HIV study participants report beneficial social impact: HVTN analysisDecember 4, 2020
Participants in HIV prevention trials feel good when helping others, found a NIAID-funded HIV Vaccine Trials Network (HVTN) cross-protocol analysis.
Titled Social Impacts among Participants in HIV Vaccine Trial Network (HVTN) preventive HIV vaccine trials, the analyses showed that the 6572 study participants who reported at least one beneficial social impact (BSI) as a result of their participation in HVTN studies were motivated by altruistic reasons (43%), followed by healthcare-related benefits such as receiving HIV risk reduction counseling (30%), and access to medical care and medical care information (including HIV testing) (29%) as factors that motivated their decision to participate.
The study, which was designed to assess the self-reported beneficial and negative social impacts (NSI) experienced by study participants, was published earlier this year in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).
The study enrolled 8347 people across 48 completed preventive HIV vaccine trials, which were conducted between December 2000 and September 2017.
Among participants who reported beneficial social impacts, those in the US or Switzerland were more likely to report altruism/feeling good helping others as a BSI (50%), while participants in sub-Saharan Africa reported receipt of medical care or medical care information as the most often experienced BSI (65%), followed by receipt of risk-reduction counseling (61%). For participants in South America altruism or feeling good about helping others (21%) was the most often experienced BSI, followed by receipt of medical care or medical care information (20%).
The cross-protocol analysis elucidated regional differences in self-reported NSIs and BSIs. Whereas psychological benefits such as feeling good about helping others and positive feelings associated with altruistic behaviours were most reported by study participants in the U.S. and Switzerland, tangible benefits, such as receipt of medical care, medical information, or HIV risk reduction counseling, were the most often reported by participants in sub-Saharan Africa and South America. This is likely due to differences in access to resources and medical care across these regions.
The analysis revealed that study participants who disclosed their involvement in HIV prevention clinical trials were subject to negative social impacts (NSIs) such as stigma, discrimination, and impacts on their personal relationships.
Overall, 686 participants (8%) reported 819 NSIs. Negative reactions from friends, family and partners accounted for most (79%) of trial related NSIs, underscoring the pervasive impact of stigma. Of the 686 participants reporting an NSI event, 503 (73%) considered the impact minimal, 134 (20%) considered it moderate, and 49 (7%) reported a major impact.
Of the 48 completed clinical trials, 43 were phase 1, three phase 2a, and two were categorized as phase 2b. Participants in the trials were enrolled from 43 clinical research sites in Botswana, Brazil, Haiti, Jamaica, Peru, South Africa, Switzerland, Thailand, Trinidad and Tobago, and the US. Participants in phase 1 trials were at low risk of acquiring HIV infection, those in phase 2b trials were at high risk, and participants in phase 2a trials were a mix of low to high risk depending on the trial. Eligibility varied by protocol, and in general participants were aged 18 to 50 years.
According to the study team, knowledge of, and a greater understanding of the social impacts (BSIs and NSIs) reported in HIV prevention clinical trials assists in identifying strategies to mitigate negative impacts. In addition, it informs processes and procedures that promote positive study participant experiences, generating data to ensure adequate trial participation that supports the successful development of a preventive HIV vaccine.
“Our analysis aims to broaden understanding of social impacts associated with preventive HIV vaccine trials to improve participant experiences,” said Michele Andrasik, Ph.D., director of Social Behavioral Sciences and Community Engagement for the HVTN, senior staff scientist in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center, and affiliate assistant professor at the University of Washington.
A deep dive into the analysis revealed that NSIs were primarily attributed to disagreements with family, friends, or partners about the participant’s decision to join the study, driven by worry about side effects, and misunderstandings of the participant’s HIV status or risk of HIV acquisition. Although participants in the Caribbean and South America were less likely to report an NSI, the NSIs that they reported were slightly more likely to have a major impact on quality of life (5.2% and 2.4% in the Caribbean and South America, respectively, reported a major impact on quality of life compared to 0.8% in sub-Saharan Africa and 0.4% in the United States and Switzerland).
Although NSIs are associated with trial participation, the analysis reveals that reports of them are infrequent in preventive HIV vaccine clinical trials.