Positive Lifestyles Using Safety

NCT00836290 | Completed

• 2 other identifiers: 0701002257UR6PS000391
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; HIV Infections

Keywords

risk reduction; HIV prevention; HIV education; HIV Seronegativity

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Pre-release

EXPERIMENTAL

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)

Post-release

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

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.

Pre-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.

Post-release

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Yale AIDS Program, Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

HIV Infections; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Study Officials

• Frederick Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)