HIVNCT06171919
Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions
A study testing Organizational Partnerships and HIV Continuum Care in people with HIV, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV
- What is being tested?
- Organizational Partnerships and HIV Continuum Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2024to 1 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Living with HIV (as confirmed by medical record)
- HIV viral load of more than 200 copies/mL (as confirmed by medical record)
- Report history of incarceration
- Willing and able to consent to participate in the trial (including accessing their medical records at the health care organization)
- No intent to relocate within the 6 months following their enrollment in the study.
Who cannot join
- Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32816
Amoy Fraser, PhD, CCRP, PMP, 4072668742, amoy.fraser@ucf.edu
Erica Martin, BS, 4072668742, erica.martin@ucf.edu
About this study
The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal partnerships and improving clinic level outcomes, including communication among providers. The training includes several topics including health disparities impacting formerly incarcerated individuals, health-harming legal needs and risks, screening for health-harming legal needs and risks, medical-legal partnership structure and operations, prerequisites for MLPs, embedding legal expertise within regularized case management, co-location of legal services, and data collection and analysis.
Read the detailed description
Formerly incarcerated individuals are impacted by health-harming legal needs and risks, including lack of access to HIV care, unsafe housing safety, unstable employment, and other issues that often disrupt HIV care. Providing access to legal services can address barriers to HIV care and improve HIV care continuum outcomes for formerly incarcerated individuals. The proposed study, led by the University of Central Florida (Hispanic Serving Institution), together with the University of Miami, and Hope and Help Inc., aims to pilot test a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to optimize timely HIV linkage, retention and viral suppression among formerly incarcerated individuals. MLPs have been used by social justice-oriented medical, health, social, and legal service practices to identify and address health-harming legal needs and risks that create barriers to treatment, care, and recovery for several health conditions. MLPs offer an integrated structural intervention that could improve HIV care continuum and psychosocial outcomes among formerly incarcerated individuals. Our CTI-MLP intervention package consists of: 1) training for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health-harming legal needs and risks impacting formerly incarcerated individuals, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) training for case managers and court advocate on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-locating legal services in health care agencies through MLP inter-organizational partnership; and 5) tailoring and implementing organizational best-practices in communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. In year 1, the investigators will engage a local community advisory board, scientific advisory board, and legal expert panel to finalize protocols and the Medical Legal Partnership Training Manual. In year 2, the investigators will implement the training and pilot test a CTI-MLP initiative with formerly incarcerated individuals living with HIV (n=100). Over a 6-month period, the team will collect (1) patients' health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life; (2) data on legal needs and risk factors; (3) patient HIV care clinical outcomes; and (4) clinic-level indicators, including provider-patient communication and readiness for continued implementation and sustainability. The study will be guided by Reach, Effectiveness, Adoption, Implementation, and Maintenance and Consolidated Framework for Implementation Research frameworks. Active engagement will ensure the effective translation and dissemination of our findings into practice. Completion this project will result in an innovative, evidence-based, community driven structural intervention to improve HIV care continuum outcomes among formerly incarcerated individuals.
- Conditions
- HIV
- Being tested
- Organizational Partnerships, HIV Continuum Care
- Keywords
- HIV, Care, Incarcerated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organizational PartnershipsOther
Component 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs and risks of formerly incarcerated individuals living with HIV. Component 3 includes the provision of legal support.
HIV Continuum CareOther
Participants will be included in the pilot trial. The investigative team will work with the staff at Hope and Help Inc. to identify and recruit those out of care through reviewing electronic medical records.
| Study group | Role | What they receive |
|---|---|---|
| CTI-MLP approach | Experimental | To finalize protocols and a medical-legal partnership training manual for health and social service providers at Hope and Help Inc. Receives: Other: Organizational Partnerships |
| CTI-MLP assessment | Experimental | To assess the feasibility and acceptability of a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to improve HIV care continuum outcomes among formerly incarcerated individuals and determine the most efficient mechanisms for CTI-MLP delivery Receives: Other: HIV Continuum Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load using polymerase chain reaction (PCR)
HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test
Measured: 6 months
HIV linkage and retention and antiretroviral therapy adherence using surveys
Measured: 6 months
Secondary outcomes (2)
Quality of Life checklist
A 36-item health questionnaire. It has 8 scales which provide a profile of functionally participant and welfare. The scales contain two general measures, the PCS (Physical Health Component Summary), and MCS (Mental Health Component Summary).
Measured: 1 year
Mental health indicators survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start5 Oct 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, National Institute of Mental Health (NIMH), Hope and Help Center of Central Florida Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171919
- Sponsor's protocol ID
- STUDY00006010
- Other IDs
- 3P30MH133399-01S2
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions
- ClinicalTrials.gov ID
- NCT06171919
- Acronym / sponsor ID
- STUDY00006010
- Conditions
- HIV
- Keywords
- HIV, Care, Incarcerated
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- University of Miami, National Institute of Mental Health (NIMH), Hope and Help Center of Central Florida Incorporated
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 15 Dec 2023 (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.
