Nationally up to 60 % of persons living with HIV are neither taking antiretroviral therapy (ART) nor well engaged in HIV care, mainly racial/ethnic minorities. This study examined a new culturally targeted multi-component intervention to address emotional, attitudinal, and social/structural barriers to ART initiation and HIV care. Participants (N = 95) were African American/Black and Latino adults with CD4 < 500 cells/mm3 not taking ART, randomized 1:1 to intervention or control arms, the latter receiving treatment as usual. Primary endpoints were adherence, evaluated via ART concentrations in hair samples, and HIV viral load suppression. The intervention was feasible and acceptable. Eight months post-baseline, intervention participants tended to be more likely to evidence “good” (that is, 7 days/week) adherence (60 vs. 26.7 %; p = 0.087; OR = 3.95), and had lower viral load levels than controls (t(22) = 2.29, p = 0.032; OR = 5.20), both large effect sizes. This highly promising intervention merits further study.
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Price includes VAT (USA)
Tax calculation will be finalised during checkout.
Granich R, Williams B, Montaner J. Fifteen million people on antiretroviral treatment by 2015: treatment as prevention. Curr Opin HIV AIDS. 2013;8(1):41–9.
Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493–505.
Buchbinder SP, Liu AY. CROI 2014: new tools to track the epidemic and prevent HIV infections. Top Antivir Med. 2014;22(2):579–93.
Doshi RK, Malebranche D, Bowleg L, Sangaramoorthy T. Health care and HIV testing experiences among Black men in the South: implications for “Seek, Test, Treat, and Retain” HIV prevention strategies. AIDS Patient Care STDS. 2013;27(2):123–33.
Mayer KH. Introduction: linkage, engagement, and retention in HIV care: essential for optimal individual- and community-level outcomes in the era of highly active antiretroviral therapy. Clin Infect Dis. 2011;52(Suppl 2):S205–7.
Montague BT, Vuylsteke B, Buve A. Sustainability of programs to reach high risk and marginalized populations living with HIV in resource limited settings: implications for HIV treatment and prevention. BMC Public Health. 2011;11:701.
Nachega JB, Uthman OA, Del Rio C, Mugavero MJ, Rees H, Mills EJ. Addressing the Achilles’ heel in the HIV care continuum for the success of a test-and-treat strategy to achieve an AIDS-free generation. Clin Infect Dis. 2014;59(Suppl 1):S21–7.
Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011;52(6):793–800.
Bradley H, Hall HI, Wolitski RJ, et al. Vital Signs: hIV diagnosis, care, and treatment among persons living with HIV—United States, 2011. MMWR Morb Mortal Wkly Rep. 2014;63(47):1113–7.
Center for Disease Control and Prevention. HIV in the United States: the stages of care. November 2014 Available at: http://www.cdc.gov/nchhstp/newsroom/docs/HIV-Stages-of-Care-Factsheet-508.pdf. Accessed 1 Dec 2014.
Beer L, Fagan JL, Garland P, et al. Medication-related barriers to entering HIV care. AIDS Patient Care STDS. 2012;26(4):214–21.
Tobias CR, Cunningham W, Cabral HD, et al. Living with HIV but without medical care: barriers to engagement. AIDS Patient Care STDS. 2007;21(6):426–34.
Kalichman SC, Graham J, Luke W, Austin J. Perceptions of health care among persons living with HIV/AIDS who are not receiving antiretroviral medications. AIDS Patient Care STDS. 2002;16(5):233–40.
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.
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. p. 451–510.
Deci EL, Ryan RM. The “what” and “why” of goal pursuits: human needs and the self-determination of behavior. Psychol Inq. 2000;11(4):227–68.
Vansteenkiste M, Sheldon KM. There’s nothing more practical than a good theory: integrating motivational interviewing and self-determination theory. Br J Clin Psychol. 2006;45(Pt 1):63–82.
van Ryn M. Research on the provider contribution to race/ethnicity disparities in medical care. Med Care. 2002;40(1 Suppl):I140–51.
Whetten K, Leserman J, Whetten R, et al. Exploring lack of trust in care providers and the government as a barrier to health service use. Am J Public Health. 2006;96(4):716–21.
Bogart LM, Thorburn S. Are HIV/AIDS conspiracy beliefs a barrier to HIV prevention among African Americans? J Acquir Immune Defic Syndr. 2005;38(2):213–8.
Shavers VL, Shavers BS. Racism and health inequity among Americans. J Natl Med Assoc. 2006;98(3):386–96.
