HIVSHARENCT06810973
Substance Use and HIV Action for Reentry and Engagement.
A study testing SUCCESS-E and Key Informant Interviews in people with HIV, run by Emory University at 1 site in United States.
Trial summary
This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- SUCCESS-E and Key Informant Interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Cis- and transgender men and women
- Able to understand and give informed consent
- Willing to participate in study activities
- People with HIV (PWH) or people at high risk of seroconversion (PHRS)
- History of SUD, defined as a score of 2 or more items in the past year on the Justice Community Opioid Innovation Network (JCOIN) SUD assessment tool
- Resident of study jail and agree to participate in the SUCCESS-E program, or released from study jail within six weeks, and agree to participate in the SUCCESS-E program
Show all 10Show fewer
- Participant who completed the intervention or
- A jail administrator/staff member
- Able to give informed consent
- Willing to participate in study activities
Who cannot join
- Uncontrolled serious mental illness or moderate to severe intellectual impairment, and/or cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)
- Admission to a prison facility (Federal or state)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. The goal is to see if this approach improves clients' ability to access healthcare and drug treatment after being released from jail.
Read the detailed description
The goal of this jail-based study is to test an intervention aimed at helping individuals with substance use disorder (SUD) who have HIV or are at high risk of contracting HIV maintain medications for managing or preventing HIV when transitioning back to the community. Approximately 75% of individuals in jail have SUD and a subset of this group either has HIV or is at risk of seroconversion. People living with HIV require antiretroviral medications to suppress the virus to non-infectious levels, but these medications are often discontinued during the chaotic period following release from jail. Those at risk of HIV can also take antiretroviral therapy as a preventive measure to lower the risk of seroconversion.
Preliminary data suggest that SUCCESS-E, a strengths-based case management and peer navigation program developed via a pilot grant, can help connect individuals to medical care upon release to ensure continued drug therapy. A manual for delivering SUCCESS-E was previously developed to guide case managers and peer navigators.
In this phase, 100 eligible individuals will be enrolled from the Fulton County Jail (FCJ). Participants will be randomly assigned to one of two groups: SUCCESS-E intervention or controls receiving an enhanced version of the jail's discharge planning services.
Data will be collected through medical chart reviews, baseline and follow-up surveys with participants (each taking less than an hour), and single-visit interviews with approximately 30 stakeholders (jail staff, community advocates, and individuals post-program). These key informant interviews will typically last less than an hour and will be recorded for qualitative analysis. Data will also be collected to estimate the cost of delivering the intervention.
The project will apply implementation science to introduce innovations in case management for transitioning individuals from jail back to the community. The case management intervention will be delivered to individuals with HIV or those at high risk of seroconversion, both in jail and post-release. If proven effective, this strategy could help reduce the incidence of new HIV cases by maintaining viral suppression in individuals with HIV and ensuring that those at risk for HIV seroconversion remain on preventive therapy.
The study will focus on individuals, with or without HIV, who have SUD and are either incarcerated or have been released from jails in Georgia within the past six weeks. Participants will ideally be within one week of their release.
The study aims to address the following questions:
- For people without HIV, how can they access a clinic offering HIV prevention medication (Pre-Exposure Prophylaxis, or PrEP)?
- For people living with HIV, how can they access a clinic to receive their HIV medications (Antiretroviral Therapy, or ART)?
- For everyone, how can they get treatment for Substance Use Disorder (SUD)?
- Conditions
- HIV
- Being tested
- SUCCESS-E, Enhanced Standard of Care, Key Informant Interviews
- Keywords
- Jail Facilities, ART/PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUCCESS-EBehavioural
Also called Sustained, Unbroken, Connection to Care Entry Services, and Suppression/Stopping of HIV, Enhanced with Peer Navigators
SUCCESS-E is a previously developed intervention based on the evidence-based Antiretroviral Treatment and Access to Services (ARTAS) intervention, modified for those detained within a jail system. It is a manualized six-session program delivered by a case management team, composed of a professional case manager and paraprofessional peer navigators.
