Directly Observed Therapy for Community-Released HIV+ Prisoners

NCT00786396 | Completed

• 1 other identifier: R01 DA 0179059
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to develop effective interventions for HIV-infected prisoners who are released to the community. The intervention that we will study will be directly observed therapy (DAART/DOT) and we will compare this to the current standard of care that involves self-administered therapy (SAT). All subjects will get transitional case management and all subjects with a prior history of opiate dependence will be offered opiate substitution therapy (buprenorphine or methadone). Hypotheses:

• At the end of six months those receiving DAART will have a higher level of adherence to HAART as compared to the SAT group.
• The DAART Intervention will result in subjects having lower viral loads and higher CD4 counts as compared to the SAT group.
• At the end of six months, the DAART group will have a lower rate of recidivism to jail/prison as compared to the SAT group.
• Over the year, the DAART group will be more likely to make repeated primary HIV care visits than the SAT group.

Conditions

HIV/AIDS; Substance Abuse

Keywords

HIV; AIDS; substance abuse; directly administered antiretroviral therapy; adherence; Substance Abuse and Dependency

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.

  12 months

Secondary Outcomes (2)

• DAART subjects will be more likely to make primary HIV care visits than those receiving SAT.

  12

• Lower rate of recidivism and to illicit drug use

  12 months

Study Arms (2)

DAART

EXPERIMENTAL

Group that will be observed daily taking their medications for a period of six months. Followed by the remaining six months of the intervention in which the subject will take medications on their own.

Behavioral: Directly administered antiretroviral therapy

2

NO INTERVENTION

SAT (standard of care) group will take their medications as directed by their physicians for the period of one year.

Interventions

Directly administered antiretroviral therapy BEHAVIORAL

Daily observation of subjects taking their HIV medications

DAART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV seropositive
• years of age or older
• incarcerated for a minimum of 90days
• living in New Haven or Hartford
• currently on HAART or willing to begin HAART medications

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale University-Yale Clinical Research

Hartford, Connecticut, 06106, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (4)

• 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 Mar;33(2):436-44. doi: 10.1016/j.cct.2011.11.002. Epub 2011 Nov 12.

  PMID: 22101218 BACKGROUND

• Springer SA, Chen S, Altice F. Depression and symptomatic response among HIV-infected drug users enrolled in a randomized controlled trial of directly administered antiretroviral therapy. AIDS Care. 2009 Aug;21(8):976-83. doi: 10.1080/09540120802657555.

  PMID: 20024753 BACKGROUND

• 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 Jul;87(4):592-602. doi: 10.1007/s11524-010-9438-4.

  PMID: 20177974 BACKGROUND

• Meyer JP, Qiu J, Chen NE, Larkin GL, Altice FL. Emergency department use by released prisoners with HIV: an observational longitudinal study. PLoS One. 2012;7(8):e42416. doi: 10.1371/journal.pone.0042416. Epub 2012 Aug 3.

  PMID: 22879972 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Frederick L Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Gerald Friedland, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: July 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

US (2)