Kreuter MW, Skinner CS, Steger-May K, et al. Responses to behaviorally vs culturally tailored cancer communication among African American women. Am J Health Behav. 2004;28(3):195–207.
Schneider TR, Salovey P, Apanovitch AM, et al. The effects of message framing and ethnic targeting on mammography use among low-income women. Health Psychol. 2001;20(4):256–66.
Barrera M Jr, Castro FG, Strycker LA, Toobert DJ. Cultural adaptations of behavioral health interventions: a progress report. J Consult Clin Psychol. 2013;81(2):196–205.
Kreuter MW, Lukwago SN, Bucholtz DC, Clark EM, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav. 2003;30(2):133–46.
Fagan JL, Beer L, Garland P, et al. The influence of perceptions of HIV infection, care, and identity on care entry. AIDS Care. 2012;24(6):737–43.
Jenness SM, Myers JE, Neaigus A, Lulek J, Navejas M, Raj-Singh S. Delayed entry into HIV medical care after HIV diagnosis: risk factors and research methods. AIDS Care. 2012;24(10):1240–8.
Udeagu CC, Webster TR, Bocour A, Michel P, Shepard CW. Lost or just not following up: public health effort to re-engage HIV-infected persons lost to follow-up into HIV medical care. AIDS. 2013;27(14):2271–9.
Kalichman SC, Catz S, Ramachandran B. Barriers to HIV/AIDS treatment and treatment adherence among African-American adults with disadvantaged education. J Natl Med Assoc. 1999;91(8):439–46.
Tugenberg T, Ware NC, Wyatt MA. Paradoxical effects of clinician emphasis on adherence to combination antiretroviral therapy for HIV/AIDS. AIDS Patient Care STDS. 2006;20(4):269–74.
Bogart LM, Wagner G, Galvan FH, Banks D. Conspiracy beliefs about HIV are related to antiretroviral treatment nonadherence among African American men with HIV. J Acquir Immune Defic Syndr. 2010;53(5):648–55.
Sandelowski M, Voils CI, Chang Y, Lee EJ. A systematic review comparing antiretroviral adherence descriptive and intervention studies conducted in the USA. AIDS Care. 2009;21(8):953–66.
Nordqvist O, Sodergard B, Tully MP, Sonnerborg A, Lindblad AK. Assessing and achieving readiness to initiate HIV medication. Patient Educ Couns. 2006;62(1):21–30.
Alfonso V, Bermbach N, Geller J, Montaner JS. Individual variability in barriers affecting people’s decision to take HAART: a qualitative study identifying barriers to being on HAART. AIDS Patient Care STDS. 2006;20(12):848–57.
Gold RS, Hinchy J, Batrouney CG. The reasoning behind decisions not to take up antiretroviral therapy in Australians infected with HIV. Int J STD AIDS. 2000;11(6):361–70.
Horne R, Cooper V, Gellaitry G, Date HL, Fisher M. Patients’ perceptions of highly active antiretroviral therapy in relation to treatment uptake and adherence: the utility of the necessity-concerns framework. J Acquir Immune Defic Syndr. 2007;45(3):334–41.
Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;58(1):e1–34.
Mugavero MJ, Lin HY, Allison JJ, et al. Failure to establish HIV care: characterizing the “no show” phenomenon. Clin Infect Dis. 2007;45(1):127–30.
Tegger MK, Crane HM, Tapia KA, Uldall KK, Holte SE, Kitahata MM. The effect of mental illness, substance use, and treatment for depression on the initiation of highly active antiretroviral therapy among HIV-infected individuals. AIDS Patient Care STDS. 2008;22(3):233–43.
Gwadz M, Applegate E, Cleland C, et al. HIV-Infected individuals who delay, decline, or discontinue antiretroviral therapy: comparing clinic- and peer-recruited cohorts. Front Public Health. 2014;2:81.
Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006;25(4):462–73.
Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Longitudinal relationships between antiretroviral treatment adherence and discrimination due to HIV-serostatus, race, and sexual orientation among African-American men with HIV. Ann Behav Med. 2010;40(2):184–90.
Pollini RA, Blanco E, Crump C, Zuniga ML. A community-based study of barriers to HIV care initiation. AIDS Patient Care STDS. 2011;25(10):601–9.
Owen-Smith A, McCarty F, Hankerson-Dyson D, Diclemente R. Prevalence and predictors of complementary and alternative medicine use in African-Americans with acquired immune deficiency syndrome. Focus Altern Complement Ther. 2012;17(1):33–42.
