HIVSUCCESSNCT02185742
Planning for SUCCESS
A study testing Strength Based Case Management in people with HIV, run by Emory University at 1 site in United States.
Trial summary
Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and Suppression) is a project to improve the connection to community care for HIV infected persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV
- What is being tested?
- Strength Based Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2016
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected (HIV+); age of or over 18 years;
- Mentally able to give consent; understand spoken English;
- Detained or sentenced in either the Fulton County Jail or the Atlanta City Detention Center; and
- Likely to leave within 6 weeks
Who cannot join
- Unable to give consent because of mental illness or inebriation;
- A recent participant in a randomized trial conducted by the investigators of an intervention to increase retention in HIV care (e.g., ARTAS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Planning for Sustained, Unbroken Connections to Care, Entry Services, and Suppression (SUCCESS)-- A Project to Improve the Connection to Community Care for HIV Infected Persons Leaving Jail in Atlanta
Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and Suppression) is a project to improve the connection to community care for HIV infected persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.
Hypothesis: Participants who receive the intervention will be more likely to link to medical care after jail release than similar participants who do not receive the intervention.
Read more
Rationale and objective: This project aims to make sure HIV positive persons leaving jail maintain medical care. Case managers will use strength based case management and phone texting technology to improve release's connections to care in the community.
This study will have extensive tracking of outcomes. The key outcome will be whether HIV infected participants receiving an intervention experience suppression of their viral load after release from jail . The investigators wish to demonstrate the ability to recruit participants into the SUCCESS intervention and repeatedly check community medical records to see how well their infection is being controlled after they linked to care. Investigators also want to conduct a survey at baseline, 3 months and 12 months.
Investigators will compare the viral load of participants receiving the intervention to participants passing through the jail who do not receive the outcome.
- Conditions
- HIV
- Being tested
- Strength Based Case Management
- Keywords
- HIV, jail, detainee, Linkage and Retention, Treatment as Prevention, Strength Based Case Management, releases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength Based Case ManagementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Strength Based Case Management | Experimental | Strength Based Case Management Receives: Behavioral: Strength Based Case Management |
| Contemporary, HIV+ Jail Detainees | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load
HIV viral load can be drawn; obtaining it shows that the person is in care. Ideally, it should be suppressed 12 months out of jail.
One measurement of viral load within three months after release will demonstrate linkage; two clinical visits occurring within 12 months post release, with at least 2 clinical visits spaced a minimum of 3 months apart, will indicate retention.
Measured: 12 months after release from jail
Secondary outcomes (1)
Show feasibility of conducting protocol
Demonstrate that 14 persons can be recruited per month and that delivery of the intervention is feasible.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Anne C Spaulding, Emory University
- Investigators
- Anne C Spaulding, MD MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185742
- Sponsor's protocol ID
- IRB00064852
- Other IDs
- 1R34DA035728-01A1
- Acronym
- SUCCESS
- Status last verified
- Jan 2017
- First submitted
- 7 Jul 2014
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Spaulding AC, Drobeniuc A, Frew PM, Lemon TL, Anderson EJ, Cerwonka C, Bowden C, Freshley J, Del Rio C. Jail, an unappreciated medical home: Assessing the feasibility of a strengths-based case management intervention to improve the care retention of HIV-infected persons once released from jail. PLoS One. 2018 Mar 30;13(3):e0191643. doi: 10.1371/journal.pone.0191643. eCollection 2018.
PubMed 29601591
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planning for Sustained, Unbroken Connections to Care, Entry Services, and Suppression (SUCCESS)-- A Project to Improve the Connection to Community Care for HIV Infected Persons Leaving Jail in Atlanta
- ClinicalTrials.gov ID
- NCT02185742
- Acronym / sponsor ID
- SUCCESS / IRB00064852
- Conditions
- HIV
- Keywords
- HIV, jail, detainee, Linkage and Retention, Treatment as Prevention, Strength Based Case Management, releases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 2014 (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.
Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and Suppression) is a project to improve the connection to community care for HIV infected persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.
Hypothesis: Participants who receive the intervention will be more likely to link to medical care after jail release than similar participants who do not receive the intervention.
Rationale and objective: This project aims to make sure HIV positive persons leaving jail maintain medical care. Case managers will use strength based case management and phone texting technology to improve release's connections to care in the community.
This study will have extensive tracking of outcomes. The key outcome will be whether HIV infected participants receiving an intervention experience suppression of their viral load after release from jail . The investigators wish to demonstrate the ability to recruit participants into the SUCCESS intervention and repeatedly check community medical records to see how well their infection is being controlled after they linked to care. Investigators also want to conduct a survey at baseline, 3 months and 12 months.
Investigators will compare the viral load of participants receiving the intervention to participants passing through the jail who do not receive the outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Based Case Management | Experimental | Behavioral: Strength Based Case ManagementStrength Based Case Management |
| Contemporary, HIV+ Jail Detainees | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected (HIV+); age of or over 18 years;
- Mentally able to give consent; understand spoken English;
- Detained or sentenced in either the Fulton County Jail or the Atlanta City Detention Center; and
- Likely to leave within 6 weeks
Key exclusion criteria (2 listed)
- Unable to give consent because of mental illness or inebriation;
- A recent participant in a randomized trial conducted by the investigators of an intervention to increase retention in HIV care (e.g., ARTAS)
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 |
|---|---|---|
| Strength Based Case Management | Behavioural | Strength Based Case Management |
Primary outcome
HIV viral load
Time frame: 12 months after release from jail
HIV viral load can be drawn; obtaining it shows that the person is in care. Ideally, it should be suppressed 12 months out of jail. One measurement of viral load within three months after release will demonstrate linkage; two clinical visits occurring within 12 months post release, with at least 2 clinical visits spaced a minimum of 3 months apart, will indicate retention.
1 secondary outcome
Show feasibility of conducting protocol
Time frame: Four months
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 23 Jan 2017.
- Derived from this study: PubMed 29601591Spaulding AC, Drobeniuc A, Frew PM, Lemon TL, Anderson EJ, Cerwonka C, Bowden C, Freshley J, Del Rio C. Jail, an unappreciated medical home: Assessing the feasibility of a strengths-based case management intervention to improve the care retention of HIV-infected persons once released from jail. PLoS One. 2018 Mar 30;13(3):e0191643. doi: 10.1371/journal.pone.0191643. eCollection 2018.
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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.
Anne C Spaulding, MD MPH principal investigator
Emory 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 Strength Based Case Management in people with HIV, run by Emory 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 4 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 23 Jan 2017. 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?
HIV viral load (time frame: 12 months after release from jail). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185742, which also lists 1 linked publication.
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 23 Jan 2017.