Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia

References

• Walmsley R. World Prison Population List. 12th ed. London: Institute for Criminal Policy research; 2018.
   Google Scholar
• Dolan K, Wirtz AL, Moazen B, et al. Global burden of HIV, viral hepatitis, and tuberculosis in prisoners and detainees. Lancet. 2016;388(10049):1089–1102.
   PubMed Web of Science ®Google Scholar
• Herbert K, Plugge E, Foster C, Doll H. Prevalence of risk factors for non-communicable diseases in prison populations worldwide: a systematic review. Lancet. 2012;379(9830):1975–1982.
   PubMed Web of Science ®Google Scholar
• Kouyoumdjian FG, McIsaac KE, Liauw J, et al. A systematic review of randomized controlled trials of interventions to improve the health of persons during imprisonment and in the year after release. Am J Public Health. 2015;105(4):e13–e33.
   PubMed Web of Science ®Google Scholar
• Iroh PA, Mayo H, Nijhawan AE. The HIV care cascade before, during, and after incarceration: a systematic review and data synthesis. Am J Public Health. 2015;301(8):e1–e12.
   Web of Science ®Google Scholar
• Baillargeon J, Giordano TP, Rich JD, et al. Accessing antiretroviral therapy following release from prison. JAMA. 2009;301(8):848–857.
   PubMed Web of Science ®Google Scholar
• Loeliger KB, Altice FL, Desai MM, Ciarleglio MM, Gallagher C, Meyer JP. Predictors of linkage to HIV care and viral suppression after release from jails and prisons: a retrospective cohort study. Lancet HIV. 2018;5(2):e96–e106.
   Web of Science ®Google Scholar
• Binswanger IA, Nowels C, Corsi KF, et al. Return to drug use and overdose after release from prison: a qualitative study of risk and protective factors. Addict Sci Clin Pract. 2012;7(1):3.
   PubMedGoogle Scholar
• Winter RJ, Young JT, Stoové M, Agius PA, Hellard ME, Kinner SA. Resumption of injecting drug use following release from prison in Australia. Drug Alcohol Depend. 2016;168:104–111.
   Web of Science ®Google Scholar
• Wildeman C, Wang EA. Mass incarceration, public health, and widening inequality in the USA. Lancet. 2017;389(10077):1464–1474.
   PubMed Web of Science ®Google Scholar
• Milloy MJ, Kerr T, Buxton J, et al. Dose-response effect of incarceration events on nonadherence to HIV antiretroviral therapy among injection drug users. J Infect Dis. 2011;203(9):1215–1221.
   PubMed Web of Science ®Google Scholar
• Patterson EJ. The dose-response of time served in prison on mortality: New York State, 1989-2003. Am J Public Health. 2013;103(3):523–528.
   PubMed Web of Science ®Google Scholar
• Loeliger KB, Altice FL, Ciarleglio MM, et al. All-cause mortality among people with HIV released from prison in Connecticut, 2007-2014. Lancet HIV. 2018;5(11):e617–e628.
   Web of Science ®Google Scholar
• Springer SA, Spaulding AC, Meyer JP, Altice FL. Public health implications for adequate transitional care for HIV-infected prisoners: five essential components. Clin Infect Dis. 2011;53(5):469–479.
   Web of Science ®Google Scholar
• Meyer JP, Althoff AL, Altice FL. Optimizing care for HIV-infected people who use drugs: evidence-based approaches to overcoming healthcare disparities. Clin Infect Dis. 2013;57(9):1309–1317.
   PubMed Web of Science ®Google Scholar
• Wohl DA, Golin CE, Knight K, et al. Randomized controlled trial of an intervention to maintain suppression of HIV viremia after prison release: the impact trial. J Acquir Immune Defic Syndr. 2017;75(1):81–90.
   PubMed Web of Science ®Google Scholar
• Saber-Tehrani AS, Springer SA, Qiu J, Herme M, Wickersham J, Altice FL. Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes. Contemp Clin Trials. 2012;33(2):436–444.
   Web of Science ®Google Scholar
• Gordon MS, Kinlock TW, Schwartz RP, O’Grady KE. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release. Addiction. 2008;103(8):1333–1342.
   PubMed Web of Science ®Google Scholar
• Rich JD, McKenzie M, Larney S, et al. Methadone continuation versus forced withdrawal on incarceration in a combined US prison and jail: a randomised, open-label trial. Lancet. 2015;386(9991):350–359.
   PubMed Web of Science ®Google Scholar
• Springer SA, Qiu J, Saber-Tehrani AS, Altice FL. Retention on buprenorphine is associated with high levels of maximal viral suppression among HIV-infected opioid dependent released prisoners. PLoS One. 2012;7(5):e38335.
