Impact of dedicated women’s outreach workers (WOWs) on recruitment of women in ACTG clinical studies

References

• UNAIDS. Global HIV & AIDS statistics — 2020 fact sheet. 2020.
   Google Scholar
• Hodder SL, Justman J, Hughes JP, et al. HIV acquisition among women from selected areas of the United States: a cohort study. Ann Intern Med. 2013;158(1):10–18.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Diagnoses of HIV infection in the United States and dependent areas, 2018 (updated). HIV Surveillance Report. 2020;31doi:http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html
   Google Scholar
• Scully EP. Sex Differences in HIV Infection. Curr HIV/AIDS Rep. 2018;15(2):136–146.
   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):20706.20706
   Google Scholar
• Cohn J, Ake J, Moorhouse M, Godfrey C. Sex Differences in the Treatment of HIV. Curr HIV/AIDS Rep. 2020;17(4):373–384.
   Web of Science ®Google Scholar
• Soon GG, Min M, Struble KA, et al. Meta-analysis of gender differences in efficacy outcomes for HIV-positive subjects in randomized controlled clinical trials of antiretroviral therapy (2000-2008). AIDS Patient Care STDS. 2012;26(8):444–453.
   PubMed Web of Science ®Google Scholar
• d'Arminio Monforte A, González L, Haberl A, Sherr L, Ssanyu-Sseruma W, Walmsley SL. Better mind the gap: addressing the shortage of HIV-positive women in clinical trials. Aids. 2010;24(8):1091–1094.
   Web of Science ®Google Scholar
• Gong IY, Tan NS, Ali SH, et al. Temporal trends of women enrollment in major cardiovascular randomized clinical trials. Can J Cardiol. 2019;35(5):653–660.
   PubMed Web of Science ®Google Scholar
• Khan SU, Khan MZ, Raghu Subramanian C, et al. Participation of women and older participants in randomized clinical trials of lipid-lowering therapies: a systematic review. JAMA Netw Open. 2020;3(5):e205202.
   Web of Science ®Google Scholar
• Kwiatkowski K, Coe K, Bailar JC, Swanson GM. Inclusion of minorities and women in cancer clinical trials, a decade later: Have we improved? Cancer 2013;119(16):2956–2963.
   PubMed Web of Science ®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
• Sullivan KA, Little MO, Rosenberg NE, et al. Women's views about contraception requirements for biomedical research participation. PLoS One. 2019;14(5):e0216332.
   Web of Science ®Google Scholar
• Gandhi M, Ameli N, Bacchetti P, et al. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. Aids. 2005;19(16):1885–1896.
   PubMed Web of Science ®Google Scholar
• Fabian KE, Huh D, Kemp CG, et al. Moderating Factors in an Anti-stigma Intervention for African American Women with HIV in the United States: A Secondary Analysis of the UNITY Trial. AIDS Behav. 2019;23(9):2432–2442.
   Web of Science ®Google Scholar
• Gollub EL. Human rights is a US problem, too: the case of women and HIV. Am J Public Health. 1999;89(10):1479–1482.
   PubMed Web of Science ®Google Scholar
• Jones BL, Vyhlidal CA, Bradley-Ewing A, Sherman A, Goggin K. If we would only ask: how Henrietta lacks continues to teach us about perceptions of research and genetic research among African Americans today. J Racial Ethn Health Disparities. 2017;4(4):735–745.
   PubMed Web of Science ®Google Scholar
• Brincks AM, Shiu-Yee K, Metsch LR, et al. Physician mistrust, medical system mistrust, and perceived discrimination: associations with HIV care engagement and viral load. AIDS Behav. 2019;23(10):2859–2869.
   PubMed Web of Science ®Google Scholar
• ACTG Network. About the ACTG. https://actgnetwork.org/about-the-actg/
   Google Scholar
• Smeaton LM, Kacanek D, Mykhalchenko K, et al. Screening and enrollment by sex in human immunodeficiency virus clinical trials in the United States. Clin Infect Dis 2020;71(5):1300–1305.
   Web of Science ®Google Scholar
• ACTG Network. Understanding the importance of women and minorities participating in ACTG network clinical trials. 2016. https://www.youtube.com/watch?v=jmaaMv1PalA
   Google Scholar
• Kalichman S, Shkembi B, Hernandez D, Katner H, Thorson KR. Income inequality, HIV stigma, and preventing HIV disease progression in rural communities. Prev Sci. 2019;20(7):1066–1073.
