期刊论文详细信息
BMC Infectious Diseases
A text messaging intervention to improve retention in care and virologic suppression in a U.S. urban safety-net HIV clinic: study protocol for the Connect4Care (C4C) randomized controlled trial
Joan F Hilton5  Jordan Akerley4  Veesta Falahati6  Lara S Coffin7  Leslie Wilson1  Judith T Moskowitz2  Adam W Carrico3  Jacqueline Tulsky7  Elise D Riley7  Katerina A Christopoulos7 
[1] School of Pharmacy, University of California San Francisco, San Francisco, CA, USA;Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA;School of Nursing, University of California San Francisco, San Francisco, CA, USA;HIV Services, The Shanti Project, San Francisco, CA, USA;Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA;Global Health Sciences, University of California San Francisco, San Francisco, CA, USA;HIV/AIDS Division, San Francisco General Hospital, University of California San Francisco, 995 Potrero Avenue, 4th Floor, San Francisco 94110, CA, USA
关键词: Retention in HIV care;    HIV;    Text messaging;    SMS;    Short message service;   
Others  :  1127137
DOI  :  10.1186/s12879-014-0718-6
 received in 2014-12-11, accepted in 2014-12-15,  发布年份 2014
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【 摘 要 】

Background

Few data exist on the use of text messaging as a tool to promote retention in HIV care and virologic suppression at the clinic level in the United States. We describe the protocol for a study designed to investigate whether a text messaging intervention that supports healthy behaviors, encourages consistent engagement with care, and promotes antiretroviral persistence can improve retention in care and virologic suppression among patients in an urban safety-net HIV clinic in San Francisco.

Methods/Design

Connect4Care (C4C) is a single-site, randomized year-long study of text message appointment reminders vs. text message appointment reminders plus thrice-weekly supportive, informational, and motivational text messages. Eligible consenting patients are allocated 1:1 to the two arms within strata defined by HIV diagnosis within the past 12 months (i.e. “newly diagnosed”) vs. earlier. Study participants must receive primary care at the San Francisco General Hospital HIV clinic, speak English, possess a cell phone and be willing to send/receive up to 25 text messages per month, a have viral load >200 copies/μL, and be either new to the clinic or have a history of poor retention. The primary efficacy outcome is virologic suppression at 12 months and the key secondary outcome, which will also be examined as a mediator of the primary outcome, is retention in HIV care, as operationalized by kept and missed primary care visits. Process outcomes include text message response rate and percent of time in study without cell phone service. Generalized estimating equation log-binomial models will be used for intent to treat, per protocol, and mediation analyses. An assessment of the cost and cost-effectiveness of the intervention is planned along with a qualitative evaluation of the intervention.

Discussion

Findings from this study will provide valuable information about the use of behavioral-theory based text messaging to promote retention in HIV care and virologic suppression, further elucidate the challenges of using texting technology with marginalized urban populations, and help guide the development of new mobile health strategies to improve HIV care cascade outcomes.

