HIVPhase 2NCT01402466
Urban Health Study II
A Phase 2 study testing Standard Referral and Project Bridge in people with HIV, run by RTI International at 1 site in United States.
Trial summary
The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV
- What is being tested?
- Standard Referral and Project Bridge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2014
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- HIV antibody positive
- not currently receiving HIV care
Who cannot join
- already in care
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
RTI International Urban Health Program
San Francisco, California, 94104
About this study
Official title: Finding, Testing and Treating High-Risk Probationers and Parolees With HIV
The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.
Read the detailed description
The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.
HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.
The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.
- Conditions
- HIV
- Being tested
- Standard Referral, Project Bridge
- Keywords
- Drug users, criminal justice, HIV care, HAART, incarceration
- Medical subject headings
- Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ReferralBehavioural
Participants randomized to this arm will be referred to local HIV care resources
Project BridgeBehavioural
Arm 2
| Study group | Role | What they receive |
|---|---|---|
| Standard Referral | Active comparator | Participants randomized to this arm will be referred to local HIV care resources Receives: Behavioral: Standard Referral |
| Project Bridge | Experimental | Participants randomized to this arm will be given the Project Bridge intervention Receives: Behavioral: Project Bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log10 viral load
Changes in viral load over time will be compared between the standard referral and Project Bridge Groups
Measured: Every 3 months for 2 years
Secondary outcomes (2)
Engagement in HIV Care
The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups
Measured: Every 3 months for 2 years
Initiation of Highly Active Antiretroviral Therapy (HAART)
The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups
Measured: Every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionDec 2014
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.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Alex H Kral, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402466
- Sponsor's protocol ID
- 12690
- Other IDs
- R01MH094090
- Status last verified
- Mar 2016
- First submitted
- 28 Jun 2011
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding, Testing and Treating High-Risk Probationers and Parolees With HIV
- ClinicalTrials.gov ID
- NCT01402466
- Acronym / sponsor ID
- 12690
- Conditions
- HIV
- Keywords
- Drug users, criminal justice, HIV care, HAART, incarceration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jul 2011 (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.
The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.
Detailed description
The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.
HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.
The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Referral | Active comparator | Behavioral: Standard ReferralParticipants randomized to this arm will be referred to local HIV care resources |
| Project Bridge | Experimental | Behavioral: Project BridgeParticipants randomized to this arm will be given the Project Bridge intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- HIV antibody positive
- not currently receiving HIV care
Key exclusion criteria (2 listed)
- already in care
- unable to provide informed consent
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 |
|---|---|---|
| Standard ReferralParticipants randomized to this arm will be referred to local HIV care resources | Behavioural | Standard Referral |
| Project BridgeArm 2 | Behavioural | Project Bridge |
Primary outcome
Log10 viral load
Time frame: Every 3 months for 2 years
Changes in viral load over time will be compared between the standard referral and Project Bridge Groups
2 secondary outcomes
Engagement in HIV Care
Time frame: Every 3 months for 2 years
Initiation of Highly Active Antiretroviral Therapy (HAART)
Time frame: Every 3 months for 2 years
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 28 Mar 2016.
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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.
Alex H Kral, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Referral and Project Bridge in people with HIV, run by RTI International 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 3 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 28 Mar 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Log10 viral load (time frame: Every 3 months for 2 years). 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 28 Mar 2016.