   Web of Science ®Google Scholar
• Willie TC, Stockman JK, Perler R, Kershaw TS. Associations between intimate partner violence, violence-related policies, and HIV diagnosis rate among women in the United States. Ann Epidemiol. 2018;28(12):881–885.
   Web of Science ®Google Scholar
• Goff SL, Youssef Y, Pekow PS, et al. Successful strategies for practice-based recruitment of racial and ethnic minority pregnant women in a randomized controlled trial: the IDEAS for a healthy baby study. J Racial and Ethnic Health Disparities. 2016;3(4):731–737.
   Web of Science ®Google Scholar
• Peindl KS, Wisner KL. Successful recruitment strategies for women in postpartum mental health trials. J Psychiatr Res. 2003;37(2):117–125.
   Web of Science ®Google Scholar
• Aguirre TM, Koehler AE, Joshi A, Wilhelm SL. Recruitment and retention challenges and successes. Ethn Health. 2018;23(1):111–119.
   PubMed Web of Science ®Google Scholar
• King DW, Duello TM, Miranda PY, et al. Strategies for recruitment of healthy premenopausal women into the African American Nutrition for Life (A NULIFE) study. J Womens Health (Larchmt). 2010;19(5):855–862.
   PubMed Web of Science ®Google Scholar
• Braun LA, Kennedy HP, Sadler LS, Dixon J, Research On US. Research on U.S. military women: recruitment and retention challenges and strategies. Mil Med. 2015;180(12):1247–1255.
   Web of Science ®Google Scholar
• Leonard A, Hutchesson M, Patterson A, Chalmers K, Collins C. Recruitment and retention of young women into nutrition research studies: practical considerations. Trials 2014;15(1):23.
   PubMed Web of Science ®Google Scholar
• Webster K, Carter A, Proulx-Boucher K, et al. Strategies for recruiting women living with human immunodeficiency virus in community-based research: lessons from Canada. Prog Community Health Partnersh. 2018;12(1):21–34.
   PubMedGoogle Scholar
• Loutfy MR, V LK, Mohammed S, et al. Recruitment of HIV-positive women in research: discussing barriers, facilitators, and research personnel's knowledge. TOAIDJ 2014;8(1):58–65.
   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 (Larchmt). 2011;20(7):1043–1050.
   PubMed Web of Science ®Google Scholar
• DeMarco RF, Lanier LR. The concept of "silencing the self" in low-income, aging, HIV-infected African American women: a 10-year community-based participatory program of research with results. J Assoc Nurses AIDS Care. 2014;25(2):112–122.
   Web of Science ®Google Scholar
• Radix A, Sevelius J, Deutsch MB. Transgender women, hormonal therapy and HIV treatment: a comprehensive review of the literature and recommendations for best practices. J Int AIDS Soc. 2016;19(3 Suppl 2):20810.20810
   PubMedGoogle Scholar
• Kemp CG, Lipira L, Huh D, et al. HIV stigma and viral load among African-American women receiving treatment for HIV. Aids. 2019;33(9):1511–1519.
   PubMed Web of Science ®Google Scholar
• Aldous A, Magnus M, Roberts A, et al. Challenges in conducting research on sexual violence and HIV and approaches to overcome them. Am J Reprod Immunol. 2017;78(1):e12699.
   Web of Science ®Google Scholar
• Smith LR, Yore J, Triplett DP, et al. Impact of Sexual Violence Across the Lifespan on HIV Risk Behaviors Among Transgender Women and Cisgender People Living With HIV. J Acquir Immune Defic Syndr. 2017;75(4):408–416.
   Web of Science ®Google Scholar
• Tenkorang EY, Asamoah-Boaheng M, Owusu AY. Intimate Partner Violence (IPV) Against HIV-Positive Women in Sub-Saharan Africa: A Mixed-Method Systematic Review and Meta-Analysis. Trauma Violence Abuse. Advance online publication. 2020.
   Google Scholar
• Harrison SE, Brown M, Cho H. Links between sexual trauma exposure and Quality of Life (QoL) domains among people living with HIV in the Southern United States. AIDS Care. 2020;32(sup2):91–98.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Emergency contraception. 2018.
