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The AIDS Linked to the IntraVenous Experience (ALIVE) Study

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Shruti H. Mehta
Gregory D. Kirk
Department of Epidemiology
Johns Hopkins Bloomberg School of Public Health
Ferbruary 22, 2017

Published in: Health & Medicine
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The AIDS Linked to the IntraVenous Experience (ALIVE) Study

  1. 1. The AIDS Linked to the IntraVenous Experience (ALIVE) Study Shruti H. Mehta Gregory D. Kirk Department of Epidemiology Johns Hopkins Bloomberg School of Public Health February 22, 2016 http://www.jhsph.edu/research/affiliated-programs/AIDS-linked-to-the-intravenous-experience/
  2. 2. Proposal submitted to recruit 640 PWID and follow them for 5 years to identify factors associated with AIDS 1986 1989 1994-1995 1998 2000 2005-2008 1987 1988 ALIVE I study funded ALIVE II study funded ALIVE Clinic opens and recruits 2938 PWID in 13 months 434 new PWID recruited 244 new PWID recruited 51 women from the HERS study enrolled in ALIVE 1004 new PWID recruited History B Frank Polk 1942-1988 David Vlahov ALIVE I PI Kenrad Nelson ALIVE II PI Steffanie Strathdee ALIVE II PI Greg Kirk ALIVE I PI Shruti Mehta ALIVE II PI 2015-2017 450 (of 600 planned) new PWID recruited; 5021 total enrollees
  3. 3. Overview of the ALIVE Study  Location: Baltimore, MD  Design: Community-based prospective cohort  Enrollment: 1988-89, 1994-95, 1998, 2005-08, 2015-2016  Recruitment: Community-based street outreach  Follow-up visits: Semi-annual  Total enrolled: 5,021  Currently in follow-up: ~1100  Inclusion criteria: – >18 years of age – Injection drug use in prior year • Incidence: <1% per year • Mortality: 2-3% per year • Loss to follow-up: <5% per year
  4. 4. Core data collected at semi-annual visits • Interviewer administered – Alcohol / drug treatment – Barriers to health care access – Social support • Nurse administered (REDCAP) – Medical history – Health care utilization – HIV medicines, adherence – Hepatitis C treatment history • Audio computer-assisted self-interview (ACASI) – Drug use & risk behaviors – Sexual risk behaviors – Incarceration history – Psychosocial, Quality of life • Clinical Evaluation – Physical exam (HIV+) – Vitals, BMI – FibroScan – Functional status (SPPB) – Spirometry • Laboratory testing – HIV antibody (HIV-) – HIV viral load (HIV+) – CD4 cell count (HIV+) – CBC – Lipid panel, Hgb-A1c, urine protein – Serum chemistries, liver enzymes – Periodic testing- HCV, HBV, HPV – Repository (plasma, sera, cells, CVL, DNA cell lines) • Contextual – Geocoded residential address – Links to census data, data from Baltimore Neighborhood Indicators Alliance • Outcome Ascertainment – Medical records – NDI linkage – Database linkages (Hopkins HIV Clinic, MD Medicaid, USRDS, Cancer registry) – CRISP (Chesapeake Regional Information System for Patients) All data collection instruments revised in 2015
  5. 5. Periodic surveys • Food insecurity • Health literacy • Social network survey added in 3/2016 (focused on HIV and hepatitis C care support) 4. I would like you to think about the relations between the people you just mentioned. Some of them may be total strangers in the sense that they wouldn’t recognize each other if they bumped into each other on the street. Others may be especially close, as close to each other as they are to you. 4 A. First, think about [Name 1] and [Name 2]. Are _________ and ________ total strangers? Yes ASK 4.a FOR NEXT PAIR DOWN No ASK 4.B B. On a scale of 1 to 5, how are close are [Name 1] and [Name 2]? One is not close at all and 5 is very close. SHOW CARD WITH CLOSENESS SCALE ASK 4.a FOR NEXT PAIR DOWN NAME 2 NAME 3 NAME 4 NAME 5 NAME 1 A. Yes 1 A. Yes 1 A. Yes 1 A. Yes 1 No 2 No 2 No 2 No 2 B. ___ B. ___ B. ___ B. ___ NAME 2 A. Yes 1 A. Yes 1 A. Yes 1 No 2 No 2 No 2 B. ___ B. ___ B. ___ NAME 3 A. Yes 1 A. Yes 1 No 2 No 2 B. ___ B. ___ NAME 4 A. Yes 1 No 2 B. ___ NAME 5 INTERVIEWER INSTRUCTION: Refer to matrix on for question 4. Fill in unshaded boxes for each pair of network members.