   Web of Science ®Google Scholar
• Springer SA, Chen S, Altice FL. Improved HIV and substance abuse treatment outcomes for released HIV-infected prisoners: the impact of buprenorphine treatment. J Urban Health. 2010;87(4):592–602.
   PubMed Web of Science ®Google Scholar
• Springer SA, Di Paola A, Azar M, Altice FL .Extended-release naltrexone improves viral suppression among incarcerated persons living with HIV with opioid use disorders transitioning to the community: results of a double-blind, placebo-controlled randomized trial. J Acquir Immune Defic Syndr. 2018;78(1):43–53.
   Web of Science ®Google Scholar
• Larney S. Does opioid substitution treatment in prisons reduce injecting-related HIV risk behaviours? A systematic review. Addiction. 2010;105(2):216–223.
   PubMed Web of Science ®Google Scholar
• Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease. J Subst Abuse Treat. 2009;37(3):277–285.
   PubMed Web of Science ®Google Scholar
• Zweben A, Fucito LM, O'Malley SS. Effective strategies for maintaining research participation in clinical trials. Drug Inf J. 2009;43(4):459–467.
   Google Scholar
• Goshin LS, Byrne MW. Predictors of post-release research retention and subsequent reenrollment for women recruited while incarcerated. Res Nurs Health. 2012;35(1):94–104.
   Web of Science ®Google Scholar
• Robinson KA, Dennison CR, Wayman DM, Pronovost PJ, Needham DM. Systematic review identifies number of strategies important for retaining study participants. J Clin Epidemiol. 2007;60(8):757–765.
   PubMed Web of Science ®Google Scholar
• Western B, Braga A, Hureau D, Sirois C. Study retention as bias reduction in a hard-to-reach population. Proc. Natl. Acad. Sci. USA. 2016;113(20):5477–5485.
   PubMed Web of Science ®Google Scholar
• Bazazi AR, Wickersham JA, Wegman MP, et al. Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia. Contemp Clin Trials. 2017;59:1–12.
   Web of Science ®Google Scholar
• Copenhaver MM, Tunku N, Ezeabogu I, et al. Adapting an evidence-based intervention targeting HIV-infected prisoners in Malaysia. AIDS research and treatment. 2011;2011:131045.
   Google Scholar
• Culbert GJ, Pillai V, Bick J, et al. Confronting the HIV, tuberculosis, addiction, and incarceration syndemic in Southeast Asia: lessons learned from Malaysia. J Neuroimmune Pharmacol. 2016;11(3):446–455.
   Web of Science ®Google Scholar
• Joint United Nations Programme on HIV/AIDS. Ending AIDS: Progress towards the 90-90-90 targets. Geneva: UNAIDS;2017.
   Google Scholar
• Bazazi AR, Crawford F, Zelenev A, Heimer R, Kamarulzaman A, Altice FL. HIV prevalence among people who inject drugs in greater Kuala Lumpur recruited using respondent-driven sampling. AIDS Behav. 2015;19(12):2347–2357.
   Web of Science ®Google Scholar
• Bick J, Culbert G, Al-Darraji HA, et al. Healthcare resources are inadequate to address the burden of illness among HIV-infected male prisoners in Malaysia. Int J Prison Health. 2016;12(4):253–269.
   Web of Science ®Google Scholar
• Wickersham JA, Zahari MM, Azar MM, Kamarulzaman A, Altice FL. Methadone dose at the time of release from prison significantly influences retention in treatment: implications from a pilot study of HIV-infected prisoners transitioning to the community in Malaysia. Drug Alcohol Depend. 2013;132(1-2):378–382.
   PubMed Web of Science ®Google Scholar
• Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol.2003;22(2):223–228.
   PubMed Web of Science ®Google Scholar
• Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705–714.
   PubMed Web of Science ®Google Scholar
• Berger BE, Ferrans CE, Lashley FR. Measuring stigma in people with HIV: psychometric assessment of the HIV stigma scale. Res Nurs Health. 2001;24(6):518–529.
   PubMed Web of Science ®Google Scholar
• Ware J, Sherbourne C. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–483.
   PubMed Web of Science ®Google Scholar
• Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas.1977;1(3):385–401.
   Web of Science ®Google Scholar
• Saunders JB, Aasland OG, Babor TF, De la Fuente JR, Grant M. Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption-II. Addiction. 1993;88(6):791–804.
   PubMed Web of Science ®Google Scholar
• McLellan AT, Kushner H, Metzger D, et al. The fifth edition of the addiction severity index. J Subst Abus.1992;9(3):199–213.
   Google Scholar
• Degroot AM, Dannenburg L, Vanhell JG. Forward and backward word translation by bilinguals. J Mem Lang.. 1994;33(5):600–629.
   Web of Science ®Google Scholar
• Aronow PM, Green DP, Lee DKK. Sharp bounds on the variance in randomized experiments. Ann Stat. 2014;42(3):850–871.
