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ACT2 Peer-Driven Intervention Increases Enrollment into HIV/AIDS Medical Studies Among African Americans/Blacks and Hispanics: A Cluster Randomized Controlled Trial

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Abstract

African American/Black and Hispanic persons living with HIV/AIDS (“AABH-PLHA”) are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N = 540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3 % vs. 3.7 %; p < .001). Half (55.5 %) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7 %), almost all into observational studies (95.2 %), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions.

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References

  1. Castillo-Mancilla J, Cohn S, Krishnan S, et al. Minorities remain underrepresented in HIV/AIDS research despite access to clinical trials. HIV Clin Trials. 2014;15(1):14–26.

    Article  PubMed  Google Scholar 

  2. National Institute of Allergy and Infectious Diseases [NIAID]. HIV infection in minority populations 2008. http://www.niaid.nih.gov/topics/HIVAIDS/Understanding/PopulationSpecificInformation/Pages/minorityPopulations.aspx. Accessed 31 July 2013.

  3. Ortiz AP, Colon-Lopez V, Girona-Lozada G, et al. Report of the 2012 Capacity building for HIV-HPV clinical trials recruitment among minority underserved populations of Hispanic origin in Puerto Rico. P R Health Sci J. 2012;31(3):185–7.

    PubMed Central  PubMed  Google Scholar 

  4. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med. 2002;346(18):1373–82.

    Article  PubMed  Google Scholar 

  5. Gwadz MV, Colon P, Ritchie AS, et al. Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials. Curr HIV/AIDS Rep. 2010;7(4):194–200.

    Article  PubMed Central  PubMed  Google Scholar 

  6. Menezes P, Eron JJ, Leone PA, Adimora AA, Wohl DA, Miller WC. Recruitment of HIV/AIDS treatment-naive patients to clinical trials in the highly active antiretroviral therapy era: influence of gender, sexual orientation and race. HIV Med. 2011;12(3):183–91.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  7. Gwadz MV, Leonard NR, Cleland CM, et al. The effect of peer-driven intervention on rates of screening for AIDS clinical trials among African Americans and Hispanics. Am J Public Health. 2011;101(6):1096–102.

    Article  PubMed Central  PubMed  Google Scholar 

  8. Gulick RM, Su Z, Flexner C, et al. Phase 2 study of the safety and efficacy of vicriviroc, a CCR5 inhibitor, in HIV-1-Infected, treatment-experienced patients: AIDS clinical trials group 5211. J Infect Dis. 2007;196(2):304–12.

    Article  CAS  PubMed  Google Scholar 

  9. Wojna V, Skolasky RL, Hechavarria R, et al. Prevalence of human immunodeficiency virus-associated cognitive impairment in a group of Hispanic women at risk for neurological impairment. J Neurovirol. 2006;12(5):356–64.

    Article  PubMed  Google Scholar 

  10. McLaren PJ, Ripke S, Pelak K, et al. Fine-mapping classical HLA variation associated with durable host control of HIV-1 infection in African Americans. Hum Mol Genet. 2012;21(19):4334–47.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  11. Bacon MC, von Wyl V, Alden C, et al. The Women’s Interagency HIV Study: an observational cohort brings clinical sciences to the bench. Clin Diagn Lab Immunol. 2005;12(9):1013–9.

    CAS  PubMed Central  PubMed  Google Scholar 

  12. Corbie-Smith G, Odeneye E, Banks B, Shandor Miles M, Roman Isler M. Development of a multilevel intervention to increase HIV clinical trial participation among rural minorities. Health Educ Behav. 2013;40(3):274–85.

    Article  PubMed Central  PubMed  Google Scholar 

  13. Freedberg KA, Sullivan L, Georgakis A, Savetsky J, Stone V, Samet JH. Improving participation in HIV clinical trials: impact of a brief intervention. HIV Clin Trials. 2001;2(3):205–12.

    Article  CAS  PubMed  Google Scholar 

  14. Gwadz M, Cleland CM, Leonard NR, et al. Predictors of screening for AIDS clinical trials among African-Americans and Latino/Hispanics enrolled in an efficacious peer-driven intervention: uncovering socio-demographic, health, and substance use-related factors that promote or impede screening. AIDS Behav. 2013;17(2):801–12.

    Article  PubMed Central  PubMed  Google Scholar 

  15. Gwadz MV, Leonard NR, Nakagawa A, et al. Gender differences in attitudes toward AIDS clinical trials among urban HIV-infected individuals from racial and ethnic minority backgrounds. AIDS Care. 2006;18(7):786–94.

    Article  CAS  PubMed  Google Scholar 

  16. Russell SL, Katz RV, Wang MQ, et al. Belief in AIDS origin conspiracy theory and willingness to participate in biomedical research studies: findings in whites, blacks, and Hispanics in seven cities across two surveys. HIV Clin Trials. 2011;12(1):37–47.