The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly incarcerated individuals. In addition, the investigators would like to assess the effectiveness of a comprehensive training for providers in increasing knowledge about medical legal partnerships and improving clinic level outcomes, including communication among providers. The training includes several topics including health disparities impacting formerly incarcerated individuals, health-harming legal needs and risks, screening for health-harming legal needs and risks, medical-legal partnership structure and operations, prerequisites for MLPs, embedding legal expertise within regularized case management, co-location of legal services, and data collection and analysis.
Detailed description
Formerly incarcerated individuals are impacted by health-harming legal needs and risks, including lack of access to HIV care, unsafe housing safety, unstable employment, and other issues that often disrupt HIV care. Providing access to legal services can address barriers to HIV care and improve HIV care continuum outcomes for formerly incarcerated individuals. The proposed study, led by the University of Central Florida (Hispanic Serving Institution), together with the University of Miami, and Hope and Help Inc., aims to pilot test a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to optimize timely HIV linkage, retention and viral suppression among formerly incarcerated individuals. MLPs have been used by social justice-oriented medical, health, social, and legal service practices to identify and address health-harming legal needs and risks that create barriers to treatment, care, and recovery for several health conditions. MLPs offer an integrated structural intervention that could improve HIV care continuum and psychosocial outcomes among formerly incarcerated individuals. Our CTI-MLP intervention package consists of: 1) training for all MLP staff (clinical, social and behavioral services, and legal) on HIV continuum of care, health-harming legal needs and risks impacting formerly incarcerated individuals, and MLP structure and operations to ensure that an integrated and collaborative environment is established from the earliest stages of the program; 2) training for case managers and court advocate on the legal continuum of care; 3) embedding of legal expertise within regularized case management team meetings; 4) co-locating legal services in health care agencies through MLP inter-organizational partnership; and 5) tailoring and implementing organizational best-practices in communication and information-sharing protocols among providers within MLP, anchored in patient autonomy and choice. In year 1, the investigators will engage a local community advisory board, scientific advisory board, and legal expert panel to finalize protocols and the Medical Legal Partnership Training Manual. In year 2, the investigators will implement the training and pilot test a CTI-MLP initiative with formerly incarcerated individuals living with HIV (n=100). Over a 6-month period, the team will collect (1) patients' health and functioning, including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life; (2) data on legal needs and risk factors; (3) patient HIV care clinical outcomes; and (4) clinic-level indicators, including provider-patient communication and readiness for continued implementation and sustainability. The study will be guided by Reach, Effectiveness, Adoption, Implementation, and Maintenance and Consolidated Framework for Implementation Research frameworks. Active engagement will ensure the effective translation and dissemination of our findings into practice. Completion this project will result in an innovative, evidence-based, community driven structural intervention to improve HIV care continuum outcomes among formerly incarcerated individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTI-MLP approach | Experimental | Other: Organizational PartnershipsTo finalize protocols and a medical-legal partnership training manual for health and social service providers at Hope and Help Inc. |
| CTI-MLP assessment | Experimental | Other: HIV Continuum CareTo assess the feasibility and acceptability of a comprehensive critical-time intervention medical legal partnership (CTI-MLP) approach to improve HIV care continuum outcomes among formerly incarcerated individuals and determine the most efficient mechanisms for CTI-MLP delivery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Living with HIV (as confirmed by medical record)
- HIV viral load of more than 200 copies/mL (as confirmed by medical record)
- Report history of incarceration
- Willing and able to consent to participate in the trial (including accessing their medical records at the health care organization)
Key exclusion criteria (1 listed)
- Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 6 months from proposed enrollment in the study
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 |
|---|---|---|
| Organizational PartnershipsComponent 1 is a comprehensive training for all MLP care providers delivered to clinical, social and behavioral, and legal staff to establish a collaborative environment. Component 2 consists of the screening tool and screening protocol that is designed to identify health-harming legal needs and risks of formerly incarcerated individuals living with HIV. Component 3 includes the provision of legal support. | Other | CTI-MLP approach |
| HIV Continuum CareParticipants will be included in the pilot trial. The investigative team will work with the staff at Hope and Help Inc. to identify and recruit those out of care through reviewing electronic medical records. | Other | CTI-MLP assessment |
Primary outcome
HIV viral load using polymerase chain reaction (PCR)
Time frame: 6 months
HIV viral load through HIV Nucleic Acid Amplification Test (NAAT) HIV by PCR HIV RNA Test
HIV linkage and retention and antiretroviral therapy adherence using surveys
Time frame: 6 months
2 secondary outcomes
Quality of Life checklist
Time frame: 1 year
Mental health indicators survey
Time frame: 1 year
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 23 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organizational Partnerships and HIV Continuum Care in people with HIV, run by University of Central Florida 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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?
Contact Omar Martinez, JD, MPH, MS (4072668742, omar.martinez@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral load using polymerase chain reaction (PCR) (time frame: 6 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 23 Feb 2026.