   Web of Science ®Google Scholar
• Robins JM, Hernan MA, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology. 2000;11(5):550–560.
   PubMed Web of Science ®Google Scholar
• Cole SR, Hernan MA. Constructing inverse probability weights for marginal structural models. Am J Epidemiol. 2008;168(6):656–664.
   PubMed Web of Science ®Google Scholar
• Kang JDY, Schafer JL. Demystifying double robustness: a comparison of alternative strategies for estimating a population mean from incomplete data. Stat Sci. 2007;22(4):523–539.
   Web of Science ®Google Scholar
• Bang H, Robins JM. Doubly robust estimation in missing data and causal inference models. Biometrics. 2005;61(4):962–973.
   PubMed Web of Science ®Google Scholar
• Efron B, Tibshirani R. An Introduction to the Bootstrap. Vol. 57. Boca Raton: Chapman & Hall/CRC; 1993.
   Google Scholar
• Zeger SL, Liang KY, Albert PS. Models for longitudinal data - a generalized estimating equation approach. Biometrics. 1988;44(4):1049–1060.
   PubMed Web of Science ®Google Scholar
• Halekoh U, Hojsgaard S, Yan J. The R package geepack for generalized estimating equations. J Stat Softw. 2006;15(2):1–11.
   Web of Science ®Google Scholar
• Menendez E, White MC, Tulsky JP. Locating study subjects: predictors and successful search strategies with inmates released from a US county jail. Control Clin Trials. 2001;22(3):238–247.
   Google Scholar
• White MC, Tulsky JP, Goldenson J, Portillo CJ, Kawamura M, Menendez E. Randomized controlled trial of interventions to improve follow-up for latent tuberculosis infection after release from jail. Arch Intern Med. 2002;162(9):1044–1050.
   Google Scholar
• Merrall EL, Kariminia A, Binswanger IA, et al. Meta-analysis of drug-related deaths soon after release from prison. Addiction. 2010;105(9):1545–1554.
   PubMed Web of Science ®Google Scholar
• Ranapurwala SI, Shanahan ME, Alexandridis AA, et al. Opioid overdose mortality among former North Carolina inmates: 2000–2015. Am J Public Health. 2018;108(9):1207–1213.
   PubMed Web of Science ®Google Scholar
• Zlodre J, Fazel S. All-cause and external mortality in released prisoners: systematic review and meta-analysis. Am J Public Health. 2012;102(12):e67–e75.
   PubMedGoogle Scholar
• Culbert GJ, Crawford FW, Murni A, et al. Predictors of mortality within prison and after release among persons living with HIV in Indonesia. Res Rep Trop Med. 2017;8:25–35.
   Web of Science ®Google Scholar
• Huber F, Merceron A, Madec Y, et al. High mortality among male HIV-infected patients after prison release: ART is not enough after incarceration with HIV. PLoS One. 2017;12(4):e0175740.
   Web of Science ®Google Scholar
• Quinn C, Byng R, Shenton D, et al. The feasibility of following up prisoners, with mental health problems, after release: a pilot trial employing an innovative system, for engagement and retention in research, with a harder-to-engage population. Trials. 2018;19(1):530.
   Google Scholar
• Iguchi MY, London JA, Forge NG, Hickman L, Fain T, Riehman K. Elements of well-being affected by criminalizing the drug user. Public Health Rep.2002;117 (Suppl 1):S146–S150.
   Google Scholar
• Robinson KA, Dinglas VD, Sukrithan V, et al. Updated systematic review identifies substantial number of retention strategies: using more strategies retains more study participants. Journal of clinical epidemiology. 2015;68(12):1481–1487.
   PubMed Web of Science ®Google Scholar
• Low AJ, Mburu G, Welton NJ, et al. Impact of opioid substitution therapy on antiretroviral therapy outcomes: a systematic review and meta-analysis. Clin Infect Dis. 2016;63(11):1094–1104.
   Web of Science ®Google Scholar
• Wegman MP, Altice FL, Kaur S, et al. Relapse to opioid use in opioid-dependent individuals released from compulsory drug detention centres compared with those from voluntary methadone treatment centres in Malaysia: a two-arm, prospective observational study. Lancet Glob Health. 2017;5(2):e198–e207.
   PubMed Web of Science ®Google Scholar
• Dolan K, Salimi S, Nassirimanesh B, Mohsenifar S, Allsop D, Mokri A. Six-month follow-up of Iranian women in methadone treatment: drug use, social functioning, crime, and HIV and HCV seroincidence. Subst Abuse Rehabil. 2012;3(Suppl 1):37–43.
   Google Scholar
• Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013;346:e8668.
   PubMed Web of Science ®Google Scholar
• Restricted residence act of 1933 (Revised 1989). Malaysia Legislation. http://www.commonlii.org/my/legis/consol_act/rra19331989280/
   Google Scholar