The use of highly active antiretroviral therapy (HAART) has resulted in marked reductions in AIDS incidence, mortality and hospitalization. Unfortunately, these successes have not been uniform among all groups of people living with HIV, particularly among HIV infected injecting drug users (IDUs). The stunning benefits of HAART have been blunted and limited by difficulties in access and adherence to therapy. Despite the impressive successes of directly observed therapy (DOT) for tuberculosis control, only a few pilot studies of this intervention have been implemented for the treatment of HIV disease. Most of these studies of DOT using HAART have been accomplished in the controlled setting of either methadone maintenance or prisons, yet as few as 15-20 percent of IDUs are likely to be in these settings. For those who are in these settings, relapse to active drug use is common. Thus, in order to accomplish increased access to and utilization of HAART by HIV infected IDUs, innovative programs that effectively reach out-of-drug treatment IDUs are desperately needed. One such way to effectively interact with these IDUs is through needle exchange programs (NEPs). In this study, we propose to conduct a randomized, controlled trial comparing modified DOT dispensed HAART through NEP-based health services to standard of care. Recruited subjects of out-of-drug treatment HIV+ IDUs will be randomized based on census-block code and experience with antiretroviral therapy. Modified DOT will be administered to the intervention group; for twice daily regimens, they will receive one dose per day as DOT and will receive a programmed reminder to take their next dose on their own. Primary endpoints include standardized measures of adherence, reduction in HIV-1 RNA levels and time to development of a primary HIV-1 resistance mutation. Secondary measures of interest include quality of life measures, health care utilization and entry into drug treatment.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
3R01DA013805-04S1
Application #
6870881
Study Section
Special Emphasis Panel (ZDA1)
Program Officer
Czechowicz, Dorynne D
Project Start
2000-09-30
Project End
2004-08-31
Budget Start
2004-04-01
Budget End
2004-08-31
Support Year
4
Fiscal Year
2004
Total Cost
$88,034
Indirect Cost
Name
Yale University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Nachega, Jean B; Skinner, Donald; Jennings, Larissa et al. (2016) Acceptability and feasibility of mHealth and community-based directly observed antiretroviral therapy to prevent mother-to-child HIV transmission in South African pregnant women under Option B+: an exploratory study. Patient Prefer Adherence 10:683-90
Nachega, Jean B; Adetokunboh, Olatunji; Uthman, Olalekan A et al. (2016) Community-Based Interventions to Improve and Sustain Antiretroviral Therapy Adherence, Retention in HIV Care and Clinical Outcomes in Low- and Middle-Income Countries for Achieving the UNAIDS 90-90-90 Targets. Curr HIV/AIDS Rep 13:241-55
Morano, Jamie P; Zelenev, Alexei; Lombard, Andrea et al. (2014) Strategies for hepatitis C testing and linkage to care for vulnerable populations: point-of-care and standard HCV testing in a mobile medical clinic. J Community Health 39:922-34
Morano, Jamie P; Zelenev, Alexei; Walton, Mary R et al. (2014) Latent tuberculosis infection screening in foreign-born populations: a successful mobile clinic outreach model. Am J Public Health 104:1508-15
Gibson, Britton A; Ghosh, Debarchana; Morano, Jamie P et al. (2014) Accessibility and utilization patterns of a mobile medical clinic among vulnerable populations. Health Place 28:153-66
Di Paola, Angela; Altice, Frederick L; Powell, Mary Lindsay et al. (2014) A comparison of psychiatric diagnoses among HIV-infected prisoners receiving combination antiretroviral therapy and transitioning to the community. Health Justice 2:
Morano, Jamie P; Walton, Mary R; Zelenev, Alexei et al. (2013) Latent tuberculosis infection: screening and treatment in an urban setting. J Community Health 38:941-50
Ing, Eileen C; Bae, Jason W; Maru, Duncan Smith-Rohrberg et al. (2013) Medication persistence of HIV-infected drug users on directly administered antiretroviral therapy. AIDS Behav 17:113-21
Bae, Jason W; Guyer, William; Grimm, Kristy et al. (2011) Medication persistence in the treatment of HIV infection: a review of the literature and implications for future clinical care and research. AIDS 25:279-90
Izenberg, Jacob M; Altice, Frederick L (2010) Next steps for Ukraine abolition of HIV registries, implementation of routine human immunodeficiency virus testing and expansion of services. Addiction 105:569-70

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