Drug users constitute a majority of HIV-infected individuals in many poor urban areas in the U.S. Observational studies, including those from our working group, indicate that drug users underutilize antiretroviral therapy, have higher rates of non-adherence, and experience suboptimal treatment outcomes, compared to other HIV-infected demographic groups. Tuberculosis treatment with directly observed therapy (DOT) has proven effective in addressing issues currently being confronted in HIV management. However, translating the tuberculosis DOT model to HIV poses challenges because of salient differences between the two diseases and their management. Methadone maintenance is an effective treatment for opioid dependence and provides a setting in which directly administered antiretroviral therapy (DAART) may be feasible for prolonged periods of time. This approach is conceptually appealing because it facilitates the integration of the traditionally separate realms of HIV medical care and drug dependence treatment.
Specific aim 1 is to conduct a randomized, controlled trial of DAART versus self-administered therapy (SAT) in 200 HIV-infected individuals receiving methadone maintenance therapy in one of three clinics in Baltimore, Maryland. Based on encouraging 3-year pilot data, we hypothesize that DAART will be associated with clinically meaningful improvements in HIV treatment outcomes compared to SAT. Our primary study outcome will be suppression of the viral load at 3, 6 and 12 months. Secondary outcomes will include changes in CD4+ cell counts, the development of antiretroviral drug resistance, retention to methadone maintenance therapy, ongoing use of drugs and alcohol, and changes in psychosocial mediators of adherence. We will perform an outcome assessment at 18 months (6 months after DAART has concluded) to assess the durability of the interventional effect.
Specific aim 2 is to compare objectively-measured adherence, using electronic medication event monitors (MEMS caps), in the DAART and SAT arms. The development and rigorous assessment of strategies to optimize HIV treatment outcomes in marginalized populations is a high priority. Our research team has an established history of collaboration in this area, and brings together a wealth of research expertise in HIV treatment outcomes, substance abuse, and behavioral aspects of adherence.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA018577-04
Application #
7462361
Study Section
AIDS Clinical Studies and Epidemiology Study Section (ACE)
Program Officer
Jones, Dionne
Project Start
2005-09-25
Project End
2010-07-31
Budget Start
2008-08-01
Budget End
2009-07-31
Support Year
4
Fiscal Year
2008
Total Cost
$608,055
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Solomon, Sunil Suhas; Srikrishnan, Aylur K; Vasudevan, Canjeevaram K et al. (2014) Voucher incentives improve linkage to and retention in care among HIV-infected drug users in Chennai, India. Clin Infect Dis 59:589-95
Lucas, Gregory M; Mullen, Bernadette Anna; Galai, Noya et al. (2013) Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial. PLoS One 8:e68286
Mullen, Bernadette Anna; Cook, Katie; Moore, Richard D et al. (2011) Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs. BMC Infect Dis 11:45
Lucas, Gregory M (2011) Substance abuse, adherence with antiretroviral therapy, and clinical outcomes among HIV-infected individuals. Life Sci 88:948-52
George, Elizabeth; Lucas, Gregory M; Nadkarni, Girish N et al. (2010) Kidney function and the risk of cardiovascular events in HIV-1-infected patients. AIDS 24:387-94
Solomon, Sunil S; Desai, Monica; Srikrishnan, A K et al. (2010) The profile of injection drug users in Chennai, India: identification of risk behaviours and implications for interventions. Subst Use Misuse 45:354-67
Lucas, Gregory M; Clarke, William; Kagaayi, Joseph et al. (2010) Decreased kidney function in a community-based cohort of HIV-Infected and HIV-negative individuals in Rakai, Uganda. J Acquir Immune Defic Syndr 55:491-4
Lucas, Gregory M; Chaudhry, Amina; Hsu, Jeffrey et al. (2010) Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial. Ann Intern Med 152:704-11
Parkhie, Shyam M; Fine, Derek M; Lucas, Gregory M et al. (2010) Characteristics of patients with HIV and biopsy-proven acute interstitial nephritis. Clin J Am Soc Nephrol 5:798-804
Yanik, Elizabeth L; Lucas, Gregory M; Vlahov, David et al. (2010) HIV and proteinuria in an injection drug user population. Clin J Am Soc Nephrol 5:1836-43

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