Catz SL, McClure JB, Jones GN, Brantley PJ. Predictors of outpatient medical appointment attendance among persons with HIV. AIDS Care. 1999;11(3):361–73.
Waldrop-Valverde D, Guo Y, Ownby RL, Rodriguez A, Jones DL. Risk and protective factors for retention in HIV care. AIDS Behav. 2014;18(8):1483–91.
Earnshaw VA, Bogart LM, Dovidio JF, Williams DR. Stigma and racial/ethnic HIV disparities: moving toward resilience. Am Psychol. 2013;68(4):225–36.
Rao KC, Enriquez M, Gantt TC, et al. Nonengagement in HIV care: a descriptive and qualitative study in hospitalized patients and community-based analysis. J Int Assoc Provid AIDS Care. 2013;12(3):178–84.
Sayles JN, Wong MD, Kinsler JJ, Martins D, Cunningham WE. The association of stigma with self-reported access to medical care and antiretroviral therapy adherence in persons living with HIV/AIDS. J Gen Intern Med. 2009;24(10):1101–8.
Sumartojo E. Structural factors in HIV prevention: concepts, examples, and implications for research. AIDS. 2000;14(Suppl 1):S3–10.
Mugavero MJ, Norton WE, Saag MS. Health care system and policy factors influencing engagement in HIV medical care: piecing together the fragments of a fractured health care delivery system. Clin Infect Dis. 2011;52(Suppl 2):S238–46.
Aidala AA, Lee G, Abramson DM, Messeri P, Siegler A. Housing need, housing assistance, and connection to HIV medical care. AIDS Behav. 2007;11(6 Suppl):101–15.
Des Jarlais DC. Structural interventions to reduce HIV transmission among injecting drug users. AIDS. 2000;14(Suppl 1):S41–6.
Cunningham WE, Andersen RM, Katz MH, et al. The impact of competing subsistence needs and barriers on access to medical care for persons with human immunodeficiency virus receiving care in the United States. Med Care. 1999;37(12):1270–81.
Riley ED, Gandhi M, Hare C, Cohen J, Hwang S. Poverty, unstable housing, and HIV infection among women living in the United States. Curr HIV/AIDS Rep. 2007;4(4):181–6.
Ickovics JR, Meade CS. Adherence to HAART among patients with HIV: breakthroughs and barriers. AIDS Care. 2002;14(3):309–18.
Craw JA, Gardner LI, Marks G, et al. Brief strengths-based case management promotes entry into HIV medical care: results of the antiretroviral treatment access study-II. J Acquir Immune Defic Syndr. 2008;47(5):597–606.
Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91–111.
Miller WR, Rollnick S. Motivational interviewing: helping people change. New York: Guilford Press; 2012.
DiMatteo MR. Social support and patient adherence to medical treatment: a meta-analysis. Health Psychol. 2004;23(2):207–18.
Resnicow K, McMaster F. Motivational Interviewing: moving from why to how with autonomy support. Int J Behav Nutr Phys Act. 2012;9:19.
Joseph-Williams N, Elwyn G, Edwards A. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns. 2014;94(3):291–309.
Piantadosi S. Clinical trials: a methodological perspective. New York: Wiley; 2005.
Liu AY, Yang QY, Huang Y, et al. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). Plos One. 2014;9(1):e83736.
Gandhi M, Ameli N, Bacchetti P, et al. Protease inhibitor levels in hair strongly predict virologic response to treatment. AIDS. 2009;23(4):471–8.
Huang Y, Gandhi M, Greenblatt RM, Gee W, Lin ET, Messenkoff N. Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry. Rapid Commun Mass Spectrom. 2008;22(21):3401–9.
Huang Y, Yang Q, Yoon K, et al. Microanalysis of the antiretroviral nevirapine in human hair from HIV-infected patients by liquid chromatography-tandem mass spectrometry. Anal Bioanal Chem. 2011;401(6):1923–33.
Hickey MD, Salmen CR, Tessler RA, et al. Antiretroviral concentrations in small hair samples as a feasible marker of adherence in rural Kenya. J Acquir Immune Defic Syndr. 2014;66(3):311–5.
Gandhi M, Ameli N, Bacchetti P, et al. Atazanavir concentration in hair is the strongest predictor of outcomes on antiretroviral therapy. Clin Infect Dis. 2011;52(10):1267–75.
National Institute on Drug Abuse. Seek, test, treat and retain for vulnerable populations: data harmonization measure (demographics measure). Available at: http://www.drugabuse.gov/sites/default/files/sttrfiles/DemographicsV.pdf. Accessed 3 Feb 2015.
