Antiretroviral therapy (ART) is highly successful at controlling HIV and preventing progression to AIDS, but ART does not eliminate latent viral reservoirs, which rebound after ART cessation. HIV cure research currently is focused on multiple strategies, including Cell and Gene Therapy (C>). This approach involves the transfer of genetic material or cells to a patient to encourage their own immune system to kill HIV-infected cells or to render cells resistant to HIV infection. Most C> studies have not progressed past preclinical development, but some are currently being tested in people living with HIV (PLWH); however, these studies are too preliminary to directly benefit study participants. Therefore, attitudes toward C> in HIV-positive communities are important factors in the consideration of C> as a feasible HIV cure strategy, especially in the African American population, which bears a disproportionately high burden of HIV. The defeatHIV Community Advisory Board (CAB) identified an assessment of these attitudes to be of great importance for both researchers and community. To understand and integrate the perspectives of PLWH regarding C> into biomedical research, Karine Dubé of the University of North Carolina, along with the Fred Hutch Vaccine and Infectious Disease Division, the defeatHIV Clinical Core, and UW Department of Psychology, conducted focus group discussions (FGD) with PLWH in the Seattle area and published their results in AIDS Research and Human Retroviruses.
Following the principles of community-based participatory research, the authors worked alongside the defeatHIV CAB in December 2017 to conduct FGDs to solicit PLWH attitudes, feelings, and beliefs regarding C> relevant to future clinical trials recruitment and practices. A total of 19 HIV-positive participants were enrolled, and African Americans as well as men who have sex with men were purposely oversampled as both groups bear disproportionately high burdens of HIV infection. Dr. Simoni conducted the FGDs by enquiring about previous knowledge and experience with HIV clinical research and C>, supplied a description of C> and its uses in HIV, gathered initial reactions and concerns to the proposed treatments, and inquired about participants’ understanding of risks and benefits. The facilitators also asked what information and precautions would make participants willing to try C>.
The authors found that none of the participants had heard of C>, and once introduced, most participants were wary of the strategy, with their apprehension primarily based on fears of receiving injected material and gene manipulation. Furthermore, many felt that the risks of C> would outweigh the benefits, since many of the participants currently lead normal and healthy lives on ART and would prefer not to interfere with their stable treatment regimen, especially since C> would require ART interruption. Additional concerns centered on unintended and long-term effects of C>, its irreversibility, and worries that physical appearance would change or that offspring would inherit genetic changes. However, some participants expressed hope and potential interest in C> if more information about the treatment were made available, allowing individuals to calculate risk-benefit outcomes. Those who were curious about C> noted that they would like to speak to people who underwent or receive approval from their HIV care physicians before they would consider C>. Overall, PLWH were cautious around the use of C> as a strategy investigated for curing HIV infection. These findings highlight the importance of conducting behavioral research and incorporating diverse community perspectives while designing novel HIV clinical trials.
This study is the first to qualitatively assess preconceptions, concerns, and acceptance of C> in PLWH. This work focused on populations that are often excluded or lack access to medical research, scientific knowledge, and clinical trial participation, and found that a low percentage of this relevant demographic would be willing to undergo C>. Dubé expanded on these results, saying that the authors “believe the perspectives of people living with HIV should be paramount in planning future research efforts.” She hopes that social sciences research will “open an important dialogue around essential considerations to engage communities around early-phase HIV cure science, as well as research priorities for the future.”
This work was supported by the Martin Delaney defeatHIV Collaboratory and the University of Washington/Fred Hutch Center for AIDS Research.
Dubé K, Simoni J, Louella M, Sylla L, Mohamed ZH, Patel H, Luter S, Collier AC. 2019. Acceptability of Cell and Gene Therapy for Curing HIV Infection Among People Living with HIV in the Northwestern United States: A Qualitative Study. AIDS Res Hum Retroviruses. doi: 10.1089/AID.2019.0021. Epub 2019 May 21.