Following young people with perinatal HIV infection from adolescence into adulthood: the protocol for PHACS AMP Up, a prospective cohort study

Katherine Tassiopoulos, Kunjal Patel, Julie Alperen, Deborah Kacanek, Angela Ellis, Claire Berman, Susannah M Allison, Rohan Hazra, Emily Barr, Krystal Cantos, Suzanne Siminski, Michael Massagli, Jose Bauermeister, Danish Q Siddiqui, Ana Puga, Russell Van Dyke, George R Seage 3rd, Pediatric HIV/AIDS Cohort Study, Katherine Tassiopoulos, Kunjal Patel, Julie Alperen, Deborah Kacanek, Angela Ellis, Claire Berman, Susannah M Allison, Rohan Hazra, Emily Barr, Krystal Cantos, Suzanne Siminski, Michael Massagli, Jose Bauermeister, Danish Q Siddiqui, Ana Puga, Russell Van Dyke, George R Seage 3rd, Pediatric HIV/AIDS Cohort Study

Abstract

Introduction: The first generation of adolescents born with HIV infection has reached young adulthood due to advances in treatment. It is important to continue follow-up of these individuals to assess their long-term medical, behavioural and mental health and ability to successfully transition to adulthood while coping with a chronic, potentially stigmatising condition. To accomplish this, and to maintain their interest in long-term research participation, we need to accommodate the changing lifestyles and interests of young adult study participants while ensuring valid data collection. We report the protocol for Pediatric HIV/AIDS Cohort Study (PHACS) Adolescent Master Protocol (AMP) Up, a prospective cohort study enrolling young adult participants for long-term follow-up.

Methods and analysis: AMP Up is recruiting 850 young men and women 18 years of age and older-600 perinatally HIV-infected and a comparison group of 250 perinatally HIV-exposed, uninfected-at 14 clinical research sites in the USA and Puerto Rico. Recruitment began in April 2014 and is ongoing, with 305 participants currently enrolled. Planned follow-up is ≥6 years. Data are collected with a flexible hybrid of online and in-person methods. Outcomes include: transition to adult clinical care and retention in care; end-organ diseases; malignancies; metabolic complications; sexually transmitted infections; reproductive health; mental health and neurocognitive functioning; adherence to antiretroviral treatment; sexual behaviour and substance use; hearing and language impairments; and employment and educational achievement.

Ethics and dissemination: The study received ethical approval from the Harvard T.H. Chan School of Public Health's institutional review board (IRB), and from the IRBs of each clinical research site. All participants provide written informed consent; for cognitively impaired individuals with legally authorised representatives, legal guardian permission and participant assent is obtained. Findings will be disseminated through peer-reviewed journals, conference presentations and participant summaries.

Keywords: EPIDEMIOLOGY; PUBLIC HEALTH.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