    Article  PubMed Central  PubMed  Google Scholar 

  17. Stone VE, Mauch MY, Steger K, Janas SF, Craven DE. Race, gender, drug use, and participation in AIDS clinical trials. Lessons from a municipal hospital cohort. J Gen Intern Med. 1997;12(3):150–7.

    CAS  PubMed Central  PubMed  Google Scholar 

  18. Durant RW, Legedza AT, Marcantonio ER, Freeman MB, Landon BE. Different types of distrust in clinical research among Whites and African Americans. J Natl Med Assoc. 2011;103(2):123–30.

    PubMed Central  PubMed  Google Scholar 

  19. Sullivan PS, McNaghten AD, Begley E, Hutchinson A, Cargill VA. Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. J Natl Med Assoc. 2007;99(3):242–50.

    PubMed Central  PubMed  Google Scholar 

  20. Wendler D, Kington R, Madans J, et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2006;3(2):e19.

    Article  PubMed Central  PubMed  Google Scholar 

  21. Simoni JM, Huh D, Wilson IB, et al. Racial/ethnic disparities in ART adherence in the United States: findings from the MACH14 study. J Acquir Immune Defic Syndr. 2012;60(5):466–72.

    Article  PubMed Central  PubMed  Google Scholar 

  22. Kyser M, Buchacz K, Bush TJ, et al. Factors associated with non-adherence to antiretroviral therapy in the SUN study. AIDS Care. 2011;23(5):601–11.

    Article  PubMed  Google Scholar 

  23. Feinberg J, Saag M, Squires K, et al. Health-related quality of life in the gender, race, and clinical experience trial. AIDS Res Treat. 2011;2011:349165.

    PubMed Central  PubMed  Google Scholar 

  24. Anastasi JK, Capili B, Kim GH, Chung A. Clinical trial recruitment and retention of a vulnerable population: HIV patients with chronic diarrhea. Gastroenterol Nurs. 2005;28(6):463–8.

    Article  PubMed  Google Scholar 

  25. Ickovics JR, Meisler AW. Adherence in AIDS clinical trials: a framework for clinical research and clinical care. J Clin Epidemiol. 1997;50(4):385–91.

    Article  CAS  PubMed  Google Scholar 

  26. Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006;83(2):139–41.

    Article  PubMed Central  PubMed  Google Scholar 

  27. Bradford JB, Coleman S, Cunningham W. HIV system navigation: an emerging model to improve HIV care access. AIDS Patient Care STDS. 2007;21(Suppl 1):S49–58.

    PubMed  Google Scholar 

  28. Broadhead RS, Volkanevsky VL, Rydanova T, et al. Peer-driven HIV interventions for drug injectors in Russia: first year impact results of a field experiment. Intl J Drug Policy. 2006;17(5):379–92.

    Article  Google Scholar 

  29. Flay BR, Snyder F, Petraitis J. The theory of triadic influence. In: DiClimente RJ, Kegler MC, Crosby RA, editors. Emerging theories in health promotion practice and research. New York: Jossey-Bass; 2009.

    Google Scholar 

  30. Heckathorn DD. Respondent-driven sampling: a new approach to the study of hidden populations. Soc Probl. 1997;44(2):174–99.

    Article  Google Scholar 

  31. Miller W, Rollnick S. Motivational interviewing: preparing people for change. 2nd ed. New York: Guilford; 2002.

    Google Scholar 

  32. Leonard NR, Banfield A, Riedel M, et al. Description of an efficacious behavioral peer-driven intervention to reduce racial/ethnic disparities in AIDS clinical trials. Health Educ Res. 2013;28(4):574–90.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  33. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):834–40.

    Article  PubMed  Google Scholar 

  34. Engel S, Cleland CM. The experience of screening for HIV/AIDS medical studies among African-American/Black and Latino/Hispanic persons living with HIV/AIDS: a mixed-methods exploration. J AIDS Clin Res. 2013;4:223.

    Article  Google Scholar 

  35. 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):1885–96.

    Article  PubMed  Google Scholar 

  36. Marshak A, Costantini G, Middleton S, et al. Screening for AIDS clinical trials in the project ACT cohort of racial/ethnic minorities and women in New York City: substantial interest but low eligibility. In: 4th International AIDS Society Conference, Sydney; 2007.

  37. Hays RD, Spritzer KL, McCaffrey D, et al. The HIV cost & services utilization study (HCSUS) measures of health-related quality of life. Santa Monica: Rand; 1998.

