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

References

• UNAIDS. UNAIDS Global AIDS update. Geneva; 2022. https://www.unaids.org/sites/default/files/media_asset/2022-global-aids-update_en.pdf.
   Google Scholar
• UNAIDS. Dangerous Inequalities: World AIDS Day Report 2022. 2022. https://www.unaids.org/sites/default/files/media_asset/dangerous-inequalities_en.pdf. Accessed January 8, 2023.
   Google Scholar
• UNAIDS. HIV and Transgender and Other Gender-Diverse People – Human rights fact sheet series. 2021. https://www.unaids.org/sites/default/files/media_asset/04-hiv-human-rights-factsheet-transgender-gender-diverse_en.pdf. Accessed February 6, 2023.
   Google Scholar
• Curno MJ, Rossi S, Hodges-Mameletzis I, Johnston R, Price MA, Heidari S. A systematic review of the inclusion (or exclusion) of women in HIV research: from clinical studies of antiretrovirals and vaccines to cure strategies. J Acquir Immune Defic Syndr. 2016;71(2):181–188.
   PubMed Web of Science ®Google Scholar
• Tordoff D, Minalga B, Beck Gross B, et al. Erasure and health equity implications of using binary male/female categories in sexual health research and human immunodeficiency virus/sexually transmitted infectious surveillance: recommendations for transgender-inclusive data collection and reporting. Sex Transm Dis. 2022;49(2):e45–e49.
   PubMed Web of Science ®Google Scholar
• Gianella S, Tsibris A, Barr L, Godfrey C. Barriers to a cure for HIV in women. J Int AIDS Soc. 2016;19(1):1–10.
   Google Scholar
• Smeaton LM, Kacanek D, Mykhalchenko K, et al. Screening and enrollment by sex in HIV clinical trials in the United States. Clin Infect Dis. 2019;71(5):1300–1305.
   Web of Science ®Google Scholar
• Barr E, Dubé K, Swaminathan S, et al. Impact of dedicated women’s outreach workers (WOWs) on recruitment of women in ACTG clinical studies. HIV Res Clin Pract. 2021;22(2):37–45.
   PubMedGoogle Scholar
• Grewe ME, Ma Y, Gilbertson A, Rennie S, Tucker JD. Women in HIV cure research: multilevel interventions to improve sex equity in recruitment. J Virus Erad. 2016;2:e15–e17.
   Google Scholar
• NIH. National Institutes of Health Revitalization Act of 1993. 1993. https://orwh.od.nih.gov/sites/orwh/files/docs/NIH-Revitalization-Act-1993.pdf. Accessed January 9, 2023.
   Google Scholar
• ORWH [Internet]. 2016. NIH policy on sex as a biological variable. https://orwh.od.nih.gov/sex-gender/nih-policy-sex-biological-variable#:∼:text=NIH%20expects%20that%20sex%20as,to%20study%20only%20one%20sex. Accessed January 9, 2023.
   Google Scholar
• Johnston R, Heitzeg M. Sex, age, race and intervention type in clinical studies of HIV cure: a systematic review. AIDS Res Hum Retroviruses. 2015;31(1):85–97.
   PubMed Web of Science ®Google Scholar
• Deeks SG, Archin N, Cannon P, et al. Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021. Nat Med. 2021; Available from: https://www.nature.com/articles/s41591-021-01590-5.
   Google Scholar
• Julg B, Dee L, Ananworanich J, et al. Recommendations for analytical treatment interruptions in HIV research trials. Report of a consensus meeting. Lancet HIV. 2019;6(4):e259–e268.
   PubMed Web of Science ®Google Scholar
• Bryson Y. HIV-1 Remission with CCR5 Delta32 Haplo-cord transplant in a U.S. woman: impact P1107. In Conference on retroviruses and opportunistic infections (CROI) [Internet]. 2022. https://www.impaactnetwork.org/sites/default/files/inline-files/Final%20IMPAACTP1107_FINAL%20CROI%20%20revised%2012Feb2022%20BRYSON%203.pdf. Accessed January 9, 2023.
   Google Scholar
• Turk G, Seiger K, Lian X, et al. A possible sterilizing cure of HIV-1 infection without stem cell transplantation. Ann Intern Med. 2022;175(1):95–100. https://www.acpjournals.org/doi/epdf/10.7326/L21-0297
   PubMed Web of Science ®Google Scholar
• Grabar S, Selinger-Leneman H, Abgrall S, Pialoux G, Weiss L, Costagliola D. Prevalence and comparative characteristics of long-term nonprogressors and HIV controller patients in the French Hospital Database on HIV. AIDS. 2009;23(9):1163–1169.
   PubMed Web of Science ®Google Scholar
• Saez-Cirion A, Hamimi C, Bergamaschi A, et al. Restriction of HIV-1 replication in macrophages and CD4+ T cells from HIV controllers. Blood 2011;118(4):955–964.