In Jail Sessions:
- Build Trust
- Assess Strengths
- Explore life on ART Post-Release Sessions:
- Link with care
- Enhance self-efficacy for HIV care/PrEP
- Future transitions
Enhanced Standard of CareBehavioural
A list of referral sites for follow-up SUD care will be shared. This information sharing without strength-based, longitudinal case management will be an enhancement to treatment as usual. Also, information about HIV/PrEP follow-up in the community will be placed around the jail, such as affixed to the nurses' medication carts that they push from housing unit to unit, twice a day when residents are due for prescription medications.
Key Informant InterviewsBehavioural
Also called KII
Key informant interviews (KII) will be conducted with jail staff and community stakeholders in the R61 phase to examine perceptions, barriers, and facilitators to SUD and HIV/PrEP service and treatment utilization, as well as document the experiences of SUCCESS-E participants from the pilot phase.
| Study group | Role | What they receive |
|---|---|---|
| SUCCESS-E | Experimental | Participants with SUD, living with HIV or at high risk for seroconversion, will be placed in strength-based case management, delivered by a case manager and peer navigators, both in jail and in the community, leading to linkage and retention in healthcare and SUD treatment. Receives: Behavioral: SUCCESS-E |
| Control Group | Other | Participants not placed in the intervention group will have healthcare services inform them of possible medical homes for HIV/PrEP care and a list of referral sites for follow-up SUD care. Receives: Behavioral: Enhanced Standard of Care |
| Key informant interviews (KII) | Other | Jail staff and community members willing to participate in Key Informant Interviews (KIIs) Receives: Behavioral: Key Informant Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to ART
Linkage to ART care for individuals with lived experience of HIV or PrEP for PHRS.
Measured: 3 months
Program Retention
Program Retention at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start9 Jun 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During the two-year R61 phase, the investigators will compare the Intervention vs Enhanced Standard of Care. The investigators will work with new criminal legal institutions and conduct interviews among recently released PWH/PHRS to see how transitional needs in new jurisdictions differ from those experienced by those in FCJ. Building relationships in the R61 phase will position the researchers to scale up a larger study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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 Spaulding, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810973
- Sponsor's protocol ID
- STUDY00008607
- Other IDs
- R61DA062365
- Acronym
- SHARE
- Status last verified
- Aug 2025
- First submitted
- 31 Jan 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use and HIV Action for Reentry and Engagement.
- ClinicalTrials.gov ID
- NCT06810973
- Acronym / sponsor ID
- SHARE / STUDY00008607
- Conditions
- HIV
- Keywords
- Jail Facilities, ART/PrEP
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- 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.
This study will test a behavioral intervention with a case manager/peer navigator team pairing with clients to deliver transition planning services. The interactions help clients recognize and use their strengths. The goal is to see if this approach improves clients' ability to access healthcare and drug treatment after being released from jail.
Detailed description
The goal of this jail-based study is to test an intervention aimed at helping individuals with substance use disorder (SUD) who have HIV or are at high risk of contracting HIV maintain medications for managing or preventing HIV when transitioning back to the community. Approximately 75% of individuals in jail have SUD and a subset of this group either has HIV or is at risk of seroconversion. People living with HIV require antiretroviral medications to suppress the virus to non-infectious levels, but these medications are often discontinued during the chaotic period following release from jail. Those at risk of HIV can also take antiretroviral therapy as a preventive measure to lower the risk of seroconversion.
Preliminary data suggest that SUCCESS-E, a strengths-based case management and peer navigation program developed via a pilot grant, can help connect individuals to medical care upon release to ensure continued drug therapy. A manual for delivering SUCCESS-E was previously developed to guide case managers and peer navigators.
In this phase, 100 eligible individuals will be enrolled from the Fulton County Jail (FCJ). Participants will be randomly assigned to one of two groups: SUCCESS-E intervention or controls receiving an enhanced version of the jail's discharge planning services.
Data will be collected through medical chart reviews, baseline and follow-up surveys with participants (each taking less than an hour), and single-visit interviews with approximately 30 stakeholders (jail staff, community advocates, and individuals post-program). These key informant interviews will typically last less than an hour and will be recorded for qualitative analysis. Data will also be collected to estimate the cost of delivering the intervention.
