Three studies go beyond clinical work
By Amy K Johnson, George Greene, and Jim Pickett

Interest in HIV cure research is growing exponentially, and we’ve seen an increase in funding available for HIV cure research in the past five years. The majority of research is in the clinical science sphere—with approximately 100 clinical trials being conducted globally (go to treatmentactiongroup.org/cure/trials).

Early and ongoing engagement of stakeholders, such as people living with HIV, is critical to navigating complex ethical issues as well as ensuring acceptable implementation strategies should there be an opportunity to scale up cure activities.

HIV cure can be thought of in two distinct ways:

  1. eradication, or sterilizing, cure in which HIV is completely eliminated from the body; and
  2. remission, in which some HIV remains but is undetected in the blood without ongoing medication

A cure for HIV would get rid of the need for ongoing medication, stop onward transmission, and would halt viral progression. The promise of a cure is exciting and has the potential to positively impact the health and wellbeing of many as well as reduce the global economic impact of lifelong treatment. Most, if not all, of the current trials are in the very early “proof-of-concept” stages.

This important work will contribute greatly to the cure field, but honestly won’t offer much, if any, clinical benefit to participants—yet participation could pose a number of risks.

The potential benefit of finding a cure for HIV is great, and highlights the need for people living with HIV to look at every aspect of the research agenda. Clinical cure trials may involve significant risk to participants, requiring close external monitoring, ongoing examination of risk-benefit ratios, careful informed consent procedures, and mechanisms for reporting findings as trials progress.

All clinical cure trials should have a well-planned community engagement strategy, inclusive of ongoing monitoring and feedback mechanisms. Research designs and methods should be reviewed by community representatives and advocates, allowing time for discussion, feedback, and revision as needed.

The possibility of being cured of HIV is a strong incentive to participate in cure research activities. Research involvement, however, may pose significant short- and long-term risks with very little promise of study participants being cured (at this stage of research).

One example under investigation is analytic treatment interruption, in which HIV-positive participants stop taking antiretrovirals (ARVs) and are monitored over time for sustained viral suppression.

Ongoing dialogue needs to occur between the scientific community and communities impacted by HIV about how to determine and communicate the risks and potential benefits of participating in cure research.

Jim Pickett, Sr. Director of Prevention Advocacy and Gay Men’s Health at AIDS Foundation of Chicago and Key Personnel on a community-based cure research project, affirms the need for people living with HIV to be front and center in cure research. “Having worked most of my career in advocacy for new HIV prevention strategies like PrEP and microbicides, I am delighted to be working on HIV cure research as well,” said Pickett. “Frankly, when I found out I was HIV-positive in 1995, I had no expectation I would be here at age 51, and I certainly could not have conceived of such a robust cure agenda. That said, we collectively need to step up our game in terms of socio-behavioral research. Humans are messy and complex—and cure research is anything but easy and straightforward.”

Developing a cure for HIV requires a combination of innovative clinical techniques and interventions, as well as the collaboration of multiple sectors and key stakeholders.

To that end there are three studies focused on community perspectives of HIV cure, currently funded by Gilead Sciences, which aim to explore social and behavioral implications of HIV cure research.

1: Chicago Unites in Research to End HIV (CURE HIV)

CURE HIV is a partnership among the AIDS Foundation of Chicago, Northwestern University, and Lurie Children’s Hospital of Chicago. The project’s long-term goals are to increase the acceptability and willingness to engage in future HIV cure research and therapy among four key populations: young gay men and other men who have sex with men, men of color who have sex with men, and women of color, inclusive of transgender women. The CURE HIV project also aims to increase scientists’ ability to engage in ethical and acceptable HIV cure research with highly impacted communities. To achieve these goals, it seeks to engage communities disproportionately affected by HIV in mixed methods research, using focus groups and surveys, to assess understanding of, and interest in, HIV cure research. Using findings from this formative research, the study team will develop a curriculum to educate and train community liaisons and cure researchers to increase and sustain dialogue about research. Finally, the CURE HIV Project will host community events to enhance education on HIV cure research to both facilitate community involvement and disseminate accurate information. The CURE HIV Project is unique as it includes inquiry with both communities most impacted by HIV and cure scientists themselves.

2: Women’s Willingness to Participate in HIV Cure Research and Principles of Stakeholder Engagement

Data that are currently available on participation in cure trials under-represent women living with HIV. To address those limitations, a partnership between Project Inform, the University of North Carolina Gillings School of Global Public Health, The Forum for Collaborative Research, NMAC, and the Women’s Research Initiative on HIV/AIDS, led by principal investigator David Evans (of Project Inform), will be conducting in-depth interviews, focus groups, and online surveys to determine the characteristics of a hypothetical cure that would be most or least appealing to women living with HIV, and how they feel about the types of cure-oriented research likely to move forward in the near future, with all of its attendant risks, benefits, and burdens. A second aim of the research collaboration is to define some of the factors that might distinguish the best community participatory practices for HIV cure science. For example, effective community engagement has not only improved the conduct of clinical trials for PrEP, but also the dissemination of research results to the community and the wider public.

3: HIV Cure Research Perception Among HIV-infected African American MSM, and Affected Communities in the Deep American South: A Multi-Level Mixed Methods Perspective

Principal investigator Dr. DeMarc Hickson at My Brother’s Keeper in Mississippi will focus on adding the perspectives and experiences of African American and black men who have sex with men from the South to the HIV cure research agenda. This community research will use focus groups and surveys to gather data from community participants. We know little about the knowledge and beliefs that black men in the South have about cure research, yet the South experiences much of the U.S. HIV epidemic and would be a crucial intervention point should a cure be viable.

Summary

These three projects funded by Gilead Sciences represent some of the social science involvement in cure research and an inventory of current social science research on HIV cure is being undertaken. As cure research advances, expanding the role of systematic collaboration of multiple sectors ensures that the approaches tested will be acceptable for scale-up and implementation.

sources

Grossman, C. I., Ross, A. L., Auerbach, J. D., Ananworanich, J., Dubé, K., Tucker, J. D.,Noseda, V., Possas, C. & Rausch, D. M. (2016). Towards multidisciplinary HIV-cure research: integrating social science with biomedical research. Trends in microbiology24(1), 5-11.

Dubé, K., Evans, D., Sylla, L., Taylor, J., Weiner, B. J., Skinner, A., Thirumurthy, H., Tucker, J.D., Rennie, S & Greene, S. B. (2017). Willingness to participate and take risks in HIV cure research: survey results from 400 people living with HIV in the US. Journal of Virus Eradication3(1), 40.