Strategies to engage Black, Hispanic/Latinx, transgender, and nonbinary individuals in a PrEP trial

What is it about?

Studies looking at strategies to prevent HIV have not always included communities that have been the most affected by HIV, especially Black, Hispanic/Latinx, and transgender and gender nonbinary individuals. This publication describes what has been done in a clinical study (PURPOSE 2 - https://www.purposestudies.com/purpose2/) of an investigational medicine, lenacapavir, to help make sure that communities most affected by HIV are represented in the study and that their voices are heard. What is PrEP? PrEP is short for pre-exposure prophylaxis. PrEP is an approach for preventing HIV where people who do not have HIV take a medication regularly to reduce their chance of getting HIV. This is a similar way to how people take anti-malaria medication to prevent malaria when they travel to countries where malaria is present. If a person is taking PrEP and is exposed to HIV, the PrEP medication helps stop the virus from replicating and prevents the person from developing the infection. Lenacapavir is being studied to see if it works as PrEP. What did the researchers do? The researchers looked at earlier studies in HIV and other fields for effective strategies that would help increase engagement with people underrepresented in HIV PrEP studies. The researchers met in-person and via web conference with advocacy leaders who represented the communities that have been impacted the most by HIV. These meetings included multiple discussions with community members, activists, people living with HIV, people who are using PrEP, and civil society organizations so that the researchers could understand their communities’ HIV prevention needs, concerns, and challenges before designing the PURPOSE 2 study. Based on their input and recommendations, the researchers established the Global Community Advisory and Accountability Group or GCAG. The GCAG is made up of community advocates from different underrepresented groups who have expertise in HIV prevention and clinical trials. The researchers meet with the GCAG on an ongoing basis so that they can advise the researchers on how the study is designed, how it is implemented, and to keep the researchers accountable to the community. What did the researchers find? Effective strategies to engage with underrepresented groups that the researchers found from their review included: - Working closely with community advocates and stakeholders at each step of the study, including establishing a community advisory group (like the GCAG). GCAG members are paid for their time and for their expertise. - Working with research sites that have investigators and staff who are culturally-sensitive and are from the communities that the study wants to reach. - Sites should also have their own local community advisory boards and have strong relationships with community-based organizations focused on HIV prevention. - Designing the study so that it is inclusive and sensitive to the needs of the communities it wants to reach. How did the results change the PURPOSE 2 study? GCAG members were involved in each step of the study design and implementation process. Important changes based on GCAG recommendations included the inclusion of transgender men, gender nonbinary people, and adolescents in the study. The researchers worked with GCAG members on how research sites should be selected and where those research sites should be located. The site selection survey was changed to get a better understanding of the site staff’s demographics, their expertise in working with people from diverse racial, ethnic, and gender backgrounds, and their experience in working with adolescents and in providing gender-affirming care. The researchers also focused on finding research sites in the United States (US) with high numbers of HIV cases, especially sites in the South. They used data from the Ending the HIV Epidemic Initiative to find locations where more than half of new HIV infections in the US are diagnosed. Participant enrollment goals were set to help make sure that individuals from groups that have been heavily impacted by HIV are represented in the study. Overall goals are to enroll 50% Black men who have sex with men (MSM) and 20% Hispanic/Latinx MSM in the US and 20% transgender women globally. Goals were also set for each site based on the demographics and how common HIV is in their area. The study made mandatory requirements for all investigators and research staff to complete trainings on Good Participatory Practices, gender inclusivity, and antiracism. Why are these approaches important? Black, Hispanic/Latinx, transgender, and gender nonbinary communities, often most affected by HIV, need to be included in clinical studies of medicines that can help them. This helps scientists to understand the needs of the whole community, as well as to build trust and engagement with the research process. This means that the right people gain access to and benefit from PrEP. The strategies used by the PURPOSE 2 study team can also help future researchers to achieve balanced representation in clinical studies. The study is not finished so we do not yet know exactly how many people from each group will be included. However, the study team will share the results and whether they achieved their targets once the recruitment stage of the study is complete. This article is for anyone who has been affected by HIV but has not been given a voice in HIV prevention studies, and the advocates who work with these communities. This article is also for people involved in research who are interested in making concrete steps to make clinical trials more diverse, inclusive, and equitable. Healthcare professionals who provide care to people on PrEP and those who may benefit from PrEP may also find this article helpful to understand the work being done to make sure that data from HIV prevention studies represent the patients they serve and answer questions that are the most important to their patients.

