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Completed

NCT Number: NCT00836290

Positive Lifestyles Using Safety

Project PLUS tests an HIV risk reduction/adherence behavioral intervention with HIV-infected individuals in Connecticut prisons. Participants are randomly assigned to one of three groups: prior to release from incarceration (Group 1), after release from incarceration (Group 2), and treatment-as-usual (Group 3). We hypothesize that the intervention groups (Groups 1 & 2) will demonstrate significantly greater knowledge regarding drug- and sex- related HIV risk behavior and HIV medication adherence, greater motivation to reduce HIV risk behavior and improve HIV medication adherence, and enhanced skills for engaging in HIV risk reduction behavior and HIV medication adherence vs. the treatment-as-usual group. We will also compare these outcomes between Groups 1 and 2.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale AIDS Program, Yale University School of Medicine

New Haven, Connecticut, 06510, United States

About this study

Project PLUS is an HIV risk reduction/Highly Active Antiretroviral Therapy (HAART) adherence behavioral intervention for persons being released from prisons in Connecticut. The intervention is delivered one-on-one to HIV-infected individuals prior to release from incarceration (Group 1) vs. after release from incarceration (Group 2) vs. treatment as usual (Group 3). The primary hypothesis is that the intervention groups (Groups 1 & 2) will demonstrate significantly greater reduction in rates of HIV sexual and drug risk behaviors and a significantly greater increase in HAART adherence compared to Group 3 participants at 4 months following release from prison. (However, those in Group 3 may come back to participate in the educational sessions, as non-study participants, after their participation has been completed). Based on the IMB model of health behavior change, the primary outcomes of interest are HIV risk reduction knowledge, motivation, behavioral skills (Fisher & Fisher, 1992) and specific event-level partner-by-partner drug and sex risk outcomes including the frequency of unprotected sex episodes across different partners categorized by perceived HIV-status of each partner, numbers of different sexual partners, changes in the frequency of condom use, changes in reported adherence to HIV medication, and changes in reported drug use episodes across different partners categorized by perceived HIV-status of each partner. Additional outcomes of interest include greater knowledge regarding drug- and sex- related HIV risk behaviors and HAART adherence, greater motivation to reduce HIV risk behaviors and improve HAART adherence, enhanced skills for engaging in HIV risk reduction behaviors and HAART adherence. A comparison between Groups 1 & 2 has never been examined, so an important part of this study is to explore this comparison.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are 18 years of age or older
  • Meet DSM-IV criteria for opioid-dependence
  • Are scheduled to be released from prison within the next 30 days
  • Are confirmed to be HIV-infected
  • Report drug- or sex-related HIV risk behavior prior to incarceration
  • Are willing to provide locator information
  • Able to read and understand the questionnaires and consent form
  • No minimum duration of incarceration
  • Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., pending court case or warrant).

Exclusion criteria

  • Have an untreated bipolar or psychotic disorder
  • Suicidal or homicidal ideation

Treatment and study plan

Pre-Release (Group 1)

Behavioral

Participants in the pre-release intervention group will receive four sessions in the four-week period prior to release and will receive a comprehensive booster session four weeks after release.

Post-release (Group 2)

Behavioral

Participants in the post-release intervention group will receive one comprehensive introductory session four weeks before release and four sessions during the four-week period after release.

Primary outcomes

  1. Frequency of unprotected sex episodes across different partners categorized by perceived HIV-status of each partner

    Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

  2. Numbers of different sexual partners

    Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

  3. Changes in the frequency of condom use reported

    Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

  4. Changes in reported HIV medication adherence

    Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

  5. Changes in reported drug use episodes across different partners categorized by perceived HIV-status of each partner

    Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • AIDS Project Hartford
  • Centers for Disease Control and Prevention
  • Connecticut State, Department of Correction
  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: Project PLUS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2009
Registry last updated
Oct 21, 2015

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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