Shapiro M, Morton S, McCaffrey D, et al. Variations in the care of HIV-infected adults in the United States: results from the HIV Cost and Services Utilization Study. JAMA. 1999;281(24):2305–15.
Huba GJ, Melchior LA, Staff of the Measurement Group, HRSA/HAB’s SPNS Cooperative Agreement Steering Committee. Module 26B:CES-D8 Form. Culver City: The Measurement Group, 1995. Available at: www.TheMeasurementGroup.com.
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):1008–12.
Huba GJ, Melchior LA, Staff of the Measurement Group, HRSA/HAB’s SPNS Cooperative Agreement Steering Committee. Module 11: Client Satisfaction Survey. Culver City: The Measurement Group, 1997. Available at: www.TheMeasurementGroup.com.
Beumer JH, Bosman IJ, Maes R. Hair as a biological specimen for therapeutic drug monitoring. Int J Clin Pract. 2001;55(6):353–7.
Mannheimer SB, Mukherjee R, Hirschhorn LR, et al. The CASE adherence index: a novel method for measuring adherence to antiretroviral therapy. AIDS Care. 2006;18(7):853–61.
Mugavero MJ, Amico KR, Horn T, Thompson MA. The state of engagement in HIV care in the United States: from cascade to continuum to control. Clin Infect Dis. 2013;57(8):1164–71.
Department of Health and Human Services. Clinical Care Guidelines. Available at: http://aidsinfo.nih.gov/guidelines. Accessed 21 Sept 2014.
Chinn S. A simple method for converting an odds ratio to effect size for use in meta-analysis. Stat Med. 2000;19(22):3127–31.
R Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2014.
Wagner GJ, Lovely P, Schneider S. Pilot controlled trial of the adherence readiness program: an intervention to assess and sustain HIV antiretroviral adherence readiness. AIDS Behav. 2013;17(9):3059–65.
Kalichman SC, Cherry C, Kalichman MO, et al. Integrated behavioral intervention to improve HIV/AIDS treatment adherence and reduce HIV transmission. Am J Public Health. 2011;101(3):531–8.
Parsons JT, Golub SA, Rosof E, Holder C. Motivational interviewing and cognitive-behavioral intervention to improve HIV medication adherence among hazardous drinkers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2007;46(4):443–50.
Simoni JM, Amico KR, Pearson CR, Malow R. Strategies for promoting adherence to antiretroviral therapy: a review of the literature. Curr Infect Dis Rep. 2008;10(6):515–21.
Higa DH, Marks G, Crepaz N, Liau A, Lyles CM. Interventions to improve retention in HIV primary care: a systematic review of U.S. studies. Curr HIV/AIDS Rep. 2012;9(4):313–25.
Berg KM, Arnsten JH. Practical and conceptual challenges in measuring antiretroviral adherence. J Acquir Immune Defic Syndr. 2006;43(Suppl 1):S79–87.
Kagee A, Nel A. Assessing the association between self-report items for HIV pill adherence and biological measures. AIDS Care. 2012;24(11):1448–52.
Johnson BT, Michie S, Snyder LB. Effects of behavioral intervention content on HIV prevention outcomes: a meta-review of meta-analyses. J Acquir Immune Defic Syndr. 2014;66(Suppl 3):S259–70.
Koenig LJ, Pals SL, Bush T, Pratt Palmore M, Stratford D, Ellerbrock TV. Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy. Health Psychol. 2008;27(2):159–69.
Holstad MM, DiIorio C, Kelley ME, Resnicow K, Sharma S. Group motivational interviewing to promote adherence to antiretroviral medications and risk reduction behaviors in HIV infected women. AIDS Behav. 2011;15(5):885–96.
Simoni JM, Amico KR, Smith L, Nelson K. Antiretroviral adherence interventions: translating research findings to the real world clinic. Curr HIV/AIDS Rep. 2010;7(1):44–51.
Kemppainen JK, Holzemer WL, Nokes K, et al. Self-care management of anxiety and fear in HIV disease. J Assoc Nurses AIDS Care. 2003;14(2):21–9.
Ortony A, Turner TJ. What’s basic about basic emotions. Psychol Rev. 1990;97(3):315–31.
Öhman A. Fear and anxiety: evolutionary, cognitive, and clinical perspectives. In: Haviland-Jones MLJM, editor. Handbook of emotions. New York: The Guilford Press; 2000. p. 573–93.
