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Erschienen in: AIDS and Behavior 9/2019

22.08.2019 | Editorial

When is Enough, Enough? How the Absence of Dose-Determination Trials Impedes Implementation of HIV Behavioral Interventions

verfasst von: Seth C. Kalichman

Erschienen in: AIDS and Behavior | Ausgabe 9/2019

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Abstract

Carefully controlled clinical trials have determined that theory-based behavioral interventions delivered by adherence nurses, professional and paraprofessional counselors, and case managers improve ART adherence and viral suppression. However, there are no studies that empirically inform how much intervention is needed for which patient populations and at what cost. This Editorial raises the issue of how a lack of intervention dosing limits interpretation of trial results and impedes implementation, therefore calling for behavioral intervention dose-finding studies.
Literatur
1.
Zurück zum Zitat 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.CrossRef 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.CrossRef
2.
Zurück zum Zitat Crepaz N, Tang T, Marks G, Mugavero MJ, Espinoza L, Hall HI. Durable viral suppression and transmission risk potential among persons with diagnosed HIV infection: United States, 2012–2013. Clin Infect Dis. 2016;63(7):976–83.CrossRef Crepaz N, Tang T, Marks G, Mugavero MJ, Espinoza L, Hall HI. Durable viral suppression and transmission risk potential among persons with diagnosed HIV infection: United States, 2012–2013. Clin Infect Dis. 2016;63(7):976–83.CrossRef
3.
Zurück zum Zitat Marks G, Patel U, Stirratt MJ, Mugavero MJ, Mathews WC, Giordano TP, et al. Single viral load measurements overestimate stable viral suppression among HIV patients in care: clinical and public health implications. J Acquir Immune Defic Syndr. 1999;73(2):205.CrossRef Marks G, Patel U, Stirratt MJ, Mugavero MJ, Mathews WC, Giordano TP, et al. Single viral load measurements overestimate stable viral suppression among HIV patients in care: clinical and public health implications. J Acquir Immune Defic Syndr. 1999;73(2):205.CrossRef
4.
Zurück zum Zitat Marks G, Gardner LI, Rose CE, Zinski A, Moore RD, Holman S, et al. Time above 1500 copies: a viral load measure for assessing transmission risk of HIV-positive patients in care. AIDS. 2015;29(8):947–54.CrossRef Marks G, Gardner LI, Rose CE, Zinski A, Moore RD, Holman S, et al. Time above 1500 copies: a viral load measure for assessing transmission risk of HIV-positive patients in care. AIDS. 2015;29(8):947–54.CrossRef
5.
Zurück zum Zitat Iwuji C, Newell ML. Towards control of the global HIV epidemic: addressing the middle-90 challenge in the UNAIDS 90-90-90 target. PLoS Med. 2017;14(5):e1002293.CrossRef Iwuji C, Newell ML. Towards control of the global HIV epidemic: addressing the middle-90 challenge in the UNAIDS 90-90-90 target. PLoS Med. 2017;14(5):e1002293.CrossRef
6.
Zurück zum Zitat Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, et al. Working group on modelling of antiretroviral therapy monitoring strategies in Sub-Saharan Africa sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015;528(7580):S68–76.CrossRef Phillips A, Shroufi A, Vojnov L, Cohn J, Roberts T, et al. Working group on modelling of antiretroviral therapy monitoring strategies in Sub-Saharan Africa sustainable HIV treatment in Africa through viral-load-informed differentiated care. Nature. 2015;528(7580):S68–76.CrossRef
7.
