By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA
Early phase HIV vaccine clinical trials are designed to assess if an investigational HIV vaccine is safe and well tolerated in study participants. In addition, researchers study if the vaccine will stimulate the body’s immune system to make responses against HIV. Study participants who enroll in the trials must be HIV seronegative and less vulnerable to the transmission of HIV. Knowing this made it necessary for me to meet the first author of a published manuscript titled, “A descriptive analysis of transgender participants in phase 1 -2a trials of the HIV Vaccine Trials Network (HVTN) in the United States and Peru.”
For the layperson, the manuscript can deter you from reading – it contains a range of graphs and scientific terms that necessitate a place for the Oxford dictionary in your office, or google.com on “speed click.” Dr. Michele Andrasik is the Director of Social and Behavioral Sciences and Community Engagement for the NIAID-funded HIV Vaccine Trials Network (HVTN), and we met to talk about the manuscript, the result of a cross-protocol study that analyzed data from 694 participants enrolled in six early phase clinical trials conducted by the HVTN.
Andrasik exudes a pleasant disposition and smiled radiantly in a thought-provoking discussion about the importance of early phase HIV vaccine trials in this cross-protocol analysis. The study measured several variables to determine why 681 (98%) cisgender and 13 (2%) transgender study participants enrolled in the HVTN’s early phase studies conducted between 2009 and 2014. The primary reasons for participation were altruistic for all participants.
Figure 2 illustrates the reasons why transgender and cisgender people enrolled in the early phase trials.
Overall, figure 2 confirms that transgender and cisgender people had similar motivations for participating in early phase trials. Participants expressed that the most compelling reasons for participation were to help find an effective HIV vaccine, to help their community, and to be informed about HIV research. Transgender participants were less motivated by financial incentives, naming “knowing someone living with HIV” as a more compelling reason to enroll as a participant.
“It is really clear that the communities most impacted want a resolution to a four-decade old pandemic [HIV/AIDS],” Andrasik pointed out.
Statistics from the 2015 US Transgender Survey (USTS) reported that “one-third (33%) of transgender participants experienced at least one negative health care experience related to being transgender.” Verbal harassment and refusal to provide treatment because of gender identity are two reasons noted by transgender people for why they actively avoid seeking healthcare. And, in Peru structural factors such as legislation that restricts changes to gender markers and legal names on official documents” limits access to healthcare for transgender individuals.
In addition, “multilevel social and structural factors such as poverty, discrimination, mental illness, homelessness, abuse, distrust of the health care community, and concerns about disclosing transgender status” make transgender people more vulnerable to the transmission of HIV.
Knowing the lopsided burden that HIV places on transgender communities, and the factors that create barriers for transgender individuals’ participation clinical trials, requires transformation strategies to create an experience where the individual’s interest and willingness to participate in a clinical trial is met by a transgender-affirming healthcare setting.
“We need to continue and enhance our efforts to create clinical trial environments that are equipped to welcome and affirm our diverse communities who are willing to enroll and move science forward,” stated Andrasik.
Creating transgender-affirming environments is no easy undertaking. In 2007, the HVTN took bold steps when it established a Transgender Working Group to “identify and provide input regarding operational and clinical needs related to the inclusion of transgender participants in HVTN trials.” First, the Network adapted its demographics Case Report Forms (CRFs) to collect data on sex assigned at birth and self-identified gender identity – a process known as the two-step method. Secondly, clinical trial staff were trained to be more culturally responsive to transgender participants. Having site staff who were familiar with gender transition and affirmation procedures, specific health concerns, hormone use, and identity documents specifying gender identities or legal names are all factors that impact the retention of transgender people and their experience as study participants.
“The results, after implementing data-driven strategies to create transgender-affirming environments at our clinical trial sites, are noteworthy,” Andrasik beamed.
Furthermore, the study confirmed that “transgender participants reported no negative social impacts due to clinical trial participation, and 93% of transgender participants identified having experienced at least one social benefit of participation.”
Additionally, researchers wondered whether it was plausible to enroll transgender study participants in early phase clinical trials. When the population has higher vulnerability, can individuals with low vulnerability be identified, enrolled, and retained?
Data from this cross-protocol study provided evidence that transgender people can not only be eligible for trials enrolling people who are determined to have low vulnerability to the transmission of HIV, but they are also able to remain HIV uninfected over the course of their study participation. The study team suggests that transgender participants in early phase HIV vaccine trials are more likely to be in communities where there is high HIV incidence. This explains why “I know someone with HIV infection” was cited as a reason why transgender participants get involved in preventive HIV vaccine trials. Transgender participants also demonstrated excellent retention, as shown by only three missed visits (2.1%) and no discontinuation of vaccinations across the six protocols included in the analysis.
Andrasik is adamant, “We must conduct clinical trials that are inclusive. In order to do so we must be aware of the factors that make some people in our communities more vulnerable to HIV transmission than others. In many cases these factors also create barriers to participation. Whenever possible, we should be prepared to mitigate these challenges.”
Aziel Gangerdine is the Director of Communications for the HVTN.