Legal Aid and Training for HIV Care

Overseen By Omar Martinez, JD, MPH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Incarceration sentence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the impact of legal assistance on the healthcare of individuals living with HIV who have been incarcerated. It also seeks to determine if training healthcare providers in medical-legal partnerships can enhance communication and care at clinics. The trial will explore various methods to deliver this legal assistance and training, known as Critical Time Legal Interventions. It seeks participants who have HIV, have been incarcerated, and are experiencing high viral loads. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could enhance healthcare and legal support for people with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on legal aid and training for HIV care, so it's best to ask the trial organizers for more details.

What prior data suggests that this protocol is safe for improving HIV care among formerly incarcerated individuals?

Research shows that Critical Time Legal Interventions (CTI) are being explored for their potential to improve HIV care, particularly for individuals who have been in prison. This study is marked as "Not Applicable" in terms of phase, indicating it doesn't follow the usual steps of clinical trials that test new drugs for safety. Consequently, there isn't much direct safety data as found with new medications.

CTI provides legal help and training instead of medication, so there are no typical side effects. The goal is to determine how these interventions can improve health by addressing legal issues that might prevent access to necessary care.

A Data and Safety Monitoring Board has approved the study, ensuring that any risks are closely monitored. Since this isn't a drug trial, the usual concerns about physical side effects aren't the focus. Instead, the study examines how the intervention affects health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to improving HIV care for formerly incarcerated individuals. Unlike traditional treatments that focus solely on medical aspects, this trial integrates critical-time intervention with medical-legal partnerships (CTI-MLP). This means it not only addresses health needs but also tackles legal and social barriers that can affect access to care. By assessing the feasibility and creating training manuals for providers, this approach aims to create a comprehensive support system, potentially leading to better health outcomes and continuity of care for a vulnerable population.

What evidence suggests that this trial's interventions could be effective for improving HIV care among formerly incarcerated individuals?

Research has shown that adding legal help to HIV care can improve health for people who have been in prison. In this trial, participants will engage in different arms studying the Critical Time Legal Interventions (CTI-MLP) approach. Studies find that legal support increases the likelihood of staying on HIV treatment and accessing necessary medication. Outreach efforts have also been linked to lower death rates and increased use of healthcare services. This method, known as a medical-legal partnership (MLP), addresses legal problems that can affect health. By including legal services in healthcare, patients are more likely to adhere to treatment plans and improve their overall health. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who were previously incarcerated and are living with HIV/AIDS. It aims to explore how legal aid can improve their health outcomes. Participants should be interested in receiving legal assistance and willing to engage with healthcare providers trained in medical-legal partnerships.

Inclusion Criteria

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Protocol Finalization

Engagement with advisory boards and finalization of protocols and training manual for the CTI-MLP approach

1 year

Implementation and Pilot Testing

Implementation of training and pilot testing of the CTI-MLP initiative with formerly incarcerated individuals living with HIV

6 months

Follow-up

Participants are monitored for HIV care continuum outcomes and quality of life improvements

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Critical Time Legal Interventions

Trial Overview The study tests the effect of providing legal aid on HIV care for those formerly incarcerated, alongside a training program for healthcare providers. The goal is to see if these interventions help patients stay on track with their HIV treatment and improve communication among caregivers.

How Is the Trial Designed?

Group I: CTI-MLP assessment Experimental Treatment 1 Intervention

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

Group II: CTI-MLP approach Experimental Treatment 1 Intervention

To finalize protocols and a medical-legal partnership training manual for health and social service providers at Hope and Help Inc.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Hope and Help Center of Central Florida Incorporated

Collaborator

Trials

1

Recruited

100+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In England and Wales, the HIV sector has successfully influenced the Crown Prosecution Service to create Legal Guidance for prosecutors regarding HIV transmission cases, aiming to improve fairness in the legal process.

This intervention seeks to mitigate harm to individuals living with HIV by ensuring that prosecutions are handled with greater understanding and sensitivity, although the article assesses the actual benefits of this guidance for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing guidance for HIV prosecutions: an example of harm reduction? Azad, Y.[2016]

International human rights law can be effectively utilized by public health advocates to promote better responses to the HIV/AIDS epidemic, ensuring that these responses align with sound public health principles and best practices.

There is a growing trend in development assistance to incorporate rights-based approaches, emphasizing collaboration between health professionals and communities affected by HIV/AIDS, which enhances the effectiveness of legal and human rights advocacy strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International law, human rights and HIV/AIDS. Patterson, D., London, L.[2014]

A study of 6,847 HIV-infected individuals showed that early mortality rates significantly decreased from 8.8 deaths per 100 person-years in 2006 to 2.5 in 2016, largely due to improved patient care and earlier ART initiation at higher CD4 counts.