Trial registration

NCT01917994 webcite

【 授权许可】

   
2014 Christopoulos et al.; licensee BioMed Central.

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【 参考文献 】
  • [1]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.
  • [2]Mugavero MJ, Lin HY, Willig JH, Westfall AO, Ulett KB, Routman JS, Abroms S, Raper JL, Saag MS, Allison JJ: Missed visits and mortality among patients establishing initial outpatient HIV treatment. Clin Infect Dis 2009, 48(2):248-256.
  • [3]Ulett KB, Willig JH, Lin HY, Routman JS, Abroms S, Allison J, Chatham A, Raper JL, Saag MS, Mugavero MJ: The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDS 2009, 23(1):41-49.
  • [4]Giordano TP, Gifford AL, White AC Jr, Suarez-Almazor ME, Rabeneck L, Hartman C, Backus LI, Mole LA, Morgan RO: Retention in care: a challenge to survival with HIV infection. Clin Infect Dis 2007, 44(11):1493-1499.
  • [5]Cavaleri MA, Kalogerogiannis K, McKay MM, Vitale L, Levi E, Jones S, Wallach F, Flynn E: Barriers to HIV care: an exploration of the complexities that influence engagement in and utilization of treatment. Soc Work Health Care 2010, 49(10):934-945.
  • [6]Metsch LR, Pereyra M, Messinger S, Del Rio C, Strathdee SA, Anderson-Mahoney P, Rudy E, Marks G, Gardner L: Antiretroviral Treatment and Access Study (ARTAS) Study Group: HIV transmission risk behaviors among HIV-infected persons who are successfully linked to care. Clin Infect Dis 2008, 47(4):577-584.
  • [7]Centers for Disease Control and Prevention (CDC): Vital signs: HIV prevention through care and treatment–United States MMWR. Morbidity and mortality weekly report 2011, 60(47):1618-1623.
  • [8]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):1164-1171.
  • [9]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):313-325.
  • [10]Simoni JM, Chen WT, Huh D, Fredriksen-Goldsen KI, Pearson C, Zhao H, Shiu CS, Wang X, Zhang F: A preliminary randomized controlled trial of a nurse-delivered medication adherence intervention among HIV-positive outpatients initiating antiretroviral therapy in Beijing, China. AIDS Behav 2011, 15(5):919-929.
  • [11]Perron NJ, Dao MD, Kossovsky MP, Miserez V, Chuard C, Calmy A, Gaspoz JM: Reduction of missed appointments at an urban primary care clinic: a randomised controlled study. BMC Fam Pract 2010, 11:79. BioMed Central Full Text
  • [12]Henry SR, Goetz MB, Asch SM: The effect of automated telephone appointment reminders on HIV primary care no-shows by veterans. J Assoc Nurses AIDS Care 2012, 23(5):409-418.
  • [13]Gardner LI, Giordano TP, Marks G, Wilson TE, Craw JA, Drainoni ML, Keruly JC, Rodriguez AE, Malitz F, Moore RD, Bradley-Springer LA, Holman S, Rose CE, Girde S, Sullivan M, Metsch LR, Saag M, Mugavero MJ: Retention in Care Study Group: Enhanced personal contact with HIV patients improves retention in primary care: a randomized trial in six U.S. HIV clinics. Clin Infect Dis 2014, 59(5):725-34.
  • [14]Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR: Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS 2011, 25(6):825-834.
  • [15]van der Kop ML, Ojakaa DI, Patel A, Thabane L, Kinagwi K, Ekström AM, Smillie K, Karanja S, Awiti P, Mills E, Marra C, Kyomuhangi LB, Lester RT: The effect of weekly short message service communication on patient retention in care in the first year after HIV diagnosis: study protocol for a randomised controlled trial (WelTel Retain). BMJ Open 2013, 3(6):e003155.
  • [16]Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA: Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet 2010, 376(9755):1838-1845.
  • [17]Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R: Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res 2012, 14(2):e51.
  • [18]Harris JL, Furberg R, Martin N, Kuhns L, Lewis MA, Coomes C, Williams P, Uhrig JD: Implementing an SMS-based intervention for persons living with human immunodeficiency virus. J Public Health Manag Pract 2013, 19(2):E9-16.
  • [19]Ingersoll K, Dillingham R, Reynolds G, Hettema J, Freeman J, Hosseinbor S, Winstead-Derlega C: Development of a personalized bidirectional text messaging tool for HIV adherence assessment and intervention among substance abusers. J Subst Abus Treat 2014, 46(1):66-73.
  • [20]Uhrig JD, Lewis MA, Bann CM, Harris JL, Furberg RD, Coomes CM, Kuhns LM: Addressing HIV knowledge, risk reduction, social support, and patient involvement using SMS: results of a proof-of-concept study. J Health Commun 2012, 17(Suppl 1):128-145.
  • [21]Norton BL, Person AK, Castillo C, Pastrana C, Subramanian M, Stout JE: Barriers to using text message appointment reminders in an HIV clinic. Telemed J E Health 2014, 20(1):86-89.
  • [22]Gelberg L, Andersen RM, Leake BD: The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res 2000, 34(6):1273-1302.
  • [23]Christopoulos KA, Das M, Colfax GN, Christopoulos KA, Das M, Colfax GN: Linkage and retention in HIV care among men who have sex with men in the United States. Clin Infect Dis 2011, 52(Suppl 2):S214-222.
