Directly Observed Antiretroviral Therapy Among Active Drug Users
2 other identifiers
interventional
125
1 country
1
Brief Summary
The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 21, 2006
CompletedFirst Posted
Study publicly available on registry
August 22, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 31, 2020
August 1, 2009
5 years
August 21, 2006
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.
Secondary Outcomes (5)
Mean change in HIV-1 viral load from baseline to six months at the end of the intervention.
Virological Success at six months following the termination of the intervention.
3-Day Recall measures of adherence at the end of six months on the intervention.
Mean change in HIV-1 viral load from baseline six months following the termination of the intervention.
Mean change in CD4+ T cells from baseline to the end of six months on the intervention.
Interventions
Eligibility Criteria
You may qualify if:
- being HIV seropositive;
- being eligible for and/or being prescribed HAART
- living within the city of New Haven
- actively using heroin and/or cocaine in the previous six months
- receiving no more than a twice-daily regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Related Publications (2)
Altice FL, Mezger JA, Hodges J, Bruce RD, Marinovich A, Walton M, Springer SA, Friedland GH. Developing a directly administered antiretroviral therapy intervention for HIV-infected drug users: implications for program replication. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S376-87. doi: 10.1086/421400.
PMID: 15156426BACKGROUNDAltice FL, Maru DS, Bruce RD, Springer SA, Friedland GH. Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial. Clin Infect Dis. 2007 Sep 15;45(6):770-8. doi: 10.1086/521166. Epub 2007 Aug 13.
PMID: 17712763DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick L Altice, M.D.
Yale AIDS Program
- PRINCIPAL INVESTIGATOR
Gerald H Friedland
Yale AIDS Program
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 21, 2006
First Posted
August 22, 2006
Study Start
June 1, 2001
Primary Completion
June 1, 2006
Study Completion
December 1, 2006
Last Updated
March 31, 2020
Record last verified: 2009-08