  6. 6. Characteristics of participants at enrollment (n=5021) 1988-89 1994-95 1998 2005-08 2015-16 Median age 34 yrs 37 yrs 40 yrs 43 yrs 45 yrs % male 82 67 65 64 77 % African American 88 95 95 66 58 % with at least high school education 47 47 42 42 66 Median duration of drug injection 13 yrs 15 yrs 18 yrs 19 yrs 18 yrs % HIV positive 23 11 31 23 18 % Ever shared needles 96 83 72 87 91 % Ever shooting gallery 46 59 61 87 84
  7. 7. Characteristics of participants in active follow-up (n=1101) HIV negative HIV positive Median age 55 yrs 55 yrs % Male 67 67 % African-American 85 92 % Unemployed 87 90 % HCV antibody + 78 91 % Active alcohol use 48 47 % Non-injection drug use 27 31 % Active drug injection 32 22
  8. 8. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary research ALIVEIIALIVEI
  9. 9. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary ALIVEIIALIVEI
  10. 10. Trajectories of drug injection over 20 years Early cessation (19%) Delayed cessation (16%) Late cessation (18%) Frequent relapse (16%) Persistent injection (32%) Genberg BL et al Am J Epidemiol 2011
  11. 11. Impact of residential rehabilitation on injection drug use patterns Linton S et al Health Place 2014; Linton S et al J Urb Health 2014
  12. 12. Changing trends in drug use (Newer initiates start with prescription drugs) 0 10 20 30 40 50 60 70 80 90 100 1950/1960s 1970s 1980s 1990/2000s Current Time period Pills Non-injection Injection First drug used Cepeda J et al Submitted
  13. 13. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary ALIVEIIALIVEI
  14. 14. Development of multi-assay algorithms for measuring cross-sectional HIV incidence Cousins MM, Konikoff J, Sabin D, Khaki L, Longosz AF, et al. (2014) A Comparison of Two Measures of HIV Diversity in Multi-Assay Algorithms for HIV Incidence Estimation. PLoS ONE 9(6): e101043. doi:10.1371/journal.pone.0101043 http://journals.plos.org/plosone/article?id=info:doi/10.1371/journal.pone.0101043
  15. 15. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary ALIVEIIALIVEI
  16. 16. A transmission model to determine potential impact of HCV treatment as prevention among PWID Mier-y-Teran Romerp L et al CROI 2016
  17. 17. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary research ALIVEIIALIVEI
  18. 18. Westergaard R et al, AIDS, 2013 Improved survival but ART uptake & utilization is still not optimal
  19. 19. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary research ALIVEIIALIVEI
  20. 20. NCD and geriatric phenotypes evaluated in ALIVE • Liver fibrosis, ESLD • Lung disease (COPD, PAH) • Hypertension, cardiac fibrosis • Diabetes, obesity, BMI • CKD, proteinuria, ESRD • Cancer • Neurocognitive function • Bone disease, falls • Multimorbidity • Frailty • Physical performance • Gait speed, grip strength, balance, SPPB
  21. 21. Frailty predicts mortality independent of HIV Piggott DA et al. PLoS One 2013 7 Fold More Likely to Die If you have HIV and are FRAIL
  22. 22. Major aims of the ALIVE Study 1. Natural history of drug abuse 2. Incidence of HIV, HCV and other blood-borne infections 3. Impact of community-based interventions (e.g., NSEP, OAT, HCV test and treat initiatives) 4. Natural/treated history of HIV infection 5. Barriers to optimal engagement in HIV care 6. Natural/treated history of co-infections and comorbidities 7. Serve as a platform for multidisciplinary ALIVEIIALIVEI
  23. 23. Multidisciplinary Scope of the ALIVE Study • Research ranges from behavioral, clinical, epidemiologic and laboratory / translational • >30 ALIVE faculty investigators with broad expertise • Repository with 1.2 million unique aliquots of sera, plasma PBMCs and other biospecimens • Supports research by students, fellows, and junior faculty • >400 peer-reviewed publications • In last funding period, >25 R01 or similar NIH grants and 6 K-awards • Avenir, Fulbright and Amos Award winners in last year
  24. 24. How can I initiate a collaboration? • Email Principal Investigators – Shruti Mehta smehta@jhu.edu – Greg Kirk gdk@jhu.edu • Collaboration can be – Data request – Data analysis – Repository request
  25. 25. Acknowledgements • Study participants • Study and admin support staff • NIDA funding • Many, many collaborators

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