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Why is it important?

Which populations are the most affected by HIV? Black, Hispanic/Latinx, transgender, and gender nonbinary communities are affected more by HIV than any other groups. In addition, adolescents, especially those from racial, ethnic, gender and sexual minority groups also have high rates of HIV infection. - HIV infection in the United States (US) among Black and Hispanic/Latinx men who have sex with men (MSM) is estimated to be eight and four times higher, respectively, than White MSM - In 2016–2017, more than half of all new HIV diagnoses in the US were in Southern US states o 47% of these were among Black MSM o 28% among Hispanic/Latinx MSM - HIV also overly affects transgender women o Worldwide, HIV among transgender women is 49 times higher than in cisgender individuals o Rates of HIV among transgender women is believed to be up to 40% in some US cities, mostly in Black and Hispanic/Latinx transgender women - It is thought that about 11% of transgender MSM in the US have HIV - An estimated 1.75 million adolescents are living with HIV globally o 5% of people living with HIV in the US are aged 15–17 years Although people from these groups have often been included in clinical studies of HIV preventative medicines, they have not been in high enough numbers to be representative. This makes it difficult to understand any issues that may be unique to these communities and develop HIV prevention strategies that effectively address their needs or answer their concerns. What is PrEP? PrEP is short for pre-exposure prophylaxis. PrEP is an approach for preventing HIV where people who do not have HIV take a medication regularly to reduce their chance of getting HIV. This is a similar way to how people take anti-malaria medication to prevent malaria when they travel to countries where malaria is present. If a person is taking PrEP and is exposed to HIV, the PrEP medication helps stop the virus from replicating and prevents the person from developing the infection. Although PrEP is known to be good at reducing the chance of getting HIV, many people who could benefit from PrEP are not currently using it. Lenacapavir is being studied to see if it works as PrEP (Figure 1). Why is it so important to include underrepresented groups in PrEP clinical studies? It is important that clinical studies reflect the people who could benefit from those medicines in the real world. Unfortunately, many studies of medicines used to stop HIV have not always involved the groups that have been affected the most by the epidemic. This applies particularly to those from Black, Hispanic/Latinx, transgender, and gender nonbinary communities. Individuals from these communities often face multiple challenges with getting care or staying on PrEP, including racism, transphobia, stigma, healthcare discrimination, safety, and not having enough time or money to regular clinic visits. Each of these groups also have unique needs, concerns, and barriers around HIV prevention that we need to fully understand and address so that we can effectively provide care. For example, many in the trans community have said that it is important for any HIV prevention medicine to not interact with their gender affirming hormones. Without having any data to show this, people will not want to take the medicine. A lack of engagement with people from these underrepresented groups has slowed the success of HIV prevention efforts. By increasing the inclusion of racial, ethnic, gender and sexual minority groups in clinical studies, researchers can help increase the use of PrEP and reduce the burden of illness among those most affected by HIV. Building trust with communities who are affected most by HIV is important in stopping the disease. If successful, the strategies from this PURPOSE 2 study can be used in future studies to help include these important communities. What approaches did the study team use to ensure that underrepresented individuals were included? The study team used several approaches to increase the number of people in the PURPOSE 2 study from communities that have been underrepresented in PrEP clinical studies in the past: (Figure 2). How did the research findings lead to changes in the PURPOSE 2 study? The researchers found several findings that could improve how the PURPOSE 2 study should be conducted. Each of these changes was implemented (Figure 3) What training do all study staff involved in the PURPOSE 2 study receive? All study staff involved in the PURPOSE 2 study received at least three areas of mandatory training. These trainings were given live but also made available for on-demand use. 1. Training based on ‘Good Participatory Practice’ guidelines The Good Participatory Practice (GPP) Guidelines were originally developed in 2007. They provide clear guidance for study staff on how to effectively connect with participants and other stakeholders during studies looking at prevention of getting HIV. https://www.avac.org/good-participatory-practice 2. Gender inclusivity training on how to create an inclusive culture towards people who are gender diverse 3. Training on racism and implicit bias in clinical studies

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