Improved patient care practices accounted for 46% of the reduction in early mortality, highlighting the importance of not only starting ART earlier but also enhancing the overall quality of care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal trends of early mortality and its risk factors in HIV-infected adults initiating antiretroviral therapy in Uganda. Ssempijja, V., Namulema, E., Ankunda, R., et al.[2022]

The Treatment Advocacy Program Intervention was designed to improve medication adherence and sexual safety skills among African American communities affected by HIV/AIDS, addressing the specific needs of a low socio-economic status, urban patient population.

The intervention included tailored, peer-based education sessions that focused on practical skills, highlighting the importance of culturally appropriate approaches in effectively engaging patients in their HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Treatment Advocacy Program--Sinai: a peer-based HIV prevention intervention for working with African American HIV-infected persons. Raja, S., McKirnan, D., Glick, N.[2022]

The UNDP project successfully advanced legal changes to support the rights of key populations affected by HIV in sub-Saharan Africa, highlighting the importance of government-led assessments and capacity building for those impacted.

Engaging in multi-stakeholder dialogues and focusing on broader legal frameworks beyond just 'HIV laws' can lead to significant improvements in knowledge and attitudes, ultimately contributing to more effective legal reforms that positively influence HIV-related outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing changes in HIV-related legal and policy environments: Lessons learned from a multi-country evaluation. Ferguson, L., Nicholson, A., Henry, I., et al.[2018]

Approximately 40% of people living with HIV (PLHIV) in New South Wales, Australia, accessed legal services from the HIV/AIDS Legal Centre (HALC) in the last five years, highlighting the importance of legal support in the HIV response.

There has been a significant increase in legal services related to immigration law for PLHIV, rising from 36% in 2010 to 53% in 2019, while issues related to discrimination have decreased, indicating changing legal needs within this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-related Legal Needs, Demographic Change, and Trends in Australia since 1992: A Review of Legal Administrative Data. Carter, DJ., Rahmani, A., Evans, R., et al.[2023]

A review of 32 articles highlighted that the knowledge of clinic staff about HIV significantly influences patient satisfaction, emphasizing the importance of well-informed healthcare providers.

While three instruments for measuring patient satisfaction in HIV care were identified, no gold standard exists, indicating a need for a valid and user-friendly tool to enhance service quality based on patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-derived outcome measures for HIV services in the developed world: a systematic review. Land, L., Nixon, S., Ross, JD.[2019]

Case management interventions were most consistently linked to improvements in immunological outcomes for people living with HIV/AIDS, although they did not show clear benefits for other health measures.

Outreach interventions demonstrated significant improvements in mortality rates, access to antiretroviral medications, and overall healthcare utilization, suggesting they are effective strategies for enhancing care for HIV/AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization of care for persons with HIV-infection: a systematic review. Handford, CD., Tynan, AM., Agha, A., et al.[2019]

A comprehensive intervention has been created to enhance HIV medication adherence specifically targeting individuals who are at high risk of missing doses or medical appointments.

This initiative aims to address the challenges faced by these individuals, potentially leading to better health outcomes and improved management of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study looks at care model to improve drug adherence. Retention care counselor is major feature. [2007]

Interviews with 21 HIV-positive men who have sex with men in Manila revealed that legal protections for people living with HIV are seen as empowering, helping them combat internalized stigma and discrimination.

Despite feeling that these laws signal government support, participants expressed skepticism about the effectiveness of the legal process in protecting their rights, indicating a need for improvements in advocacy and legal support for PLHIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sword and Shield: Perceptions of law in empowering and protecting HIV-positive men who have sex with men in Manila, Philippines. Adia, AC., Restar, AJ., Lee, CJ., et al.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/improving-hiv-care-continuum-outcomes-among-formerly-incarcerated-individuals-through-critical-time

Improving HIV Care Continuum Outcomes Among Formerly ... The purpose of this research is to better understand the impact of receiving legal aid on HIV care continuum outcomes among formerly ...

2. clinicaltrial.be clinicaltrial.be/en/details/419249?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Improving HIV Care Continuum Outcomes Among Formerly ... Improving HIV Care Continuum Outcomes Among Formerly Incarcerated Individuals Through Critical Time Legal Interventions. NCT06171919. NCT.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579377/

Integrating Legal Aid into HIV Care: Evaluating the Impact of a ... Health-harming legal needs identified by people with HIV: data from a medical-legal partnership study to improve HIV care continuum outcomes. J Med Law ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6864982/

Examining the impact of medical legal partnerships in ... This on-going mixed-methods study utilizes institutional case study and intervention mapping methodologies to develop an HIV-specific medical ...

5. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-hiv-infections-9-2023-c19b9

Legal Aid and Training for HIV Care Outreach interventions demonstrated significant improvements in mortality rates, access to antiretroviral medications, and overall healthcare utilization, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9580720/

Medical-legal partnerships: An integrated approach to ... The MLP approach as a structural intervention has the potential to alleviate barriers to HIV/AIDS treatment and care and thus dramatically ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/09581596.2025.2575803

Justice as care: embedding legal services into HIV ... This study obtained review and approval from the Data and Safety Monitoring Board (DSMB) for Forging Sustainable Solutions for HIV Continuity of ...