  • [24]Smith LR, Fisher JD, Cunningham CO, Amico KR: Understanding the behavioral determinants of retention in HIV care: a qualitative evaluation of a situated information, motivation, behavioral skills model of care initiation and maintenance. AIDS patient care and STDs 2012, 26(6):344-355.
  • [25]Johnson MO, Rose CD, Dilworth SE, Neilands TB: Advances in the conceptualization and measurement of Health Care Empowerment: development and validation of the Health Care Empowerment inventory. PLoS One 2012, 7(9):e45692.
  • [26]Folkman S: The case for positive emotions in the stress process. Anxiety Stress Coping 2008, 21(1):3-14.
  • [27]Coomes CM, Lewis MA, Uhrig JD, Furberg RD, Harris JL, Bann CM: Beyond reminders: a conceptual framework for using short message service to promote prevention and improve healthcare quality and clinical outcomes for people living with HIV. AIDS Care 2012, 24(3):348-357.
  • [28]Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed on December 7, 2014.
  • [29]Finitsis DJ, Pellowski JA, Johnson BT: Text Message Intervention Designs to Promote Adherence to Antiretroviral Therapy (ART): A Meta-Analysis of Randomized Controlled Trials. PLoS One 2014, 9(2):e88166.
  • [30]Amico KR, Barta W, Konkle-Parker DJ, Fisher JD, Cornman DH, Shuper PA, Fisher WA: The information-motivation-behavioral skills model of ART adherence in a Deep South HIV+ clinic sample. AIDS Behav 2009, 13(1):66-75.
  • [31]Radloff LS: The CES-D Scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977, 1:385-401.
  • [32]Fredrickson BL, Cohn MA, Coffey KA, Pek J, Finkel SM: Open hearts build lives: positive emotions, induced through loving-kindness meditation, build consequential personal resources. J Pers Soc Psychol 2008, 95(5):1045-1062.
  • [33]Cutrona CE: Ratings of social support by adolescents and adult informants: degree of correspondence and prediction of depressive symptoms. J Pers Soc Psychol 1989, 57(4):723-730.
  • [34]Hays RD, Morales LS: The RAND-36 measure of health-related quality of life. Ann Med 2001, 33(5):350-357.
  • [35]Johnson MO, Sevelius JM, Dilworth SE, Saberi P, Neilands TB: Preliminary support for the construct of health care empowerment in the context of treatment for human immunodeficiency virus. Patient Prefer Adherence 2012, 6:395-404.
  • [36]Mugavero MJ, Westfall AO, Zinski A, Davila J, Drainoni ML, Gardner LI, Keruly JC, Malitz F, Marks G, Metsch L, Wilson TE, Giordano TP: Retention in Care (RIC) Study Group: Measuring retention in HIV care: the elusive gold standard. J Acquir Immune Defic Syndr 2012, 61(5):574-580.
  • [37]Gartlehner G, Hansen RA, Nisssman D, et al.: Technical Reviews, No. 12. Criteria for Distinguishing Effectiveness from Efficacy Trials in Systematic Reviews. Agency for Healthcare Research and Quality, Rockville, MD; 2006.
  • [38]Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R: Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol 2003, 3:28. BioMed Central Full Text
  • [39]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148(4):295-309.
  • [40]Irvine L, Falconer DW, Jones C, Ricketts IW, Williams B, Crombie IK: Can text messages reach the parts other process measures cannot reach: an evaluation of a behavior change intervention delivered by mobile phone? PLoS One 2012, 7(12):e52621.
  • [41]Chandler R, Kahana SY, Aklin W, Fletcher B, Jones D, Webb C, Hamill KR: Enhancing Seek, Test, Treat and Retain Research Through Data Harmonization. International AIDS Society. International AIDS Conference, Washington, D. C; 2012.
  • [42]San Francisco Department of Public Health. HIV/AIDS Epidemiology Annual Report. 2012. Available at: http://www.sfdph.org/dph/comupg/oprograms/hivepisec/default.asp. Accessed on December 7, 2014.
  • [43]Geng EH, Hare CB, Kahn JO, Jain V, Van Nunnery T, Christopoulos KA, Deeks SG, Gandhi M, Havlir DV: The effect of a "universal antiretroviral therapy" recommendation on HIV RNA levels among HIV-infected patients entering care with a CD4 count greater than 500/muL in a public health setting. Clin Infect Dis 2012, 55(12):1690-1697.
  • [44]Spiegelman D, Hertzmark E: Easy SAS calculations for risk or prevalence ratios and differences. Am J Epidemiol 2005, 162(3):199-200.
  • [45]Deddens JA, Petersen MR: Re: "Estimating the relative risk in cohort studies and clinical trials of common outcomes". Am J Epidemiol 2004, 159(2):213-214. author reply 214–215
  • [46]Robinson LA, Hammitt JK: Behavioral Economics and the Conduct of Benefit-Cost Analysis: Towards Principles and Standards. J Benefit-Cost Anal 2011, 2(2):Article 5.
  • [47]Gold MR, Siegel JE, Russell LB, Weinstein MC: Cost-Effectiveness in Health and Medicine. Oxford University Press, New York; 1996.
  • [48]Drummond M, O'Brien B, Stoddart GL, Torrance GW: Methods for the Economic Evaluation of Helath Care Programs. 2nd edition. Oxford University Press, New York; 1996.
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