References

    1. Jacobson DL, Patel K, Siberry GK et al. . Body fat distribution in perinatally HIV-infected and HIV-exposed but uninfected children in the era of highly active antiretroviral therapy: outcomes from the Pediatric HIV/AIDS Cohort Study. Am J Clin Nutr 2011;94:1485–95. 10.3945/ajcn.111.020271
    1. Malee KM, Tassiopoulos K, Huo Y et al. . Mental health functioning among children and adolescents with perinatal HIV infection and perinatal HIV exposure. AIDS Care 2011;23:1533–44. 10.1080/09540121.2011.575120
    1. Miller TI, Borkowsky W, DiMeglio LA et al. . Metabolic abnormalities and viral replication are associated with biomarkers of vascular dysfunction in HIV-infected children. HIV Med 2012;13:264–75. 10.1111/j.1468-1293.2011.00970.x
    1. Patel K, Wang J, Jacobson DL et al. . Aggregate risk of cardiovascular disease among adolescents perinatally infected with the human immunodeficiency virus. Circulation 2014;129:1204–12. 10.1161/CIRCULATIONAHA.113.001978
    1. Purswani M, Patel K, Kopp JB et al. . Tenofovir treatment duration predicts proteinuria in a multiethnic United States Cohort of children and adolescents with perinatal HIV-1 infection. Pediatr Infect Dis J 2013;32:495–500. 10.1097/INF.0b013e31827f4eff
    1. Rice ML, Buchanan AL, Siberry GK et al. . Language impairment in children perinatally infected with HIV compared to children who were HIV-exposed and uninfected. J Dev Behav Pediatr 2012;33:112–23. 10.1097/DBP.0b013e318241ed23
    1. Siberry GK, Patel K, Van Dyke RB et al. . CD4+ lymphocyte-based immunologic outcomes of perinatally HIV-infected children during antiretroviral therapy interruption. J Acquir Immune Defic Syndr 2011;57:223–9. 10.1097/QAI.0b013e318218e068
    1. Tassiopoulos K, Moscicki AB, Mellins C et al. . Sexual risk behavior among youth with perinatal HIV infection in the United States: predictors and implications for intervention development. Clin Infect Dis 2013;56:283–90. 10.1093/cid/cis816
    1. Torre P III, Zeldow B, Hoffman HJ et al. . Hearing loss in perinatally HIV-infected and HIV-exposed but uninfected children and adolescents. Pediatr Infect Dis J 2012;31:835–41. 10.1097/INF.0b013e31825b9524
    1. Van Dyke RB, Patel K, Siberry GK et al. . Antiretroviral treatment of US children with perinatally acquired HIV infection: temporal changes in therapy between 1991 and 2009 and predictors of immunologic and virologic outcomes. J Acquir Immune Defic Syndr 2011;57:165–73. 10.1097/QAI.0b013e318215c7b1
    1. Alperen J, Brummel S, Tassiopoulos K et al. . Prevalence of and risk factors for substance use among perinatally human immunodeficiency virus-infected and perinatally exposed but uninfected youth. J Adolesc Health 2014;54:341–9. 10.1016/j.jadohealth.2013.09.003
    1. Williams PL, Abzug MJ, Jacobson DL et al. . Pubertal onset in children with perinatal HIV infection in the era of combination antiretroviral treatment. AIDS 2013;27:1959–70. 10.1097/QAD.0b013e328361195b
    1. Mellins CA, Tassiopoulos K, Malee K et al. . Behavioral health risks in perinatally HIV-exposed youth: co-occurrence of sexual and drug use behavior, mental health problems, and nonadherence to antiretroviral treatment. AIDS Patient Care STDS 2011; 25:413–22. 10.1089/apc.2011.0025
    1. Geffner ME, Patel K, Miller TL et al. . Factors associated with insulin resistance among children and adolescents perinatally infected with HIV-1 in the pediatric HIV/AIDS cohort study. Horm Res Paediatr 2011;76:386–91. 10.1159/000332957
    1. Lipshultz SE, Williams PL, Wilkinson JD et al. . Cardiac status of children infected with human immunodeficiency virus who are receiving long-term combination antiretroviral therapy: results from the Adolescent Master Protocol of the Multicenter Pediatric HIV/AIDS Cohort Study. JAMA Pediatr 2013;167:520–7. 10.1001/jamapediatrics.2013.1206
    1. The Pediatric HIV/AIDS Cohort Study (PHACS). (accessed Jan 2016).
    1. DiMeglio LA, Wang J, Siberry GK et al. . Bone mineral density in children and adolescents with perinatal HIV infection. AIDS 2013;27:211–20. 10.1097/QAD.0b013e32835a9b80
    1. Sohn AH, Hazra R. The changing epidemiology of the global paediatric HIV epidemic: keeping track of perinatally HIV-infected adolescents. J Int AIDS Soc 2013;16:18555.