   PubMed Web of Science ®Google Scholar
• Goujard C, Girault I, Rouzioux C, et al. HIV-1 control after transient antiretroviral treatment initiated in primary infection: role of patient characteristics and effect of therapy. Antivir Ther. 2012;17(6):1001–1009.
   PubMed Web of Science ®Google Scholar
• Scully EP. Sex differences in HIV infection. Curr HIV/AIDS Rep. 2018;15(2):136–146.
   PubMed Web of Science ®Google Scholar
• Scully EP, Street NW. Sex differences in HIV infection: mystique versus machismo. Pathog Immun. 2018;3(1):82–113.
   PubMedGoogle Scholar
• Gianella S, Rawlings S, Dobrowolski C, et al. Sex differences in human immunodeficiency virus persistence and reservoir size during aging. Clin Infect Dis. 2022;75(1):73–80.
   PubMed Web of Science ®Google Scholar
• Dubé K, Hosey L, Starr K, et al. Participant perspectives in an HIV cure-related trial conducted exclusively in women in the United States: results from AIDS Clinical Trials Group (ACTG) 5366. AIDS Res Hum Retroviruses. 2020;36(4):268–282.
   PubMed Web of Science ®Google Scholar
• Rossouw T, Tucker JD, van Zyl GU, Sikwesi K, Godfrey C. Barriers to HIV remission research in low and middle-income countries. J Int AIDS Soc. 2017;20(1):21521. http://www.jiasociety.org/index.php/jias/article/view/21521
   PubMedGoogle Scholar
• NASEM. Improving the representation of women and underrepresented minorities in clinical trials and research. 2022. https://www.nationalacademies.org/our-work/improving-the-representation-of-women-and-underrepresented-minorities-in-clinical-trials-and-research.
   Google Scholar
• Griesbeck M, Scully E, Altfeld M. Sex and gender differences in HIV-1 infection. Clin Sci. 2016;130(16):1435–1451.
   Web of Science ®Google Scholar
• Walker RL, MacKay D, Waltz M, Lyerly AD, Fisher JA. Ethical criteria for improved human subject protections in phase I healthy volunteer trials. Ethics Hum Res. 2022;44(5):2–21.
   PubMedGoogle Scholar
• Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36(4):391–409.
   Web of Science ®Google Scholar
• Cresswell J. Research Design. Qualitative, Quantitative, and Mixed Methods Approaches. 4th ed. London: Sage Publications; 2013.
   Google Scholar
• Cresswell J. Turning the story. In Qualitative Inquiry and Research Design. Thousand Oaks, CA: Sage; 1998. p. 219–29.
   Google Scholar
• Wallterstein N, Duran B, Oetzel J, Minkler M. Community-Based Participatory Research for Health: Advancing Social and Health Equity. San Francisco, CA: Jossey-Bas.; 2017.
   Google Scholar
• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–1288.
   PubMed Web of Science ®Google Scholar
• Guest G, Bunce A, Johnson L. How many interviews are enough?: An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82. http://fmx.sagepub.com/cgi/doi/10.1177/1525822X05279903
   Web of Science ®Google Scholar
• Dubé K, Barr L, Palm D, Brown B, Taylor J. Putting participants at the centre of HIV cure research. Lancet HIV. 2019;3018(19):18–19.
   Google Scholar
• Campbell D, Cowlings P, Tholanah M, et al. “In diversity there is beauty and there is strength.” – Dr. Maya Angelou – a community call to action to prioritize inclusion and enrollment of women in HIV cure-related research. J Acquir Immune Defic Syndr. 2022;91(5):e12–e14.
   Google Scholar
• APHA. Support for women’s inclusion in HIV-related clinical research. 2022. p. 1–13. https://apha.org/Policies-and-Advocacy/Public-Health-Policy-Statements/Policy-Database/2023/01/18/Womens-Inclusion-in-HIV-Research. Accessed January 25, 2023.
   Google Scholar
• BEAT-HIV. BEAT-HIV Position Paper. Joining forces to advance HIV cure research [Internet]. Philadelphia; 2020. https://beat-hiv.org/ati-position-paper/. Accessed January 2, 2023.
   Google Scholar
• WRI. Advancing meaningful inclusion of all women in HIV research and clinical trials. 2022. https://www.thewellproject.org/hiv-information/wri-2022-advancing-meaningful-inclusion-all-women-hiv-research-and-clinical-trials#:∼:text=The%20Women’s%20Research%20Initiative%20on,May%2012%2D15%2C%202022. Accessed January 4, 2023.
   Google Scholar
• Kozlov M. FDA to require diversity plan for clinical trials. Nature 2023;2023:4.
   Google Scholar
• Bowleg L. Evolving intersectionality withing public health: from analysis to action. Am J Public Health. 2021;111(1):88–90.
   PubMed Web of Science ®Google Scholar
• Barr L, Jefferys R. A landscape analysis of HIV cure-related clinical research in 2019. J Virus Erad. 2020;6(4):100010.