The project will apply implementation science to introduce innovations in case management for transitioning individuals from jail back to the community. The case management intervention will be delivered to individuals with HIV or those at high risk of seroconversion, both in jail and post-release. If proven effective, this strategy could help reduce the incidence of new HIV cases by maintaining viral suppression in individuals with HIV and ensuring that those at risk for HIV seroconversion remain on preventive therapy.
The study will focus on individuals, with or without HIV, who have SUD and are either incarcerated or have been released from jails in Georgia within the past six weeks. Participants will ideally be within one week of their release.
The study aims to address the following questions:
- For people without HIV, how can they access a clinic offering HIV prevention medication (Pre-Exposure Prophylaxis, or PrEP)?
- For people living with HIV, how can they access a clinic to receive their HIV medications (Antiretroviral Therapy, or ART)?
- For everyone, how can they get treatment for Substance Use Disorder (SUD)?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- During the two-year R61 phase, the investigators will compare the Intervention vs Enhanced Standard of Care. The investigators will work with new criminal legal institutions and conduct interviews among recently released PWH/PHRS to see how transitional needs in new jurisdictions differ from those experienced by those in FCJ. Building relationships in the R61 phase will position the researchers to scale up a larger study.
| Arm | Type | Receives |
|---|---|---|
| SUCCESS-E | Experimental | Behavioral: SUCCESS-EParticipants with SUD, living with HIV or at high risk for seroconversion, will be placed in strength-based case management, delivered by a case manager and peer navigators, both in jail and in the community, leading to linkage and retention in healthcare and SUD treatment. |
| Control Group | Other | Behavioral: Enhanced Standard of CareParticipants not placed in the intervention group will have healthcare services inform them of possible medical homes for HIV/PrEP care and a list of referral sites for follow-up SUD care. |
| Key informant interviews (KII) | Other | Behavioral: Key Informant InterviewsJail staff and community members willing to participate in Key Informant Interviews (KIIs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cis- and transgender men and women
- Able to understand and give informed consent
- Willing to participate in study activities
- People with HIV (PWH) or people at high risk of seroconversion (PHRS)
- History of SUD, defined as a score of 2 or more items in the past year on the Justice Community Opioid Innovation Network (JCOIN) SUD assessment tool
Key exclusion criteria (2 listed)
- Uncontrolled serious mental illness or moderate to severe intellectual impairment, and/or cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)
- Admission to a prison facility (Federal or state)
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 |
|---|---|---|
| SUCCESS-EAlso: Sustained, Unbroken, Connection to Care Entry Services, and Suppression/Stopping of HIV, Enhanced with Peer NavigatorsSUCCESS-E is a previously developed intervention based on the evidence-based Antiretroviral Treatment and Access to Services (ARTAS) intervention, modified for those detained within a jail system. It is a manualized six-session program delivered by a case management team, composed of a professional case manager and paraprofessional peer navigators. In Jail Sessions: 1. Build Trust 2. Assess Strengths 3. Explore life on ART Post-Release Sessions: 4. Link with care 5. Enhance self-efficacy for HIV care/PrEP 6. Future transitions | Behavioural | SUCCESS-E |
| Enhanced Standard of CareA list of referral sites for follow-up SUD care will be shared. This information sharing without strength-based, longitudinal case management will be an enhancement to treatment as usual. Also, information about HIV/PrEP follow-up in the community will be placed around the jail, such as affixed to the nurses' medication carts that they push from housing unit to unit, twice a day when residents are due for prescription medications. | Behavioural | Control Group |
| Key Informant InterviewsAlso: KIIKey informant interviews (KII) will be conducted with jail staff and community stakeholders in the R61 phase to examine perceptions, barriers, and facilitators to SUD and HIV/PrEP service and treatment utilization, as well as document the experiences of SUCCESS-E participants from the pilot phase. | Behavioural | Key informant interviews (KII) |
Primary outcome
Linkage to ART
Time frame: 3 months
Linkage to ART care for individuals with lived experience of HIV or PrEP for PHRS.
Program Retention
Time frame: 3 months
Program Retention at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be available for sharing.
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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.
Anne 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 SUCCESS-E and Key Informant Interviews 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 10 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Linkage to ART (time frame: 3 months). The study lists 2 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 11 Aug 2025.