HIVProject PLUSNCT00836290
Positive Lifestyles Using Safety
A study testing Pre-Release (Group 1) and Post-release (Group 2) in people with HIV and HIV Infections, run by Yale University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Pre-Release (Group 1) and Post-release (Group 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- Have an untreated bipolar or psychotic disorder
- Suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale AIDS Program, Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
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.
Read the 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.
- Conditions
- HIV, HIV Infections
- Being tested
- Pre-Release (Group 1), Post-release (Group 2)
- Keywords
- risk reduction, HIV prevention, HIV education, HIV Seronegativity
- Medical subject headings
- HIV Infections, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Release (Group 1)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unprotected sex episodes across different partners categorized by perceived HIV-status of each partner
Measured: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Numbers of different sexual partners
Measured: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in the frequency of condom use reported
Measured: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in reported HIV medication adherence
Measured: 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
Measured: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, National Institute on Drug Abuse (NIDA), AIDS Project Hartford, Connecticut State, Department of Correction
- Responsible party
- Sponsor
- Investigators
- Frederick Altice, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836290
- Sponsor's protocol ID
- 0701002257
- Other IDs
- UR6PS000391
- Acronym
- Project PLUS
- Status last verified
- Oct 2015
- First submitted
- 2 Feb 2009
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Lifestyles Using Safety
- ClinicalTrials.gov ID
- NCT00836290
- Acronym / sponsor ID
- Project PLUS / 0701002257
- Conditions
- HIV, HIV Infections
- Keywords
- risk reduction, HIV prevention, HIV education, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, National Institute on Drug Abuse (NIDA), AIDS Project Hartford, Connecticut State, Department of Correction
- Study start
- Jan 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-release | Experimental | 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 | Experimental | 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Have an untreated bipolar or psychotic disorder
- Suicidal or homicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pre-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. | Behavioural | Post-release |
Primary outcome
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
Numbers of different sexual partners
Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in the frequency of condom use reported
Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Changes in reported HIV medication adherence
Time frame: 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
Time frame: Pre-release, Day of Release, 1-mo ff-up, 3-mo ff-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Altice, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Release (Group 1) and Post-release (Group 2) in people with HIV and HIV Infections, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.