Gray JA. The neuropsychology of anxiety. Oxford: Oxford University Press; 1982.
Turner MM. Using emotional appeals in health messages. In: Cho H, editor. Health communication message design. Thousand Oaks: Sage Publications, Inc.; 2012. p. 59–73.
Govindasamy D, Ford N, Kranzer K. Risk factors, barriers and facilitators for linkage to antiretroviral therapy care: a systematic review. AIDS. 2012;26(16):2059–67.
Deci EL, Ryan RM. Self-determination theory: a macrotheory of human motivation, development, and health. Can Psychol. 2008;49(3):182.
Vansteenkiste M, Williams GC, Resnicow K. Toward systematic integration between self-determination theory and motivational interviewing as examples of top-down and bottom-up intervention development: autonomy or volition as a fundamental theoretical principle. Int J Behav Nutr Phys Act. 2012;9:23.
Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-infected adolescents and adults. May 2014. Available at: http://aidsinfo.nih.gov/contentfiles/adultandadolescentgl.pdf. Accessed 25 Sept 2014.
New York City Department of Health and Mental Hygiene. Antiretroviral Therapy. Available at: http://www.nyc.gov/html/doh/html/living/nyc-hivart.shtml. Accessed 1 Oct 2014.
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.
Liau A, Crepaz N, Lyles CM, et al. Interventions to promote linkage to and utilization of HIV medical care among HIV-diagnosed persons: a qualitative systematic review, 1996–2011. AIDS Behav. 2013;17(6):1941–62.
Kim JJ, Maulsby C, Kinsky S, et al. The development and implementation of the national evaluation strategy of access to care, a multi-site linkage to care initiative in the United States. AIDS Educ Prev. 2014;26(5):429–44.
Holmes-Rovner M, Kroll J, Schmitt N, et al. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Mak. 1996;16(1):58–64.
Stacey D, Bennett CL, Barry MJ, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011(10):CD001431.
Wills CE, Holmes-Rovner M. Integrating decision making and mental health interventions research: research directions. Clin Psychol. 2006;13(1):9–25.
Shechter SM, Bailey MD, Schaefer AJ, Roberts MS. The optimal time to initiate HIV therapy under ordered health states. Oper Res. 2008;56(1):20–33.
Centers for Disease Control and Prevention. HIV in the United States: At A Glance. Available at: http://www.cdc.gov/hiv/statistics/basics/ataglance.html. Accessed 10 Oct 2014.
Mohareb AM, Rothman RE, Hsieh YH. Emergency department (ED) utilization by HIV-infected ED patients in the United States in 2009 and 2010: a national estimation. HIV Med. 2013;14(10):605–13.
Parashar S, Chan K, Milan D, et al. The impact of unstable housing on emergency department use in a cohort of HIV-positive people in a Canadian setting. AIDS Care. 2014;26(1):53–64.
We wish to thank the men and women who participated in the study, the Peter Krueger Center for Immunological Disorders at Mount Sinai Beth Israel, Spencer Cox Center for Health at Mount Sinai St. Luke’s-Roosevelt Hospital Center, and Gay Men’s Health Crisis for making this study possible. Special thanks to Rob Shiau at the Peter Krueger Center and Zach Hennessey, MA at Spencer Cox for facilitating study implementation. This work would not have been possible without Lisa Sanfilippo, RN; Andrea Wagner, RN; Christopher Hilliard, MPH; Amy Braksmajer, Ph.D.; and Victoria Sharp, MD. The study was supported by the National Institutes of Mental Health (R34MH093352) and the Center for Drug Use and HIV Research (CDUHR; P30 DA011041). Dr. Monica Gandhi was supported by NIAID/NIH RO1AI098472 and we thank Drs. Yong Huang and Howard Horng, directors of the hair analysis laboratory at UCSF. We particularly wish to acknowledge our Program Officer at the National Institute of Mental Health (NIMH), Michael Stirratt, Ph.D., Program Chief at the NIMH Division of AIDS Research for scientific guidance throughout the study.
About this article
Cite this article
Gwadz, M., Cleland, C.M., Applegate, E. et al. Behavioral Intervention Improves Treatment Outcomes Among HIV-Infected Individuals Who Have Delayed, Declined, or Discontinued Antiretroviral Therapy: A Randomized Controlled Trial of a Novel Intervention. AIDS Behav 19, 1801–1817 (2015). https://doi.org/10.1007/s10461-015-1054-6
- Antiretroviral therapy
- Motivational interviewing