Overall, proper planning, simple messaging techniques, and teamwork were vital ingredients for engaging communities, gaining their trust, and motivating them to participate in new studies, some of which were scientifically complex. Incorporating these techniques for every new study would likely be beneficial. “It is exciting to see the importance of the community entry process being recognized and catered for in the [planning] budgets,” Omoro said.

So, what’s next? The Kisumu CRS is working with its CAB to develop a team of volunteers, called trainers of trainers, or ToTs, who will continuously educate fellow community members on HIV research concepts and principles. The more educated people in a study community are about research, the more engaged they will be in the development and implementation of studies.