   PubMed Web of Science ®Google Scholar
• Barr L, Jefferys R. A landscape analysis of HIV cure-related clinical trials and observational studies in 2018. J Virus Erad. 2019;5(4):212–219.
   PubMed Web of Science ®Google Scholar
• Falcon R, Bridge DA, Currier J, et al. Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the gender, race and clinical experience study. J Womens Health. 2011;20(7):1043–1050.
   PubMed Web of Science ®Google Scholar
• Currier JS, Martorell C, Osiyemi O, et al. Effects of darunavir/ritonavir-based therapy on metabolic and anthropometric parameters in women and men over 48 weeks. AIDS Patient Care STDS. 2011;25(6):333–340.
   PubMed Web of Science ®Google Scholar
• Squires K, Feinberg J, Bridge DA, et al. Insights on GRACE (gender, race, and clinical experience) from the patient’s perspective: GRACE participant survey. AIDS Patient Care STDS. 2013;27(6):352–362.
   PubMed Web of Science ®Google Scholar
• Dubé K, Auerbach JD, Stirratt MJ, Gaist P. Applying the Behavioural and Social Sciences Research (BSSR) functional framework to HIV cure research. J Int AIDS Soc. 2019;22:e25404.
   PubMed Web of Science ®Google Scholar
• Grossman CI, Ross AL, Auerbach JD, et al. Towards multidisciplinary HIV-cure research: integrating social science with biomedical research. Trends Microbiol. 2016;24(1):5–11. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4698010&tool=pmcentrez&rendertype=abstract
   PubMed Web of Science ®Google Scholar
• HANC. The representative studies rubric: a tool to enhance the representativeness of study populations in clinical research. 2022. p. 1–6. https://www.hanc.info/content/dam/hanc/resources/RSR-HANC-Website.pdf. Accessed January 5, 2023.
   Google Scholar
• Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and gender equity in research rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016;1(1):2.
   PubMedGoogle Scholar
• Roberts C, Creamer E, Boone CA, Young AT, Magnus M. Short communication: population representative in HIV cure research: a review of diversity within HIV cure studies based in the United States. AIDS Res Hum Retroviruses. 2022;38(8):631–644.
   PubMed Web of Science ®Google Scholar
• NASEM. Measuring sex, gender identity, and sexual orientation. 2022. https://nap.nationalacademies.org/catalog/26424/measuring-sex-gender-identity-and-sexual-orientation. Accessed January 25, 2023.
   Google Scholar
• Dubé K, Eskaf S, Evans D, Sauceda J, Saberi P, Brown B. The dose response: perceptions of people living with HIV in the United States on alternatives to oral daily antiretroviral therapy. AIDS Res Hum Retroviruses. 2019;36(4):324–348.
   PubMed Web of Science ®Google Scholar
• FDA. The voice of the patient. 2014. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM389379.pdf.
   Google Scholar
• Namiba A, Kwardem L, Dhairyawan R, et al. From presumptive exclusion towards fair inclusion: perspectives on the involvement of women living with HIV in clinical trials, including stakeholders’ views. Ther Adv Infect Dis. 2022;9:20499361221075454.
   Web of Science ®Google Scholar
• Dubé K, Kanazawa JT, Campbell C, et al. Considerations for increasing racial, ethnic, gender and sexual diversity in HIV cure-related research with analytical treatment interruptions: a qualitative inquiry. AIDS Res Hum Retroviruses. 2022;38(1):50–63.
   PubMed Web of Science ®Google Scholar
• Baral SD, Poteat T, Strömdahl S, Wirtz AL, Guadamuz TE, Beyrer C. Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. Lancet Infect Dis. 2013;13(3):214–222.
   PubMed Web of Science ®Google Scholar
• Minalga B, Chung C, Davids J, Martin A, Perry NL, Shook A. Research on transgender people must benefit transgender people. Lancet. 2022;399(10325):628.
   PubMed Web of Science ®Google Scholar
• Poteat T, Aqil A, Corbett D, Evans D, Dubé K. I would really want to know that they had my back”: transgender women’s perceptions of HIV cure-related research in the United States. PLoS One. 2020;15(12):e0244490.
   PubMed Web of Science ®Google Scholar
• Wilkins C. Effective engagement requires trust and being trustworthy. Med Care. 2018;56(10 Suppl 1):S6–S8.
   PubMed Web of Science ®Google Scholar
• Karris MY, Dubé K, Moore AA. What lessons it might teach us? Community engagement in HIV research. Curr Opin HIV AIDS. 2019;15(2):142–149.
   Web of Science ®Google Scholar
• Hatcher A, Woollett N, Pallitto C, Garcia-Moreno C. A conceptual framework and intervention approach for addressing intimate partner violence in pregnancy. In: Withers M, Erausquin JT, eds. Global Perspectives on Women’s Reproductive and Sexual Health across the Lifecourse. New York: Springer Books; 2017:233–53.
   Google Scholar