    Google Scholar 

  38. Derogatis L, Melisaratos N. The brief symptom inventory: an introductory report. Psychol Med. 1983;13:595–605.

    Article  CAS  PubMed  Google Scholar 

  39. Des Jarlais DC, Friedman SR, Novick DM, et al. HIV-1 infection among intravenous drug users in Manhattan, New York City, from 1977 through 1987. JAMA. 1989;261(7):1008–112.

    Article  CAS  PubMed  Google Scholar 

  40. Fleiss JL. Measuring nominal scale agreement among many raters. Psychol Bull. 1971;76:378–82.

    Article  Google Scholar 

  41. Albert A, Anderson A. On the existence of maximum likelihood estimates in logistic regression models. Biometrika. 1984;71:1–10.

    Article  Google Scholar 

  42. Firth D. Bias reduction of maximum likelihood estimates. Biometrika. 1993;80:27–38.

    Article  Google Scholar 

  43. Fay MP. Two-sided exact tests and matching confidence intervals for discrete data. R J. 2010;2(1):53–8.

    Google Scholar 

  44. Burger JM. The foot-in-the-door compliance procedure: a multiple-process analysis and review. Pers Soc Psychol Rev. 1999;3(4):303–25.

    Article  CAS  PubMed  Google Scholar 

  45. Gwadz MV, Cylar K, Leonard NR, et al. An exploratory behavioral intervention trial to improve rates of screening for AIDS clinical trials among racial/ethnic minority and female persons living with HIV/AIDS. AIDS Behav. 2010;14(3):639–48.

    Article  PubMed  Google Scholar 

  46. Penberthy L, Brown R, Wilson-Genderson M, Dahman B, Ginder G, Siminoff LA. Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment. Clin Trials. 2012;9(6):788–97.

    Article  PubMed  Google Scholar 

  47. Collins LM, Baker TB, Mermelstein RJ, et al. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011;41(2):208–26.

    Article  PubMed Central  PubMed  Google Scholar 

  48. Murphy SA. An experimental design for the development of adaptive treatment strategies. Stat Med. 2005;24(10):1455–81.

    Article  CAS  PubMed  Google Scholar 

  49. Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy S. A “SMART” design for building individualized treatment sequences. Ann Rev Clin Psychol. 2012;8:21–48.

    Article  CAS  Google Scholar 

  50. Hall HI, Frazier EL, Rhodes P, et al. Differences in human immunodeficiency virus care and treatment among subpopulations in the United States. JAMA Intern Med. 2013;173(14):1337–44.

    Article  PubMed  Google Scholar 

  51. Torian LV, Wiewel EW. Continuity of HIV-related medical care, New York City, 2005–2009: do patients who initiate care stay in care? AIDS Patient Care STDS. 2011;25(2):79–88.

    Article  PubMed  Google Scholar 

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Acknowledgments

This study was supported by a Grant from the National Institute of Allergy and Infectious Diseases (R01AI070005) and the Center for Drug Use and HIV Research (P30DA011041) at the New York University College of Nursing. The project is dedicated to the memory of Keith Cylar, MSW, Co-founder and Co-chief Executive Officer of Housing Works, Inc. We would like to thank the men and women who participated in the study, Amy Braksmajer, Ph.D. and Christopher Hilliard, MPH for editorial assistance, Dr. Usha Sharma, the study’s Program Officer, and members of the ACT2 Collaborative Research Team: Michael Aguirre, Noreen Boadi, MA, DeShannon Bowens, MA, Patricia Chang, MA, Gwen Costantini, FNP-C, Rebecca de Guzman, Ph.D., Ann Marshak, Sondra Middleton, PA-C, Corinne Munoz-Plaza, MPH, Maya Tharaken, MSSW, Robert Quiles, and Mougeh Yasai, MA.

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Authors and Affiliations

  1. Center for Drug Use and HIV Research, New York University College of Nursing, 726 Broadway, 10th Floor, New York, NY, 10003, USA

    Marya Gwadz, Charles M. Cleland, Mindy Belkin, Amanda Ritchie, Noelle Leonard, Angela Banfield & Pablo Colon

  2. School of Social Work, Columbia University, New York, NY, USA

    Marion Riedel

  3. National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

    Vanessa Elharrar & Jonathan Kagan

  4. Division of Infectious Diseases, Mt. Sinai Beth Israel Medical Center, New York, NY, USA

    Donna Mildvan

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  1. Marya Gwadz
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Correspondence to Marya Gwadz.

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Gwadz, M., Cleland, C.M., Belkin, M. et al. ACT2 Peer-Driven Intervention Increases Enrollment into HIV/AIDS Medical Studies Among African Americans/Blacks and Hispanics: A Cluster Randomized Controlled Trial. AIDS Behav 18, 2409–2422 (2014). https://doi.org/10.1007/s10461-014-0829-5

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