Public Engagement during a Typhoid Conjugate Vaccine Trial in Lalitpur, Nepal - Experience, Challenges and Lessons Learnt

"Public engagement conducted for this study clearly shows that staying connected with the community stakeholders helped to gain trust and support for the study despite publication of negative news article in a national daily."

Typhoid is a public health problem in many low- and middle-income countries, including Nepal. To reduce the morbidity and mortality caused by S.Typhi, the Typhoid Vaccine Acceleration Consortium (TyVAC) works to support the introduction of typhoid conjugate vaccine (TCV) for Gavi-eligible countries with a typhoid disease burden. To generate evidence on the impact of TCV, a phase 3, double-blind, randomised controlled trial was conducted in Lalitpur, Nepal. This article describes the experience, challenges, and lessons learned in conducting public engagement (PE) for TyVAC-Nepal.

Community engagement in health research describes an array of activities that include information dissemination, consultation and collaboration in decision-making, empowerment, partnership building, and request for guidance from community leaders. It involves a creating a collaborative relationship between the research team and relevant stakeholders. Research has shown that PE helps build community trust in research, ensure the trial procedures are acceptable in the local setting, facilitate participant enrollment, and assist in post-trial follow-up.

As part of the TyVAC trial, 20,000 children aged between 9 months and 16 years were vaccinated from November 20 2017 to April 9 2018; participants were actively followed for safety and efficacy over 2 years through passive surveillance (PS) clinics. Several challenges were encountered during vaccination and PS stemming from misinformation, misconception, and fear around clinical trials in the community. As the article outlines, negative community perception and distrust regarding research is prevalent in the Nepali community. Past audits of clinical trials have reported issues like failure to secure ethical approval, subject enrollment without informed consent, and data fabrication.

In that context, PE activities were conducted across three tiers - moving from decision makers in the first tier to elected local representatives in the second tier and ending with interaction in community with parents/guardians of the intended population, including school engagement with students and teachers. All three tiers of TyVAC-Nepal engagement activities were continuously conducted before, during, and after vaccination. Prior and during vaccination, engagement was conducted to inform the community about the study and to discuss the importance of vaccination. Post-vaccination, engagement was conducted to inform about PS clinics, alleviate study concerns, and share study updates.

The article describes challenges faced in conducting PE and strategies developed to overcome them. For example:

• Some of the ward leaders were hesitant to permit vaccination in their wards, which was not delivered by the Government of Nepal. The PE team explained to them that the study was approved by Nepal Health Research Council, that the study vaccines received license from Department of Drugs Administration, and that National Immunization Advisory Committee members supported the study. Each ward then provided a venue for vaccination clinics and forwarded names of community volunteers who could be engaged in home visits to inform people about the study. They distributed study information sheets to households and invited parents to visit the vaccination clinics to get more information about the study and ask any questions they had.
• With skeptical parents doubting the study vaccines, involvement of locals during the vaccination consent process helped in part to build a trusting relationship. Furthermore, involving trusted community figures (ward chairperson) who had vaccinated their own children in TyVAC-Nepal in community engagement helped to build confidence amongst the community members. In addition, the PE team started to involve the study medical doctors in PE covering various health topics, which helped encourage direct interaction between them and community members.
• The biggest setback the PE team faced was the front-page publication of articles about the vaccination programme in the national daily newspaper. Some of these articles characterised Nepali children as guinea pigs being used for experimentation. In response to such media, the parents whose children were vaccinated in the study, including the elected ward representatives, started questioning the credibility of the vaccine. To tackle this issue, PE team engaged with the elected representatives first, as they would be the ones who would eventually be questioned by the community. After regaining their trust, the PE team approached parents of vaccinated children, clarified their queries, and reiterated the details of the study based on the checklist of likely questions prepared by the study investigators. During community-based engagement, elected representatives were invited to share their understanding and positive feedback about the study. This approach helped refute the rumours about the study amidst the negative environment created by the news articles. At the same time, interim results of TyVAC-Nepal were shared in the community and with national-level stakeholders, who spread positive messages about TCV. Over time, the PE team learned to avoid using the terms "trial" or "experiment", instead reframing the randomised controlled "trial" as a "study"; the community considered a "trial" to be experimentation on animals.
• It proved challenging to convince community members to attend the engagement events. To overcome this, the PE team started engaging with every mothers' and women's group in the community. They started to conduct engagement activities at the same time these groups would normally meet, which allowed them to address a large group in one sitting. However, a difficulty arose because the members of these groups were mostly elderly women or grandmothers of the vaccinated children. It was unclear whether these women really grasped the messages. To make the best use of PE events, the team started mobilising tole health promoters (THPs), who were from the same community, to identify the parents of the vaccinated children and invite them to attend PE. Also, in light of working parents' schedules, multiple PE events were conducted, even on the same day. Furthermore, with an awareness of the religious and cultural calendar within the community, PE events were planned during festivals and public holidays to facilitate attendance.
• There were logistical issues, such as the fact that PE activities were conducted at venues that sometimes had no electricity. At times, because of power outages, the PE team had to adapt and explain verbally despite prepared to use PowerPoint presentations. Occasionally, PE events were conducted in the living rooms, balconies, and open spaces of the participant's homes or temples because of unavailability of other venues. Flexibility was critical within the PE team to overcome these kinds of hurdles.
• There were 2 major challenges during school engagement with teachers and students in grades 7 and above. First, not all students in the classes were part of the study, and therefore, if the discussion purely focused TyVAC-Nepal, it was difficult to maintain everyone's attention. Second, it was questionable how well they could relay the discussed information to their parents. With time and experience, the PE team learned that short but interactive sessions with children would keep them engaged. Teachers were also invited to attend the events, which meant that when they were asked about the study, the key messages could be communicated to other students and parents, too.

In conclusion: "Direct and continuous interaction with community stakeholders, including parents/guardians of the targeted population contributed to build trust around the study and community willingness to be involved. It helped to raise awareness, drive away misconceptions, and allowed adaptation according to feedback from community members."