Zurück zum Zitat Charania, Marshall KJ, Lyles CM, Crepaz N, Kay LS, Koenig LJ, et al. Identification of evidence-based interventions for promoting HIV medication adherence: findings from a systematic review of U.S.-based studies, 1996–2011. AIDS Behav. 2014;18(4):646–60.CrossRef Charania, Marshall KJ, Lyles CM, Crepaz N, Kay LS, Koenig LJ, et al. Identification of evidence-based interventions for promoting HIV medication adherence: findings from a systematic review of U.S.-based studies, 1996–2011. AIDS Behav. 2014;18(4):646–60.CrossRef
8.
Zurück zum Zitat Kunutsor S, Walley J, Katabira E, Muchuro S, Balidawa H, Namagala E, et al. Improving clinic attendance and adherence to antiretroviral therapy through a treatment supporter intervention in Uganda: a randomized controlled trial. AIDS Behav. 2011;15(8):1795–802.CrossRef Kunutsor S, Walley J, Katabira E, Muchuro S, Balidawa H, Namagala E, et al. Improving clinic attendance and adherence to antiretroviral therapy through a treatment supporter intervention in Uganda: a randomized controlled trial. AIDS Behav. 2011;15(8):1795–802.CrossRef
9.
Zurück zum Zitat Haberer JE, Sabin L, Amico KR, Orrell C, Galarraga O, Tsai AC, et al. Improving antiretroviral therapy adherence in resource-limited settings at scale: a discussion of interventions and recommendations. J Int AIDS Soc. 2017;20(1):21371.CrossRef Haberer JE, Sabin L, Amico KR, Orrell C, Galarraga O, Tsai AC, et al. Improving antiretroviral therapy adherence in resource-limited settings at scale: a discussion of interventions and recommendations. J Int AIDS Soc. 2017;20(1):21371.CrossRef
10.
Zurück zum Zitat Shaw S, Amico KR. Antiretroviral therapy adherence enhancing interventions for adolescents and young adults 13–24 years of age: a review of the evidence base. J Acquir Immune Defic Syndr. 2016;72(4):387–99.CrossRef Shaw S, Amico KR. Antiretroviral therapy adherence enhancing interventions for adolescents and young adults 13–24 years of age: a review of the evidence base. J Acquir Immune Defic Syndr. 2016;72(4):387–99.CrossRef
12.
Zurück zum Zitat Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load. A meta-analytic review of randomized controlled trials. J Acquir Immune Defic Syndr. 1999;43(01):S23. Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load. A meta-analytic review of randomized controlled trials. J Acquir Immune Defic Syndr. 1999;43(01):S23.
13.
Zurück zum Zitat Voils CI, Chang Y, Crandell J, Leeman J, Sandelowski M, Maciejewski ML. Informing the dosing of interventions in randomized trials. Contemp Clin Trials. 2012;33(6):1225–30.CrossRef Voils CI, Chang Y, Crandell J, Leeman J, Sandelowski M, Maciejewski ML. Informing the dosing of interventions in randomized trials. Contemp Clin Trials. 2012;33(6):1225–30.CrossRef
14.
Zurück zum Zitat Voils CI, King HA, Maciejewski ML, Allen KD, Yancy WS Jr, Shaffer JA. Approaches for informing optimal dose of behavioral interventions. Ann Behav Med. 2014;48(3):392–401.CrossRef Voils CI, King HA, Maciejewski ML, Allen KD, Yancy WS Jr, Shaffer JA. Approaches for informing optimal dose of behavioral interventions. Ann Behav Med. 2014;48(3):392–401.CrossRef
15.
Zurück zum Zitat Kalichman SC, Kalichman MO, Cherry C, Eaton LA, Cruess D, Schinazi RF. Randomized factorial trial of phone-delivered support counseling and daily text message reminders for HIV treatment adherence. J Acquir Immune Defic Syndr. 2016;73(1):47–54.CrossRef Kalichman SC, Kalichman MO, Cherry C, Eaton LA, Cruess D, Schinazi RF. Randomized factorial trial of phone-delivered support counseling and daily text message reminders for HIV treatment adherence. J Acquir Immune Defic Syndr. 2016;73(1):47–54.CrossRef
