Determining whether a study product works or does not work in a particular population is one of the evaluation objectives of clinical studies. Among other processes, this involves evaluating the interaction of the product and the genetic, biological and environmental factors of the participants because these could influence safety and efficacy. It has been shown that there are differences in the body's response to a drug or vaccine between people of different ethnic groups, but also due to factors related to health conditions such as HIV, tuberculosis, etc. However, despite efforts to facilitate access to participation in clinical trials, it is still a challenge to achieve equitable participation for all populations.
Added to this situation are other social determinants that cut across the realities of the participants’ lives, including accessibility of the research centers, socioeconomic level, illiteracy, lack of job opportunities, gender violence, and low confidence of community members regarding research. Faced with this, clinical research sites develop community involvement plans with approaches tailored to the various populations and individuals with whom we interact, paying extra attention to populations that are poorly represented in the protocols.
Always Close to You
We start from the idea that we should get closer to people. For this reason, in tuberculosis studies we periodically visit the health centers in the areas with the highest number of reported cases, characterized by low-income families who mostly come from the Andean regions of the country. In partnership with health department personnel, we sensitize and inform people about the importance of timely testing for tuberculosis, and the need for shorter and more effective preventive or curative treatments. To get people’s attention, pre-tested educational materials are developed and adjusted to the characteristics of the populations to whom we are targeting. The information must be simple, clear, and attractive, with which the population can identify.
For HIV prevention studies, we reach out to the communities of trans women and gender non-binary people, who face expulsion by their families because of their identities, causing deterioration in their quality of life, unemployment, dropping out of studies, having little economic income to cover food expenses, precarious housing, and other social problems. Given this, the "Trans Houses" or "Houses of Ball Room" have emerged as self-managed spaces for protection, emotional support and development of artistic abilities that allow community members to stand out in Balls or beauty pageants. In this sense, we not only seek to disseminate information about advances in HIV research, but we also contribute to the development of their organizational capacities. Currently, the community involvement team of the Impacta Barranco CRS and Impacta San Miguel CRS provide advice to House XXXX about building a support network with institutions that address mental health, job opportunities, physical health, entrepreneurship, and more.
Meet our Participants
Previous work in community education in the areas of the city at greatest risk for TB facilitates entry into the homes of the most vulnerable families, and allows the identification of social and cultural barriers that could affect adherence to the study product and/or retention. In addition, people with recently diagnosed cases with whom contact is made are identified to inform them about studies, as well as the importance of prevention among their close contacts. A relationship of trust is built with the families, who identify us as leaders in the approach to the disease. Accessibility of the study sites is key, and even more so in the case of family groups affected by the social determinants of health. For this reason, transportation to the site is facilitated and visit schedules that are adjusted to their work commitments are offered. We also provide vouchers to purchase food in a supermarket chain, to supplement the diet of our participants.
For HIV studies, a presence on social networks and dating apps such as Facebook, Instagram, TikTok, Telegram, Grindr, and others has been added to the strategies of visiting places of socialization. This allows us to reach LGTBQIA+ populations of all ages and social strata. In addition, , private transportation is facilitated in order to optimize visit times, especially for trans women and participants who have a disability.
Mental Health: The Importance of Listening
HIV prevention studies have allowed us to build the retention strategy called tutoring or case management. With it we seek to ensure continuity in the study, but we also contribute to addressing social determinants such as mental health, lack of job opportunities, violence, or barriers to accessing other health services. We created emotional support services, links to comprehensive health services, and legal advice (in cases of violence), as well as access to a database of job opportunities. Using this strategy, it has been possible to generate an empathetic bond, and our participants recognize our concern for them as people beyond their participation in a study.
All these strategies cannot be implemented by a single actor, but in coordination with state entities, civil society, and communities. We must all aim at the elimination of inequalities. In our case, we must begin by evaluating and reinforcing our work to achieve greater representation of the diversity of populations, which results in finding vaccines and medicines that benefit everyone.
Felipe Vilcachagua is a Community Educator in the Barranco CRS of the IMPACT CTU, and MaR León is the Head of Community Involvement at the IMPACTA CTU in Lima, Peru.