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Positive Lifestyles Using Safety (Project PLUS)

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-Release (Group 1)
Post-release (Group 2)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring risk reduction, HIV prevention, HIV education, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale AIDS Program, Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pre-release

Post-release

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2009
Last Updated
October 19, 2015
Sponsor
Yale University
Collaborators
Centers for Disease Control and Prevention, National Institute on Drug Abuse (NIDA), Yale AIDS Program, AIDS Project Hartford, Connecticut State, Department of Correction
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1. Study Identification

Unique Protocol Identification Number
NCT00836290
Brief Title
Positive Lifestyles Using Safety
Acronym
Project PLUS
Official Title
Positive Lifestyles Using Safety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Centers for Disease Control and Prevention, National Institute on Drug Abuse (NIDA), Yale AIDS Program, AIDS Project Hartford, Connecticut State, Department of Correction

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
risk reduction, HIV prevention, HIV education, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-release
Arm Type
Experimental
Arm Description
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.
Arm Title
Post-release
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pre-Release (Group 1)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Post-release (Group 2)
Intervention Description
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 Outcome Measure Information:
Title
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
Title
Numbers of different sexual partners
Time Frame
Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Title
Changes in the frequency of condom use reported
Time Frame
Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Title
Changes in reported HIV medication adherence
Time Frame
Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Altice, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale AIDS Program, Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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Positive Lifestyles Using Safety

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