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Completed

NCT Number: NCT00786396

Directly Observed Therapy for Community-Released HIV+ Prisoners

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Abuse Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University-Yale Clinical Research, Hartford, Connecticut, United States

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About this study

Any individual that is HIV positive and incarcerated for at least a period of 90 days and on antiretroviral medications would be referred to the study by the medical staff of the incarceration facilities prior to release or within 30 days of release an individual would be able to self refer.

Subjects would be screened and consented and interviewed prior to their release from incarceration, on their day of release, and monthly for a period of one year. At the time of their day of release interview, subjects are randomized to either the intervention DAART group or the standard of care SAT group. All subjects would be assessed and offered opiate substitution therapy if there was a prior history of opiate dependency as a means of relapse prevention.

Subjects in DAART would be seen everyday for a period of six months by a team of research assistants who observe the subjects taking their medications, and their last six months would be done as standard of care. Standard of care SAT subjects would continue to take their medications on their own as prescribed. All subjects would be interviewed monthly and quarterly would have laboratory blood tests completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV seropositive
  • 18 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

Exclusion criteria

  • Not meeting inclusion criteria

Treatment and study plan

Directly Administered Antiretroviral Therapy

Behavioral

Daily observation of subjects taking their HIV medications

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.

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12

  2. Lower rate of recidivism and to illicit drug use

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: Connect

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2008
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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