Increasing the meaningful involvement of women in HIV cure-related research: a qualitative interview study in the United States

Abstract

Background

Cisgender women represent over half of people living with HIV globally. However, current research efforts toward a cure for HIV focus predominantly on cisgender men. The under-representation of women in HIV cure clinical studies is particularly problematic given data suggesting that sex-dependent phenotypes limit scientific discovery.

Objective

We aimed to generate considerations to increase the meaningful involvement of women in HIV cure-related research.

Materials and methods

We conducted in-depth interviews with biomedical researchers and community members to better understand factors that could increase the meaningful involvement of women in HIV cure clinical trials. Participants were affiliated with academia, industry, community advisory boards, and community-based organizations, and were identified using listings from the AIDS Clinical Trials Group and the Martin Delaney Collaboratories. We used conventional content analysis to analyze the qualitative data.

Results

We recruited 27 participants, of whom 11 were biomedical researchers and 16 were community members. Participants included 25 cisgender women, 1 transgender woman, and 1 cisgender man. Key considerations emerged, including the need to ensure that HIV cure studies reflect HIV epidemiologic trends and having accurate representation by sex and gender in HIV cure research. To increase the meaningful involvement of women, recommendations included instituting intentional enrollment goals, frequent and mandatory reporting on enrollment, and incentives for sites to enroll women. Additional themes included the need for agency and self-determination, attention to lived experiences, trauma and healing, and adequate support for women (e.g. logistical, psychosocial, mental, emotional, and physical). Participants noted that women would be willing to participate in HIV cure trials, related procedures (e.g. biopsies), and analytical treatment interruptions. They also expressed a desired for women-centered and holistic clinical trial designs that account for intersectionality.

Conclusions

Our empirical inquiry extends recent calls to action to increase diversity of people involved in HIV cure research. Redressing the under-inclusion of women in HIV cure research is an urgent imperative. The entire field must mobilize and reform to achieve this goal. Meaningfully involving women across the gender spectrum in HIV cure research is needed to ensure that interventions are safe, effective, scalable, and acceptable for all people with HIV.

Keywords:

• Women
• HIV
• clinical trials
• participation
• meaningful involvement
• HIV cure research

Acknowledgements

The authors are deeply indebted to all the participants who took part in this study. The authors would also like to thank all community members who helped design and review the study questions.

Author’s contributions

K.D. designed the study, conducted interviews, drafted the initial version of this manuscript and led data analysis.

E.B., M.P., A.P.-B., B.M., B.Pe., D.A., B.Pi., K.M., C.C., M.M., M.C., G.G., L.D., D.D.D., E.G., A.K., T.D., J.D.A, E.S, K.L.S and S.G participated in data review, reviewed the manuscript for intellectual contents, and approved the final manuscript.

All authors read and approved the final manuscript.

Disclaimers

EB is an employee of the United States (U.S.) National Institutes of Health (NIH). The views and opinions expressed in this commentary are those of the authors only and do not necessarily represent the views, official policy, or position of the U.S. Department of Health and Human Services or any of its affiliated institutions or agencies.

Disclosure statement

KD provides advisory services to Gilead Sciences, Inc. All other authors report that there are no competing interests to declare.

Additional information

Funding

This work was supported by an Ethics Administrative Supplement to R21MH118120 to K.D., who also received support from UM1AI126620 (BEAT-HIV Collaboratory) co-funded by NIAID, NIMH, NINDS and NIDA) and from R01MH126768.