The purpose of this study is to evaluate effectiveness of directly observed, once-a-day, highly active antiretroviral therapy (HAART) in the sustained suppression of viral replication in HIV-infected substance abusers.
Our specific aims i nclude: l) To determine whether directly observed once-a- day HAART, administered over a twelve-month period, is more effective than self-administered once-a-day HAART in the suppression of plasma HIV RNA in substance abusers. 2) To evaluate and compare patterns of adherence in the DOT arm and the control arm during all phases of the study utilizing audio computer assisted self-interview (ACASI). 3) To compare the development of antiretroviral resistance between the DOT and standard of care arms. 4) To determine the effect of a period of DOT on subsequent plasma HIV RNA and patterns of adherence. We plan to enroll 120 HW-infected individuals with no more than 30 days of prior antiretroviral therapy and with a history of having used heroin or cocaine within the 90 days prior to enrollment. All patients will be treated with a once-a-day HAART regimen. Patients will be randomized to either a directly observed therapy (DOT) intervention arm or to a standard-of- care control arm in which medications are self-administered. All patients will receive comprehensive medical care at the Immunology Center, a multidisciplinary clinic devoted exclusively to the care of patients with HIV infection. The total study duration will be five years. In the initial intensive phase of the intervention (duration:12 months), patients in the DOT arm will be visited every day by an outreach worker who will deliver the daily dose of antiretroviral medication and observe the patient taking the dose. This phase will be followed by a tapering phase (duration: 6 months), during which the frequency of visits will be gradually decreased to once a week. Throughout the study period, adherence will be assessed by patient self-report in an ACASI questionnaire. HIV RNA quantification, drug resistance testing by genotype, and CD4+ cell count determinations will be used to assess the effect of DOT on virologic suppression and development of resistance. The ACASI questionnaire will be administered and sera collected for laboratory assays at baseline, 1,3,6,9,12,15,18,21, and 24 months.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA013767-04
Application #
6655502
Study Section
Special Emphasis Panel (ZDA1-MXV-P (17))
Program Officer
Jones, Noble
Project Start
2000-09-30
Project End
2005-08-31
Budget Start
2003-09-01
Budget End
2005-08-31
Support Year
4
Fiscal Year
2003
Total Cost
$651,268
Indirect Cost
Name
Miriam Hospital
Department
Type
DUNS #
063902704
City
Providence
State
RI
Country
United States
Zip Code
02906
Ma, Mindy; Brown, Billy R; Coleman, Melissa et al. (2008) The feasibility of modified directly observed therapy for HIV-seropositive African American substance users. AIDS Patient Care STDS 22:139-46
Macalino, Grace E; Hogan, Joseph W; Mitty, Jennifer A et al. (2007) A randomized clinical trial of community-based directly observed therapy as an adherence intervention for HAART among substance users. AIDS 21:1473-7
Ciambrone, Desiree; Loewenthal, Helen G; Bazerman, Lauri B et al. (2006) Adherence among women with HIV infection in Puerto Rico: the potential use of modified directly observed therapy (MDOT) among pregnant and postpartum women. Women Health 44:61-77
Flanigan, Timothy P; Mitty, Jennifer A (2006) The good, the bad, and the ugly: providing highly active antiretroviral therapy when it is most difficult. Clin Infect Dis 42:1636-8
Mitty, Jennifer A; Macalino, Grace E; Bazerman, Lauri B et al. (2005) The use of community-based modified directly observed therapy for the treatment of HIV-infected persons. J Acquir Immune Defic Syndr 39:545-50
Flanigan, Timothy P; Taylor, Lynn E; Mitty, Jennifer A (2005) Use of community-based, directly observed therapy for HIV infection: lessons learned for treatment of hepatitis C virus infection. Clin Infect Dis 40 Suppl 5:S346-8
Mitty, Jennifer Adelson; Flanigan, Timothy P (2004) Community-based interventions for marginalized populations. Clin Infect Dis 38 Suppl 5:S373-5
Macalino, Grace E; Mitty, Jennifer A; Bazerman, Lauri B et al. (2004) Modified directly observed therapy for the treatment of HIV-seropositive substance users: lessons learned from a pilot study. Clin Infect Dis 38 Suppl 5:S393-7
Harwell, Joseph I; Flanigan, Timothy P; Mitty, Jennifer A et al. (2003) Directly observed antiretroviral therapy to reduce genital tract and plasma HIV-1 RNA in women with poor adherence. AIDS 17:1990-3
Mitty, Jennifer Adelson; Stone, Valerie E; Sands, Michael et al. (2002) Directly observed therapy for the treatment of people with human immunodeficiency virus infection: a work in progress. Clin Infect Dis 34:984-90

Showing the most recent 10 out of 11 publications