    1. Mofenson LM, Cotton MF. The challenges of success: adolescents with perinatal HIV infection. J Int AIDS Soc 2013;16:18650.
    1. Galea S, Tracy M. Participation rates in epidemiologic studies. Ann Epidemiol 2007;17:643–53. 10.1016/j.annepidem.2007.03.013
    1. Morton LM, Cahill J, Hartge P. Reporting participation in epidemiologic studies: a survey of practice. Am J Epidemiol 2006;163:197–203. 10.1093/aje/kwj036
    1. Callahan ST, Winitzer RF, Keenan P. Transition from pediatric to adult-oriented health care: a challenge for patients with chronic disease. Curr Opin Pediatr 2001;13:310–16. 10.1097/00008480-200108000-00004
    1. Vander Stoep A, Beresford SA, Weiss NS et al. . Community-based study of the transition to adulthood for adolescents with psychiatric disorder. Am J Epidemiol 2000;152:352–62. 10.1093/aje/152.4.352
    1. Fair CD, Sullivan K, Dizney R et al. . ‘It's like losing a part of my family‘: transition expectations of adolescents living with perinatally acquired HIV and their guardians. AIDS Patient Care STDS 2012;26:423–9. 10.1089/apc.2012.0041
    1. Committee On Pediatric Aids. Transitioning HIV-infected youth into adult health care. Pediatrics 2013;132:192–7.
    1. Baer A, Saroiu S, Koutsky LA. Obtaining sensitive data through the Web: an example of design and methods. Epidemiology 2002;13:640–5. 10.1097/01.EDE.0000032360.92664.BC
    1. Smith B, Smith TC, Gray GC et al. . When epidemiology meets the Internet: Web-based surveys in the Millennium Cohort Study. Am J Epidemiol 2007;166:1345–54. 10.1093/aje/kwm212
    1. Weisel CP, Weiss SH, Tasslimi A et al. . Development of a Web-based questionnaire to collect exposure and symptom data in children and adolescents with asthma. Ann Allergy Asthma Immunol 2008;100:112–19. 10.1016/S1081-1206(10)60419-X
    1. Huntington A, Gilmour J, Schluter P et al. . The Internet as a research site: establishment of a web-based longitudinal study of the nursing and midwifery workforce in three countries. J Adv Nurs 2009;65:1309–17. 10.1111/j.1365-2648.2009.04995.x
    1. Huybrechts KF, Mikkelsen EM, Christensen T et al. . A successful implementation of e-epidemiology: the Danish pregnancy planning study ‘Snart-Gravid’. Eur J Epidemiol 2010;25:297–304. 10.1007/s10654-010-9431-y
    1. van Gelder MM, Bretveld RW, Roeleveld N. Web-based questionnaires: the future in epidemiology? Am J Epidemiol 2010;172:1292–8. 10.1093/aje/kwq291
    1. Lenhart A. Teen, Social Media and Technology Oveview 2015 2015. (accessed Jan 2016).
    1. File T, Camille R. Computer and Internet Use in the United States: 2013. American Community Survey Reports, ACS-28 Washington DC, 2014. (accessed Dec 2015).
    1. Wechsler D. The Wechsler Intelligence Scale for Children-Fourth Edition. San Antonio, TX: The Psychological Corporation; 2003.
    1. Aidala A, Havens J, Mellins CA et al. . Development and validation of the Client Diagnostic Questionnaire (CDQ): a mental health screening tool for use in HIV/AIDS service settings. Psychol Health Med 2004;9:362–80. 10.1080/13548500410001721927
    1. Zhang W, O'Brien N, Forrest JI et al. . Validating a shortened depression scale (10 item CES-D) among HIV-positive people in British Columbia, Canada. PLoS ONE 2012;7:e40793 10.1371/journal.pone.0040793
    1. Gershon RC, Wagster MV, Hendrie HC et al. . NIH toolbox for assessment of neurological and behavioral function. Neurology 2013;80(Suppl 3):S2–6. 10.1212/WNL.0b013e3182872e5f
    1. Semel E, Wiig E, Secord W. Clinical evaluation of language fundamentals-4th edition. San Antonio, TX: The Psychological Corporation, 2003.
    1. NutritionQuest. Block Physical Activity Screener—Adults. (accessed Sep 2015).
    1. DatStat. DatStat. (accessed Jan 2016).
    1. Bajardi P, Paolotti D, Vespignani A et al. . Association between recruitment methods and attrition in Internet-based studies. PLoS ONE 2014;9:e114925 10.1371/journal.pone.0114925
    1. International Epidemiologic Databases to Evaluate AIDS (IeDEA). (accessed Jan 2016).
    1. Enhancing clinical and epidemiological HIV research in Europe through cohort collaboration (EuroCoord). (Accessed Jan 2016).

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다