Positive Lifestyles Using Safety

HIV Infections Clinical Trial

— Project PLUS  

Official title:

Positive Lifestyles Using Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836290
• Other study ID #: 0701002257
• Secondary ID: UR6PS000391
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: October 19, 2015
• Start date: January 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale AIDS Program, Yale University School of Medicine	New Haven	Connecticut

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Numbers of different sexual partners		Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up	No
Primary	Changes in the frequency of condom use reported		Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up	No
Primary	Changes in reported HIV medication adherence		Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up	No
Primary	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	No