16.
Zurück zum Zitat Citrome L, Reist C, Palmer L, Montejano L, Lenhart G, Cuffel B, et al. Dose trends for second-generation antipsychotic treatment of schizophrenia and bipolar disorder. Schizophr Res. 2009;108(1–3):238–44.CrossRef Citrome L, Reist C, Palmer L, Montejano L, Lenhart G, Cuffel B, et al. Dose trends for second-generation antipsychotic treatment of schizophrenia and bipolar disorder. Schizophr Res. 2009;108(1–3):238–44.CrossRef
17.
Zurück zum Zitat Hansen NB, Lambert MJ. An evaluation of the dose-response relationship in naturalistic treatment settings using survival analysis. Mental Health Serv Res. 2003;5(1):1–12.CrossRef Hansen NB, Lambert MJ. An evaluation of the dose-response relationship in naturalistic treatment settings using survival analysis. Mental Health Serv Res. 2003;5(1):1–12.CrossRef
18.
Zurück zum Zitat Cook PF, Emiliozzi S, McCabe MM. Telephone counseling to improve osteoporosis treatment adherence: an effectiveness study in community practice settings. Am J Med Qual. 2007;22(6):445–56.CrossRef Cook PF, Emiliozzi S, McCabe MM. Telephone counseling to improve osteoporosis treatment adherence: an effectiveness study in community practice settings. Am J Med Qual. 2007;22(6):445–56.CrossRef
19.
Zurück zum Zitat Ivanova A. A new dose-finding design for bivariate outcomes. Biometrics. 2003;59(4):1001–7.CrossRef Ivanova A. A new dose-finding design for bivariate outcomes. Biometrics. 2003;59(4):1001–7.CrossRef
20.
Zurück zum Zitat Ivanova A, Xiao C, Tymofyeyev Y. Two-stage designs for Phase 2 dose-finding trials. Stat Med. 2012;31(24):2872–81.CrossRef Ivanova A, Xiao C, Tymofyeyev Y. Two-stage designs for Phase 2 dose-finding trials. Stat Med. 2012;31(24):2872–81.CrossRef
21.
Zurück zum Zitat Administration FaD. Harmonisation International Conference; guidelines availability: Dose-response information to support drug registration. Federal Register: US Government; 1994. Administration FaD. Harmonisation International Conference; guidelines availability: Dose-response information to support drug registration. Federal Register: US Government; 1994.
22.
Zurück zum Zitat Pinkerton SD, Holtgrave DR. The cost-effectiveness of HIV prevention from a managed care perspective. J Public Health Manag Pract. 1998;4(1):59–66.CrossRef Pinkerton SD, Holtgrave DR. The cost-effectiveness of HIV prevention from a managed care perspective. J Public Health Manag Pract. 1998;4(1):59–66.CrossRef
23.
Zurück zum Zitat Kurth AE, Spielberg F, Cleland CM, Lambdin B, Bangsberg DR, Frick PA, et al. Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial. J Acquir Immune Defic Syndr. 2014;65(5):611–20.CrossRef Kurth AE, Spielberg F, Cleland CM, Lambdin B, Bangsberg DR, Frick PA, et al. Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial. J Acquir Immune Defic Syndr. 2014;65(5):611–20.CrossRef
24.
Zurück zum Zitat Remien RH, Stirratt MJ, Dolezal C, Dognin JS, Wagner GJ, Carballo-Dieguez A, et al. Couple-focused support to improve HIV medication adherence: a randomized controlled trial. AIDS. 2005;19(8):807–14.CrossRef Remien RH, Stirratt MJ, Dolezal C, Dognin JS, Wagner GJ, Carballo-Dieguez A, et al. Couple-focused support to improve HIV medication adherence: a randomized controlled trial. AIDS. 2005;19(8):807–14.CrossRef
25.
