Positive Lifestyles Using Safety (Project PLUS)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV
• Intervention / Treatment: Behavioral: Pre-Release (Group 1); Behavioral: Post-release (Group 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale AIDS Program, Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of unprotected sex episodes across different partners categorized by perceived HIV-status of each partner	Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Numbers of different sexual partners	Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in the frequency of condom use reported	Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in reported HIV medication adherence	Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in reported drug use episodes across different partners categorized by perceived HIV-status of each partner	Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); Centers for Disease Control and Prevention; Yale AIDS Program; AIDS Project Hartford; Connecticut State, Department of Correction

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (ESTIMATE): February 4, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV prevention; risk reduction; HIV education
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 0701002257; UR6PS000391 (NIH)