Engaging communities in tuberculosis research: The experience of the TB-PRACTECAL trial

In the wake of the 49th Union World Conference on lung health, multidrug resistant tuberculosis (MDR-TB) remains a major global public health threat. It was responsible for 230 000 deaths in 2017 alone, demonstrating that there is clearly an unmet need to determine robust, efficacious, and tolerable treatment combinations for drug resistant TB strains.1 Médecins Sans Frontières (MSF) is sponsoring research to do exactly that, including the TB-PRACTECAL study, which is evaluating the efficacy and safety of all oral six month regimens. The research compares treatments, including two new anti-TB medications versus the current standard of care, with the aim of providing new recommendations to the international TB community.

Reflecting the global nature of TB, the TB-PRACTECAL trial sites are located in very different cultural settings. Several of the participating countries are naïve to clinical research and harbour communities where TB is still highly stigmatised, with patients facing exclusion and isolation after diagnosis. We hope that by sharing our experience of conducting the TB-PRACTECAL study in countries with some of the highest MDR-TB burdens, we can pave the way for future research in similar contexts.

Following proven success in HIV research, the development of The Good Participatory Guidelines for TB Drug Trials2 in 2012 marked a positive step towards acknowledging the importance of community engagement (CE) within TB research. The document provides a framework for developing activities that will support a trial throughout its life cycle. Improving research literacy, empowering communities, and developing a two way dialogue with key stakeholders are important tenets.

Our experience of initiating and conducting TB-PRACTECAL within countries where TB is endemic has highlighted the need for an adaptable approach to community engagement. CE activities are driven by the cultures, beliefs, and environment within the locality of the recruiting hospital. Simple factors, such as the vocabulary used during the informed consent discussion, can largely impact patient perspectives. Where the native language lacks appropriate terminology to explain trial procedures, such as randomisation, we have observed that words such as “experimentation” and “lottery” possess negative connotations.

Mapping stakeholders who are both directly and indirectly affected by the clinical trial, and their influence over its successful implementation, is a vital first step in the development of a CE plan. Strategies to engage key groups are then tailored to that specific site. Although MSF provides overall oversight, the design and implementation of CE activities would be impossible without close collaboration and consultation with Ministry of Health staff in the recruiting hospitals.

One approach, taken by our most established research site, saw the formation of a community advisory board (CAB) at the beginning of 2012. Board members represent the key stakeholders in the site’s catchment area. These include community activists, unemployed graduates, non-governmental organisations, the religious sector, and LGBTI representatives. In their quarterly meetings, the CAB promotes research literacy and receives updates on clinical trials that are recruiting in the hospital. The site also runs educational sessions targeted towards key opinion leaders within the community. Traditional healers in the local area, whose opinions may be held in higher esteem than specialist TB clinicians, are among them.

Uniquely, MSF possesses a wealth of expertise in anthropological research, which can provide insight into the patient journey and community perceptions, allowing us to improve stakeholder engagement as the study proceeds. In response to one such qualitative assessment, another trial site has recently focused on promoting communication between study patients and those on the standard of care TB drugs. Joint discussion sessions have provided a forum for TB-PRACTECAL participants to share personal experiences of taking part in a clinical trial, and for health practitioners to provide basic information on the protocol and address pre-existing misconceptions. Following successful feedback, these sessions are being rolled out to patients attending local general health clinics for non-TB related reasons, to engage the families, community influencers, and patients themselves who may encounter the trial in the future.

Regardless of their location, a patient approached to take part in a TB trial has the right to make an informed decision, free from prejudice, fear, or misconception. By tailoring community engagement activities to a specific context, we hope to better understand our participants and help overcome the pervasive stigma surrounding TB once and for all.

Emma Douch is a clinical research associate working on the TB-PRACTECAL, which is sponsored by Médecins Sans Frontières.

Competing interests: None declared.

[1] World Health Organisation. (2018). Global tuberculosis report 2018. Geneva. Available at: http://www.who.int/tb/publications/global_report/en/
[2] Critical Path to TB Drug Regimens. (2012). Good Participatory Practice Guidelines for TB Drug Trials. Retrieved from http://www.cptrinitiative.org/downloads/resources/GPP-TB%20Oct1%202012%20FINAL.pdf