Zurück zum Zitat Kalichman SC, Cherry C, Kalichman MO, Amaral CM, White D, Pope H, et al. Integrated behavioral intervention to improve HIV/AIDS treatment adherence and reduce HIV transmission. Am J Public Health. 2011;101(3):531–8.CrossRef Kalichman SC, Cherry C, Kalichman MO, Amaral CM, White D, Pope H, et al. Integrated behavioral intervention to improve HIV/AIDS treatment adherence and reduce HIV transmission. Am J Public Health. 2011;101(3):531–8.CrossRef
26.
Zurück zum Zitat Hoffmann CJ, Mabuto T, Ginindza S, Fielding KL, Kubeka G, Dowdy DW, et al. Strategies to accelerate HIV care and antiretroviral therapy initiation after HIV diagnosis: a randomized trial. J Acquir Immune Defic Syndr. 2017;75(5):540–7.CrossRef Hoffmann CJ, Mabuto T, Ginindza S, Fielding KL, Kubeka G, Dowdy DW, et al. Strategies to accelerate HIV care and antiretroviral therapy initiation after HIV diagnosis: a randomized trial. J Acquir Immune Defic Syndr. 2017;75(5):540–7.CrossRef
27.
Zurück zum Zitat Johnson MO, Charlebois E, Morin SF, Remien RH, Chesney MA. Effects of a behavioral intervention on antiretroviral medication adherence among people living with HIV: the healthy living project randomized controlled study. J Acquir Immune Defic Syndr. 2007;46(5):574–80.CrossRef Johnson MO, Charlebois E, Morin SF, Remien RH, Chesney MA. Effects of a behavioral intervention on antiretroviral medication adherence among people living with HIV: the healthy living project randomized controlled study. J Acquir Immune Defic Syndr. 2007;46(5):574–80.CrossRef
28.
Zurück zum Zitat 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.CrossRef 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.CrossRef
29.
Zurück zum Zitat Gross R, Bellamy SL, Chapman J, Han X, O’Duor J, Palmer SC, et al. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013;173(4):300–6.CrossRef Gross R, Bellamy SL, Chapman J, Han X, O’Duor J, Palmer SC, et al. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013;173(4):300–6.CrossRef
30.
Zurück zum Zitat de Bruin M, Oberje EJM, Viechtbauer W, Nobel HE, Hiligsmann M, van Nieuwkoop C, et al. Effectiveness and cost-effectiveness of a nurse-delivered intervention to improve adherence to treatment for HIV: a pragmatic, multicentre, open-label, randomised clinical trial. Lancet Infect Dis. 2017;17(6):595–604.CrossRef de Bruin M, Oberje EJM, Viechtbauer W, Nobel HE, Hiligsmann M, van Nieuwkoop C, et al. Effectiveness and cost-effectiveness of a nurse-delivered intervention to improve adherence to treatment for HIV: a pragmatic, multicentre, open-label, randomised clinical trial. Lancet Infect Dis. 2017;17(6):595–604.CrossRef
31.
Zurück zum Zitat Milam J, Richardson JL, McCutchan A, Stoyanoff S, Weiss J, Kemper C, et al. Effect of a brief antiretroviral adherence intervention delivered by HIV care providers. J Acquir Immune Defic Syndr. 2005;40(3):356–63.CrossRef Milam J, Richardson JL, McCutchan A, Stoyanoff S, Weiss J, Kemper C, et al. Effect of a brief antiretroviral adherence intervention delivered by HIV care providers. J Acquir Immune Defic Syndr. 2005;40(3):356–63.CrossRef
Metadaten
Titel
When is Enough, Enough? How the Absence of Dose-Determination Trials Impedes Implementation of HIV Behavioral Interventions
verfasst von
Seth C. Kalichman
Publikationsdatum
22.08.2019
Verlag
Springer US
Erschienen in
AIDS and Behavior / Ausgabe 9/2019
Print ISSN: 1090-7165
Elektronische ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-019-02650-1

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