Positive Lifestyles Using Safety (Project PLUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Yale AIDS Program
AIDS Project Hartford
Connecticut State, Department of Correction
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00836290
First received: February 2, 2009
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
HIV
HIV Infections
Behavioral: Pre-Release (Group 1)
Behavioral: Post-release (Group 2)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Positive Lifestyles Using Safety

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Numbers of different sexual partners [ Time Frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up ] [ Designated as safety issue: No ]
  • Changes in the frequency of condom use reported [ Time Frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up ] [ Designated as safety issue: No ]
  • Changes in reported HIV medication adherence [ Time Frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-release
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.
Behavioral: Pre-Release (Group 1)
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.
Experimental: Post-release
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.
Behavioral: Post-release (Group 2)
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.
No Intervention: Control
Participants in the control group do not receive education sessions during their term in the study. However, these sessions are available to them after completing the study.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836290

Locations
United States, Connecticut
Yale AIDS Program, Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Yale AIDS Program
AIDS Project Hartford
Connecticut State, Department of Correction
Investigators
Principal Investigator: Frederick Altice, MD Yale University
  More Information

No publications provided

Responsible Party: Frederick Altice, MD, Yale AIDS Program, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00836290     History of Changes
Other Study ID Numbers: 0701002257, UR6 PS000391
Study First Received: February 2, 2009
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
risk reduction
HIV prevention
HIV education
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014