Positive Lifestyles Using Safety (Project PLUS)
Recruitment status was Active, not recruiting
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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 |
- 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 |
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| United States, Connecticut | |
| Yale AIDS Program, Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| 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 June 17, 2013