   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 5366. AIDS Res Hum Retroviruses. 2020;36(4):268–282.
   PubMed Web of Science ®Google Scholar
• Tannenbaum C, Schwarz JM, Clayton JA, de Vries GJ, Sullivan C. Evaluating sex as a biological variable in preclinical research: the devil in the details. Biol Sex Differ. 2016;7:13.
   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;6(3):e147–e149.
   PubMed Web of Science ®Google Scholar
• Kaida A, Carter A, Nicholson V, et al. Hiring, training, and supporting peer research associates: operationalizing community-based research principles within epidemiological studies by, with, and for women living with HIV. Harm Reduct J. 2019;16(1):47.
   PubMedGoogle Scholar
• Kennedy T, Teti M, Hayes D, Pichon LC, Farnan R. Unmasked to a positive triumph": women with HIV share the benefits of showing their faces through photovoice. Prog Community Health Partnersh. 2016;10(4):505–513.
   Google Scholar
• Rao D, Andrasik MP, Lipira L. HIV stigma among black women in the United States: intersectionality, support, resilience. Am J Public Health. 2018;108(4):446–448.
   PubMed Web of Science ®Google Scholar
• McCree DH, Chesson H, Bradley ELP, Lima A, Fugerson AG. US regional changes in racial/ethnic disparities in HIV diagnoses among women in the United States, 2012 and 2017. AIDS Behav. 2020;24(4):1118–1123.
   Web of Science ®Google Scholar
• Reisner SL, Chaudhry A, Cooney E, Garrison-Desany H, Juarez-Chavez E, Wirtz AL. It all dials back to safety': A qualitative study of social and economic vulnerabilities among transgender women participating in HIV research in the USA. BMJ Open. 2020;10(1):e029852.
   PubMed Web of Science ®Google Scholar
• Erickson M, Shannon K, Sernick A, et al. Women, incarceration and HIV: a systematic review of HIV treatment access, continuity of care and health outcomes across incarceration trajectories. Aids. 2019;33(1):101–111.
   PubMed Web of Science ®Google Scholar
• Sullivan KA, Schultz K, Ramaiya M, Berger M, Parnell H, Quinlivan EB. Experiences of women of color with a nurse patient navigation program for linkage and engagement in HIV care. AIDS Patient Care STDS. 2015;29(S1):S49–S54.
   Google Scholar
• Byrd KK, Hardnett F, Clay PG, et al. Retention in HIV care among participants in the patient-centered HIV care model: a collaboration between community-based pharmacists and primary medical providers. AIDS Patient Care STDS. 2019;33(2):58–66.
   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. 2020;15(2):142–149.
   PubMed Web of Science ®Google Scholar
• Lessard D, Engler K, Vicente S, Bilodeau M, Lebouché B. Challenges of patient engagement in an HIV clinical research program: a qualitative analysis of stakeholder accounts. J Patient Exp. 2020;7(6):925–930.
   Google Scholar
• King WD, Defreitas D, Smith K, et al. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study. AIDS Patient Care STDS. 2007;21(8):551–563.
   Web of Science ®Google Scholar
• Geter A, Sutton MY, Hubbard McCree D. Social and structural determinants of HIV treatment and care among black women living with HIV infection: a systematic review: 2005-2016. AIDS Care. 2018;30(4):409–416.
   PubMed Web of Science ®Google Scholar
• Erves JC, Mayo-Gamble TL, Malin-Fair A, et al. Needs, priorities, and recommendations for engaging underrepresented populations in clinical research: a community perspective. J Commun. Health. 2017;42(3):472–480.
   PubMed Web of Science ®Google Scholar
• Siskind RL, Andrasik M, Karuna ST, et al. Engaging transgender people in NIH-funded HIV/AIDS clinical trials research. J Acquir Immune Defic Syndr. 2016;72(3):S243–S7.
   Google Scholar
• Jaiswal J, Singer SN, Siegel K, Lekas HM. HIV-related 'conspiracy beliefs': lived experiences of racism and socio-economic exclusion among people living with HIV in New York City. Cult Health Sex. 2019;21(4):373–386.
   PubMed Web of Science ®Google Scholar